The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research.  Here are the significant changes:

Compound Authorizations

The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission.  An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research.  However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, payment, enrollment in a health plan or eligibility for benefits on the individual’s provision of the authorization (a “conditioned authorization”), and the other authorization or permission does not contain such a condition (an “unconditioned authorization”).  The purpose of this limitation on certain compound authorizations was to ensure that individuals could decline the activity described in the unconditioned authorization, yet still receive the treatment, services or benefits outlined in the conditioned authorization.  For example, research may include both treatment as part of the clinical trial and the banking of tissue and associated PHI.  The subject often must sign an authorization for use of his or her PHI in order to receive the research-related treatment (a “conditioned authorization”), but he or she is free to sign or to decide not to sign the tissue and data banking authorization (“unconditioned authorization”).

Under the current HIPAA rule, a single authorization form cannot be used in this situation.  Instead, the covered entity must obtain two separate authorizations from research subjects:  one allowing use and disclosure of PHI to receive the research-related treatment and another allowing use and disclosure of PHI for the tissue and data banking.  Many researchers and research institutions expressed concerns about the additional paperwork and confusion that results from the separate form requirement.  In addition, they expressed concerns about the inconsistency of the current HIPAA rule with the Common Rule informed consent requirements (45 CFR Part 46) and with research documentation requirements outside the United States.

In response to these concerns, the Final Rule allows a covered entity to combine, in one form, conditioned and unconditioned authorizations for research, ^[1] provided that the authorization clearly differentiates between the conditioned and unconditioned components and clearly allows the subject the option to participate in the unconditioned research activities.  These changes will allow covered entities to combine authorizations for use and disclosure of PHI for clinical trials and related tissue and data banking activities, as well as in other common research scenarios, such as a clinical trial involving an optional pharmacokinetics sub-study or a tissue banking protocol that permits future secondary research use of the data.

The Final Rule gives covered entities, researchers and institutional review boards discretion regarding how authorizations distinguish between conditioned and unconditioned activities.  In Commentary to the Final Rule, the Department of Health and Human Services (HHS) noted that a check-box or extra page explaining the “unconditioned” activity may be appropriate – but the Final Rule allows covered entities to determine the best approach.^[2]

Authorization for Future Research Use and Disclosure

In the preamble to the Final Rule, HHS reversed its prior interpretation of the Privacy Rule that a research authorization must be study-specific and therefore may not include authorization for future research use.  As HHS explained, this interpretation was based on a concern that individuals would not have sufficient information to make truly informed decisions about the future research.  This interpretation, however, encumbered secondary research and diverged from Common Rule standards regarding subjects’ informed consent for future research.

Under HHS’s modified interpretation in the Final Rule, an authorization for the use or disclosure of PHI for research purposes does not have to be study-specific.  Rather, in order to satisfy the requirement that an authorization include a description of each purpose of the requested use or disclosure, an authorization for uses and disclosures of PHI for future research purposes must describe those purposes in a manner such that it would be reasonable for the individual to expect that his or her PHI could be used or disclosed for such future research.  The Final Rule gives covered entities, researchers, and IRBs flexibility to determine how to adequately describe the future research purpose, the information to be used or disclosed for the future research, and the recipients of the PHI for the future research.  In addition, HHS specifically noted that a description of the PHI to be used for the future research may include information collected beyond the time of the original study.  Finally, HHS stated that covered entities and researchers may rely on an IRB-approved consent obtained prior to the effective date of the Final Rule that reasonably informs individuals about future research, as long as the informed consent is combined with a HIPAA-compliant authorization.  HHS may issue additional guidance with respect to revocations of authorizations for future research uses.

Decedents’ Protected Health Information

The Final Rule modifies the privacy protections applicable to decedents’ health information.  Currently, the Privacy Rule requires covered entities to safeguard the privacy of a decedent’s PHI indefinitely, in the same manner required for the PHI of living individuals.  If an authorization is required for a particular use or disclosure of PHI, the covered entity must obtain the authorization from the decedent’s personal representative.  Under the Final Rule, any information that would otherwise constitute PHI of a decedent under 45 CFR § 160.201 ceases to be PHI 50 years after the death of the decedent.  This declassification will benefit research, as it can be burdensome to locate the personal representative of a decedent to obtain an authorization for use of the decedent’s health information for research, especially if a significant period of time has passed since the individual’s death.  HHS determined that 50 years is sufficient time to account for the privacy interests of living individuals related to the decedent.

Conclusions and Recommendations

The Final Rule provisions discussed above have important implications for research:

• The changes concerning compound authorizations will alleviate administrative burdens on clinical trial subjects and researchers and facilitate harmonization with the Common Rule and global requirements for research documentation.
• The revised interpretation regarding authorization for future research use will remove barriers on researchers’ ability to use data for future research purposes – some of which cannot even be contemplated at the time the data is gathered, but which could hold great promise to advance science and medical care.
• The declassification as “PHI” of certain information of decedents over time will ease researchers’ ability to perform research using such information.

Researchers, research institutions and research sponsors have until September 23, 2013, to come into full compliance with the Final Rule.  In order to take advantage of the enhanced efficiencies in research initiatives that the Final Rule provides, however, those involved in research should begin revising research policies, procedures and forms now.  In addition, those involved in research should keep abreast of future regulatory developments and guidance on these and other issues, such as revocation of authorizations of use of PHI for future research use, additional guidance related to research use of genetic information, and harmonization of Final Rule provisions with FDA standards for informed consent.

_{[1] This provision does not allow for the use of compound authorizations for research that involves the use or disclosure of psychotherapy notes.}

_{[2] The Commentary notes, however, that the Final Rule does not permit a combined authorization that allows the individual to opt out of the unconditioned research activities only (e.g., “check here if you do NOT want your data provided to the biospecimen bank.”), because such an opt-out provision does not provide individuals a clear ability to authorize the optional research activity, and may be viewed as coercive.  Moreover, as HHS further explained, the Final Rule does not remove the requirement that an individual must affirmatively authorize the unconditioned research activities; it simply provides flexibility to streamline the authorization process by combining forms.}