APA responds to proposed federal changes in human research protections
By Jenna McGwin and Sangeeta Panicker, PhD
The American Psychological Association (APA) has formally responded to the U.S. Department of Health and Human Services (HHS) regarding proposed revisions to federal regulations for the protection of human research participants (45 CFR 46, the Common Rule). As reported previously, the proposed changes were detailed in an advance notice of proposed rulemaking (ANPRM) that appeared on July 26, 2011, in the Federal Register.
APA’s comments on the ANPRM were made in a letter (PDF, 188KB) submitted to the HHS Office for Human Research Protections (OHRP). The comments are based on a comprehensive review of the ANPRM conducted by APA’s Committee on Human Research and Research Ethics Office and incorporate suggestions from other scientists as well.
In its letter, APA expresses agreement that the Common Rule is in need of revision and offers support for such proposals as:
Calibrating level of review to the level of risk of harm.
Expanding exempt research categories but APA urges OHRP to retain the current practice for exempt studies rather than adopt the proposed “excused research model.”
Periodically reviewing and revising the list of research categories eligible for expedited review.
Eliminating continuing review of studies initially approved using the expedited review mechanism and of studies approved by convened review but which no longer involve interaction with human participants.
Mandating a single Institutional Review Board (IRB) of record for multi-site studies.
Creating a central database that allows researchers to upload specific information about their study as well as any adverse events or unanticipated problems that occurred.
Clarifying and harmonizing regulatory requirements and guidance across all Common Rule agencies.
However, APA also expresses strong concerns about other proposed revisions and their potential impacts on the conduct of behavioral and psychological science research. The letter elaborates on APA’s opposition to:
The new requirements for data security and information protection based on the HIPAA Privacy Rule.
The inclusion of prescriptive language for the format and content of consent forms, as such prescriptive language will be inappropriate for many types of research and thus increase administrative burden.
A broad, general, open-ended consent for unspecified future use of data as APA believes this threatens the fundamental ethical principle of respect for persons.
APA encourages psychological scientists as well as scientific and academic organizations to submit their own comments on the ANPRM to OHRP, and to share their comments with the APA Research Ethics Office (by email). The deadline for receipt of comments is no later than 5:00 p.m. on October 26, 2011. Comments may be submitted online through the Federal eRulemaking Portal at Regulations.gov. Enter the docket ID number (HHS-OPHS-2011-0005) in the “Enter Keyword or ID” field and click “Search.” On the next page, click on “Submit a Comment” and follow the instructions. Comments may also be submitted by hard-copy to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wooton Parkway, Suite 200, Rockville, MD 20852. Any comments received will be posted to Regulations.gov.
See: APA letter to OHRP (PDF, 188KB) on proposed federal changes in human research protections
Jenna McGwin, MS, is Research Ethics Program Associate in the APA Research Ethics Office. Sangeeta Panicker, PhD, is director of the Research Ethics Office and serves as staff liaison to the Committee for Human Research.