ASN Responds to Proposed HIPAA and Conflict of Interest Changes

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In response to a series of recent proposals related to the Health Insurance Portability and Accountability Act (HIPAA) and conflicts of interest (COI) standards and enforcement, the ASN submitted comments aimed at ensuring opportunities for robust and sustained research are protected. The proposed rules suggest changes to existing regulations governing HIPAA and COI. Federal agencies will take into consideration outside commentary (such as that submitted by the ASN) before issuing final rules.

National Institutes of Health Conflicts of Interest

The National Institutes of Health (NIH) has proposed a rule that would alter the way COI are policed at research institutions working with NIH grants. The ASN favors most of the proposals related to institutional COI, including lowering the monetary threshold for a researcher’s financial stake to meet the definition of significant financial interest while also supporting public reporting of these interests online. Through written comments, the ASN advocated for uniformity and fairness of COI enforcement across research institutions. The ASN suggested that the NIH develop and disseminate clear guidelines related to administration of COI standards at institutions. Furthermore, a centralized online repository of significant financial interest information would be preferable to each individual institution collecting and posting this information in disparate formats and with varying degrees of timeliness, ASN said in its comments.

Health and Human Services HIPAA

The HIPAA proposed rule relaxes standards for researchers who use data that are covered as protected health information (PHI) under HIPAA. Although the ASN strongly supports PHI, the process of collecting consent forms authorizing its use is burdensome for researchers, institutions, and patients alike.

The first change to HIPAA would eliminate dual consent forms, paving the way for the use of compound authorization forms. Compound authorization would permit use of PHI for both immediate and future research projects while giving patients the choice to opt out.

A second proposal would allow authorizations to cover use of medical specimens in undefined future research activities, typically involving databases or repositories, rather than requiring researchers to specifically cite the intended research purpose at the time of authorization collection.

Finally, the proposed rule would ease rules that bar financial remuneration for preparation and transmission of PHI. If remuneration covers no other expenses, and the intended use of PHI is for research, reimbursement can be provided.

A working group of experts made up of ASN members assisted in crafting the ASN’s commentary. Complete comment letters relating to COI and HIPAA are available on the ASN Web site at http://www.asn-online.org/policy_and_public_affairs/medical-research.aspx.

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