The obligations of organisations associated with policy formation and implementation of international mass public health programmes are explored. Lines of responsibility are considered to become unclear because of the large number of agencies associated with such programmes. A separation of the relevant obligations among the bodies responsible for the formulation and those responsible for the implementation of the policies is suggested. The continuing oral polio vaccine campaign against poliomyelitis in India is used to illustrate the general argument. Although (...) the aim of the programme is legitimate and laudable, unnecessary harm is currently being caused to some children as a result of elements of the policy and this should be rectified immediately. Such mass programmes should take care to ensure that people are not unnecessarily sacrificed in the drive to attain the desirable ends of the policy. (shrink)

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular (...) institutional role. I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private‐for‐profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private‐for‐profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice‐based account of standard of care. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, (...) access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the (...) treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the (...) trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances,this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is (...) exemplified through resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

In research involving patients with implantable brain–computer interfaces (BCIs), there is a regulatory gap concerning post-trial responsibilities and duties of sponsors and investigators towards implanted patients. In this article, we analyse the case of patient R, who underwent non-voluntary explantation of an implanted BCI, causing a discontinuation in her sense of agency and self. To clarify the post-trial duties and responsibilities involved in this case, we first define the ontological status of the BCI using both externalist (EXT) and internalist (...) (INT) theories of cognition. We then give particular focus to the theories of extended and embedded cognition, hence considering the BCI either as a constitutive component of the patient’s mind or as a causal supporter of her brain-based cognitive capacities. We argue that patient R can legitimately be considered both as an embedded and extended cognitive agent. Then, we analyse whether the non-voluntary explantation violated patient R’s (neuro)rights to cognitive liberty, mental integrity, psychological continuity and mental privacy. We analyse whether and how different mental ontologies may imply morally relevant differences in interpreting these prima facie neurorights violations and the correlational duties of sponsors and investigators. We conclude that both mental ontologies support the identification of emerging neurorights of the patient and give rise to post-trial obligations of sponsors and investigators to provide for continuous technical maintenance of implanted BCIs that play a significant role in patients’ agency and sense of self. However, we suggest that externalist mental ontologies better capture patient R’s self-conception and support the identification of a more granular form of mental harm and associated neurorights violation, thus eliciting stricter post-trial obligations. (shrink)

Over the last eight years, there has been a sharp increase in government censorship and officially sponsored persecution of the Moroccan free press. The Moroccan press still enjoys greater freedoms now than under the late King Hassan II, thanks to the liberalization efforts he facilitated toward the end of his life, which were also continued in the early years of his son’s reign. However, the freedoms media activists worked so hard to obtain at the end of the last century have (...) rapidly begun to erode, particularly after the 2003 terrorist attacks in Casablanca. Morocco remains an important Arab ally to both the United States and Europe, but the monarchy risks that relationship by tightening the reigns on speech and violating international human rights laws. Moreover, the monarchy puts itself at risk domestically every time it imprisons a journalist or imposes a bankrupting fine on a popular periodical, as Moroccan human rights groups grow less enchanted by their king. Over the last two years, criminal charges against the media have increased significantly, causing some publications to close and leaving a number of journalists in jail for their writings. In addition, since 2008, the Moroccan government has begun to censor the Internet, arresting bloggers and satirists and temporarily suspending access to popular websites, such as YouTube. This article explores Morocco's obligations under international and domestic law relating to freedom of expression and examines some recent court cases involving the Moroccan media. (shrink)

According to prominent bioethics scholars and international guidelines, researchers and sponsors have obligations to ensure that the products of their research are reasonably available to research participants and their communities. In other words, the claim is that research is unethical unless it has local social value. In this article, we argue that the existing conception of reasonable availability should be replaced with a social value obligation that extends to the global poor. To the extent the social value requirement (...) has been understood as geographically constrained to the communities that host research and the countries that can afford the products of research, it has neglected to include the global poor as members of the relevant society. We argue that a new conception of social value obligations is needed for two reasons. First, duties of global beneficence give reason for researchers, sponsors, and institutions to take steps to make their products more widely accessible. Second, public commitments made by many institutions acknowledge and engender responsibilities to make the products of research more accessible to the global poor. Future research is needed to help researchers and sponsors discharge these obligations in ways that unlock their full potential. (shrink)

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to accepted research (...) norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

