Alphabetical:

Amdur, RJ; and Biddle, CJ. “An Algorithm for Evaluating the Ethics of a Placebo-Controlled Trial.” International Journal of Cancer (Radiation Oncology Investigations) 96.5 (2001): 261–269. Web 9 September 2013.

Association of the British Pharmaceutical Industry (ABPI). “Clinical Trial Compensation Guidelines.” ABPI. (1994). Web 9 September 2013.

Beh, Hazel. “Compensation for Research Injuries.” IRB: Ethics & Human Research 27.3 (2005): 11-15 Web 9 September 2013.

Beskow, LM; Burke, W. “Offering Individual Genetic Research Results: Context Matters.” Science Translational Medicine 2.38 (2010): 38. Web 9 September 2013.

Capron, Alexander M. “When Experiments Go Wrong: The US Perspective.”  Journal of Clinical Ethics 15.1 (2004): 22-29. Web 9 September 2013.

Cavazos, N; Forster, D; and Bowen, AJ. “Ethical Concerns in Placebo-Controlled Studies: An Analytic Approach.”  Drug Information Journal 36.02 (2002) Web  9 September 2013.

Chan, A-W; Tetzlaff, JM; Gtzche, PC; Altman, DG; Mann, H; Berlin, J; Dickersin, K; Hróbjartsson, A; Schulz, KF; Parulekar, WR; Krleža-Jerić, K; Laupacis, A; Moher, D. “SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials.” British Medical Journal. (2013): 346;e7586. See Items 2, 3. Web 9 September 2013.

Chan, A-W; Tetzlaff, JM; Gtzche, PC; Altman, DG; Mann, H; Berlin, J; Dickersin, K; Hróbjartsson, A; Schulz, KF; Parulekar, WR; Krleža-Jerić, K; Laupacis, A; Moher, D. “SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials.” British Medical Journal (2013): 346;e7586. Web 9 September 2013.

Clinical and Translational Science Awards Consortium Community Engagement Key Function Committee Task Force on the Principles of Community Engagement. “Principles of Community Engagement Second Edition.” National Institutes of Health. (2011) Web 9 September 2013.

Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance.” Department of Health and Human Services. (1996) See Sections 4.3.2 and 5.8.2 Web 9 September 2013

Council for International Organizations of Medical Science (CIOMS) and World Health Organization. “International Ethical Guidelines for Epidemiological Studies.” CIOMS. (2009) See Guideline 24: Use of Stored Biological Samples and Related Data Web 9 September 2013.

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” (2002) See Guideline 10. Web 9 September 2013.

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” CIOMS. (2002) Web 9 September 2013. 

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” CIOMS. (2002) Web 9 September 2013. See Guideline 9.

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” CIOMS. (2002) Web 9 September 2013. See Guidelines 4-6

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” (2002) See Guideline 21 Web 9 September 2013.

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” (2002) See Guideline 7.  Web 9 September 2013.

Council for International Organizations of Medical Sciences (CIOMS). “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” (2002) See Guideline 19.  Web 9 September 2013.

Davis, Amy L. “The Study Population: Women, Minorities and Children” in Institutional Review Board: Management and Function, 2d Ed. Edited by Robert Amdur and Elizabeth Bankert. Jones and Bartlett Publishers. Sudbury, MA. (2006). Web 5 November 2014

Department of Health and Human Services Subpart A: 45 CFR 46. Web 9 September 2013.

Department of Health and Human Services Subpart A: 45 CFR 46.111(a)(3) Criteria for IRB Approval of Research. Web  9 September 2013.

Department of Health and Human Services. 45 CFR 46Web 9 September 2013.

Dresser, Rebecca. “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.” Journal of Law, Medicine and Ethics. 37.1 (2009): 38-50. Web September 30, 2013.

Effective Interventions Unit of Scotland. “Effective Engagement: A Guide to Principles and Practice. Web 9 September 2013.

Elliot, Carl and Abadie, Roberto. “Exploiting a Research Underclass in Phase 1 Clinical Trials.” The New England Journal of Medicine. 358.22 (2008): 2316-2317. Web 10 October 2013.

Emanuel, EJ; Wendler, D, et al. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” Journal of Infectious Diseases 189.5 (2004): 930-937. Web 9 September 2013.

Emanuel, Ezekiel J.  “Ending Concerns About Undue Inducement.” The Journal of Law, Medicine, and Ethics. 32.1 (2004): 100-1005. Web 10 October 2013.

