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Legal and Ethical Protections for Study Patients/Subjects

Legal and Ethical Protections for Study Patients/Subjects. Linda L. Chezem, J.D. Professor, Dept of Youth Development and Agriculture Education, College of Agriculture Purdue University And Adjunct Professor, Indiana University School of Medicine Dept of Medicine.

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Legal and Ethical Protections for Study Patients/Subjects

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  1. Legal and Ethical Protections for Study Patients/Subjects Linda L. Chezem, J.D.Professor,Dept of Youth Development and Agriculture Education,College of AgriculturePurdue University And Adjunct Professor,Indiana University School of MedicineDept of Medicine

  2. Today, like all good investigators… We seek to discover the • What • Who • When • How • Where • Why Of Certificates of Confidentiality.

  3. Certificates of Confidentiality What is a Certificate of confidentiality? An authorization that gives the investigator protection from being compelled to reveal identity or identifiers. A critical tool that, used skillfully, can protect research subjects and patients from being identified as participants in a study that collects their sensitive information. The Certificate authorizes an investigator to protect the identity of the study subjects. From that protection flows the protection of the subjects’ information.

  4. The letter of the Law Original language §3 (a) Section 303 of the Public Health Service Act is amended by adding after and below paragraph (2) the following: The Secretary may authorize persons engaged in research on the use and effect of drugs to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals.

  5. AND (emphasis added) Persons so authorized to protect the privacy of such individuals may not becompelled in any Federal, State, or local civil , criminal, administrative, legislative or other proceedings to identify such individuals. 42 USC S 241 (D) From the Original Act

  6. Current language The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals. 42 USC S 241 (D) As amended from the Original Act

  7. Who is authorized to issue? • The Secretary has delegated authority via regulation to HHS agencies. • At NIAAA, Director Ken Warren, Ph.D. , signs the Certificates. • Isabel Ellis, M.S.W. conducts the initial review and, if needed, consults with Patricia Powell, Ph.D. and Linda L. Chezem, JD • Typically, NIAAA issues between 150 and 250 certificates per year.

  8. Who can apply Investigators • Conducting biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) • Conducting studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. (added by OHRP-HHS) (need test) • Collecting individually identified information

  9. When • After IRB approval or when IRB approval is contingent only on the receipt of the certificate • Only when duly authorized institutional signatures have been obtained • AND before enrolling subjects in the study

  10. How does the process start? • Read First; Write after • background information and instructions on Certificates of Confidentiality, which are available at http://grants.nih.gov/grants/policy/coc/background.htm. • See also Frequently Asked Questions http://grants.nih.gov/grants/policy/coc/faqs.htm. • Contents of application letter at http://grants.nih.gov/grants/policy/COC/appl_extramural.htm

  11. Where can the harm be? • Criminal investigation • Family litigation • Civil torts • Governmental investigations that are not aimed at the study patient as a specific defendant. Grand jury is one example.

  12. Why • Serious ethical questions from enrolling subjects in a study that may expose their private information without informing them of the risk. • The legal issues include significant liability for the investigator and institution if a study patient is harmed by the disclosure of sensitive information.

  13. NIJ Privacy Certificate • 28 CFR §22.23 and should be used as a guide to completing the Privacy Certificate. • http://www.ojp.usdoj.gov/nij/funding/humansubjects/welcome.htm

  14. Citation • 42 USC § 241

  15. Cites • Office for Human Research Protections (OHRP)Department of Health and Human Services (HHS) • Guidance on Certificates of Confidentiality • Date: February 25, 2003

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