Announcements
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January 2009
- 01/13 Surgeon General Releases Updated Family History Tool and HHS Releases Related HIPAA Privacy Rule FAQs
The U.S. Department of Health and Human Services today released an updated and improved version of the Surgeon General’s Internet-based family health history tool. The new tool makes it easier for consumers to assemble and share family health history information. It can also help practitioners make better use of health history information so they can provide more informed and personalized care for their patients.
The news release is available here and the tool is available at My Family Health Portrait.
In conjunction with the release of this tool, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has published new HIPAA Privacy Rule frequently asked questions (FAQs) related to family medical history. These FAQs support the roll out of the Surgeon General’s family health history portal. Individuals using this portal to assemble, download and transmit family history information may have questions about privacy and how family history can be used or shared by health care providers. The new FAQs provide answers to these questions.
These new HIPAA FAQs are available here. Additional information regarding HIPAA is available on the OCR Privacy Rule Web Site here.
- 01/13 FDA Request for Comment - Participation of Certain Population Subsets in Clinical Drug Trials
The FDA is seeking information and comments on issues related to the enrollment of certain vulnerable and underserved populations in clinical drug trials. This request relates to the Food and Drug Administration Amendments Act (FDAAA) of 2007's requirement that the FDA report to Congress on "recommendations regarding impediments to the participation of elderly populations, children, racially and ethnically diverse communities and medically underserved populations in clinical drug trials" and recommendations that address "best practice approaches for increasing the inclusion of such subsets of the general population."
The Federal Register notice is available here and written or electronic comments must be submitted by February 27, 2009.
December 2008
- 12/30 New OHRP Frequently Asked Questions and Answers on Quality Improvement Activities
The U.S. Office for Human Research Protections (“OHRP”) has posted a new set of Frequently Asked Questions and Answers (FAQs) on quality improvement activities. These FAQs provide guidance on OHRP’s current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited.
The quality improvement activities FAQs can be accessed at: OHRP FAQ
- 12/15-12/16 - The DSIC KC will be attending the 5th NHIN Forum: Nationwide Health Information Network (NHIN) Trial Implementations: A Path to Production
- 12/1 FDA & OHRP Release Guidance on Clinical Trial Subject Withdrawal
On December 1, 2008, the U.S. Office for Human Research Protections (“OHRP”) and Food and Drug Administration (“FDA”) issued parallel guidance intended to help clarify how to handle data and specimen retention and destruction following a research participant’s decision to withdraw from a study. OHRP is soliciting comments through January 30, 2009; FDA’s guidance was published as final.
Both the Common Rule and FDA regulations require that informed consent documents include a “statement that participation is voluntary … and that the subject may discontinue participation at any time[;]” and, “when appropriate,” information about the “consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject[.]” 45 C.F.R. §§ 46.116(a)(8) and (b)(4); 21 C.F.R. §§ 50.25(a)(8) and (b)(4). But the meaning of “participation” and consequences of “withdrawal” have been the subject of substantial controversy for many years. See, e.g., Wash. Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007), cert. denied, 128 S. Ct. 1122 (2008). Institutional and ethics committee policies have varied widely. The agency guidance was intended to clarify the meaning of the regulations and, in FDA’s case, to assure the retention of documentation relevant to product approvals and safety. In brief, the agencies have clarified that investigators may continue to analyze previously collected data – even individually identifiable data – about a research participant following the individual’s withdrawal from a research study. FDA’s position is premised on the idea that withdrawal does not justify destruction and, if done in a non-random or informative manner, could undermine data validity and integrity. OHRP’s guidance focuses on the definition of a “human subject” and meaning of the word “participation,” with a similar result.
Although the OHRP document explicitly references FDA’s guidance and characterizes the two as harmonized, they may not be entirely consistent. OHRP’s guidance includes case studies suggesting that new data extractions from previously collected specimens are barred following complete withdrawal (but are permitted in partial withdrawal cases where the participant agrees to ongoing data collection). FDA does not explicitly address specimens but its reasoning seems to suggest that destruction of specimens containing as-yet unextracted data relevant to previously approved and anticipated study analysis might be problematic.
Research institutions and researchers should anticipate updated data retention language in sponsors’ clinical trial agreements, and are encouraged to review institutional policies to assure consistency with the agency guidance and, where possible, avoid case-by-case policymaking through IRB discussions on individual studies. For example, many research pathology labs perform batch analyses to more efficiently do their work, and do not routinely remove previously collected specimens from those batches even following complete withdrawal from a study. This approach arguably is consistent with the FDA guidance but clearly would not comply with the Common Rule as now interpreted by OHRP. Research institutions may also wish to consider updating their informed consent templates to address data and specimen disposition following withdrawal, and development of standard IRB-approved forms to document a participant’s wishes regarding ongoing data collection in those circumstances.
The guidance documents are available on the agencies’ respective websites at:
The Office for Civil Rights’ previously issued guidance on retention of protected health information in connection with a research study following withdrawal is available online at link
This summary originally was prepared for the American Health Lawyers' Association, Teaching Hospitals and Academic Medical Centers practice group. A copy of this document is available: AHLA Briefing.
November 2008
- 11/14 - The DSIC KC will be attending the TBPT F2F meeting
October 2008
- 10/17 - The DSIC KC will be attending the CTSA Informatics - Data Repository Best Practices Symposium
- 10/16 OHRP - Final Guidance on Engagement of Institutions in Human Subjects Research
The guidance applies to research involving human subjects that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document describes:
- scenarios that, in general, would result in an institution being considered engaged in a human subjects research project;
- scenarios that would result in an institution being considered not engaged in a human subjects research project; and
- IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project.
The guidance can be found at OHRP Engagement Guidance. This guidance is consistent with the December 2006 draft guidance and is reflected in Human Research Considerations Decision Support Tool.
- 10/1 ClinicalTrials.gov Accepting "Basic Results" Information
The Protocol Registration System at clinicaltrials.gov has announced that "basic results" information may now be submitted for posting. A Data Entry Test System is available for use by registered users. Additional information, including Data Element Definitions and 'Basic Results' Data Element Definitions is available on the PRS site. Additional information on mandated registration of clinical trials and results reporting under the FDA Amendments Act of 2007 ("FDAAA") and earlier legislation is also available online (scroll down to "Additional Information"). See also the The International Committee of Medical Journal Editors' site which provides links to its initiative to improve transparency in clinical trials. The University of Michgan has also developed guidance on clinical trials registration and reporting mandates.
September 2008
- 9/23-9/24 - The DSIC KC will be attending the ICR F2F meeting
