In assessing the various suggestions and recommendations presented in the report entitled "NIH Initiative to Reduce Regulatory Burden" and after consideration of public comment on the report, a number of activities have been identified from the report that the NIH can readily commit to pursuing in the immediate future. These activities lend themselves to immediate action and in addition, are selected because their promise in reducing regulatory burden for the research community, while continuing to provide the intended protections, is significant. As these activities get underway, it is expected that additional ones will be identified from the report and considered for pursuit.
The first of the four FTEs was filled with the recent hiring of a Human Subjects Associate Director for Education (HSADE). The HSADE has developed and begun to implement a program of educational outreach visits to awardee institutions and national professional organizations. Contacts have been established with organizations interested in developing "best practices" guidelines and dialogue with these organizations will continue during Fall 1999. The first of a series of web-based tutorials has been drafted and will be brought on-line for testing in November. Fall 1999 activities will also include work on long-range projects such as revising the OPRR Institutional Review Board (IRB) Guidebook, updating the OPRR training videos, expanding the OPRR website, and increasing contacts with the smaller HHS Agencies.
Position announcements to fill the three remaining education FTEs have been prepared and forwarded for posting. Recruitment for these positions should be completed during Fall 1999.
OPRR has recently prepared internal guidance on (i) IRB knowledge of local research context, and (ii) engagement in research, in order to ensure consistency in OPRR staff interpretation of regulatory requirements. Efforts will be made during Fall 1999 to disseminate this guidance to the research community. Monthly meetings of OPRR's Division of Human Subject Protections staff will be held over the next 6 months to address remaining areas of inconsistency. It is anticipated that guidance will be developed in Fall 1999 related to (i) conflict of interest for IRB members, and (ii) qualifications and responsibilities of Assurance Signatory Officials.
Additional education efforts are being undertaken by a bioethicist recently hired in the NIH Office of Extramural Research (OER), who has already established a bioethics resources website at http://www.nih.gov/sigs/bioethics.
OPRR will continue to consult with organizations interested in developing human subject protection accreditation programs. OPRR's goal is to foster development of a viable accreditation program that genuinely strengthens the protection of human subjects while reducing regulatory inefficiencies. OPRR recognizes that a successful accreditation program must incorporate meaningful outcome measures. Such measures must be developed through consensus building within the human subject protection community. During Fall 1999, OPRR will work with interested organizations to begin developing such a consensus.
For example, OPRR currently permits use of telephone conferencing for IRB meetings in extraordinary or emergency situations, while FDA's policy on telephone conferencing is more liberal. OPRR will consult with FDA during Fall 1999 in order to develop reasonable and consistent guidance on IRB telephone conferencing. OPRR will also work with FDA during Fall 1999 to develop consistent guidance on quorum requirements for IRB meetings. November 9 has been tentatively set for the first meeting.
The NIH has recently published guidance in the NIH Guide for Grants and Contracts (6/11/99) to promote more efficient and effective reporting to IRBs of adverse events in multicenter clinical trials. This issue is also a concern for FDA, which is in the process of developing Agency policy in this area. OER will continue to consult with FDA to ensure that the research community receives reasonable and consistent guidance on adverse event reporting.
OPRR and FDA recently expanded significantly the categories of research that IRBs can review utilizing expedited procedures. During Fall 1999, OPRR will begin to work with FDA and the Federal Policy (Common Rule) Agencies to develop and propose regulatory changes that would permit flexible timing of continuing IRB review, more flexible use of expedited IRB review procedures, and designation of additional exemption categories.
During Fall 1999, OPRR will (i) finalize the redesigned Assurance document; (ii) pilot test the redesigned process; (iii) pilot test the Assurance tutorial; and (iv) develop an appropriate computer tracking system. OPRR anticipates implementing the redesigned Assurance process in Spring 2000.
September 29 - National Capitol Area Branch of the American Association for Laboratory Animal Science.
October 2-5 - UC Davis/Georgetown University/OPRR joint meeting in Lake Tahoe, CA
October 8 - New Jersey Association for Biomedical Research
October 17 - Society for Research Administrators in Denver, CO
October 24 - Society for Neuroscience annual meeting in Miami, FL
November 8-11 - National Meeting of AALAS in Indianapolis, IN
December 6-7 - OPRR Workshop in conjunction with the University of Texas, San Antonio, and the Scientists Center for Animal Welfare (SCAW) in San Antonio
This coming fiscal year and in subsequent years, two additional meetings are planned (with $35,000 per year being budgeted) for the expressed purpose of improved dialog with institutional representatives and the research community. In addition, OPRR/DAW and USDA are currently discussing the future inclusion of OPRR/DAW in USDA-sponsored public forums.
The NIH is committed to working with EPA in facilitating recommended changes that would serve to reduce regulatory burden for the research community. The NIH has already initiated discussions with Dr. Emmett Barkeley of the Howard Hughes Medical Institute (HHMI), whose office is also committed to efforts at streamlining and reducing burden in the area of hazardous waste. The NIH participated, along with EPA, in an August 23/24 workshop at HHMI to look at collaborative ways to identify and implement best practices for managing hazardous wastes in major academic institutions. In addition, NIH's responsible official for regulatory burden activities, Dr. Anthony Demsey, will initiate contacts with EPA's new Associate Administrator for Reinvention, Dr. Richard Farrell, and Associate Administrator for Research, Dr. Norine Noonan. It is expected that a first meeting between Dr. Demsey and Drs. Farrell and Noonan to discuss mutual interests and possible future directions will occur within the next month.
In the area of research integrity, the implementation of regulations to reduce regulatory burden is somewhat premature; activities are currently ongoing that will impact on the organization and functions of the Office of Research Integrity and on operational definitions and implementation.
Discussions will begin immediately with the NIH Director on how best, most efficiently and effectively, to establish a Working Group of community experts to assist and advise the NIH Extramural Programs on issues related broadly to regulatory burden. Currently, this Working Group is envisioned as a subcommittee to an existing NIH FACA Advisory Committee.
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