• National Advisory General Medical Sciences Council: General Information
• What You Get and What To Do with It
• Council Guidelines and Operating Procedures
• MERIT Award Nominations
• MERIT Award Extensions
• Conflict of Interest -- General Policy

NATIONAL ADVISORY GENERAL MEDICAL SCIENCES COUNCIL
General Information on Council Meetings and Functions

The National Advisory General Medical Sciences (NAGMS) Council meets three times a year to provide advice to the Director, National Institute of General Medical Sciences (NIGMS) on policy matters; to recommend concurrence or non-concurrence with recommendations of initial review groups’ evaluations of applications for support of research and research training; and to provide redress of real or apparent errors that may have occurred during initial review. This is required by law (Public Health Service Act) and reiterated in the NAGMS Council Charter.

OPEN SESSION

Part of most Council meetings is open to the public, and any member of the public, including the press, may attend on a space-available basis. This is a time for information exchange between Institute staff and Council members and can lead to policy recommendations. The open session also provides an opportunity for the Council to provide feedback to NIGMS on the effects of Institute policies and operating procedures. For example, discussions on policies concerning Research Career Development Awards, the number of Method to Extend Research in Time (MERIT) Awards NIGMS should make, and principles for awarding grants during tight budgetary situations have been conducted in the open session. Discussions on the inclusion of women and minorities in programs supported by NIGMS, reports from meetings or workshops, and overarching issues of review policy are also appropriate for the open session. Issues concerning specific grant applications and other confidential matters must NOT be discussed in the open session.

CLOSED SESSION

The review of individual applications is considered confidential, and the portion of the meeting concerned with their review is not open to the public.

The primary function of the Council is to provide the second level of review for grant applications. Except under very special circumstances, only those applications considered to have significant and substantial merit by both the scientific review group and the Council may receive a grant award. The Council provides oversight to ensure that the initial review for scientific and technical merit conducted by the study section was fair and in compliance with policy. Council review complements--rather than duplicates--study section review. Council also considers appeal letters received from applicants who believe that the review process or study section recommendation was flawed. Differences with reviewers’ scientific opinions do not constitute an appeal.

For applications approved by the scientific review group, the Council may do any of the following:

1. concur with all recommendations of the study section including budget and duration of support;
   
   
2. concur with the scientific assessment but recommend changes in the budget, duration of support, or both;
   
   
3. recommend deferral of the application for review by the same or a different study section in those instances where the review appeared to be conducted inappropriately, the study section appeared to reach a conclusion not supported by the evidence, or the study section appeared to lack the expertise necessary for reviewing the application; or
   
   
4. not concur with the recommendations of the study section on grounds other than scientific and technical merit; the application will not be re-reviewed.

The Council is asked to apprise staff of applications with special significance, such as those in which the area of research is especially important or the method or approach is particularly outstanding. Staff also should be made aware of applications that may need special consideration because of Institute policies, such as applications from new investigators.

Applications that raise no special issues need not be discussed individually. On these, Council may vote en bloc concurrence with the recommendations of the study section.

While issues and concerns that pertain to one Division (e.g., Genetics and Developmental Biology) will be discussed in breakout sessions, some items cut across divisional boundaries and will be handled in the full closed session of Council. Applications in the Minority Opportunities in Research Division, the Center for Bioinformatics and Computational Biology, and Training fall into this category, as do applications submitted under Requests for Applications. In addition, where NIGMS serves as the lead or administrative Institute for Roadmap initiatives, the Council will perform the second level of review for these applications.

EMERGENCY PROCEDURES FOR COUNCIL MEETINGS

In the event of an emergency that would preclude the usual Council meeting from occurring, NIGMS staff will consider utilizing one or more of the following procedures:

1. consider only closed-session items, possibly only focusing on a selected subset of applications for second-level review;
   
   
2. utilize the Electronic Council Book and Secure Council Website in conjunction with electronic voting/approvals;
   
   
3. organize a telephone conference to address necessary business;
   
   
4. utilize an intranet-assisted meeting format; and/or
   
   
5. relocate the meeting to another site and/or date.

The NAGMS Council Executive Secretary, in consultation with the Director, NIGMS and Senior Staff, will communicate the altered procedures and meeting arrangements to Council members.

