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

Notes: Conflicts of Interest and Human Subjects Research

Note 3. The Role of IRBs.

   The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) added new provisions to the HHS regulations promoting the protection of human subjects in 2009.  The new regulations are meant to facilitate more federal oversight of IRBs.  See 45 C.F.R. §§46.501-505 (2009).

New Note 4.5 Informed Consent and Research using DNA Samples.

The Havasupai people, who live in the Grand Canyon, have been embroiled in a conflict with Arizona State University over the use of the tribe’s DNA samples.  See Amy Harmon, Indian Tribe Wins Fight to Limit Research of Its DNA, N.Y. Times, April 21, 2010, available at: http://www.nytimes.com/2010/04/22/us/22dna.html. University researchers took DNA samples from the Havasupai with the hope of finding genetic clues to the tribe’s high rate of diabetes. The Havasupai believed that the blood samples were collected solely for diabetes research.  However, tribe members discovered that their blood samples were used to study many other issues, including mental illnesses and the tribe’s historical migration pattern, which threatened to create conflicts with the tribe’s traditional beliefs about its origin.   After spending $1.7 million in legal fees combating lawsuits from the tribe over the misuse of the DNA samples, the university agreed to pay a $700, 000 settlement to prevent further litigation and agreed to return the blood samples.

   For further analysis of the Havasupai DNA dispute, see Dan Vorhaus, The Havasupai Indians and the Challenge of Informed Consent for Genomic Research, Genomics Law Report, April 21, 2010, available at: http://www.genomicslawreport.com/index.php/2010/04/21/the-havasupai-indians-and-the-challenge-of-informed-consent-for-genomic-research/ as well as Michelle M. Mello and Leslie Wolf, The Havasupai Indian Tribe Case - Lessons for Research Involving Stored Biologic Samples,  363(3) New Eng. J. Med. 204 (2010), available at: http://www.nejm.org/doi/pdf/10.1056/NEJMp1005203.

Note 5. The Aftermath of Grimes.

   In When Human Experimentation is Criminal, 99 J. Crim L. & Criminology 89 (2009), L. Song Richardson argues that medical researchers who “conduct experiments on individuals without their knowledge” or who “deliberately fail to disclose to individuals the known and obvious risks of participation in an experiment” should face criminal punishment.    Richardson suggests that “idealization bias” (the difficulty people have viewing doctors/researchers as criminals) and “social benefit bias” (the idea that people are more willing to overlook research misconduct because it benefits society) may explain why people are reluctant to subject researchers who commit misconduct to criminal consequences.  Do you think this would be an appropriate expansion of the criminal law?  What are the practical and theoretical differences of addressing research misconduct through criminal law versus tort law? 

Note 6. Conflicts of Interest. 

   The Institute of Medicine recently issued a major report on this issue including several significant recommendations. See, e.g., Bernard Lo and Marilyn J. Field, Editors; Committee on Conflict of Interest in Medical Research, Education, and Practice; Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (2009), available online at http://www.nap.edu/catalog.php?record_id=12598#toc. For commentary on the report see Robert Steinbrook,  Controlling Conflict of Interest – Proposals from the Institute of Medicine, 360: 21 New Eng. J. Med. 2160-2163 (2009). 

Note 8. Research on Vulnerable Populations.

a. Children.  For a recent analysis see, Doriane Lambelet Coleman, The Legal Ethics of Pediatric Research, 57 Duke L.J. 517 (2007)(author argues that just as child protection laws limit the scope of parental authority by proscribing “physical abuse, emotional abuse, and neglect”, parents should not be permitted to consent to research involving their children that would constitute maltreatment.  Author suggests an ethical framework for pediatric research that “tracks the law of child protection and parents’ decisional authority.”)

c. Mentally Ill/Incompetent Patients.  See Carl H. Coleman, Research with Decisionally Incapacitated Human Subjects:  an Argument for a Systemic Approach to Risk-Benefit Assessment, 83 Ind. L.J. 743 (2008) (suggesting “the following standard for determining whether a policy permitting research with incapacitated persons is ethically acceptable:  the risks incapacitated persons will face from the policy (i.e. the risk of being enrolled in burdensome research without their personal authorization) must be outweighed by the benefits they can expect from the additional research related to their conditions that the policy facilitates.  In other words, at the level of public policy, the question is whether the balance of burdens and benefits is fair to incapacitated persons from a long-term, systemic perspective – not whether individuals will receive net benefits from each and every study in which they are personally enrolled.”)

Note 10. Inclusion of Women and Minorities).

   For articles focusing on the inclusion of children from minority or marginalized populations in research, see Doriane Lambelet Coleman, The Legal Ethics of Pediatric Research, 57 Duke L.J. 517 (2007); and  Lisa W. Foderaro, Study Refutes Claims on AIDS Drug Trials, NY Times, January 27, 2009.

New Note 11.5. The Sentinel System.

As a result of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is creating the Sentinel System, an electronic database containing health data for 100 million persons. For information about the Sentinel System and some of the informed consent and privacy issues raised by the project, see resources linked to U.S. FDA, FDA’s Sentinel Initiative, available at: http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm (last visited October 19, 2010); and Barbara J. Evans, Authority of the Food and Drug Administration to Require Data Access and Control Use Rights in the Sentinel Data Network, 65(1) Food Drug Law J. 67 (2010).

Note 12. Research in Developing Countries. 

   For a summary of the recent debate about whether US clinical trials should follow the Helsinki Declaration or the International Conference on Harmonization's Good Clinical Practice (GCP), see Denise Normille, Clinical Trials at Odds With U.S. Policy, 322 Science 516 (2008); and Michael D.E. Goodyear et al., Editorial, Does the FDA have the authority to trump the Declaration of Helsinki?, 338BMJ1157 (May 16, 2009) (online 338 BMJ b.1559).