1. Confidentiality, Research, & Law
Dr. Robert Ursano, M.D.
Jason Kaar, JD

2. Readiness v. Privacy Epidemiology study
Importance of truthful information
Certificate of Confidentiality

3. Certificate of Confidentiality - Origins
Created in the 1970’s to allow researchers to study drug use patterns by Vietnam Vets, concern was heroin use
Program was expanded in 1988

4. Certificate of Confidentiality
What is a Certificate of Confidentiality (CoC)?
CoCs allow researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands. Certificates are issued by NIH and other Department of Health and Human Services (HHS) agencies to researchers to help protect the privacy of human subjects enrolled in sensitive, health-related research. Learn more about CoCs.
Which projects are eligible for CoCs?
Certificates of confidentiality are ONLY issued for research projects that are:
Collecting subject names or other identifying characteristics, on a sensitive research topic
Approved by an Institutional Review Board (IRB) operating under a Federalwide assurance (FWA) issued by the DHHS Office of Human Research Protections (OHRP) or with the approval of the FDA
On a topic that is within the HHS health related research mission
Storing research data in the United States
Allowable under federal regulations
Federal funding is not required but issuance is at the discretion of the issuing agency

5. What can be disclosed?
Identifying information protected by a Certificate may be disclosed under the following circumstances:
Voluntary disclosure of information by study participants themselves or any disclosure that the study participant has consented to in writing, such as to insurers, employers, or other third parties;
Voluntary disclosure by the researcher of information on such things as child abuse, reportable communicable diseases, possible threat to self or others, or other voluntary disclosures provided that such disclosures are spelled out in the informed consent form;

6. Disclosure
Voluntary compliance by the researcher with reporting requirements of state laws, such as knowledge of communicable disease, provided such intention to report is specified in the informed consent form; or
Release of information by researchers to DHHS as required for program evaluation or audits of research records or to the FDA as required under the federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)

7. Wakefield Autism Study
In 1998 Wakefield published a study linking vaccines to autism – 12 subjects
Study was used as basis of lawsuits against vaccine manufacturer’s
Questions about the medical procedures used resulted in patient record review
Review of the children revealed pre-existing conditions and in some cases no condition, many were lead to the study by plaintiff’s attorneys

8. Confidentiality within DoD
MRE 513 – Psychotherapist-patient privilege for “patient”
Privacy Act
HIPAA

9. HIV /AIDS Service members reluctant to be open
Oct 1985 SECDEF issued memo granting immunity from criminal prosecution on info provided for epidemiological assessment
Oct 1986 NDAA for 87 prohibited using “epidemiological-assessment interview with a serum-positive” SM for adverse actions

10. HIV/AIDS – Chilling Effect
20 HIV service members
In MTF 4 of 20 admitted to homosexual conduct
In civilian setting 14 of 20 admitted to homosexual conduct

11. Duty to Warn
Tarasoff v. Regents of University of California, (CA 1976)
Hembree v State of Tennessee, (TN 2001)
Harden v Dalrymple, (D Del 1995)