WORKING GROUPS

From time to time, chartered Federal advisory committees may create working groups to provide advice or recommendations to Council, gather information, or assist with a particular project. These working groups will consist of Council member(s), NIGMS staff member(s), and external consultant(s) as needed. Council members may be asked to participate in working groups as the need arises.

WHAT YOU GET AND WHAT TO DO WITH IT

ROLE OF THE COUNCIL IN REVIEW OF APPLICATIONS

SUMMARY STATEMENTS

Through the Electronic Council Book (ECB), each Council member has access to summary statements for all NIGMS applications ranked at 65th percentile or better. Applications with a secondary assignment to NIGMS must be scored better than the 30th percentile. In addition, some applications such as Small Business Innovation Research (SBIRs), Small Business Technology Transfer (STTRs), and Academic Research Enhancement Awards (AREAs) receive only a priority score; summary statements for these with priority scores better than 300 will be available. For the Minority Opportunities in Research (MORE) Division and training grants, all scored applications are available. All applications reviewed for a Request for Applications (RFA) will be listed so that members are aware of the full range of submissions. Applications assigned to another NIH institute/center, which NIGMS may wish to co-fund, must also receive Council approval. Council members also can access summary statements for applications ranked worse than the 65th percentile, have a priority score over 300, or not scored if staff, the applicant or a Council member has concerns about the review. As required by the NIH Reform Act of 2006, all new and renewal applications, regardless of requested budget amounts, shall be taken to Council for approval, within the range of scores or percentiles stipulated.

Each member is asked to read and evaluate an assigned group of summary statements. While no one is asked to read them all, we do encourage Council members to read summary statements other than those assigned so that they are aware of the range of research supported by NIGMS and of the variety of issues that arise. Ad hoc consultants need to access summary statements for which they are serving as primary reviewers, but may view others in which they may have an interest through the ECB. At the Council meeting, laptops containing access to all summaries will be available for each member.

In reading and reflecting on summary statements, it is important to remember that the Council is not a study section. The Council is charged with ensuring that the initial review process was conducted fairly and that the conclusions and recommendations of the study section are supported by the written documents. Study section reviewers are asked to provide their best professional assessment of the scientific and technical merit of an application, and it is to be expected that different individuals might reasonably assess the same proposal differently. A review may be appropriate even if the study section reached a conclusion that differs from one that a Council member might reach. Council members should ask themselves questions such as:

• Was this application reviewed by peers? Did the study section have the right expertise represented on the committee? Remember that it is not possible to assemble a review committee specifically for each application (there are over 25,000 applications received each round at NIH). Thus, within practical limitations, were the reviewers knowledgeable in the field?
  
  
• Are the comments in the critique appropriate? Does the summary statement narrative support the priority score? Did the study section raise substantive issues or are the comments trivial? Are the concerns reasonable? If the priority score is very good, the summary statement may contain only minor comments. Some comments in the summary statement are not meant as criticisms but rather as feedback to the investigator for improving the research proposal.
  
• The study section provides technical merit evaluation of grant applications to guide NIH staff in making funding decisions. While desirable, it is not necessary that a summary statement include remedies to weaknesses identified in the application.
  
  
• Are the recommendations for the budget and length of support reasonable? If the study section recommended something other than that requested by the applicant, are the reasons given appropriate?

Council members may question items in the summary statement that appear incongruous with the assessment of the scientific or technical merit and the score.

CONCERNS ABOUT THE REVIEW: APPLICANT, COUNCIL AND STAFF

A major function of the Council is to perform the second level of review, thus ensuring that the initial review was conducted fairly and providing the applicant with redress for real or apparent review errors. Applicants may raise concerns about the review of their application by writing an appeal letter. Since not all applicants communicate their concerns, Council members are asked to be alert for possible errors. Although rare, they do occur. All Council members are contacted by NIGMS staff by telephone before the meeting. Staff should be told about potential problems at this time so that they will have time to investigate the issues and will be able to ask the scientific review official (SRO) of the study section to attend the meeting. Even if Council members have not told staff about concerns in advance, they should raise issues during the meeting; it would be very helpful to alert staff to such concerns even a few minutes prior to doing so at the meeting.

