Human Subject Research Protection

World Privacy Forum urges more attention to the protection of research study participants

Human Subjects Research Protection (OHRP) — The World Privacy Forum filed comments today with the Office of Human Research Protection urging the office to do more to protect the privacy of people who are subjects of research. The comments urge the OHRP to focus more attention on providing privacy-specific training for boards overseeing research, which are often weak in knowledge about the breadth of privacy issues in research. The WPF also voiced its strong support for certificates of confidentiality for research involving human subjects, stating that”nearly all research that involves identifiable health data or other personal data about individuals should have a certificate of confidentiality unless a researcher can state a substantive reason why a certificate is not appropriate for the study.” OHRP will be accepting comments until Sept. 29.

Public Comments: September 2008 – World Privacy Forum urges more attention to the protection of research study participants

Human Subjects Research Protection (OHRP) — The World Privacy Forum filed comments with the Office of Human Research Protection urging the office to do more to protect the privacy of people who are subjects of research. The comments urge the OHRP to focus more attention on providing privacy-specific training for boards overseeing research, which are often weak in knowledge about the breadth of privacy issues in research. The WPF also voiced its strong support for certificates of confidentiality for research involving human subjects, stating that “nearly all research that involves identifiable health data or other personal data about individuals should have a certificate of confidentiality unless a researcher can state a substantive reason why a certificate is not appropriate for the study.”

World Privacy Forum files public comments and recommendations on pharmacogenomics privacy: all patient-specific PGx research should require certificates of confidentiality

information will expand greatly in the future. In public comments filed with the National Institutes of Health on pharmacogenomics (PGx) research, or research using genetic information to create highly personalized medicine, the World Privacy Forum recommended that all research activities that involve any type of patient-specific genetic information be required to have certificates of confidentiality, whether that information appears identifiable or not. The WPF also urged the NIH to require strong data use agreements to protect individuals’ privacy. The WPF also urged NIH and the Department of Health and Human Services to reinstate the position of “privacy advocate” so as to provide oversight in this area.

World Privacy Forum Comments on Privacy Issues Relating to a Nationwide Genetic Research Project

Genetic privacy — The collection of DNA material from 500,000 to 1,000,000 or more individuals as part of a large U.S. medical research project raises many challenging ethical, legal, and privacy issues. An advisory committee reporting to the Office of the Secretary of Health and Human Services ( the Secretary’s Advisory Committee on Genetics, Health and Society) has published a detailed analysis of the issues such a project and its associated databases and biobanks would raise in a draft report. The committee’s final report and policy recommendations will be submitted to the Secretary of HHS. The World Privacy Forum has submitted public comments on the draft; the comments include key policy recommendations.
The Forum’s recommendations include the need to provide protection from compelled disclosure of information, the necessity for a full-time project privacy officer with enforcement power, the need to address identifiability issues, and the need for a far-reaching and robust privacy policy that exceeds the requirements of HIPAA, among other recommendations.

Public Comments: July 2006 – WPF comments on draft report “Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease.

The collection of DNA material from 500,000 to 1,000,000 or more individuals as part of a large U.S. medical research project raises many challenging ethical, legal, and privacy issues. An advisory committee reporting to the Office of the Secretary of Health and Human Services ( the Secretary’s Advisory Committee on Genetics, Health and Society) has published a detailed analysis of the issues such a project would raise in a draft report. The committee’s final report and policy recommendations will be submitted to the Secretary of HHS. The World Privacy Forum has submitted public comments on the draft report; the comments include key policy recommendations. The Forum’s recommendations include the need to provide protection from compelled disclosure of information, the necessity for a full-time project privacy officer with enforcement power, and the need for a far-reaching and robust privacy policy that exceeds the requirements of HIPAA, among other recommendations.

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