Judith Butler follows Edward Said's late suggestion that through a consideration of Palestinian dispossession in relation to Jewish diasporic traditions a new ethos can be forged for a one-state solution. Butler engages Jewish philosophical positions to articulate a critique of political Zionism and its practices of illegitimate state violence, nationalism, and state-sponsored racism. At the same time, she moves beyond communitarian frameworks, including Jewish ones, that fail to arrive at a radical democratic notion of political cohabitation. Butler engages thinkers such (...) as Edward Said, Emmanuel Levinas, Hannah Arendt, Primo Levi, Martin Buber, Walter Benjamin, and Mahmoud Darwish as she articulates a new political ethic. In her view, it is as important to dispute Israel's claim to represent the Jewish people as it is to show that a narrowly Jewish framework cannot suffice as a basis for an ultimate critique of Zionism. She promotes an ethical position in which the obligations of cohabitation do not derive from cultural sameness but from the unchosen character of social plurality. Recovering the arguments of Jewish thinkers who offered criticisms of Zionism or whose work could be used for such a purpose, Butler disputes the specific charge of anti-Semitic self-hatred often leveled against Jewish critiques of Israel. Her political ethic relies on a vision of cohabitation that thinks anew about binationalism and exposes the limits of a communitarian framework to overcome the colonial legacy of Zionism. Her own engagements with Edward Said and Mahmoud Darwish form an important point of departure and conclusion for her engagement with some key forms of thought derived in part from Jewish resources, but always in relation to the non-Jew. Butler considers the rights of the dispossessed, the necessity of plural cohabitation, and the dangers of arbitrary state violence, showing how they can be extended to a critique of Zionism, even when that is not their explicit aim. She revisits and affirms Edward Said's late proposals for a one-state solution within the ethos of binationalism. Butler's startling suggestion: Jewish ethics not only demand a critique of Zionism, but must transcend its exclusive Jewishness in order to realize the ethical and political ideals of living together in radical democracy. (shrink)

Squeezed between increasing entitlement expenditures and static or declining real revenues, state-funded urban development is increasingly perceived as an unaffordable luxury. At the same time, the power and significance of the banking sector is giving way to new kinds of financial institutions that have little or no interest in community development. Not surprisingly, it is often argued that pension funds ought to be more sensitive to community needs. However, some analysts argue that pension funds are properly only the agents of (...) plan beneficiaries; any investment that took into account community needs would be, in effect, an unjustified tax on individuals' future welfare. Furthermore, analysts are very doubtful about the integrity of public pension plan investment decision-making. In this paper, I set out a morally informed justification of public pension plan investment in community development. In doing so, I develop a model of community development that stresses the reciprocal nature of the obligations embedded in the relationship between the community and pension plan beneficiaries. This approach also has significant implications for a wide variety of private sponsored plans. The paper begins with an assessment of pension fund decision-making and the practices of the investment management industry, drawing upon related research on pension fund capitalism. It goes on to issues of social obligation, referencing recent research on the nature of social contracts. To give the analysis empirical relevance I refer to the much disputed decision of the West Virginia legislature to require their public pension funds' Investment Management Board to invest in the state government's corrections authority. (shrink)

Squeezed between increasing entitlement expenditures and static or declining real revenues, state‐funded urban development is increasingly perceived as an unaffordable luxury. At the same time, the power and significance of the banking sector is giving way to new kinds of financial institutions that have little or no interest in community development. Not surprisingly, it is often argued that pension funds ought to be more sensitive to community needs. However, some analysts argue that pension funds are properly only the agents of (...) plan beneficiaries; any investment that took into account community needs would be, in effect, an unjustified tax on individuals’ future welfare. Furthermore, analysts are very doubtful about the integrity of public pension plan investment decision‐making. In this paper, I set out a morally informed justification of public pension plan investment in community development. In doing so, I develop a model of community development that stresses the reciprocal nature of the obligations embedded in the relationship between the community and pension plan beneficiaries. This approach also has significant implications for a wide variety of private sponsored plans. The paper begins with an assessment of pension fund decision‐making and the practices of the investment management industry, drawing upon related research on pension fund capitalism. It goes on to issues of social obligation, referencing recent research on the nature of social contracts. To give the analysis empirical relevance I refer to the much disputed decision of the West Virginia legislature to require their public pension funds’ Investment Management Board to invest in the state government's corrections authority. (shrink)

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: (...) that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host communities may deem (...) as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa research initiative. The H3Africa—a North-South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African-led research on the continent. (shrink)

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical (...) research: the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. (shrink)

