1 / 32

Secretary’s Advisory Committee on Human Subjects Protections (SACHRP)

Secretary’s Advisory Committee on Human Subjects Protections (SACHRP). Summary of Responses on: Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs (Education RFI) Elyse I. Summers, J.D. Acting Director

iago
Download Presentation

Secretary’s Advisory Committee on Human Subjects Protections (SACHRP)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Secretary’s Advisory Committee on Human Subjects Protections (SACHRP) Summary of Responses on: Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs (Education RFI) Elyse I. Summers, J.D. Acting Director Division of Education and Development July 21, 2009

  2. Background • 1998 report from the HHS Office of Inspector General (OIG) recommending that Federal requirements be enacted to help ensure that investigators and institutional review board (IRB) members be adequately educated about, and sensitized to, human subjects protections. • 2000 NIH policy requiring human subjects protection training for all “key personnel.” • 2001 NBAC report recommended ethics training for several role players in the human subjects research enterprise. • 2002 IOM report called for research organizations to ensure appropriate training for investigators, IRB members, and others substantively involved in human subjects research. • March 27, 2007, Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended that OHRP require institutions to ensure that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials.

  3. Request for Information (RFI) • Issued July 2008 • Key questions: -- whether HHS should develop a regulation requiring that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research the implementation of such training and education programs; or, -- whether OHRP should issue additional guidance recommending the implementation of such training and education programs.

  4. Comments Received • Almost 100 comments received • Six comments were “joint” (e.g., COGR, AAU, AAMC sent one) • Distributed, as follows: -- 16 from NGOs (e.g., AAAS, FASEB) -- 48 from Universities/Health Systems/Hospitals/IRBs -- 32 from Other (i.e., individuals, private sector, government)

  5. Review of Comments—New Regulations? • 24 comments were against new regulations (notables: COGR/AAU/AAMC; AAAS; ASCO) • 36 comments were for new regulations (notables: PRIMR; WIRB) • 36 comments did not explicitly state support or opposition (“unspecified”) to new regulations (e.g., narrative described support for education) Note: While there was some distribution across all types of commenters and categories (i.e., for, against, unspecified), most of the organizational comments were against new regulations

  6. Notable Comments For (from a commercial IRB): “We believe that OHRP has largely exhausted the mechanism of issuing guidance that strongly recommends training requirements. We believe the promulgation of a regulation requiring training would lead to more training being implemented.”

  7. Notable Comments For (university IRB professional): “I vote for: …HHS should develop a regulation requiring the implementation of…training and education programs. It will capture more people that need to be trained properly and [provide] review for those that [sic] already are trained properly.”

  8. Notable Comments For (anonymous individual IRB professional): “This is a great idea…[.] [I]t should be mandatory[.] I highly am for it. I would love to see this in place. I know that I can use some help and once it’s a mandatory thing, people would not look down upon it as not…important.”

  9. Notable Comments Against (university-based individual): “We have no evidence that the regulatory requirements, including those for training, have done any good whatsoever. Abuses still happen.”

  10. Notable Comments Against (university): “A federally mandated program, rather than the current method of government recommended and guided training, would represent a considerable unfunded mandate.”

  11. Notable Comments Against (university): “A more constructive approach to the development of successful protections programs would be for OHRP to partner with institutions to communicate best practices in human subject research education and training.”

  12. Review of Comments—New OHRP Guidance? • 7 comments were against new guidance (notably: all 7 were from specific institutions) • 25 comments were for new guidance (notables: AAAS; KPSC; PRIMR) • 63 comments did not explicitly state support or opposition (“unspecified”) to new guidance (e.g., narrative described general support for education) • Vast majority of comments were general, non-specific statements in support of education – how institutions should “get there” went largely unexplicated. Note: Fairly even distribution across all types of commenters and categories (i.e., for, against, unspecified)

  13. Review of Comments—The Other Questions • Beyond threshold questions of “yea” or “nay” on regulations and/or guidance, the Education RFI contained 16 additional questions. • All but two of the subsidiary questions yielded 20 or fewer specific comments. (Remember: Almost 100 overall comments) • Observation: Responders tended to confound and combine questions • Caveat: Would suggest that silence as to any particular question is difficult to interpret • Disinterested in certain areas of inquiry? • Question fatigue?

