January 29-30, 2001

Building 31C, Conference Room 10, NIH, Bethesda, MD

Dr. Wendy Baldwin welcomed the members of PROG and its subcommittee, the Regulatory Burden Working Group, as well as the ad hoc members in attendance. Dr. Baldwin also noted the presence of Dr. Ruth Kirschstein, Acting Director, NIH.

The members were asked to introduce themselves, after which the minutes of the last meeting were approved.

Dr. John McGowan presented an overview and status report of the NIH project on electronic research administration (eRA). This effort is intended to provide an electronic interface between the NIH and the applicant community for the conduct of business. Dr. McGowan noted the infusion of resources that the project is receiving.

In response to a question regarding the need to provide for training in the operations of eRA, Dr. McGowan indicated that $2 million is set aside this year for that purpose, but that that amount may need some future adjustment. A question was posed whether the NIH could not simply adopt the NSF FastLane system. Dr. McGowan noted that it is not that simple, since our policies, procedures, and business rules are different from those of NSF. He also indicated that FastLane was itself undergoing reengineering. He stated that both NSF and NIH are working together so that the systems can exchange data in the Federal Commons.

Dr. Baldwin concluded the discussion by noting that it will continue to be important that the Federal agencies and the applicant community communicate with one another throughout such development, so that the needs and capabilities of both are compatible. Information and updates on progress are found at http://era.nih.gov/.

Dr. Carlos Caban provided an overview of the status of rulemaking to revise the peer review regulations (42 C.F.R. Part 52h) under which the NIH operates. He indicated several reasons for the revision, but that most importantly, this revision would clarify conflict of interest determinations for peer review consultants who are not Federal employees.

Discussion ensued concerning the implications of this revision, and how in practical terms the peer review process should be better able to function, particularly as scientific research becomes more and more multidisciplinary and multi-institutional in character.

Dr. Baldwin introduced this agenda item by indicating that we are currently in a phase-in period for implementing the modular approach to application submission, that fine-tuning continues to occur, and that an evaluation of the mechanism is planned. Dr. Ronald Geller then provided an overview of the modular application, indicating that statistics to date do not indicate that the introduction of the modular application has caused an increase in budget requests. He also indicated that the NIH Institutes and Centers vary widely in their experiences, average costs, etc.

One member noted that there is still some concern by peer reviewers that the format for the Biosketch and Other Support is troublesome, and another member indicated that having these in two separate formats for different types of applications is problematic. The members agreed that a uniform two-page Biosketch and separate Other Support page for all applications would be preferable.

Additional points made were that the modular format has been successful in focusing reviewers on the proposed research, and that the budget narrative should still provide reviewers with the information needed to make informed recommendations in this area. It was also noted that the modular application and just-in-time processes are separate, and that some of the dissatisfaction is with the just-in-time process.

There was also discussion on the current upper limit of $250,000 for the modular application, and perhaps the need for some continual raising of that limit to keep up with inflation. This has been discussed with NIH staff, and will be considered further. Dr. Baldwin concluded the discussion by requesting that members continue this dialogue by forwarding any other thoughts to her that they may have on this issue.

Dr. Anthony Coelho provided a synopsis of the recommended changes to the NIH grant application. Notice had previously been published that the PHS 398 would be undergoing revision, and the community had been asked for input into the process. Dr. Coelho noted that in the current draft revision, the new review criteria are highlighted so that applicants are aware of precisely how their applications will be assessed. Dr. Coelho also noted that the SBIR/STTR applications are now included within the PHS 398, and that "Plain Language" has been used throughout.

No longer will the NIH print and store large quantities of forms, but will provide these electronically and interactive, thereby also permitting that it be a "dynamic" application kit in the sense of being modified more easily as new procedures are adopted. Also, manuscripts in preparation are no longer permitted as appendix material - only those that are published or in press. And most importantly, applicants will be encouraged to be succinct in preparing their applications. That is, the 25-page limit should not be considered the target number of pages, but rather an outside limit.

Dr. Anthony Demsey presented the results of an inquiry of other agencies' experiences with the need for preliminary data in grant applications, behavior of reviewers, and adherence to page limitations. There were no clear trends or patterns. A discussion ensued of the benefits of having more institutes use the R21 mechanism for studies that do not require a great deal of preliminary data. It was also noted that the use of the mechanism should be more standardized across NIH, and that currently, there is no advantage of applying for an R21, because many study sections often treat them like R01s submitted without essential preliminary data.

