Human Subjects Issues Surrounding Ethanol Administration in Humans

1. Human Subjects Issues Surrounding Ethanol Administration in Humans ARTSS Summer Program June 6, 2011

2. New Guidelines!! (May 2005) • URL: http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/job22.htm • First update in 15 years.

3. General Issues • Risk/benefit • Informed consent • Subject selection • Confidentiality

4. Issues Surrounding Subject Samples • Alcohol naïve individuals • Underage drinkers • Women of childbearing age • Alcohol dependence • Recovery status • Customary drinking practices • Medical and psychiatric status • Current medications and other drug use • High risk groups

5. Issues surrounding alcohol administration protocols • Preexperimental protocols • Dose • Routes of administration • Concentration • Vehicle • Total body water • Timing of drinks • Placebo/antiplacebo manipulations

6. Balanced-Placebo Design

7. Issues surrounding administration protocols (cont’d) • Monitoring of BAC • Monitoring the subject • Sources of discomfort • Transport • Release BAC

8. BAC Curve 2:40 4:10

9. Staffing issues • Staffing with respect to blinding/deception • Staffing with respect to subject care • What to do in an emergency

10. Asking About Underage Alcohol Use and Other Potentially Illegal Behaviors Some issues

11. Are data anonymous? • Anonymity versus confidentiality

12. Protections to confidentiality • Certificate of Confidentiality…what is it? • A Certificate of Confidentiality authorizes withholding the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate. This authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of that research.

13. Protections to confidentiality • Certificate of Confidentiality…what is it? • Persons so authorized may not, at any time, be compelled to provide the names or other identifying characteristics of the research subjects encompassed by the Certificate in any Federal, State, or local civil, criminal, administrative, legislative or other proceedings..

14. Protections to confidentiality • Certificate of Confidentiality…what is it? • The Certificate must be in effect at the time of subject participation for the information to be protected. However, when this condition is met the information is protected permanently.

15. Certificate of Confidentiality • Who may apply? • Any person engaged in research in which sensitive information is gathered from human subjects (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality • A separate application is required for each research project for which a Certificate is desired.

16. Certificate of Confidentiality • Who may apply? • A certificate is generally issued to a research institution for a single project (not broad groups or classes of projects). However, for cooperative multi-site projects, a coordinating center or "lead" institution can apply for, and receive, a Certificate on behalf of all member institutions. The lead institution must assure that all participating institutions conform to the Application assurances and inform their subjects, appropriately, about the Certificate, its protections and the circumstances in which voluntary disclosures would be made .

17. Certificate of Confidentiality • Limitations of certificate • The protection offered by a Certificate of Confidentiality is not absolute. A Certificate protects research subjects only from legally compelled disclosure of their identity. It does not restrict voluntary disclosures.

18. Certificate of Confidentiality • Limitations of certificate • the subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information; • authorized personnel of the Department of Health and Human Services (DHHS) request such information for audit or program evaluation, or for investigation of DHHS grantees or contractors and their employees; or • release of such information is required by the Federal Food, Drug, and Cosmetic Act or regulations implementing that Act.

19. Certificate of Confidentiality – What is sensitive? Includes, but is not limited to: • information relating to sexual attitudes, preferences, or practices; • information relating to the use of alcohol, drugs, or other addictive products; • information pertaining to illegal conduct; • information that, if released, could reasonably be damaging to an individual's financial standing, employability, or reputation within the community; • information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination; • information pertaining to an individual's psychological well-being or mental health; and • genetic information or tissue samples.

20. Certificate of Confidentiality – What is identifying? Includes, but is not limited to: • name • address • any identifying number • fingerprints • voiceprints • photographs • genetic information or tissue samples

21. More information on Certificates of Confidentiality • NIH Certificate of Confidentiality Kiosk • http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/ResourcesAppGrantees/coc-index.htm • NIAAA-specific • http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/ResourcesAppGrantees/confidential.htm