Human Subject Research Protection

Common Rule | Health Privacy — The World Privacy Forum filed extensive comments with the US Department of Health and Human Services about its proposed changes regarding the rules governing human subject medical research. In the comments, WPF noted that the HHS approach to privacy for research subjects was incomplete and did not use all Fair Information Practices. WPF strongly urged HHS to revise its proposal on a number of issues, including consent and the use of biospecimens in research. The World Privacy Forum is urging HHS to acknowledge that the realm of health data that is truly non-identifiable has shrunken remarkably, for example, biospecimens with DNA cannot be considered non-identifiable anymore. “In our comments, we are requesting that HHS give individuals the opportunity to make choices about the use of their own health data and specimens,” said Executive director Pam Dixon. WPF also stated in its comments that “A central database with identifiable information about participants in human subjects research is a terrible idea.” (See p. 21 of WPF comments.)

The World Privacy Forum filed extensive comments with the US Department of Health and Human Services about its proposed changes regarding the rules governing human subject medical research. In the comments, WPF noted that the HHS approach to privacy for research subjects was incomplete and did not use all Fair Information Practices. WPF strongly urged HHS to revise its proposal on a number of issues, including consent and the use of biospecimens in research. The World Privacy Forum is urging HHS to acknowledge that the realm of health data that is truly non-identifiable has shrunken remarkably, for example, biospecimens with DNA cannot be considered non-identifiable anymore. “In our comments, we are requesting that HHS give individuals the opportunity to make choices about the use of their own health data and specimens,” said Executive director Pam Dixon. WPF also stated in its comments that “A central database with identifiable information about participants in human subjects research is a terrible idea.” (See p. 21 of WPF comments.)

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.

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.”

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.