In light of a history of categorical exclusion, it is critical that pregnant people are included in research to help improve the knowledge base and interventions needed to address public health. Yet the volatile legal landscape around reproductive rights in the United States threatens to undue recent progress made toward the greater inclusion of pregnant people in research. We offer ethical and practical guidance for researchers, sponsors, and institutional review boards to take specific steps to minimize legal risks and (...) ensure the ethical conduct of research with pregnant people in an evolving legal environment. (shrink)

Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment to those (...) who seroconvert in HIV prevention trials and ask whether it is a matter of moral obligation or moral negotiation?Description: Using the tools of philosophical and regulatory analysis we examine the moral foundations of research ethics, international regulation, and the contemporary literature in search of valid arguments in support of a moral obligation to treat. Arguments supporting the obligation to provide such treatment are found in a wide variety of documents. These claims are variously rooted in the demand to compensate for research-related injury, maximization of research benefit, justice as reciprocity, and justice as equality.Lessons learned: Our analysis reveals that there is as of yet no robust moral argument supporting a moral obligation to provide treatment to participants in HIV prevention trials who seroconvert. We argue that moral negotiation offers distinct advantages over moral obligation. Moral negotiation finds support in the principle of respect for communities that holds researchers responsible to respect communal values, protect and empower social institutions and abide by the decisions of accepted communal authorities.Recommendations: Moral negotiation, rather than moral obligation, reduces the chance of polarization of positions by inviting trial participants, sponsors, researchers and all other involved parties to the table for discussion. Moral negotiation favors middle ground solutions that fit the specific health needs and priorities of the community in question. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Conflicts—and Consensus—about Conflicts of Interest in MedicineMatthew K. Wynia and Bette–Jane Crigger*This fascinating collection of essays about individual experiences of conflict of interest leaves little doubt that physicians remain divided about the importance, impact and meaning of conflicts of interest in their work. These essays offer differing views about what conflicts of interest look and feel like “on the ground” and about whether specific conflicts of interest are bad, (...) just a fact of life, or maybe even good.Conflict, Conflict EverywhereThese essays situate conflict of interest in a variety of contexts: the treatment recommendations a physician makes for an individual patient; the relationship between teaching physician and medical student or practicing physician and health care organization; the interaction between academic researchers and industry collaborators or professional bodies and industry supporters. In this, the narratives taken together reflect the scope of concern about conflict of interest in medicine familiar in the literature. In his classic 1993 essay, Dennis Thompson noted that concerns about conflict of interest encompass issues of physician self–referral, risk sharing between physicians and health care institutions, gifts from industry, hospital purchasing practices, as well as sponsored research and research with patients (Thompson 1993). To that list have subsequently been added relationships with industry in medical education at all levels, physicians’ service as consultants to industry or members of industry speakers bureau, and development of clinical practice guidelines (Lo & Fields 2009).That almost none of these essays draw attention to some widely publicized situations of conflict of interest—for example, gifts to physicians or the provision of drug samples—should, we think, be seen more as an artifact of the authors’ varied individual experiences than as a failure by the authors to engage key concerns in the ongoing professional and public debate. It could also be that the authors, asked to submit personal stories, assumed that yet another essay about the ‘traditional’ issues in the conflicts of interest literature would be seen as redundant, routine or even boring. Or, there is the tantalizing possibility that the absence of some of the more familiar conflicts from these narratives is the early fruit of efforts to address these traditional issues through policies governing interactions between physicians and industry promulgated by academic medical centers and health systems, medical specialty societies, and industry.One significant area of concern that has emerged in recent years is conflict of interest in the development of clinical practice guidelines. E.g., Choudry et al. 2002; Sniderrman & Furberg 2009; Guyatt et al. 2010. Although none of the essays in this [End Page 101] collection address it head on, Perlmutter touches on several key issues. His depiction of how an FDA committee process limited the input he was able to provide as an expert, undermined his potential to contribute to the professional dialogue, and raised concerns about the objectivity of the drug approval process echoes concerns about objectivity, the role of expert opinion, and the presence on guideline development panels of individuals with financial interests in the recommendations to be developed that have been explored at some length in the literature, most recently by the Institute of Medicine in reports on evidentiary standards (Eden et al 2011) and principles for guideline development (Graham et al. 2011).Conflict of Interest or Dual Agency?Several essays set out physicians’ experience in navigating situations of diverging expectations. Bierut, for example, reflects on the disjunction between the goals and products of academic researchers and commercial sponsors. She saw herself advancing basic knowledge and was forced to grapple with the reality of sponsors’ goals to advance commercial ends as well. Nagldinne and Mikulec each recall struggles to reconcile their obligation to exercise professional judgment on behalf of patients with the demands of health care organizations focussed also on the bottom line. Cruz–Flores attests to the challenge of making recommendations for care when one is both a practicing clinician and a clinical investigator engaged in research that might offer benefit to a patient for whom there are limited options.Thompson defined conflicts of interest as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of... (shrink)

