Revised December 2011
- I'm a relatively new investigator - where do I start to apply for support?
- How do I find out about different types of funding mechanisms and how do I know what kinds are appropriate for me?
- Are there specific opportunities for basic, applied, or clinical science researchers?
- What kind of training or career development award might be right for me and how do I find out about them?
- How do I know whether my application needs to be submitted electronically or by hard copy? Where can I get application forms?
- What does "extramural" mean? What does "intramural" mean?
- What are the roles of various NIDA extramural staff?
- What is the role of the Scientific Review Officer?
- What is the role of the NIH Program Official or Program Officer?
- What is the role of Grants Management?
- What are the roles of the Contracting Officer and Contract Specialist?
- What are the differences among a Program Announcement, a Request for Applications, and a Request for Proposals?
- What is the difference between a solicited and an unsolicited or investigator-initiated grant application?
- How much money should I request?
- Whom should I contact if I need help completing the application or proposal?
- Where do I submit my application?
- What is the Center for Scientific Review?
- What happens after submission?
- Why are some applications reviewed by CSR review panels while other applications are reviewed by NIDA review panels?
- May I suggest an assignment to NIDA or another Institute?
- May I choose where I want my application to be reviewed?
- Who will review my application or proposal?
- How do I find out who is on the review panel?
- May I suggest reviewers?
- What can I do if I think that someone on the committee is biased against my work or my application goes to the wrong committee?
- Suppose I have questions after submission?
- How do I submit additional information before my application is reviewed?
- Do I need Institutional Review Board (IRB) approval for my application?
- I've heard that I need to present plans for data safety monitoring in some applications. What is expected?
- What does it mean if I get a notice of grant application reassignment?
- What does an SRO consider in setting up a meeting?
- When will my application or proposal be reviewed?
- What happens in a review meeting?
- What scoring scale is used?
- Why are review meetings confidential?
- Can I talk to my reviewers about my application before or after the meeting?
- My application was designated "not discussed" or ND or had only **'s instead of a numerical impact score. What does this mean?
- How are percentiles calculated and what do they mean?
- What should I expect in my summary statement?
- How should I use my summary statement if I need to revise and resubmit my application?
- How can I find out my score?
- When and how do I receive my summary statement?
- Whom do I contact after I receive the summary statement?
- If I don't agree with the criticisms in the summary statement, what should I do?
- Is there an appeals process for the review?
- What is "Dual Review"?
- What is NIDA's Council's role in grant reviews?
- How is it decided if my application will be funded?
- How can I find out if my application will be funded?
- What should I do when I find out that my application will not be funded?
- What is the "just-in-time" information?
- When should I get IRB/IACUC approval?
- When does my clinical trial require a Data and Safety Monitoring Board (DSMB)?
- What is a data sharing plan and when is it required?
- What should I do when I find that my application will be funded?
- What happens after I get funded?
- What else should I know?
Begin by determining if your research interests are congruent with NIDA's mission, which is to lead the Nation in bringing the power of science to bear on drug abuse, addiction and associated infections such as HIV, HCV, TB and others. Next, talk to a Program Official about your interests and specific aspects of NIDA's mission. To find a Program Official, you can start by exploring the organization of NIDA on our home page. You can locate staff who might be relevant in a division, center, branch, or workgroup, or call the Public Information Branch (301-443-1124) for the names of Program Officials who work in the specific scientific areas of your interest. For information on funding support of grant applications, look on the NIDA home page under Funding And the related Requests for Applications, Program Announcements, and other guidelines. For information on funding support of contract proposals, look under Funding, then Contract Requests for Proposals. These funding opportunities may also be found in the NIDA Requests for Proposals and the NIH Funding Opportunities and Notices pages.
If you are in an institution of higher education, your school probably has an Office of Sponsored Programs or Office of Research Development that can assist you with developing your application.
How do I find out about different types of funding mechanisms and how do I know what kinds are appropriate for me?
NIH supports many types of research and training funding mechanisms including small R03 grants, innovative R21 grants, and traditional R01 research grant application opportunities, as well as Program Project and Center P mechanisms. Again, contacting NIDA staff by email, phone or at scientific meetings will help you to learn about the types of mechanisms that best match your research or research training interests and the current priority areas for NIDA.
NIDA supports science related to drug abuse as broadly defined, and this includes an extensive array of projects and programs involving training and research in basic, applied, and clinical research.
What kind of training or career development award might be right for me and how do I find out about them?