One suggestion was to have NIH publish a once-a-year RFA for "innovation grants," so that the NIH is committed to supporting a certain percentage of awards each year on risk-taking research. A major concern expressed was whether reviewers can actually change their mind-set, such that applications without much preliminary data can receive a fair review, even when the program is intended not to require preliminary data.

Dr. Nelson Garnett of the NIH Office of Laboratory Animal Welfare presented an overview of how the NIH has responded to recommendations in the Regulatory Burden Report. He also gave a status of the issues of the inclusion of rats, mice and birds as regulated animals, and the proposed definition and categorization of pain and distress. Dr. Ron DeHaven of USDA and John Miller of AAALAC also provided background and status from their perspectives.

The members applauded the cooperation of these separate organizations and individuals in working toward a common good. There was discussion about the requirements for implementing just-in-time IACUC approval, and the need for public comment. Dr. Baldwin indicated that we will soon have a better idea of how just-in-time IRB approval is working, to inform us in perhaps making a similar decision regarding IACUC approval.

There was also discussion about the status of third-party accreditation of IRBs, similar to AAALAC accreditation for IACUCs. It was noted that PRIM&R now has draft standards, and that implementation in 2002 is expected.

There was great concern expressed that inclusion of rats, mice and birds could cause a six-fold increase in burden at institutions. In the discussion that ensued, it was suggested that perhaps some relief could come through streamlining procedures, decreasing and/or coordinating inspections, or redefining what a "yearly inspection" consists of. It was agreed that a subgroup of the members should be formed to address these issues.

Dr. Chris Pascal of the DHHS Office of Research Integrity (ORI) reviewed current requirements that plans for training in the responsible conduct of research (RCR) be in place at institutions by October 1, 2001. He discussed what is meant by "all research staff" and stressed institutional flexibility. Requirements are that the initial training of research staff in RCR be completed by October 1, 2003.

Members questioned why the promotion of RCR training was not done by rule-making. Dr. Pascal indicated that this was a DHHS decision. Concern was also expressed that this is another unfunded mandate, and that mandatory courses are not the way to promote ethical research behavior. One member suggested that the recent re-write of the ORI policy by the Council on Governmental Relations was much better. The session concluded with the recommendation that ORI needs to be truly flexible in allowing institutional initiative, and must work to limit costs to the institutions in implementation.

Dr. Greg Koski, Director of OHRP, presented details of the new simplified assurance process for IRBs. He also discussed the concept of "uncoupling" IRBs from institutions, and promoting the concept of multiple institutions relying on centralized IRBs. He stressed the need to move toward professionalization of IRBs. There were some concerns expressed about this concept, such as increased costs and management of conflicts of interest. Concern was also expressed as to who is ultimately responsible for IRB operations - each institution, or OHRP, since it is they who approve of and register the IRB.

Dr. Koski also presented a new OHRP initiative known as the SUEE Task Force - which stands for "simplification," "uniformity," "efficiency," and "effectiveness." The concept is to form a group of representatives from over 20 diverse agencies, organizations, and stake holders to suggest modifications to current OHRP practices that can be achieved relatively quickly and easily to improve current operations. He noted that this effort builds on the work of the Regulatory Burden Working Group and Report.

Dr. Emmett Barkley of Howard Hughes Medical Institute (HHMI) presented the status of HHMI's recent efforts to streamline and rationalize hazardous waste disposal processes in the academic research institution setting. These efforts involve teams of university officials, investigators, and state environmental officials in each of the 10 regions of the US. The goal is to provide evidence to EPA that there are effective alternatives to current EPA requirements that can provide appropriate protections in the academic setting.

Best practices coming from these efforts are to be presented at a meeting in June, followed by final assessment and presentation of a proposed regulatory model for the academic research setting. While there is some EPA collaboration in this effort, it has not been extensive to date. However, with the expression of recent Congressional interest in EPA's activities in this arena, there is hope that EPA may accept HHMI's recommendations and propose regulatory change to accommodate these recommendations. EPA is required to report their progress to Congress in October.