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on researcher’s ethical responsibilities in (...) interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)

Purpose We examine the levels of post-trial responsibility ascribed to different stakeholders, following a community-based clinical trial and how the ‘responsibility’ is understood. Methods We employed photovoice, unstructured observations and key informant interviews to gain insights into contexts of access to care following transition to the public health system post trial. We used an inductive narrative analysis to explore experiences and understandings of post-trial access. Results In their photovoice stories, many participants expressed a sense of abandonment after the trial. This (...) was viewed as a contributing factor to failing to re-engage with care available in the public health system. This led to the experiences of loss as some trial participants defaulted and died. Research investigators, department of health participants and sponsor agreed that PTA was especially important for communities in resource-limited settings. The government has an obligation towards its citizens while researchers have a responsibility to ensure a smooth transition of patients to public clinics. Sponsors have a responsibility to ensure that the trial is conducted in accordance with the protocol and post-trial agreements are in place and adhered to. Research partnerships among stakeholders were affected by power imbalances making it difficult to negotiate and plan for post-trial care responsibilities. Conclusions The research community still struggles with understanding the scope of PTA responsibilities. Power dynamics between public health actors and research sponsors need to be managed to ensure that government involvement is not tokenistic. The responsibility of trial participants and ethics committees needs to be investigated further. Data are available upon request. (shrink)

This article outlines challenges to benefitting developing countries that are hosts of international research. In the context of existing guidance and frameworks for benefit‐sharing, it aims to provoke dialog about socioeconomic factors and other background conditions that influence what constitute benefits in a given host setting, and about the proportionality between benefits to hosts and benefits to sponsors and researchers. It argues that capacity‐building for critical thinking and negotiation in many developing country governments, institutions, and communities is a benefit (...) because it can help to overcome background conditions that impinge on equitable international research negotiations, partnerships, and benefits. Enhancing the capacity for both critical thinking and negotiation can, like other targets of capacity‐building, nurture respectful and trusting partnerships that benefit all stakeholders in international research. (shrink)

Este artículo considera el problema de justicia en la investigación biomédica en países en desarrollo. En particular se hace foco en la discusión de si el requisito de poner a disposición toda intervención probada efectiva puede ser considerado como una obligación post investigación de los patrocinadores hacia la comunidad anfitriona. Primero, se discuten las concepciones de la Comisión Nacional de Asesoramiento sobre Bioética (NBAC) de los Estados Unidos y de las guías éticas internacionales sobre la obligación post investigación hacia la (...) comunidad. Luego, se examinan las interpretaciones del modelo de disponibilidad razonable y el modelo de beneficios justos sobre la condición de acceso a los beneficios post investigación. Por último, presento y critico el argumento del carácter contraproducente de la obligación post investigación que afirma que la obligación post investigación limita el desarrollo de la investigación y empeora la situación de las poblaciones de los países en desarrollo. [ABSTRACT] This article refers to the problem of justice in biomedical research in developing countries and in particular it focus in the discussion of whether the requirement of making available any effective intervention could be consider a post-trial obligation of the sponsor towards the host community. First, the National Advisory Bioethics Commission’s (NBAC) conception and the international guidelines’ conception of post-trial obligations towards the community are discussed. Second, the interpretation of reasonable availability model and the fair benefits model of the condition of access to post trial benefits are examined. Finally, I present and criticize the moral counterproductive argument which affirms that post trial obligations towards the community prevent new drug research and make population in developing countries worse off. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, (...) class='Hi'>sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

