Chapter 3.C.5 (or 2.B.5)  Human Experimentation and Research

Medical researchers are concerned that progress may be hindered by over-regulation. For a discussion of a strategy to encourage patient participation see, David Orentlicher, Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research, Hastings Center Report 35, no.5 (2005): 20-28.

A recent post-Moore decision found that fully informed tissue donors retained no ownership rights to their biological materials. Washington University v. Catalona, 2006 WL 1899289 (E.D.Mo. March 31, 2006). Universities were keenly interested in this outcome due to fears that research biobanks would be severely restricted if donor-patients could control the use of their donated tissues. See, Jocelyn Kaiser, Court Decides Tissue Samples Belong to University, Not Patients, 312 Science, 21 April 2006, p. 346, available

http://www.sciencemag.org/cgi/content/full/312/5772/346  (last visited July 20, 2006).

 

For a discussion of human tissue and blood research issues and this case see, See Rebecca Skloot, Taking The Least of You, N.Y. Times Magazine, April 16, 2006 at page 38.

 

Notes: Conflict of Interest and Human Subjects Research

 

Note 1.   Federal Regulation.

 

For a discussion of regulation of research involving Americans as the test population see Susan Okie, Safety in Numbers – Monitoring Risk in Approved Drugs, 352 N. Engl. J. Med. 1173 (2005).

 

For an examination of public registration of clinical trials see Robert Steinbrook, Public Registration of Clinical Trials, 351 N. Engl. J. Med. 315 (2004); Robert Steinbrook, Registration of Clinical Trials – Voluntary of Mandatory?, 351 N. Engl. J. Med. 1820 (2004); and Catherine D. De Angelis et al, Is This Clinical Trial Fully Registered? – A Statement from the International Committee of Medical Journal Editors, 352 N. Engl. J. Med. 2436 (2005).

 

For a discussion of the importance of state regulation of pharmaceutical clinical trials, see Jeffrey Gibbs, State Regulation of Pharmaceutical Clinical Trials, 59 Food & Drug L.J. 265 (2004).

 

Note 3.  The Role of IRBs.

 

For an overview of IRB operations, a review of the sources of regulatory guidance and an examination of the weaknesses of the existing system for the protection of human research subjects, see Barbara Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. Health Care L. & Pol'y 175 (2004) and Carl Coleman, Rationalizing Risk Assessment in Human Subject Research, 46 Ariz. L. Rev. 1 (2004).

 

Note 4.  The Role of Informed Consent.

 

For an overview of the current informed consent process globally and the continuing development of informed the informed consent doctrine see Jennifer Couture, The Changes in Informed Consent in Experimental Procedures: The Evolution of a Concept, 1 J. Health & Biomedical L. 125 (2004).

 

Note 5.  Conflicts of Interest.

 

For an article discussing physician financial conflicts of interest in human subjects research, as well as the use of the informed consent doctrine as a legal construct designed to protect subjects participating in clinical research, see Kevin Williams, Managing Physician Financial Conflicts of Interest in Clinical Trials Conducted in the Private Practice Setting, 59 Food & Drug L.J. 45 (2004). See also, Robert Gatter, Walking the Talk of Trust in Human Subjects Research: The Challenge of Regulating Financial Conflicts of Interest, 52 Emory L.J. 327 (2003).

 

For a discussion of the use of gag clauses in clinical-agreements,  see Robert Steinbrook, Gag Clauses in Clinical-Trial Agreements, 352 N. Engl J. Med. 2160 (May 2005).

 

For an article that examines and obtains data regarding the legal agreements and restrictive provisions that exist between industry sponsors and academic investigators in clinical-trial agreements, see Michelle Mello, Brian Clarridge & David Studdert, Academic Medical Centers; Standards for Clinical-Trial Agreements with Industry, 352 N. Engl. J. Med. 2202 (2005).

 

Note 6.  Research on Vulnerable Populations.

 

It has become increasingly difficult to test drugs in western countries because of strict regulations governing safety, compensation and small populations.  Consequently, many research-based companies are now outsourcing some of their trials to developing countries such as India.  For a discussion involving testing in India, see Samiran Nundy & Chandra Gulhati, A New Colonialism? – Conducting Clinical Trials in India, 352 N Engl. J. Med. 1633 (2005).

 

Note 6 (a.) Children.

 

There are conflicting objectives of scientific research involving children: (1) ensuring that children benefit from the progress in medical care made possible by such research and (2) minimizing the risks to children from their participation in scientific research. For discussions on this important topic, see Marilyn Field & Richard Behrman, Ethical Conduct of Clinical Research Involving Children, Washington, D.C., National Academies Press, 2004 and Carrie Fisher & Thomas Keens, Participation of Children in Research, 26 Whittier L. Rev. 823 (2005).

 

Note 6(b).  Patients with Life-Threatening Illnesses.

 

Courts recently have considered whether clinical trial sponsors owe a fiduciary duty to participants. See, e.g. Suthers v. Amgen Inc. 2006 WL 1062895, (S.D.N.Y. April 19, 2006) (where sponsors maintain independent status throughout a clinical trial, sponsors do not owe a fiduciary duty to participants in the trial), and Abney v. Amgen Inc., 443 F.3d 540 (6th Cir. 2006) (there was no fiduciary duty as the clinical trial sponsors were not acting primarily for the benefit of the participants).

 

Note 9.  Inclusion of Women and Minorities.

 

See NIH Policy and Guidelines Concerning the Inclusion of Women and Minorities as Subjects in Clinical Research (as amended), available at http://grants.nih.gov/grants/funding/women_min/women_min.htm  (last visited July 20, 2006).

 

Note 10.  Research and Privacy.

                                                                                           

See Jack V. Tu et al., Impractability of Informed Consent in the Registry of the Canadian Stroke Network, 350 N. Eng. J. Med. 1414 (2004) and Julie R. Ingelfinger & Jeffrey M. Drazen, Registry Research and Medical Privacy, 350 N. Eng. J. Med. 1452 (2004).

 

Note 11.  Resources and Commentaries.

 

Go to: http://www.hhs.gov/ohrp/policy/index.html  (last visited July 20, 2006), a website maintained by the HHS’s Office for Human Research Protections, for key federal regulations and documents.