NIDA supports several types of training and career development programs. See Research Training Opportunities for Young Investigators and Research Training and Career Development Time Table to learn about funding mechanisms and opportunities for predoctoral, postdoctoral, early career, and career transition funding opportunities. Training is a high priority at NIDA, and the specialist NIDA program staff Research Training Committee will assist you in determining what type of award might be right for you.
How do I know whether my application needs to be submitted electronically or by hard copy? Where can I get application forms?
NIH is in the process of transitioning to electronic grant applications, and the transition plan schedule and other details are at Applying Electronically with related details at Enhancing Peer Review at NIH and Standard Due Dates for Competing Applications.
Many of the common funding mechanisms (R01, R21, R03) now require electronic submission, while a few others (e.g. P mechanisms) may transition later.
For either paper or electronic grant application submission, all applications are now submitted in response to a Funding Opportunity Announcement (FOA). The “Parent Announcement” may be used if a specific Program Announcement, RFA, etc. is not being cited. Funding Opportunity Announcement are provided at the NIH Guide for Grants and Contracts, and typically are also available at Institute websites, such as the NIDA funding opportunity website at Researchers. The PHS 398 Grant Application is still used for some research grants, research career awards, and institutional training grants. Applicants may be interested in SBIR, Loan repayment, research or other funding mechanisms, and obtaining the corresponding forms and instructions is necessary.
For grant application funding mechanisms that have transitioned to electronic application submission, most organizations have already registered for electronic submission. If it hasn’t done so, information for the organization is at Grants.gov Registration Instructions for Domestic and Foreign Organizations. Your organization’s Signing Official can enable grant applications to apply by assigning you a NIH Commons account. This login and password will enable you to enter the eCommons website, and your DUNS number and other information will be entered along with that of the organization to enable the upload of your application at the grants.gov website at Grants.gov; this process requires that both the applicant and the organization’s signing official provide information that enables the eSubmission to Grants.gov.
You will also need to download the 424 electronic form package specific to a particular funding opportunity announcement (FOA) and a specific funding mechanism (R01, R21, R03, and others that have transitioned to electronic applications). Funding opportunity announcements may be found either at the NIDA funding opportunity website, at the NIH Office of Extramural Research Funding Opportunities and Notices website, or at Grants.gov. Electronic funding opportunity announcements (FOA’s) include Program Announcements, RFA’s and FOA’s for unsolicited grant applications. Since forms and procedures are sometimes modified, use recently posted grant application packages, and when you download an application package, sign up to receive and be alert to updates.
For NIDA contracts, guidance for forms and submission procedures for NIDA Requests for Proposals are found with the related broad agency announcement and at the NIDA Requests for Proposals website at NIDA Requests for Proposals (RFPs). It may also be helpful to read guidance about contracts available at the Office of Acquistion Management and Policy website and at the NIH-wide Grants and Contracts website. An important difference from research applications is that, while it may be helpful to obtain guidance from many sources, once a contracts-related FOA is issued, the NIDA Contracts Office should be your primary point of contact. NIDA-specific FOA’s are at the NIDA Requests for Proposals (RFPs) page, and all contract opportunities are available at Fedbizopps.gov.
NIDA, like other NIH institutes, has an "intramural" program and an "extramural" program. The intramural program consists of the research activities conducted by investigators that NIDA employs; it is located in Baltimore, Maryland.
The extramural program consists of the research and associated activities that support scientific endeavors conducted mainly by non-federal persons. "Extramural" refers both to the NIDA staff who administer the extramural program and to the NIDA-supported researchers who receive extramural funds. NIDA supports extramural research projects through grants, but contracts and other mechanisms are also used.
There are four classes of professional staff that you are most likely to encounter in your interactions with NIDA. They are the Program Official (or Project Officer) (PO), the Scientific Review Officer (SRO, recently changed from Scientific Review Administrator or SRA and there may be some use of the older term in some documents), and either the Grants Management (GM) Officer or Specialist if you are developing a grant application, and the Contracting Officer (or Contract Specialist) if you are developing a contract proposal. Their roles are complementary and interlocking, and each is typically more active at different stages of the research process. The PO is usually the primary contact during the time period in which the Principal Investigator plans, develops and submits the application or proposal. The SRO has primary responsibility for the review of the application. Funding decisions and transfer of funds involve the PO and a GM or CS specialist. Research oversight and management, usually based on progress reports from the Principal Investigator, involve the PO and either the GM or CS officials.
