February 4-5, 2002
Marriott Suites, Bethesda, MD

Welcome and Introduction

Dr. Belinda Seto opened the meeting by welcoming the members of PROG and its subcommittee, the Regulatory Burden Working Group. Dr. Anthony Demsey introduced the three new members of PROG, and then asked all members to introduce themselves. The minutes of the last meeting were then approved without modification.

Secretary's Regulatory Reform Initiative

Dr. Christy Schmidt from the office of the Assistant Secretary for Planning and Evaluation (DHHS), discussed this new initiative. A committee has been formed and has held its first meeting, at which four subcommittees were established: (1) data and information; (2) flexibility; (3) communication and oversight; and (4) coordination. Four regional meetings will be held to take testimony, and written suggestions are welcome. During discussion, it was suggested that such a venue should exist long-term, since regulations and their burdens continue to increase. Dr. Schmidt acknowledged this need, and indicated that although there is currently no mechanism for cross-Agency coordination, this will likely become a necessity. The Health Insurance Portability and Accountability Act (HIPAA) was identified as a potentially significant burden, which could eventually lead to a decreased willingness for individuals to participate in clinical trials. Dr. Schmidt acknowledged that formal liaison with the Regulatory Burden Working Group would be desirable.

Hazardous Waste Disposal

Dr. Emmett Barkley of the Howard Hughes Medical Institute (HHMI) discussed activities that resulted from previous interactions with NIH and the Environmental Protection Agency (EPA), and that have now led to the development of a "best practices" document. Dr. Barkley pointed out that the two most important best practices were (1) assigning responsibility for waste determination to an institution's Environmental Health and Safety Program (EHSP) officials; and (2) encouraging the EHSF to assume responsibility to treat waste on site. A Congressional directive asked EPA to evaluate HHMI's efforts, consider incorporation of their findings into practice, and report to Congress. While EPA's response so far has not been to embrace the HHMI report wholeheartedly, HHMI's discussions with the EPA Office of Solid Waste have been promising. That Office's new Assistant Administrator has voiced interest in reviewing the Resource Conservation and Recovery Act's impact on the academic community through stakeholder meetings.

Research Integrity

Mr. Chris Pascal of the Office of Research Integrity (ORI, DHHS) discussed the status of recommendations for training in the Responsible Conduct of Research (RCR). He noted that numerous meetings with scientific organizations had been held over the past summer, and that with the appointment of a new Assistant Secretary for Health (ASH), Dr. Eve Slater, a decision on how/whether to implement RCR for the academic research community will hopefully be forthcoming soon. Members noted that the issue of costs of compliance needs to be brought to the ASH's attention, and Mr. Pascal agreed. It was also suggested that Dr. Slater might want to consider establishing an advisory committee for ORI. Mr. Pascal also discussed the status of proposed rulemaking to implement the new scientific misconduct definition and inquiry/investigation guidelines.

Proactive Compliance Site Visits

Mss. Regina White and Diane Dean of the Office of Policy for Extramural Research Administration (OPERA) discussed the progress and findings from two rounds of visits, and progress on the current third round. In all respects, these visits have met with enthusiasm from the community, and a compendium of findings has been posted on our Web site. It was noted that at the completion of this year's visits, one of the focuses of the visits, conflict of interest, will likely be the focus of an NIH meeting in the fall with the community.

Future Agenda Items

During lunch, members discussed possible future agenda items. Among those identified were (1) translating findings from animal research to human research; (2) issues related to institutional compliance with human subjects concerns - the distinction between requirements placed at the local level vs. at the level of the Office of Human Research Protections; (3) third-party consent; (4) HIPAA implementation and implications to clinical research; (5) uniformity of NIH policies and regulations, particularly as related to the use of mechanisms such as the R03 and R21; (6) regulations that may arise related to bioterrorism research; (7) data sharing; and (8) effects on research of requirements on transportation of animals.

Animal Welfare Workgroup Report

Dr. Janet Greger presented the recommendations from the Animal Welfare Workgroup. Their four major recommendations were endorsed by the full committee: (1) annual instead of semi-annual reviews; (2) implementation of just-in-time IACUC review; (3) a recommended definition of "distress;" and (4) identification of pain classifications. A fifth issue, requirements for alternatives searches, was discussed, with some potential resolution, focusing on applicants' articulation of why alternatives are simply unacceptable. This will be discussed further by the workgroup.

Subsequent to this presentation and discussion, the meeting adjourned for the day.

Human Subjects Research Enhancements Program

The meeting resumed on the morning of February 5 with Dr. Wendy Baldwin introducing the concept of a new NIH program to enhance institutions' abilities to provide for the protection of human subjects in research. Dr. Baldwin provided details of the intent of the program and eligibility. It was acknowledged that such a program would not resolve many issues related to the costs of compliance with regulations in general, but that it would be a very laudable effort nonetheless.

