Recommendation 14. IRBs should develop general guidelines for the disclosure of the results of research to subjects and require investigators to address these issues explicitly in their research plans. In general, these guidelines should reflect the presumption that the disclosure of research results to subjects represents an exceptional circumstance. Such disclosure should occur only when all of the following apply:
- the findings are scientifically valid and confirmed,
- the findings have significant implications for the subject’s health concerns, and
- a course of action to ameliorate or treat these concerns is readily available.
As noted in the Working Group’s response to Recommendations 10-13, it is important to distinguish between investigator-initiated disclosure of individual research results and disclosure of such results in response to a request from a study subject. While the discussion that prefaces NBAC’s Recommendation 14 contains references that pertain to either or both types of disclosure, the Recommendation itself does not draw a distinction. In considering the implementation of Recommendation 14, the Working Group considered both types of disclosure.
The Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulation
With respect to study subjects who desire access to their individual research results, Recommendation 14 appears to be in conflict with both the Privacy Act and provisions of the HIPAA privacy rule.
The Privacy Act, passed in 1974, applies to certain personally identifiable information held by federal agencies in a “system of records” and thus applies to any research record held by DHHS. Under this law, an agency must provide an individual access to his or her record. Moreover, the rules for protection of human subjects prohibit consent forms from including language “through which the subject or his representative is made to waive or appear to waive any of the subject’s legal rights” (45 CFR 46.116).
As interest has grown in protecting an individual’s access to his/her personal information, federal agencies are taking additional steps to ensure compliance with the Privacy Act. For example, as of March 1999, new consent forms at the NIH Clinical Center must include a statement that subjects have not waived their right to access to records about themselves. This statement must appear in consent forms for studies in which subjects are informed that the researcher does not plan to initiate disclosure of research results to study participants.
The HIPAA privacy regulation applies to health care providers who engage in certain electronic transactions. Therefore, any researcher who provides health care to research participants as part of a study, and engages in the specified electronic transactions, is covered by the regulations. It is expected that the HIPAA privacy regulation will apply to virtually all providers who conduct clinical trials. The HIPAA privacy regulation not only gives patients a right to see their own records but also requires that patients be notified of their right to see such records. None of the few exceptions in the HIPAA privacy regulation appear to apply to the situation envisioned by Recommendation 14. While its applicability to research in which health care is not provided (e.g., studies based solely on tissue samples with no clinical care component) is not entirely clear, the general rule of patient access to records may become an expected feature of the delivery of health care. Once health care facilities implement the HIPAA privacy regulation (in 2003), it is likely that subjects’ requests for access to their research results will no longer be an exceptional circumstance. The Working Group believes that such a regulatory requirement is most likely to lead to an increase in the number of subjects who are aware of and exercise their right to request and receive research results, all of which will have resource implications for the researcher. Investigators will have to be prepared to include, and IRBs to review, plans for how to respond to subjects’ requests for disclosure of research findings.
The HIPAA privacy rule is complex, and implementation will be a lengthy process. The impact of the new privacy regulations on research, including disclosure of research findings to participants will not be known for several years. The Working Group concludes that further analysis is needed before DHHS can make any judgment regarding the legality and feasibility of implementing Recommendation 14.
Conditions for disclosure of research results
The following comments relate in principle to both investigator-initiated disclosure and disclosure in response to a subject’s request. However, it is important to remember that under the HIPAA privacy regulation and the Privacy Act, a subject’s request for release of research results must be honored by an entity that is required to comply with either the HIPAA privacy regulation or the Privacy Act.
The Working Group agrees with NBAC that there are two major principles that need to be weighed when considering disclosure of research results to subjects:
- information that is preliminary and unvalidated could raise unnecessary concerns and/or lead to imprudent or inappropriate action by subjects
- subjects have the right to know what a researcher has found out about them and decide for themselves what is “significant” and what is not
Keeping these potentially conflicting principles in mind, the Working Group considered each of the three conditions in Recommendation 14 that would need to be satisfied before disclosure is permitted.