The SRO is the designated federal official responsible for ensuring a fair, equitable, and appropriate scientific review of grant applications or contract proposals. Using his or her knowledge of a variety of scientific areas, the SRO assesses the scientific content of an application or proposal to determine the types of expertise needed for its review. The SRO then identifies potential reviewers with the requisite skills, selects the review group from this pool of potential reviewers, assigns particular applications to participating reviewers for written comments, selects the committee chair, and arranges and manages the review meeting. As needed, he or she provides training regarding review criteria and procedures, as well as NIH policies. The SRO also ensures that applications are complete and ready for review and that certain requirements (e.g., human subjects protections) have been met. He or she manages and conducts the Scientific Review Group (SRG), also known as a "study section," for grant applications or the Technical Evaluation Group for contract proposals and prepares a summary that reflects the comments and recommendations of the reviewers. The SRO can also assist you by providing general information on NIH review policies, procedures, and related issues. Review staff also make presentations at scientific meetings and organize conferences and workshops to disseminate information about NIDA and NIH policies and procedures. Much of the SRO's logistical support is provided by the Extramural Support Assistant(ESA).
From the time you submit a grant application until completion of its review, the SRO is your point of contact. For contract proposals, the Contract Specialist and Contracting Officer are the points of contact.
The PO identifies areas of science in which more research is needed and communicates this information to potential grant applicants. The PO does this through writing sections of Program Announcements, Requests for Applications, and Requests for Proposals, which are documents that formally notify the field about research areas of interest to NIDA and opportunities for funding. Program staff also make presentations at scientific meetings and organize conferences and workshops to disseminate information about NIDA programs and new scientific directions. Through discussions of the applicant's research concepts and provision of information, Program staff help investigators develop their applications.
After the summary statement is made available to you at eCommons, the assigned Program Official is your point of contact. The Program Official uses the information from review meetings and summary statements to make funding recommendations, and he or she provides the Institute's scientific administration of grants and contracts once they have been awarded. Program Officials also monitor progress with research based on annual progress reports and other interactions with grantees, and evaluate possible changes in research directions and other issues raised by grantees. In the event that an application is not funded and a decision is made to resubmit, Program Officials work with applicants, providing both scientific and technical assistance as needed.
Grants management personnel include Grants Management Officers (GMOs), Grants Management Specialists (GMS), and Extramural Support Assistants (ESAs). The GMO signs the grant award and is the NIH official responsible for the business management and other non-programmatic aspects of the award. These activities include, but are not limited to, evaluating applications for administrative content and compliance with federal statutes, regulations, and guidelines; negotiating grants; and providing consultation and assistance to applicants and grantees (including interpretation of grants administration policies and provisions and administering and closing out grants). The GMO is the focal point for receiving and acting on changes in the terms and conditions of award and is the only NIH official authorized to obligate NIH to the expenditure of funds or to change the funding, duration, or other terms and conditions of a grant award. The GMS is responsible for the day-to-day management of a portfolio of grants.
Grants management personnel work closely with counterparts in other NIH institutes and as a team with program and review staff. They also work with investigators and their business organizations to ensure appropriate financial management of the grant. The Grants Management Specialist should be contacted when there are questions about fiscal requirements of a grant.
The Contracting Officer receives and acts on contract proposals, and the Contract Specialist is assigned day-to-day management responsibilities. Contract staff assist program staff in drafting contract request packages; thereafter, they solicit, negotiate, and administer the Institute's contracts. They maintain surveillance over the Institute's contract program, and they develop and implement standards for the overall management of the Institute's contract program. Contract staff serve as an important part of the Institute's overall team, as they advise personnel on contract management policies and procedures. Finally, and perhaps most importantly from the extramural researcher's point of view, all contacts, queries, and other communications about a particular Request for Proposals (RFP) are directed to the Contract staff during the stages of solicitation, review, and negotiation for award.
What are the differences among a Program Announcement, a Request for Applications, and a Request for Proposals?
A Program Announcement (PA) is a formal expression of an institute's ongoing interest in funding a particular area of science. PA’s define areas that an institute is particularly interested in funding, and they are of several types, Including a “simple” Program Announcement, a PAR or Program Announcement Reviewed within an Insitute; and a PAS, Program Announcement with Set-aside funds. Applications for grant support may cite a PA, but this is not necessary. A Request for Applications (RFA) indicates a specific interest in receipt of applications and solicits applications, and funds are set aside for applications reviewed in response to that announcement. A receipt date is specified, and the applications submitted in response to the RFA are reviewed and considered together as a group competing for funds. The application must cite the RFA to be considered with that group. A Request for Proposals (RFP) solicits contract offerors to submit their bids and proposals. PAs, RFAs, and RFPs are published in the NIH Guide to Grants and Contracts at Funding Opportunities and Notices.
What is the difference between a solicited and an unsolicited or investigator-initiated grant application?