  14. Review of Comments—Question 1(a) Have institutions holding OHRP-approved FWAs routinely implemented OHRP’s recommendations? • 16 Total comments • 15 – Yes; 1 – No • Notable comment (of 15): “Yes. Recommendations are routinely treated like regulations.” • One “No:” “It is our belief that many institutions have not routinely implemented OHRP’s recommendations for HSR training.”

  15. Review of Comments—Question 1(b) What, if any, are the reasons for institutions not implementing OHRP’s recommendations on education? • 14 total comments • Comments*: -- 7 stated: Lack of funding and administrative burden are key reasons for not implementing recommendations. -- 5 mentioned: Ignorance and/or lack of understanding as to what should be taught – “too complicated.” *When numbers given do not sum to the total number of comments, it’s because some “answers” touched upon the issues in the question but were not directly responsive.

  16. Review of Comments—Question 1(c) Has any failure of institutions to implement OHRP’s recommendations been a significant contributing factor to noncompliance with the requirements of 45 CFR part 46 and inadequate protection of the rights and welfare of human subjects? If so, please provide examples. • 14 total comments • Comments: -- 5 stated: “No.” -- 3 stated: Not clear what the reasons for noncompliance are. -- 2 stated: Not aware that OHRP had recommendations for education.

  17. Review of Comments—Question 1(d) If failure of institutions to implement OHRP’s recommendations has been a significant contributing factor to non-compliance…, would promulgation of a regulation requiring institutions to implement training…for certain individuals involved in the conduct, review, or oversight of human subjects research be the best mechanism to address this problem…? • 17 total comments • Notable Comments: -- A clear and concise OHRP guidance document would be a far better mechanism. -- I do not believe that human subjects protections will be enhanced through promulgation of a regulation. Education is already universally embraced. -- Guidance, as opposed to regulation, would allow institutions greater flexibility…[which] is essential[.]

  18. Review of Comments—Question 1(e) Even if there are no data suggesting that failure of institutions to implement OHRP’s recommendations regarding education…has been a contributing factor in non-compliance with the requirements…are there other sound reasons for developing further guidance or a regulation regarding education…, and if so, what are they? • 14 total comments • Notable Comments: -- Yes, because [such] would ensure resources are at adequate levels to carry out and monitor training. -- Many who have taken training in this area believe that completing an education requirement will help them conduct better science. -- It is reasonable to conclude that education activities are valuable with or without specific data

  19. Review of Comments—Question 2 If HHS decided to propose further guidance recommending, or a regulation requiring…education, [who] should receive education and requiring and why: IRB chairpersons; other IRB members; IRB staff; principal investigators; others involved…(e.g., co-investigators, study coordinators); FWA signatory officials; HPAs; or any other categories (please specify)? • 31 total comments • 21 of 31 specific comments chose: “All of the Above” • Other notable comments: -- Institutions should be allowed to determine -- Others singled out: IRB members OR investigators

  20. Review of Comments—Question 3(a) Should further guidance or a regulation include provisions stipulating specific content for the training…programs? If so, what should the specific content include and why (for example, should a regulation require inclusion of any or all of the following in the content of the …programs: The commitments and responsibilities of the institution under the FWA; relevant ethical principles cited in the institution’s FWA; relevant Federal regulations…; OHRP guidance; other applicable guidance; relevant state and local laws; institutional policies for the protection of human subjects; or other content (please specify)?

  21. Review of Comments—Question 3(a) Twitter version of question: Should OHRP stipulate specific content? • 26 total comments received • 20 advocated generally for clear guidance describing expected content in broad areas with allowance for institutional flexibility • 6 comments stated outright that institutions should be given full authority to determine content of education programs

  22. Review of Comments—Question 3(b) Should the training and education requirements differ depending upon the nature of the individual’s involvement in research? If so, in what manner? • 20 total comments received • 15 stated that the educational requirements should be tailored depending upon a person’s role

  23. Review of Comments—Question 3(c) Notwithstanding whether training should be tailored according to an individual’s role in the clinical research process, is there a minimum level of knowledge and skill that should be expected of anyone working in some aspect of the research enterprise? • 14 total comments • 10 supported the notion of a minimum level • Notable (representative) comment: “It is reasonable to expect a minimum level of knowledge of research personnel, but how that training is organized and delivered should remain flexible.”