The members congratulated Dr. Barkley on his efforts, and stressed the need to publicize these endeavors. Dr. Barkley noted that there is a great deal of information concerning these efforts on their web site (http://www.hhmi.org/science/labsafe/). One member suggested that perhaps the change in administration might bring with it a more accepting climate for regulatory change at EPA. It was further suggested that once the report has been made to Congress, there needs to be continued pressure to ensure follow-through by the EPA.

Mr. Gary Thompson provided an overview of the efforts to date to visit institutions around the country, and provide them with feed-back on how effective their institutional procedures are in fulfilling requirements for financial oversight, human subjects protection, assurances for conflict of interest, etc. Mr. Thompson stressed that these visits were not for cause, were not investigations or audits, but were meant to be helpful to the institutions. There have not been nor will there be any individual reports, but only information reported in aggregate as "lessons learned." The important message is for NIH staff to understand how our policies are being addressed so that we can do a better job of educating our community.

Some concern was expressed that no matter how beneficial, considerable effort goes into preparing for such visits, so there is some institutional burden and costs. Nevertheless, it was acknowledged that the benefits outweigh the costs. Mr. Thompson indicated that the visits (10 so far) will continue this year with perhaps an additional 5-7 site visits.

Dr. Baldwin listed a number of issues that came out of the meeting's deliberations that will require immediate action on the part of the group. These include the animal welfare issues noted above, the issue of institutional conflict of interest, human subjects and IRB practices and procedures, and an analysis of the collective effect of regulations. Of equal importance but probably requiring a better understanding of the attitudes of the new administration's officials at DHHS and OMB is the issue of compliance costs and compensation.

After extensive discussion, members volunteered for various subgroups, and Dr. Baldwin indicated that we would be establishing and charging these groups within the next few weeks. It was agreed that the next meeting of the Regulatory Burden Working Group should be independent of PROG and should probably occur in about six months. Other issues for PROG to address were also mentioned. Principal among them was plans for the assessment of the experience with the modular grant application format.

The January 2001 meeting of PROG was held jointly with its subcommittee, the Regulatory Burden Working Group. The meeting began with a welcome to the group by Dr. Wendy Baldwin, who introduced Dr. Ruth Kirschstein, Acting Director, NIH. The members then introduced themselves.

The first two presentations were status reports, the first by Dr. John McGowan on progress on the NIH electronic research administration effort, and the second by Dr. Carlos Caban on progress in rulemaking to revise the NIH peer review regulations.

Dr. Ronald Geller provided an update on the NIH experience with modular grant applications. There continues to be no indication that the modular format is causing an increase in the cost of grants. Members suggested a modification to the Biosketch and Other Support pages, and Dr. Baldwin indicated that fine-tuning will continue as we approach the time when an evaluation of the mechanism will be conducted. Following this presentation, Dr. Anthony Coelho presented the status of the revision of PHS 398, the grant application form.

Dr. Anthony Demsey then provided the results of a survey of other agencies' experiences with preliminary data, reviewer behavior, and adherence to page limitations. No clear trends or patterns emerged, and members reinforced the need for NIH-wide use of the R21 mechanism to support risk-taking research. Current critical animal welfare issues were then discussed through presentations by Drs. Nelson Garnett (OLAW), Ron DeHaven (USDA), and John Miller (AAALAC). The first day concluded with discussion of the new requirement for training in the responsible conduct of research, following a presentation by Dr. Chris Pascal (ORI), and with a presentation by Dr. Greg Koski (OHRP) on new IRB assurance processes and his new concepts on IRB operations.

The second day began with the conclusion of Dr. Koski's comments, and his announcement of the intent to establish a group of consultants to recommend new streamlining initiatives. Next, Dr. Emmett Barkley of HHMI presented the status of HHMI's effort to streamline and rationalize hazardous waste disposal processes in the academic research institution setting. The intent of these efforts is to provide EPA with rationale to propose regulatory change. The final presentation was on NIH proactive compliance site visits, by Mr. Gary Thompson.

General discussion ensued, in which it was agreed to establish several working groups to address regulatory burden issues. It was also noted that PROG would undertake the design of an assessment of the NIH experience with the modular grant application. The meeting was then adjourned.

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

Anthony Demsey, Ph.D.
Executive Secretary, Peer Review Oversight Group

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