Human Subjects/IRBs Workgroup Report

Ms. Ada Sue Selwitz provided an overview of the Workgroup's deliberations and recommendations. She noted that of necessity, the group's recommendations went beyond the scope of purview of NIH and DHHS, and that the focus of the group was on unnecessary regulatory burden that did not serve to protect human subjects. That is, nothing was recommended that would diminish protections. Recommendations of the workgroup related to training, harmonization of adverse event reporting requirements, resetting the clock after audits/inspections, unnecessary paper trails, IRB review of simple protocol revisions, Subpart C and participation of prisoners in clinical trials, and interactions between IRBs when there is overlap in CDC- and NIH-sponsored research. Consideration now needs to be given on how best to convey the workgroup's recommendations to the various Agencies outside of DHHS.

Institutional Conflict of Interest (COI) Workgroup Report

Dr. Arnold Smith presented the draft position and best practices recommendations of the Workgroup. The draft essentially embraces the position and recommendations of a recent Association of American Universities (AAU) task force. It was acknowledged in the ensuing discussion that this issue is not as well developed and focused as issues surrounding animal welfare and human subjects protections. Dr. Baldwin emphasized the utility of this document, that of the AAU (and perhaps the pending second half of an American Association of Medical Colleges task force's deliberations), the results of our proactive compliance site visits, and the survey of 300 university COI policies, in providing a basis for a fall meeting with the community on this issue. It was agreed that in preparation for such a meeting and to engender fuller discussion, our Workgroup's document should probably stop short of providing "set-in-concrete" best practices. Or perhaps these should be cast as "promising strategies" instead of best practices.

Evaluation of the Modular Application/Grant Process

Dr. Baldwin introduced this issue by drawing attention to an "issues and stakeholders" document that evolved from the November meeting of a PROG/Regulatory Burden workgroup. She questioned whether we were capturing all stakeholders. She also acknowledged that the sample questions were only to stimulate discussion - that a contractor to be selected to implement the evaluation would need to establish the questions properly. In dealing with institutional responses to the new requirements, it was acknowledged that institutions have adapted in variable fashion. The general consensus was that it is unlikely that anyone would want to go back in time to previous procedures for budget preparation and presentation, but that the result of this evaluation could be a fine-tuning of the current process. It was also acknowledged that any evaluation would first need to be piloted, and that focus groups could be useful at the early stages, in helping the contractor develop the questions. In conclusion, Dr. Baldwin asked members to review carefully the current document, and to send us e-mail regarding modifications, what to add, how to stratify (e.g., by type/size of institution, age/gender of PI, experience of the PI with previous budget preparation procedures), etc.

Wrap-up

Dr. Baldwin concluded by providing a status of data sharing guidelines for inclusion in grant applications. She also agreed that a workgroup on HIPAA should be established immediately, since the Notice of Proposed Rule-Making (NPRM) will be published shortly, likely with only a 30-day comment period. She indicated that members will be sent background data on the trends and impacts related to modular grants, as well as internal NIH workgroup reports on the uses of the R03 and R21 mechanisms by the various NIH Institutes and Centers. She then thanked the group for their efforts and adjourned the meeting.

Executive Summary

The February 2002 meeting of PROG was held jointly with its subcommittee, the Regulatory Burden Working Group. The meeting began the morning of February 4 with a welcome by Drs. Belinda Seto and Anthony Demsey, the introduction of members, and approval of last meeting's minutes.

The first four presentations were status reports on related activities: (1) the Secretary's Regulatory Reform Initiative (Dr. Christy Schmidt, DHHS); (2) HHMI and EPA efforts related to hazardous waste disposal regulatory burdens (Dr. Emmett Barkley, HHMI); (3) ORI issues related to training in the Responsible Conduct of Research and scientific misconduct policy implementation (Mr. Chris Pascal, ORI); and (4) Proactive Compliance Site Visits (Mss. Regina White and Diane Dean, OPERA). Subsequently, members identified potential agenda items for future meetings.

Dr. Janet Greger presented the report of the Animal Welfare Workgroup. The Workgroup's consensus recommendations were accepted by the full group, including the recommendation to begin implementation of just-in-time IACUC review. In addition, progress was made on a fifth recommendation, on alternatives searches, that will require further discussion by the Workgroup. Following Dr. Greger's report, the meeting adjourned for the day.

The meeting continued on the morning of February 5 with a presentation by Dr. Wendy Baldwin of a proposed Human Subjects Research Enhancements Program, designed to enhance institutions' activities related to human subjects protections.

Subsequently, Ms. Ada Sue Selwitz presented the recommendations of the Human Subjects/IRBs Workgroup, which were endorsed by the full group. This was followed by a presentation of the recommendations of the Workgroup on Institutional Conflict of Interest by Dr. Arnold Smith. It was agreed that this report would be useful in contributing to a fuller discussion of the issues at a fall meeting of the community, to be held on the NIH campus. Finally, Dr. Baldwin initiated a discussion of the upcoming effort to evaluate the modular application/grant process. Following this, the meeting was adjourned.

We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Anthony Demsey, Ph.D.
Executive Secretary of PROG

Wendy Baldwin, Ph.D.
Deputy Director for Extramural Research