Institutional review board approaches to the incidental findings problem

Journal of Law, Medicine and Ethics

Volumn 36, Issue 2, 2008, Pages 352-355

  Keane, Moira A ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; ETHICS; HUMAN; INCIDENTAL FINDING; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; PROFESSIONAL STANDARD; RISK ASSESSMENT; STANDARD;

BIOMEDICAL RESEARCH; DISCLOSURE; ETHICS COMMITTEES, RESEARCH; HUMANS; INCIDENTAL FINDINGS; RISK ASSESSMENT;

EID: 44949215930     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.00279.x     Document Type: Conference Paper

References (9)

1. Expectations that all drugs entering the U.S. marketplace be tested in humans were established in the mid-1960s. The federal regulations requiring that all federally funded research be reviewed by Institutional Review Boards (IRBs) followed slowly in 1974. The current set of regulations was established in 1983, with only minor revisions in content since that time. For a historical timeline of the evolution of the regulations, see "Historical Resources: Timeline of Laws Related to the Protection of Human Subjects," compiled by Joel Sparks, June 2002, available at 〈http://history.nih.gov/01docs/ historical/2020b.htm〉 (last visited February 19, 2008).
2. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research was a product of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and was presented on April 18, 1979. Still widely quoted and applied, it is considered to be the cornerstone document for modern human subjects' protections. It can be found at 〈http://ohsr.od.nih.gov/guidelines/belmont. html〉 (last visited February 19, 2008).
3. The federal regulations in Subpart D of 45 C.F.R. 46 state the requirements for direct benefit to children participating in research. The regulations outline specific requirements for IRB determinations and documentation, specific requirements for parental permission, minor assent, and waivers of consent. Regulations can be found at 〈http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.htm〉 (last visited February 19, 2008).
4. 45 C.F.R. § 46.111 (a) (2), available at 〈http://www. hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111〉 (last visited February 19, 2008).
5. 45 C.F.R. § 46.116 (b) (5), available at 〈http://www. hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111〉 (last visited February 19, 2008).
6. 45 C.F.R. § 46.103 (b) (5), available at 〈http://www. hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.103〉 (last visited February 19, 2008).
7. As recently as January 2007, the Office for Human Research Protection (OHRP) has issued guidance and interpretation of the regulations pertaining to unanticipated problems. Entitled Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, this document distinguishes the requirements for adverse event reporting from other problems requiring reporting in a research context. It can be found at 〈http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm〉 (last visited February 19, 2008). (Emphasis added.)
8. See supra note 6.
9. See supra note 5. The IRB may require that information, in addition to that specifically mentioned in § 46.116, be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.