Emanuel, Ezekiel J; Wendler, David; Grady, Christine. “An Ethical Framework for Biomedical Research” in The Oxford Textbook of Clinical Research Ethics. Edited by Ezekiel J. Emanuel and Christine Grady. Oxford University Press. New York. (2008). Textbook 5 November 2014

Emanuel, Ezekiel J; Wendler, David; Grady, Christine. “What Makes Clinical Research Ethical? Journal of the American Medical Association 283.20 (2000): 2701-2711. Web 9 September 2013.

Emanuel, Ezekiel J; Wendler, David; Grady, Christine. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” The Journal of Infectious Diseases 189.5 (2004): 930–937. Web 9 September 2013. 

Emanuel, Ezekiel J; Wendler, David; Grady, Christine. “What Makes Clinical Research Ethical?” The Journal of the American Medical Association 283.20 (2000): 2701-2711. Web 9 September 2013.

European Commission Health and Consumers Directorate-General. “The Rules Governing Medicinal Products in the European Union Volume 10: Guidance Documents Applying to Clinical Trials: Questions and Answers.” European Commission. (2010) Version 5.0 See Articles 3(2)(f) and 6(3)(h) Web 9 September 2013.

European Commission staff Working Document. “Impact Assessment Report on the Revision of the Clinical Trials Directive.” European Commission. (2012). Web 10 October 2013.

Fabsitz, RR; McGuire, A; Sharp, RR, et al. “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from an NHLBI Working Group.” Circulation: Cardiovascular Genetics 3.6 (2010): 574-580. Web 9 September 2013.

Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50, 56. 56 FR 28025 Informed Consent; Standards for Institutional Review Boards for Clinical Investigations. Web 9 September 2013.

Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50 Web 9 September 2013.

Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50.25(a)(6) Elements of Informed Consent Web 9 September 2013.

Freedman, B; Glass, KC; and Weijer, C. “Placebo Orthodoxy in Clinical Research. II: Ethical, Legal, and Regulatory Myths. Journal of Law, Medicine and Ethics 24.3 (1996): 252-9. Web 9 September 2013.

Glass, KC; and Waring, D. “Effective Trial Design Need Not Conflict with Good Patient Care.”  American Journal of Bioethics 2.2 (2002): 25-26. Web 9 September 2013.

Global Campaign for Microbiocides. “Chapter 10: After the Trial: Continued Access and Post-Approval Studies” in Rethinking the Ethical Roadmap for Clinical Testing of Microbiocides: Report on an International Consultation. (2005) Web 9 September 2013.

Grady, Christine. “Payment of Clinical Research Subjects.” The Journal of Clinical Investigation. 115.7 (2005): 1681-1687. Web 10 October 2013.

Gu, S. “The Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and Its Treatment in the Developing World.” Penn Bioethics Journal 2.2 (2006): 21-24. Web 9 September 2013.

Guest, Stephen. “Compensation for Subjects of Medical Research: The Moral Rights of Patients and the Power of Research Ethics Committees.Journal of Medical Ethics 23.3 (1997): 181-185. Web 9 September 2013.

Halpern, SD; Karlawish, JHT; Casarett, D; Berlin, JA; Townsend, RR; Asch, DA.  “Hypertensive Patients’ Willingness to Participate in Placebo-Controlled Trials: Implications for Recruitment Efficiency.” American Heart Journal 46.6 (2003): 985-992. Web 28 September 2013.

Howick, J. “Questioning the Methodologic Superiority of ‘Placebo’ Over ‘Active’ Controlled Trials.” American Journal of Bioethics-Neuroscience 9.9 (2009): 34-48. Web 9 September 2013.

Illes, J, et al.  “Incidental Findings in Brain Imaging Research.”  Science 311.5762 (2006): 783-784. Web 9 September 2013.

Indian Central Drugs Standard Control Organization. “Good Clinical Practices for Clinical Research in India.” Central Drugs Standard Control Organization. See Section 2.4.3.2(vii)-(ix) and Section 2.4.7. Web 9 September 2013.

Indian Council of Medical Research. “Ethical Guidelines for Biomedical Research on Human Participants.” (2006) See Chapter 3, Section 1(3)(ix)-(xi) and Section VI. Web 9 September 2013.

Institute of Medicine (IoM), Responsible Research: A Systems Approach to Protecting Research Participants. National Academies Press. Washington, DC. (2002) Web 9 September 2013.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). “Choice of Control Group and Related Issues in Clinical Trials (E10). “ ICH. (2000) Web  9 September 2013.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance.” Department of Health and Human Services. (1996) Web 9 September 2013

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance.” Department of Health and Human Services. (1996) Web 9 September 2013 See §4.8

Karlberg, Johan; Speers, Marjorie, eds. “Reviewing Clinical Trials: A Guide for the Ethics Committee.”  Clinical Trials Centre, The University of Hong Kong and Association for the Accreditation of Human Research Protection Programs, Inc. Washington, DC. (2010): 74-75 Web 9 September 2013.