Two kinds of claims of responsibility arise in regard to health and medical care. Claims of one kind are obligation-limiting claims about individuals’ responsibility for coming to need health care. It may be argued, for example, that individuals have no claim to state-sponsored care for injuries they suffer as a result of risky activities such as mountain climbing, sky diving, or smoking. The claim is that because they are responsible for what has happened to them, others are not obligated to (...) pay for their care. In a different context, it is claimed that because patients are, or should be, responsible for the kind of treatment they receive. They therefore need to be informed about the treatment options available to them so that they can decide which of these treatments, if any, they will undergo. The lecture provides an account of responsibility that fits claims of both of these kinds and explains how they are related. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Cloning without Prior Approval:A Response to Recent Disclosures of NoncomplianceRuth Macklin (bio)Editor's note: In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project (...) was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994.In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.My article, "Splitting Embryos on the Slippery Slope: Ethics and Public Policy" (KIEJ, September 1994), included a brief assessment of the ethics of the Hall-Stillman embryo-splitting experiment conducted at George Washington University (GWU). The article reviewed the researchers' stated purpose ("to help infertile couples by reproducing nature's ability to reproduce twins"), the features of the research itself (splitting embryos that never could become viable and with no plan to implant either the original or the split embryos), and the review procedures surrounding the experiment. I said that the researchers might be [End Page 57] faulted for not waiting until embryo research guidelines had been established at the national level; on the other hand, they surely could not fail to conform to such national guidelines when none existed.My conclusions were based on information that had been reported in the print media. Dr. Robert J. Stillman's statement that the experiment "had been approved by the university's formal review committees and peer reviewed by colleagues" was reported in the Washington Post on October 25, 1993, (Sawyer 1993). However, in light of the recent disclosure that the researchers had not obtained approval from George Washington University's IRB before proceeding with the research (Schwartz 1994), I now draw a sharply different conclusion about the ethics of the researchers' behavior.The most glaring flaw was the researchers' failure to submit a protocol to their institution's IRB in advance of embarking on the research. Following an investigation of the matter, the Office for Protection from Research Risks (OPRR) made the further determination that "the failure on the part of GWU research investigators and administrators to notify the IRB promptly about noncompliance in this research constitutes additional serious noncompliance" with research regulations (J. Thomas Puglisi, Chief of the Compliance Oversight Branch, Division of Human Subject Protections, OPRR, letter to Stephen J. Trachtenberg, President of George Washington University, 23 August 1994). Is it reasonable to suppose that these researchers were unaware of their obligations (a) to obtain prior review and approval from the IRB and (b) to notify the IRB promptly about their noncompliance? Regarding the latter item, Dr. Puglisi's letter to the President of GWU states that "the notification requirement has been a longstanding element of the GWU MPA [multiple project assurance], which should have been familiar to all members of the GWU research community." I shall concentrate on the researchers' more glaring ethical omission, failure to obtain prior review and approval from the IRB.Did either or both of these researchers contend that they were unaware of any review requirements for their research? Hall blames Stillman, Director of the Division of Reproductive Endocrinology, Fertility, and IVF Programs, for not making the requirement... (shrink)

The current coronavirus disease 2019 pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical (...) research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations. (shrink)

The case of Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. vividly illustrates many of the issues central to contemporary health research and the safety of research participants. First, it exemplifies the financial and health stakes in such research. Second, it shows deficits in the ways in which research is governed. Finally, it was and remains relevant not only in Toronto but in communities across Canada and well beyond its borders because, absent appropriate (...) policies, what happened in Toronto could have happened (and could well still happen) elsewhere. In Part One of this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight: first, the right of participants in a clinical trial to be informed of a risk that an investigator had identified during the course of the trial and the obligation of the investigator to inform participants (both her own and those of other investigators); and second, the obligation of institutions to protect and promote the well-being of research participants as well as academic freedom and research integrity, the obligations of research sponsors to inform participants, research regulators, and others about unforeseen risks, and the obligations of research regulators to ensure that participants are informed of unforeseen risks and to otherwise protect and promote research integrity. In Part Two, we relate these facts and issues to New Zealand and Australia. We also make detailed recommendations for changes to the various instruments used for the governance of research involving humans in Australasia. (shrink)

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed (...) if research groups and other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. (shrink)

El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas obligaciones son (...) los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores. [ABSTRACT] The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, (1) obligations of access to health care and (2) the obligations of access to information. The intended beneficiaries of these obligations are individual participants of research studies. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. Then I make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise the main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections. (shrink)

