Comment on FR Doc # N/A

July 23, 2010 RE: Modification of the Privacy Rule concerning subjects’ consent for future research: Should the Departmen tof Health and Human Services modify its interpretation that an authorization for the use or disclosure of protected health information for research be research-study specific? YES! As you are aware, the Common Rule under OHRP requires no specification of “future use” of patient information. The patient can give consent indicating his/her data may be used for future, unspecified research. On the other hand, the Privacy Rule under HIPAA does not allow future unspecified use of PHI. It must be specified with either a waiver of authorization from the privacy or institutional review board or consent obtained at that time. If a coded data base is established without PHI, it is no longer subject to the Privacy Rule. Practical application of such a coded data base is exceptionally difficult, especially for those evaluating longitudinal outcomes that require multiple re-entries into the source documents containing PHI. In many instances, compliance with the Privacy Rule that research be “study specific” is unrealistic and so burdensome to both the researcher and to the subject(s) as to be impractical, thereby stifling the researcher and prohibiting the subject’s authorization even where they may have no objection to use of their PHI associated data for unspecified research. The rule needs to be modified to the extent that patients/subjects can give consent to unspecified future research that may require access to and use of PHI. This would allow the researcher to establish a PHI-associated data repository that could be invaluable for unique and future studies that may not yet be envisioned. The researcher needs to provide assurance that all reasonable precautions will be employed to insure that PHI is not released to unauthorized individuals/organizations or in other print or electronic media available to the public. Subjects have the inherent right to withdraw their consent for use of PHI associated data at any time. In establishing a PHI-associated data repository, researchers should provide, to the extent reasonable, information about potential future use applications of the subject’s PHI associated data but should not be expected to predict the future and be held accountable for describing all potential future use applications. Without such relief, re-consenting subjects for the future use of their data may pose unreasonable expectations and/or constraints upon the researcher and be a burden or cause significant mental anguish to the subject or closely associated relatives. In cases where data or biologic specimens were obtained under a valid research protocol and consent for these procedures and tests was prospectively obtained, researchers should, in the same document have the ability to consent subjects for future, unspecified use of their PHI-associated data. That is, they should be able to consent the subject to allow establishing a data repository for future unspecified use. Certain kinds of sensitive research areas associated with genetic analyses or mental health issues may require some additional assurances within the consent document. In our experience in cancer treatment, it is rare for a patient to refuse consent for use of their data for research purposes. Most are anxious to freely contribute information in the hope that future subjects may be aided by data generated from their experiences. There have been numerous articles in the medical literature over the past several years that describe the barriers to clinical research from the perspective of both the researcher and the subject. In addition, many articles have pointed out the poor accrual to clinical trials despite the obvious benefits to advancing medical care implied by such trials. The costs in dollars and time associated with trial design, submission and review by the appropriate regulatory boards are excessive and wasted when accrual either does not occur or is too slow. Many consent forms are so long and complex, especially in the cancer treatment arena, as to be nearly unintelligible. The proposed modifications to the Privacy Rule are but small steps in the right direction to improve access to clinical trials for subjects and to improve accessibility trial data for researchers. Restrictions and barriers to access must be reduced to improve participation in trials by both researchers and subjects before faster improvements to cancer care can occur.