Kaufman, D; Murphy, J; Scott, J; Hudson, K.  “Subjects Matter: A Survey of Public Opinions About a Large Genetic Cohort Study.” Genetics in Medicine 10.11 (2008): 831–839. Web 9 September 2013.

Lathyris, DN; Patsopoulos, NA; Salanti, G; Ioannidis, JPA. “Industry Sponsorship and Selection of Comparators in Randomized Clinical Trials.” European Journal of Clinical Investigation 40.2 (2010): 172-182. Web 9 September 2013.

Leon, AC. “Placebo Protects Subjects from Nonresponse: A Paradox of Power.”  Archives of General Psychiatry 57.4 (2000): 329–330. Web 9 September 2013.

London, AJ.  “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research.”  Journal of Medicine and Philosophy 25.4 (2000): 379–397. Web 9 September 2013.

Macklin, Ruth. “Double Standards in Medical Research in Developing Countries,” Cambridge University Press.  Cambridge. (2004). Textbook 5 November 2014

Mariner, Wendy K., Compensation for Research Injuries, "Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies.” Vol. 2 113 (Anna C. Mastroianni et al. eds., 1994). Web November 2014

Mastroianni, Anna C; Faden, Ruth; Federman, Daniel, eds."Women's Participation in Clinical Studies" in Women and Health Research: Ethical and Legal Issues of Including women in Clinical StudiesVolume 1. The National Academies Press. Washington, DC.  (1994). Web 9 September 2013.

Meltzer, LA; Childress, JF. “What is Fair Participant Selection?” in The Oxford Textbook of Clinical Research Ethics. Edited by Ezekiel J. Emanuel and Christine Grady. Oxford University Press. New York. (2008). Textbook 5 November 2014

Miller, FG. “The Rationale for Placebo-Controlled Trials: Methodology and Policy Considerations.” American Journal of Bioethics- Neuroscience 9.9 (2009): 49-50. Web 9 September 2013

Miller, FG; Brody, H. “What Makes Placebo-Controlled Trial Unethical?” American Journal of Bioethics 2.2 (2002): 3-9. Web 9 September 2013.

National Bioethics Advisory Commission (NBAC), “Ethical and Policy Issues in Research Involving Human Participants.” NBAC. Bethesda, MD. (2001) See p. 123-26 Web 9 September 2013.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (1979). Web 9 September 2013

National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchThe Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (1979). Web 9 September 2013.

National Institute of Biomedical Imaging and Bioengineering.  “Points to Consider for Investigators: Incidental Findings in Imaging Research.” National Institutes of Health. Web 9 September 2013

National Institutes of Health Office of Extramural Research. “Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research.” (2013). Web 30 September 2013.

Ntshanga, SP; Ngcobo, PS; Mabaso, MLH. "Establishment of a Community Advisory Board (CAB) for Tuberculosis Control and Research in the Inanda, Ntuzuma and KwaMashu (INK) Area of KwaZulu-Natal, South Africa.Health Policy 95.2-3 (2010): 211–215. Web 9 September 2013.

Nuffield Council, on Bioethics, “Research in Developing Countries; the Ethics of Research Related to Healthcare in Developing Countries,” Chapter 4, “What Happens When Research is Over?” April 2002. Web 9 September 2013.

Paasche-Orlow, Michael K, Brancati, Frederick L. “Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for Research-Related Injury.” 118.2 American Journal of Medicine (2005): 178-180. Web 9 September 2013.

Pharmaceuticals for Human Use (ICH). “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance.” Department of Health and Human Services. (1996) Web 9 September 2013

Pike, Elizabeth. “Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants.” American Journal of Law and Medicine 38.1 (2012): 7-62. Web 9 September 2013.

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensating for Research Injuries. (1982) Web 9 September 2013

Presidential Commission for the Study of Bioethical Issues, “Appendix III: US Treatment/Compensation for Treatment Methods” in Moral Science: Protecting Participants in Human Subjects Research (2011): 184-185  Web 9 September 2013

Presidential Commission for the Study of Bioethical Issues, “Appendix IV: International and Transnational Requirements for Treatment and Compensation for Research Injuries” in Moral Science: Protecting Participants in Human Subjects Research (2011): 186-190 Web 9 September 2013

Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011) See p. 56-70 Web 9 September 2013

Resnik, David B. “Compensation for Research-Related Injuries, Ethical and Legal Issues.” Journal of Legal Medicine 27.3 (2006): 263-287. Web 9 September 2013.