NIGMS staff investigates the issues raised by the applicant, Council members, or NIGMS staff. Staff discusses the situation with the SRO of the study section who conducted the initial review, and if needed, the SRO discusses the concerns with study section members. Frequently, the program administrator concludes that the study section review and recommendations were appropriate and informs the Council at the meeting. Problems can often be resolved administratively to the satisfaction of all parties; these issues do not need to be discussed at Council. If the program administrator concludes that the review may have been flawed or the recommendations were inappropriate, and the issue cannot be resolved administratively, staff will prepare a Staff Summary Statement describing the problem and outlining the recommended course of action. This recommendation may be for an increase in the level of funding, an increase in the length of the award, or deferral for review by the same or different study section (note that, if deferred, the application re-reviewed is the same one that was submitted). For particularly complicated issues, staff may prepare a Staff Information Sheet that describes the issues and offers possible solutions. Council may:

1. concur with the study section recommendation in all particulars; in this case, no special action is required.
   
   
2. concur with the action recommended by NIGMS staff; a formal vote is required.
   
   
3. recommend a different course of action; a formal vote is required and a special Council Summary Statement outlining the actions and rationale will be prepared by staff after the meeting.

EXPEDITED COUNCIL CONCURRENCE VOTING

NIGMS has adopted the Expedited Council Concurrence procedure as one means of shortening the time between application receipt and award. For the best-scored applications from the current Council cycle, a subset of these applications is examined and voted on by assigned Council members and the appropriate NIGMS Program and Grants Management staff. Council members look at these summary statements for congruence between the narrative and score, appropriate expertise on the review panel, etc., as noted above. Staff also evaluate other aspects of the application (e.g., if this is a foreign grantee) which might bar an expedited award. If all three components (Council member(s), Program Director, and Grants Management Specialist) vote for the expedited process, the NIGMS staff will begin work on the Notice of Grant Award. If any concerns are noted, the application will return to the queue for the Council meeting and be considered according to usual procedures.

NATIONAL ADVISORY GENERAL MEDICAL SCIENCES COUNCIL
GUIDELINES AND OPERATING PROCEDURES FOR 2008

GUIDELINES REGARDING FUNDING DECISIONS

The mission of the National Institute of General Medical Sciences includes the support of basic research and research training of the highest quality in the areas of cell biology and biophysics, genetics and developmental biology, bioinformatics and computational biology, and pharmacology, physiology and biorelated chemistry.

In addition, the Institute promotes the broadest possible diversity of ideas and approaches to these scientific areas, and encourages the ideas and talents of established investigators and of new investigators who will provide the next generation of research accomplishments.

In order to achieve these goals, research grant applications recommended for approval by the NAGMS Council are considered for funding using the following considerations:

• scientific and technical merit of the research, as determined by peer review;
• scientific program needs and balance; and
• the availability of funds.

The NAGMS Council has recommended that the Institute scientific staff take additional factors into account in making funding decisions.

1. In determining whether or not to make an award, Institute staff should give special consideration to a highly rated application from a new investigator or other investigators who have no other significant source of research support.
   
   
2. Prior to considering awards to investigators whose total research support from all sources, including the pending award, exceeds $750,000 (annual direct costs), special analysis and justification should be required.
   
   
3. In determining the appropriate funding level for competing continuation awards, the Institute scientific staff will consider:
   
   
   1. the previously awarded level of support;
      
      
   2. special needs for equipment;
      
      
   3. whether the application is the first renewal of an investigator's initial NIH research grant.

OPERATING PROCEDURES AND GUIDELINES FOR STAFF ACTION

1. Adjustments in Amount and Time
   
   The following guidelines for negotiating adjustments of a research or training grant award are agreed to between the staff of the National Institute of General Medical Sciences and the National Advisory General Medical Sciences Council. In determining award amounts and duration, Institute staff will follow the principles developed in the NIH Extramural Portfolio Plan.
   
   
   1. Utilizing the amounts recommended by the Council as a guide, the amount to be awarded, as well as all amounts recommended for future year support, may be changed to reflect the latest information on actual or estimated needs and to be consistent with current policies regarding cost management.
      
      
   2. NIGMS staff may approve increases in the direct cost budget of a grant provided the increase does not substantially impact the scope of the project.
      
      
   3. NIGMS staff may approve increases to the FTTP level on a research training grant. A research training grant with a Council recommended level of 15 FTTPs or less may receive one additional slot. A research training grant with a Council recommended level of 16 FTTPs or more may receive up to two additional slots.
      