In Religion and the Obligations of Citizenship Paul J. Weithman asks whether citizens in a liberal democracy may base their votes and their public political arguments on their religious beliefs. Drawing on empirical studies of how religion actually functions in politics, he challenges the standard view that citizens who rely on religious reasons must be prepared to make good their arguments by appealing to reasons that are 'accessible' to others. He contends that churches contribute to democracy by enriching political (...) debate and by facilitating political participation, especially among the poor and minorities, and as a consequence, citizens acquire religiously based political views and diverse views of their own citizenship. He concludes that the philosophical view which most defensibly accommodates this diversity is one that allows ordinary citizens to draw on the views their churches have formed when voting and offering public arguments for their political positions. (shrink)

This article investigates a puzzle about gratitude—the proper response, in a beneficiary, to an act of benevolence from a benefactor. The puzzle arises from three platitudes about gratitude: 1) the beneficiary has certain obligations of gratitude; 2) these obligations are owed to the benefactor; and 3) the benefactor has no right to the fulfillment of these obligations. These platitudes suggest that gratitude is a counterexample to the “correlativity thesis” in the moral domain: the claim that strict moral (...) obligations correlate to moral rights on the part of the person to whom the obligation is owed. The goal of this chapter is to determine whether the three gratitude platitudes are true, and, if they are, what they tell us about the correlativity thesis. Sections 1 through 3 argue for the truth of each of the platitudes. It is then argued that while benefactors lack standing to demand, they do possess an imperfect right to gratitude: a special and morally significant standing to remonstrate with ungrateful beneficiaries. These facts suggest the following modification of the standard correlativity thesis: moral obligations entail moral rights on the part of the person to whom they are owed, which may be perfect (demandable) or imperfect. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over (...) research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take (...) place increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)

Biomedical research on human subjects involves exposing individuals to risks and burdens for the benefit of others, and therefore raises concerns about exploitation. While the concept of exploitation has received significant attention in recent research ethical literature, its relevance and implications in this area remain unclear and contested. This chapter explains how this concept is nonetheless important for understanding the ethical complexities of human subject research and the proper design of subject protections. The chapter provides an overview of research practices (...) often thought to raise exploitation concerns and introduces philosophical exploitation theory, focusing on aspects relevant to research ethics. Against this background, the obligations of non-exploitation held by researchers, sponsors, and third parties such as ethics committees and regulators are outlined. The chapter ends by considering how exploitative research in the past can be retroactively remediated. (shrink)

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research. (shrink)

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight‐jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, (...) is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all.In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research. (shrink)

Beazley, Margaret Australia rightfully places itself amongst democratic countries governed by the rule of law. It is a tradition in which I hold a firm belief. An essential aspect of the rule of law is its non-arbitrary application, and its guarantee of equality before the law. When describing the rule of law, A. V. Dicey stated that the rule of law meant: the absolute supremacy or predominance of regular law as opposed to the influence of arbitrary power, and excludes the (...) existence of arbitrariness, of prerogative, or even of wide discretionary authority on the part of the government. (shrink)

RICHARD RORTY’S IDEAL CHARACTER, THE “IRONIST,” is simultaneously committed to two different projects. The first is the repudiation of metaphysics, implying the abandonment of all philosophical or theological efforts “to achieve universality by the transcendence of contingency.” This first project is not so remarkable anymore, the twentieth century having seen any number of attempts to bring metaphysics to a close. But the second project has been gathering speed only in the last few decades. It is described as the attempt to (...) make something “never... dreamed of before,” which is also the attempt to get free from “inherited contingencies.” Given that many of life’s contingencies are originally inherited, getting free of them is a far-reaching business, bringing a whole Nietzschean lifestyle in its train. Sometimes Rorty talks as if the two projects were simply two sides of the one project. He says for example that a person becomes an ironist “when one’s aim becomes an expanding repertoire of alternative descriptions rather than The One Right Description,” as if renouncing the latter meant embracing the former. However, surely a person can repudiate metaphysics, and yet live peacefully with his or her current contingencies? If I regard my everyday vocabulary as a useful way of talking which my society has developed as a way of coping, why should I automatically want to change it, or move beyond it? (shrink)

Obligations of global justice rest mainly on the global rich but also to a lesser extent on the global poor. The governments of poor countries are obliged to fulfill requirements of non-aggression, good governance and decency, along with all other requirements which facilitate the achievement of global justice. So far, obligations of poor countries seem to be taken as given yet the behavior of governments in poor countries and occurrences therein attest to the contrary;this suggests a need to (...) mainstream these obligations in discussions about global justice. If poor countries do not live up to these requirements obstacles arise to the realization of global justice; and they act unjustly in relation to citizens of rich countries which provide them with aid. Uganda is taken as a case in point. (shrink)