  24. Review of Comments—Questions 3(d) and (6) How often should the content of the materials used for this training be updated (question 3(d)) and how often should the training itself be completed (question 6)? • < 10 total comments (on updating content); 19 total comments (on taking training) • All over the place: -- Leave up to institution – no need to prescribe -- Every 3 years -- Annually or biannually -- “Periodic” or “Ongoing” -- Whenever there is a change in federal, state, local laws, regulations, or institutional policies (updating content) -- Depends on type of research (taking training)

  25. Review of Comments—Question 4 Should further guidance or a regulation include provisions stipulating that proficiency in human subjects protection requirements be demonstrated in some way (please specify)? • 17 total comments • 15: Yes, but… -- Guidance should suggest, rather than require demonstration of proficiency -- Institutions should develop their own standards • Only one comment called for direct OHRP involvement, managing results/certification, etc.

  26. Review of Comments—Question 5 Should further guidance or a regulation include recommendations or requirements for individuals to complete some minimum amount of training and education prior to any involvement in the conduct, review, or oversight of human subjects research? • 17 total comments, all in general support of this notion • 10 specified the content identified elsewhere in the RFI and comments – e.g., Belmont Report, 45 CFR part 46, GCP

  27. Review of Comments—Question 7 Should further guidance or a regulation include recommendations or requirements for institutions to prepare and maintain written procedures for ensuring implementation of the training and education requirements? • 11 total comments • 7 = No • 3 = Yes • Notable comments: -- No  Since education is not a cookie cutter operation, the actual training program is likely to be an amalgam of…resources. This is difficult to document in procedures. -- Yes  Guidance should include recommendations for documentation, with flexibility.

  28. Review of Comments—Question 8 Should further guidance or a regulation include recommendations or requirements for institutions to prepare and maintain written documentation that individuals covered by the regulation have completed the required training and education activities? • 18 total comments • 12 = Yes, a few of whom envision a direct role for OHRP in maintaining such programs and documentation • 6 = No • Notable comments: -- Yes  HHS could assist by having specific programs established through OHRP -- No  Guidance, but not requirements, on institutional maintenance of training records

  29. Review of Comments—Question 9 If HHS decided to propose a regulation, what would the estimated costs of the regulation be to institutions in terms of infrastructure and man-hour costs? OHRP is interested in receiving specific information on such estimated costs from all types and sizes of institutions that hold OHRP-approved FWAs. OHRP recognizes that the HHS human subjects protection regulations extend to a wide-range of institutions, from very small organizations and businesses that employ no more than a total of 5-10 individuals, to major academic research and health centers that may have literally thousands of individuals affected by any new training and education regulation. When providing comments regarding cost estimates, please include a description of assumptions that were made for calculating cost estimated (for example, assumptions made regarding the number and types of individuals who would be required to undergo training and education, the modalities that would be used for delivering the training and education, the time it would take for covered individuals to complete initial and continuing training and education, and how often continuing training and education would need to occur).

  30. Review of Comments—Question 9 Twitter version: If HHS decided to propose a regulation, how much would it cost? • 16 total comments • All over the place: -- 1-2 % of grant money (medical college) -- not possible to estimate (university) -- .5 full-time equivalent (government health center) -- $650,000 for an institution with 750 PIs (academic medical center) -- $388,200 for a university with 3,000 investigators (university) Notable comments: -- “Regulations will add cost without clearly adding value.” -- “By requiring training to be completed on a periodic, as opposed to annual, basis and by encouraging institution-wide training…the financial burden of research ethics training on the individual institution can be ameliorated.”

  31. Summary The vast majority of comments were general, non-specific statements in support of education. Taken as a whole, there was not a definitive picture presented by the commentators as to what specific role regulations and/or guidance and/or OHRP should play in achieving the goal of educating people involved in activities related to human subjects research and protection.

  32. Office for Human Research Protections (OHRP) Elyse I. Summers, J.D. Division of Education and Development Phone: (301) 402-5559Fax: (301) 402-0527E-mail: esummers@osophs.dhhs.gov ohrp@osophs.dhhs.gov • Web Site: http://www.hhs.gov/ohrp/

More Related