Conflict of Interest and Confidentiality
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.
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 or via videocast, as of September 20, 2013. 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 underrepresented minorities in programs supported by NIGMS, reports from meetings or workshops and overarching issues of review policy are also appropriate for the open session. High-level review of possible future funding opportunity announcements are presented in the open session at the September meeting, but issues concerning specific grant applications and other confidential matters must NOT be discussed in the open 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. The Council also considers appeal letters received from applicants who believe that the review process or study section recommendation was flawed. A formal appeal must be in writing and submitted with concurrence from an institution’s Authorized Organizational Representative; all formal appeals are taken to Council. There are four bases for a formal appeal: reviewer(s) bias, unmanaged conflict of interest, lack of appropriate expertise on the review panel or significant factual error(s) that could have substantially altered the review outcome. There are two outcomes for an appeal: defer for re-review or concur with the initial review group’s recommendation. Funding decisions cannot be appealed. Differences with reviewers’ scientific opinions do not constitute an appeal, but are instead considered a grievance.
For applications approved by the scientific review group, the Council may do any of the following:
- Concur with all recommendations of the study section, including budget and duration of support;
- Concur with the scientific assessment but recommend changes in the budget, duration of support or both; or
- Recommend deferral of the application for review by the same or a different study section in those instances where the investigator submitted an appeal and Council concluded that the review appeared to have been flawed.
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 emerging, 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 those from new/early stage investigators. Council may designate an application as high program priority (HPP), indicating that it should be given additional consideration for funding. Council may also designate an application as low program priority (LPP), which signals low enthusiasm for funding.
Institute staff also bring to Council’s attention applications from well-funded investigators (those who have more than $750,000 in direct costs for research) for additional consideration.
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 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 Training, Workforce Development, and Diversity Division and the Division of Biomedical Technology, Bioinformatics, and Computational Biology fall into this category, as do applications submitted under requests for applications (RFAs). In addition, where NIGMS serves as the lead or administrative Institute for NIH Common Fund initiatives, the Council usually performs 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:
- Consider only closed-session items, possibly only focusing on a selected subset of applications for second-level review;
- Utilize the Electronic Council Book and Secure Council Web site in conjunction with electronic voting/approvals;
- Organize a telephone conference to address necessary business;
- Utilize an Intranet-assisted meeting format; and/or
- Relocate the meeting to another site and/or date.
The NAGMS Council Executive Secretary, in consultation with the Director, NIGMS, and senior NIGMS staff members, will communicate the altered procedures and meeting arrangements to Council members.
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.
Role of the Council in Review of Applications
Through the Electronic Council Book (ECB), each Council member has access to summary statements assigned to NIGMS for the current Council round. Generally, applications assigned to NIGMS as the primary institute that rank at the 75th percentile (or score of 60) or better are considered for en bloc approval. Applications with a secondary assignment to NIGMS must be scored better than the 30th percentile or receive an impact/priority score better than 40. 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 60 will be available. For the Training, Workforce Development, and Diversity (TWD) 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 75th percentile, have a priority score over 60, 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. Council members cannot view summary statement from applicants with whom they have conflicts. At the Council meeting, laptops containing the 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.
- 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?
The study section provides technical merit evaluation of grant applications to guide NIH staff in making funding decisions. 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. 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, as outlined by the investigator’s appeal letter, or the recommendations were inappropriate and the issue cannot be resolved administratively, staff will prepare a Staff Summary Statement describing the problem and offering a recommended course of action. Written comments from the SRO are also included in the materials Council evaluates. The recommendation may be for an increase in the level of funding, an increase in the length of the award or, in the case of an appeal, deferral for re-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. The Council may:
- Concur with the study section recommendation in all particulars; in this case, no special action is required;
- Concur with the action recommended by NIGMS staff; a formal vote is required; or
- 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.
When the Council defers for re-review an application for the renewal of an ongoing NIGMS-supported research project, the Institute will provide funds to support the research program at a modest level until the review is complete. These funds do not come from a special source but rather from the same funds used to make all research grant awards.
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) that might bar an expedited award. If all three components (Council member[s], program director and grants management specialist) vote for the expedited process, NIGMS staff will begin work on the Notice of Award. If any concerns are noted, the application will return to the queue for the Council meeting and be considered according to the usual procedures.
Council Guidelines and Operating Procedures
Guidelines for funding decisions and operating procedures for the NAGMS Council are available at http://www.nigms.nih.gov/Research/Application/NAGMSCouncilGuidelines.htm.
NIGMS MERIT Awards
MERIT Awards 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. For information on MERIT award nominations and extensions, see http://www.nigms.nih.gov/Research/MeritAwards.htm.
Conflict of Interest and Confidentiality
Conflict of Interest
Federal regulations concerning conflict of interest will be read at the beginning of the closed session of the Council 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 identify 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 NIGMS director or the NIGMS associate director for extramural activities. 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 NIGMS associate director for extramural activities if there are any questions.
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 NIGMS associate director for extramural activities. 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 the NIGMS 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 must not contact Council members, as this is a violation of review policy and procedure; they should contact the appropriate NIGMS program staff. NIGMS staff will notify applicants about relevant Council decisions.