Comment: Some commenters, including several industry and consumer groups, argued that the proposed rule would establish a two-tiered system for public and private research. Privately funded research conducted with an authorization for the use or disclosure of protected health information would not require IRB or privacy board review, while publically funded research conducted with authorization would require IRB review as required by the Common Rule. Many of these commenters argued that authorization is insufficient to protect patients involved in research studies and recommended that IRB or privacy board review should be required for all research regardless of sponsor. These commenters asserted that it is not sufficient to obtain authorization, and that IRBs and privacy boards should review the authorization document, and assess the risks and benefits to individuals posed by the research.
Response: For the reasons we rejected the recommendation that we eliminate the option for privacy board review and require IRB review for the waiver of authorization, we also decided against requiring documentation of IRB or privacy board approval for research conducted with authorization. HHS strongly agrees that IRB review is essential for the adequate protection of human subjects involved in research, regardless of whether informed consent and/or individuals' authorization is obtained. In fact, IRB review may be even more important for research conducted with subjects' informed consent and authorization since such research may present greater than minimal risk to participants. However, HHS' authority under HIPAA is limited to safeguarding the privacy of protected health information, and does not extend to protecting human subjects more broadly. Therefore, in the final rule we have not required documentation of IRB or privacy board review for the research use or disclosure of protected health information conducted with individuals' authorization. As mentioned above, HHS looks forward to receiving the recommendations of the National Bioethics Advisory Commission, which is currently examining the current scope of federal regulatory protections for protecting human subjects in research as part of its overarching report on the federal oversight of human subjects protections.
Comment: Due to concern about several of the elements of authorization, many commenters recommended that the final rule stipulate that "informed consent" obtained pursuant to the Common Rule be deemed to meet the requirements for "authorization." These commenters argued that the NPRM's additional authorization requirements offered no additional protection to research participants but would be a substantive impediment to research.
Response: We disagree with the comments asserting that the proposed requirements for authorization for the use or disclosure of protected health information would have offered research subjects no additional privacy protection. Because the purposes of authorization and informed consent differ, the proposed rule's requirements for authorization pursuant to a request from a researcher (§ 164.508) and the Common Rule's requirements for informed consent (Common Rule, § ___.116) contain important differences. For example, unlike the Common Rule, the proposed rule would have required that the authorization include a description of the information to be used or disclosed that identifies the information in a specific and meaningful way, an expiration date, and where, use of disclosure of the requested information will result in financial gain to the entity, a statement that such gain will result. We believe that the authorization requirements provide individuals with information necessary to determine whether to authorize a specific use or disclosure of protected health information about themselves, that are not required by the Common Rule.
Therefore, in the final rule, we retain the requirement for authorization for all uses and disclosures of protected health information not otherwise permitted without authorization by the rule. Some of the proposed requirements for authorization were modified in the final rule as discussed in the preamble on § 164.508. The comments received on specific proposed elements of authorization as they would have pertained to research are addressed below.
Comment: A number of commenters, including several from industry and consumer groups, recommended that the final rule require patients' informed consent as stipulated in the Common Rule. These commenters asserted that the proposed authorization document was inadequate for research uses and disclosures of protected health information since it included fewer elements than required for informed consent under the Common Rule, including for example, the Common Rule's requirement that the informed consent document include: (1) a description of any reasonably foreseeable risks or discomforts to the subject; (2) a description of any benefits to the subject or to others which may reasonably be expected from the research (Common Rule, § ___.116(a)).
Response: While we agree that the ethical conduct of research requires the voluntary informed consent of research subjects, as stipulated in the Common Rule, as we have stated elsewhere, the privacy rule is limited to protecting the confidentiality of individually identifiable health information, and not protecting human subjects more broadly. Therefore, we believe it would not be within the scope of the final rule to require informed consent as stipulated by the Common Rule for research uses and disclosures of protected health information.