In general, the Working Group agrees with the principles in Recommendation 14(a), since results of research do not necessarily constitute valid information. However, the Working Group believes that the definition of “scientifically valid” may need further clarification with respect to issues such as clinical validity, clinical utility, and the variability of such measures across different study populations. Furthermore, during the course of investigations involving human biological materials, unforseen information or circumstances may come to light that pose serious concerns for the safety of the subjects, individuals in contact with them, or even the public at large. In many such cases, the information will be preliminary, unvalidated, or unverified; but timely action may nevertheless be imperative.
The Working Group is troubled by the implication that failure to meet the conditions in either Recommendation 14(b) or 14(c) would always preclude investigator-initiated release of research results even when such results are valid. The Working Group is persuaded that individuals have differing personal perspectives about whether information has “significant implications” for their own health and questions whether an IRB or investigator is necessarily qualified to make such judgments on behalf of the subject. Furthermore, even if there is no prevention or treatment measure that the researcher or IRB judges to be effective, having this information may allow the subject to make certain life choices or to engage in an intervention or additional research that the subject believes may be helpful. In other cases, although no useful medical options may be available to the subject from whom the biological material was collected, interventions to protect close contacts and health care workers may be appropriate. In any such scenario, subjects will be best served if the investigator initiates disclosure of valid results. This would be far preferable to dissemination of such information to subjects via the mass media.
The Working Group is aware that reluctance on the part of investigators to disclose research results to subjects often reflects the researcher’s concern about misuse of preliminary and unvalidated research data and the potential harm that may result from inappropriate actions. Researchers must, however, be prepared to respond to subjects’ requests for preliminary or unvalidated research results. Every effort should be made to ensure that information is released in a manner that would minimize harm and maximize benefit to the subject. The need to explain concerns about the findings and to promote caution in interpreting research results will place a further burden on the time and resources of investigators.
The Working Group proposes that a separate working group be convened to analyze the potential conflicts between this NBAC recommendation and HIPAA privacy regulation and to propose an appropriate Departmental response. The new working group should be drawn from not only staff involved in overseeing human biological materials research but also staff who are knowledgeable about the DHHS privacy regulation and federal clinical laboratory regulations. Moreover, the new working group should take into consideration the views of this Working Group on Recommendation 14, especially with respect to the conditions for disclosure.
Recommendation 15. The investigator in his or her research protocol should describe anticipated research findings and circumstances that might lead to a decision to disclose the findings to a subject, as well as a plan for how to manage such a disclosure.
The Working Group concurs with Recommendation 15. The protocol submitted for IRB review should (1) address any foreseeable circumstances that might lead the investigator to conclude that individual research findings should be disclosed to a subject and (2) include a plan that describes how subjects might be contacted to share such results.
Recommendation 15 is similar to Recommendation 10(c), which entertains the possibility of disclosing individual research results to subjects when such results merit investigator-initiated disclosure to an individual who was not aware of having been a study subject. Having recommended that OHRP, in consultation with FDA, develop and disseminate guidance to implement Recommendations 10-13, including 10(c), the Working Group proposes that the guidance developed for Recommendation 10(c) be formulated in a manner that is also responsive to Recommendation 15.
The Working Group proposes that OHRP, in consultation with relevant DHHS agencies and appropriate stakeholders, develop and disseminate guidance to implement this Recommendation, in conjunction with guidance for implementation of Recommendations 10-13.
Recommendation 16. When research results are disclosed to a subject, appropriate medical advice or referral should be provided.
The Working Group concurs with Recommendation 16 and interprets it as applicable to either disclosure initiated by the investigator or in response to a subject’s request. Disclosure of research results to a subject should include such information as is necessary for the subject to understand the potential implications of the information and the options available to address any health consequences. When appropriate, a plan for disclosure of individual research results to a subject would include a description for how advice or referral would be provided. Institutions, investigators, health care providers and community health advocacy groups could collaborate to identify sources of relevant information, including individuals or groups to whom a subject could be referred, that would be made available to researchers who foresee the possibility of disclosing research results to study subjects. Often, however, only the investigators will be qualified to provide the information that subjects need to understand the implications of the research results; and additional resources may be required to support the personnel, time and effort needed to provide such information.
The Working Group proposes that issues relevant to implementation of this recommendation be included in guidance to be developed for implementation of Recommendations 10(c) and 15.