Physician Group: Revise Privacy Rule Regarding Research Issues
The American College of Physicians has updated a two-year-old policy paper to include a new position of advocating a revised privacy rule covering use of research information.
The American College of Physicians has updated a two-year-old policy paper to include a new position of advocating a revised privacy rule covering use of research information.
The paper comes as federal policymakers are accepting comment on a forthcoming proposed rule for enhancing protections for human research subjects while reducing regulatory burdens for investigators. The college will comment separately on the Department of Health and Human Services' advanced notice of rulemaking that was issued in July.
ACP's proposal for a revised privacy rule, which is the fourth of 13 policy positions in the new report, is:
"Regarding research, a revised privacy rule should maximize appropriate uses of information to achieve scientific advances without compromising ethical obligations to protect individual welfare and privacy.
"1. Participation in prospective clinical research requires fully informed and transparent consent that discloses all potential uses of Protected Health Information (PHI) and Individually Identifiable Health Information (IIHI), and an explanation of any limitations on withdrawing consent for use of data, including biological materials.
"2. ACP recognizes that further study is needed to resolve informed consent issues related to future research use of (PHI) and (IIHI) associated with existing data, including biologic materials.
"3. Informed consent documents should clearly disclose whether law enforcement agencies would have access to biobank data without a warrant.
"4. ACP recommends that regulations governing IRB review be expanded to include consideration of the preferences of research subjects whose tissue has been stored."
The full report is available here.
The paper comes as federal policymakers are accepting comment on a forthcoming proposed rule for enhancing protections for human research subjects while reducing regulatory burdens for investigators. The college will comment separately on the Department of Health and Human Services' advanced notice of rulemaking that was issued in July.
ACP's proposal for a revised privacy rule, which is the fourth of 13 policy positions in the new report, is:
"Regarding research, a revised privacy rule should maximize appropriate uses of information to achieve scientific advances without compromising ethical obligations to protect individual welfare and privacy.
"1. Participation in prospective clinical research requires fully informed and transparent consent that discloses all potential uses of Protected Health Information (PHI) and Individually Identifiable Health Information (IIHI), and an explanation of any limitations on withdrawing consent for use of data, including biological materials.
"2. ACP recognizes that further study is needed to resolve informed consent issues related to future research use of (PHI) and (IIHI) associated with existing data, including biologic materials.
"3. Informed consent documents should clearly disclose whether law enforcement agencies would have access to biobank data without a warrant.
"4. ACP recommends that regulations governing IRB review be expanded to include consideration of the preferences of research subjects whose tissue has been stored."
The full report is available here.
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