Scott, Larry D.  “Research-Related Injury: Problems and Solutions.” Journal of Law, Medicine, and Ethics 31.3 (2003): 419-428. Web 9 September 2013.

Shubis, K; Juma, O; Sharifu, R; Burgess, B; Abdulla, S. "Challenges of Establishing a Community Advisory Board (CAB) in a Low-Income, Low-Resource Setting: Experiences from Bagamoyo, Tanzania.Health Research Policy and Systems 7.16 (2009) Web 9 September 2013. 

Sofaer, Neema. “Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not be Ensured to Research Participants: A Systematic Review.” Oxford Journals Public Health Ethics  4.2 (2011): 160-184. Web 9 September 2013.

South African Department of Health, Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa. (2000) See Section 4.11 Web 9 September 2013.

SPIRIT, Item 7. Web 9 September 2013.

SPIRIT, Items 1, 2. Web 9 September 2013.

Steinbrook, Robert. “Compensation for Injured Research Subjects.”  New England Journal of Medicine 354.18 (2006): 1871-1873. Web 5 November 2014

Strauss, RP; Sengupta, S; Quinn, SC; Goeppinger, J; Spaulding, C; Kegeles, S M; Millett, G. "The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process.American Journal of Public Health 91.12 (2001): 1938–1943. Web 9 September 2013.

Symposium on Incidental Findings (assorted accompanying articles).  Journal of Law, Medicine, and Ethics 36.2 (2008) Web 5 November 2014

Temple, R; Ellenberg, SS. “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues.” Annals of Internal Medicine 133.6 (2000): 455-463. Web 9 September 2013.

The Lewin Group, Final Report: Care/Compensation for Injuries in Clinical Research (2005)(Contract Number HHS 100-03-0005, Prepared for the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation). Web 9 September 2013.

Thomas, S; Quinn, S. “Poverty and the Elimination of Urban Health Disparities: Challenge and Opportunity.”  Annals of the New York Academy of Sciences 1136 (2008): 111-125. Web 9 September 2013.

Tindana, PO; Singh, JA; Tracy, CS; Upshur, REG; Daar, AS, et al. “Grand Challenges in Global Health: Community Engagement in Research in Developing Countries.” PLoS Medicine 4.9 (2007): e273. Web 9 September 2013.

Van der Graaf, R; Roes, KCB; van Delden, JJM. “Adaptive Trials in Clinical Research.”  Journal of the American Medical Association 307.22 (2012): 2379-2380. Web 9 September 2013.

Weijer, C; Emanuel, EJ. “Protecting Communities in Biomedical Research” in Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by Ezekiel Emanuel, Robert Crouch, et.al. The Johns Hopkins University Press. Baltimore. (2003): 342. Textbook 5 November 2014

Weijer, C; Goldsand, G; Emanuel, EJ. “Protecting Communities in Research: Current Guidelines and Limits of Extrapolation” in Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by Ezekiel Emanuel, Robert Crouch, et.al. The Johns Hopkins University Press. Baltimore. (2003): 340-341. Textbook 5 November 2014

Weijer, C; Goldsand, G; Emanuel, EJ. “Protecting Communities in Research: Current Guidelines and Limits of Extrapolation.” Nature Genetics 23 (1999) 275-280. Web 9 September 2013

Wendler, D; Emanuel, EJ; and Lie, RK.  “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?” American Journal of Public Health 94.6 (2004): 923-928. Web 9 September 2013.

Wolf, SM; Crock, BN; Van Ness, B, et al. “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data-Sets.”  Genetics in Medicine 14.4 (2011): 361-384. Web 9 September 2013.

Wolf, SM; Lawrenz, FP; Nelson, CA, et al. “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine, and Ethics 36.2 (2008): 219-248. Web 9 September 2013.

World Medical Association (WMA). “Declaration of Helsinki.” WMA. Web 9 September 2013.

World Medical Association (WMA). “Declaration of Helsinki.” WMA. Web 9 September 2013. See paragraph 5

World Medical Association (WMA). “Declaration of Helsinki.” WMA. Web 9 September 2013. See Sections 24-49; 33-35

World Medical Association (WMA). “Declaration of Helsinki.” WMA. See Section 33. Web 9 September 2013.

Zawati , MH; Knoppers, BM.  “International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks.”  Genetics in Medicine 14.4 (2012): 484-488. Web 9 September 2013.