      
   4. When the Initial Review Group reduces the number of years requested by the applicant, NIGMS staff may restore up to one year without Council approval.
      
      
   5. For new investigators, NIGMS staff may award an additional year of funding to the grant duration (not to exceed five years) even if it is not requested.
   
   
2. Support of Research in Well-Funded Laboratories
   
   Well-funded laboratories are defined as those with over $750,000 in direct costs for research support, including the pending application.
   
   
   1. Renewal (formerly, competing continuation) grant applications (Type 2s)
      The Council expects the Institute to employ its usual standards and consideration for funding as it handles renewal applications from well-funded laboratories. The expectation is that Type 2 applications from well-funded laboratories will receive normal consideration for funding. Specific exceptions to this general policy will be discussed with the Council, and Institute staff will be guided by the sense of Council in making funding decisions.
      
      
   2. New grant applications (Type 1s)
      The Council expects the Institute to support new projects in well-funded laboratories only if they are highly promising and distinct from other funded work in the laboratory. The Institute’s default position is not to pay such applications. However, under special circumstances and with strong justification, staff may recommend overriding the default position. In order for the application to be funded, Council must concur with the recommendation.
      
      
   3. Budget considerations
      The Council expects the Institute to implement, where appropriate, reasoned budget reductions greater than those dictated by the cost-management principles for competing awards made to well-funded laboratories.
   
   
3. Applications from Foreign Laboratories
   
   NIGMS receives some applications from foreign institutions, and these must be brought to Council’s attention. Because staff generally recommends for funding only those applications which offer unique opportunities when evaluated in the context of existing grants in their portfolios, even well-scored applications may not be awarded. For those applications that may be considered for funding, staff will prepare a Staff Summary Statement which outlines the special opportunities, resources, etc., presented in this proposal. If Council agrees with the staff recommendation, the approval is obtained by en bloc vote; otherwise, discussion in full closed session is required. Staff will be guided by the sense of Council in making funding decisions.

The National Institute of General Medical Sciences has implemented a policy to provide interim support to some unfunded R01 applicants whose renewal applications generally fall within about 10 percentile points beyond the range at which NIGMS is funding grants during that Council round. Selection of renewal applicants who will receive interim funding will be based on several factors, including an applicant's other support, presence of an unobligated balance in the current grant, programmatic considerations, and the availability of funds. The maximum level of interim funding will normally be one-third of the current non-competing direct costs for a 12-month period. A project can receive such interim funding only once within a competing segment. If NIGMS is subsequently able to award the renewal application, funds may be prorated.

The rationale for this policy is that in the current highly competitive review process, many productive laboratories experience funding lapses and may subsequently lose valuable resources and highly trained staff. However, between 55% and 65% of investigators whose renewal applications fall within 10 percentile points of the proposed funding range will receive funding within a year of the time their grants lapse. This policy protects NIGMS' investment in meritorious research projects by ensuring that highly productive laboratories will not be dismantled while reapplying for support.

NIGMS MERIT AWARD NOMINATIONS

The objective of the MERIT Award is to provide long-term stable support to investigators whose research competence and productivity are distinctly superior and who are likely to continue to perform in an outstanding manner. The provision of long-term, stable support to such investigators is expected to foster their continued creativity and spare them the administrative burdens associated with preparation and submission of full-length research grant applications. This may allow investigators the opportunity to take greater risks, be more adventurous in their lines of inquiry, or take the time to develop new techniques. After the initial five years of support, the MERIT awardee may request an extension of three to five more years based on an eight-page progress report and a one-page abstract of the research plan for the extension period.

Nominations for MERIT Awards will be made only once a year at the May meeting of the National Advisory General Medical Sciences Council. All competing R01 grants awarded in the current fiscal year will be eligible for consideration if they meet the nomination criteria listed below. At each meeting, Council members are urged to point out to staff candidates whom they consider suitable for MERIT Award nomination from among those that have applications before the Council at that meeting.

NIGMS is very selective in making MERIT Awards, and at a minimum, grants should meet the following criteria to be recommended for MERIT Awards:

1. The research project should have received support for at least 10 years. Projects that have been supported by NIGMS for less time are eligible if they have been ongoing with other support for at least 10 years.
   