Comment: Several commenters specifically objected to the authorization requirement for a "expiration date." To remedy this concern, many of these commenters proposed that the rule exempt research from the requirement for an expiration date if an IRB has reviewed and approved the research study. In particular, some commenters asserted that the requirement for an expiration date would be impracticable in the context of clinical trials, where the duration of the study depends on several different factors that cannot be predicted in advance. These commenters argued that determining an exact date would be impossible due to the legal requirements that manufactures and the Food and Drug Administration be able to retrospectively audit the source documents when patient data are used in clinical trials. In addition, some commenters asserted that a requirement for an expiration date would force researchers to designate specific expiration dates so far into the future as to render them meaningless.
Response: We agree with commenters that an expiration date is not always possible or meaningful. In the final rule, we continue to require an identifiable expiration, but permit it to be a specific date or an event directly relevant to the individual or the purpose of the authorization (e.g., for the duration of a specific research study) in which the individual is a participant.
Comment: A number of commenters, including those from the pharmaceutical industry, were concerned about the authorization requirement that gave patients the right to revoke consent for participation in clinical research. These commenters argued that such a right to revoke authorization for the use of their protected health information would require complete elimination of the information from the record. Some stated that in the conduct of clinical trials, the retrieval of individually identifiable health information that has already been blinded and anonymized, is not only burdensome, but should this become a widespread practice, would render the trial invalid. One commenter suggested that the Secretary modify the proposed regulation to allow IRBs or privacy boards to determine the duration of authorizations and the circumstances under which a research participant should be permitted to retroactively revoke his or her authorization to use data already collected by the researcher.
Response: We agree with these concerns. In the final rule we have clarified that an individual cannot revoke an authorization to the extent that action has been taken in reliance on the authorization. Therefore, if a covered entity has already used or disclosed protected health information for a research study pursuant to an authorization obtained as required by § 164.508, the covered entity is not required under the rule, unless it agreed otherwise, to destroy protected health information that was collected, nor retrieve protected health information that was disclosed under such an authorization. However, once an individual has revoked an authorization, no additional protected health information may be used or disclosed unless otherwise permitted by this rule.
Comment: Some commenters were concerned that the authorization requirement to disclose "financial gain" would be problematic as it would pertain to research. These commenters asserted that this requirement could mislead patients and would make it more difficult to attract volunteers to participate in research. One commenter recommended that the statement be revised to state "that the clinical investigator will be compensated for the value of his/her services in administrating this clinical trial." Another commenter recommended that the authorization requirement for disclosure of financial gain be defined in accordance with FDA's financial disclosure rules.
Response: We strongly believe that a requirement for the disclosure of financial gain is imperative to ensure that individuals are informed about how and why protected health information about themselves will be used or disclosed. We agree, however that the language of the proposed requirement could cause confusion, because most activities involve some type of financial gain. Therefore, in the final rule, we have modified the language to provide that when the covered entity initiates the authorization and the covered entity will receive direct or indirect remuneration (rather than financial gain) from a third party in exchange for using or disclosing the health information, the authorization must include a statement that such remuneration will result.
Comment: A few commenters asserted that the requirement to include a statement in which the patient acknowledged that information used or disclosed to any entity other than a health plan or health care provider may no longer be protected by federal privacy law would be inconsistent with existing protections implemented by IRBs under the Common Rule. In particular they stated that this inconsistency exists because IRBs are required to consider the protections in place to protect patients' confidential information and that IRBs are charged with ensuring that researchers comply with the confidentiality provisions of the informed consent document.
Response: We disagree that this proposed requirement would pose a conflict with the Common Rule since the requirement was for a statement that the "information may no longer be protected by the federal privacy law." This statement does not pertain to the protections provided under the Common Rule. In addition, while we anticipate that IRBs and privacy boards will most often waive all or none of the authorization requirements, we clarify an IRB or privacy board could alter this requirement, among others, if the documentation requirements of § 164.512(i) have been met.