   
2. The grant must have been approved for at least five years.
   
   
3. The project must represent the central research focus for the principal investigator. It will be highly unusual for an investigator to have more than one MERIT Award.
   
   
4. The principal investigator must have an outstanding track record of productivity in the area of research represented by the grant, and there must be reasonable expectation of continued superior achievement.

For each grant nominated for a MERIT Award, staff will prepare a MERIT Award Nomination, discussing the proposed research, the professional background of the principal investigator, and the rationale for nomination. MERIT Award nominations for all NIGMS programs will be posted in the Secure Council Website for review prior to the meeting. Each nomination package will contain the MERIT Award nomination document, a copy of the latest summary statement, and a copy of the principal investigator's biographical sketch and bibliography.

The Council will recommend to the Director, NIGMS, which of the nominees should receive MERIT Awards. The Director, NIGMS, will make the final decision and will notify the principal investigators.

MERIT AWARD EXTENSIONS

The objective of the MERIT Award is to provide long-term, stable support to outstanding investigators. After the initial five years of support, the MERIT awardee may request an extension of three to five more years based on an eight-page progress report and a one-page abstract of the research plan for the extension period. Peer review is provided by the National Advisory General Medical Sciences (NAGMS) Council. The NAGMS Council reviews applications for MERIT Award extensions approximately 15 months before the end of the initial MERIT Award project period (approximately 3.5 years after the beginning of the project period). This allows the applicant sufficient time to prepare an application for study section and Council review without a lapse in funding in the event that the Council decides not to approve an extension. However, because the application is prepared so early, the investigator may not have had sufficient time to reap the full benefits of the MERIT Award, and Council should take this into account when reviewing the extension application. Applications for extension should propose a continuation of the previously pursued line of research and an overall level of effort similar to that of the previous competing segment. Applicants wishing to propose the initiation of major new lines of research and/or significantly increased levels of effort will be advised to submit a regular competing R01 application or a competing supplement at the appropriate time. NIGMS staff will conduct an in depth analysis of the application and will develop a staff recommendation for consideration by the Council. This recommendation will include an analysis of recent progress and the proposed research and a recommendation for the length of the MERIT Award extension period and budget. Council members will receive the staff recommendation memo, the complete extension application, the summary statement from the review of the previous competing application, and any other information that might be pertinent. The Council should consider the appropriateness of the proposed plans and the progress since the most recent competing application. Council should ascertain whether the MERIT Awardee has continued to be a leader in her/his field. The NAGMS Council may advise the Director, NIGMS to take one of the following actions:

1. Approval for up to five years’ extension at a specified budget level for each budget period;
   
   
2. Deferral for additional information; or
   
   
3. No extension; the principal investigator will be advised to submit a competing application.
   

CONFLICT OF INTEREST AND CONFIDENTIALITY

CONFLICT OF INTEREST

Federal regulations concerning conflict of interest will be read at the Council subcommittee meeting, and each member will be asked to sign a statement that he/she has not participated in the review of applications in which there is a real or perceived conflict of interest. En bloc concurrences with study section recommendations are exempted. Institute staff identifies conflicts of interest that arise because of institutional affiliations. However, if a Council member is negotiating with another institution for a job, the member has a conflict of interest with that institution and should notify either the Director, NIGMS or the Associate Director for Extramural Activities, NIGMS. It is not necessary to give a reason. Proposals from individuals with whom a Council member has or had a close personal relationship or significant professional collaboration or disagreement may also present a conflict. This may include former graduate students or postdoctoral associates. Council members should talk with the Associate Director for Extramural Activities, NIGMS, if there are any questions.

CONFIDENTIALITY

All the summary statements and related review materials (appeal letters, staff memos, etc.) are considered confidential and should not be shared with anyone else without specific permission from the Associate Director for Extramural Activities, NIGMS. Because the Institute needs to keep records about who has seen confidential material, a Council member who needs to have a colleague with the appropriate expertise evaluate a summary statement should first check with Associate Director for Extramural Activities.

All deliberations and decisions by the Council during the closed part of the meeting are also considered confidential. Members of Council should not discuss these proceedings with anyone other than NIGMS staff and other Council members. Applicants or other interested individuals who ask Council members for information should be referred to NIGMS staff. NIGMS staff will notify applicants about relevant Council decisions.