All applications to NIH must now identify a specific funding opportunity announcement. However some FOA’s are generic to a funding mechanism (e.g. an “unsolicited” R01, R21, R03 application) and some FOA’s are specific to given Institute/Center(s) or announcement (e.g. a “solicited” R01, R21, R03 with a specific NIDA theme). All NIDA funding opportunity announcements (FOA’s) are available at the NIDA website, NIH Guide, and Grants.gov websites provided above. Solicited applications that use FOA’s that are announced priority areas for NIDA include Requests for Applications (RFAs) or Program Announcements (PAs) in which NIDA participates. If your application theme can fit well within one of these (again, discussion with NIDA Program Staff is recommended), use the SF 424 R&R form available for that FOA. Remember that each grant funding mechanism supported by NIH has a more general “parent” funding opportunity announcement that is also used for unsolicited (aka investigator-initiated) applications, so if you do not find a specific PA or RFA of interest to you, you certainly may still submit an application by citing the parent or generic FOA for the funding mechanism (R01, R21, R03, etc. as described at Parent Announcements (For Unsolicited or Investigator-Initiated Applications)). Investigator-initiated or unsolicited grant applications remain the majority of applications received by NIDA and NIH.
Budget limits and guidelines for preparation are provided with each funding opportunity announcement, and these differ significantly for each funding mechanism; generally R03, K and R21 budgets are lower than R01, T or P mechanism budgets. Your application should request only what is necessary to conduct the research that you propose. Your budget should be consistent with the project. If you request more than $500,000 direct costs for any year of a grant project, you will need to document written prior approval from a Program Official NIH Grants Policy Statement. If you request under $250,000 per year, the budget should use a simpler modular format as described at NIH Modular Research Grant Applications.
A NIDA Program Official familiar with your area of science can give general advice on whether your research is relevant to NIDA's mission and on how to prepare and submit a grant application. Program Officials can often help you locate investigators doing work similar to yours, and they can help you understand the intent and purpose of DHHS, NIH, and NIDA policies. See "How do I start to apply for support?" above if you do not have a NIDA program contact.
Both program and review staff can explain the different types of grant mechanisms NIDA supports as well as the scientific areas of interest to NIDA.
The SRO can explain review processes, review procedures, review-related policies, and review group expertise. SROs can also explain the intent and purpose of DHHS, NIH and NIDA policies and procedures related to application submission and review.
For contract proposals, contact only the Contracting Officer or Contract Specialist listed in the Request for Proposals or Presolicitation Announcement.
For new, revised, and competing renewal grant applications, follow the instructions in the PHS 398 or other application kit. Paper applications will be directly submitted to the Center for Scientific Review (CSR). Electronic applications will be uploaded by the submitting organization to the grants.gov website. The CSR assigns application numbers and initiates the complex processing of applications throughout NIH. Although NIDA's Office of Extramural Program Review occasionally requests a "courtesy copy" to assist in planning the review, you do not submit your official application to any NIDA staff person. Competing applications are not considered submitted unless they are sent to, and received by, the Center for Scientific Review.
Applications for non-competing supplements should not be submitted without prior discussion with your Program Official, who will give you instructions on submission procedures.
For contract proposals, submit only to the Contracting Officer or Contract Specialist at the address specified in the Request for Proposals.
The Center for Scientific Review (CSR) is an NIH organization under the Office of the Director of NIH. It serves NIDA and all other NIH institutes, as well as some non-NIH government agencies. CSR provides a central receipt and referral point for competing applications, and it also manages the review process for most of NIH's grant applications, including NIDA applications. More information on CSR can be found at: public.csr.nih.gov.
For grant applications, there is a two-step referral process. First, the Center for Scientific Review assigns the application to no more than one Scientific Review Group for review purposes, and, second, it assigns the application to at least one NIH institute for potential funding. Applications are assigned to more than one institute when the institutes have shared or overlapping interests in the science of the applications. In performing these referrals, the Center for Scientific Review logs in the application, checks the history of the application, and makes assignments to review groups and Institutes on the basis of established referral guidelines. For paper applications, the CSR also makes copies that are distributed to review group administrators, grants management staff, program staff, and others. From the NIH eCommons system you will receive an email from CSR 1-2 days after submission, and this email will tell you the institute assignment and the name and contact information for the NIH official (i.e., the Scientific Review Official (SRO)) responsible for the review of your application.
Why are some applications reviewed by CSR review panels while other applications are reviewed by NIDA review panels?
There are standing agreements between CSR and NIDA that help to determine where particular applications will be reviewed, and referral officers at CSR and NIDA help to make these decisions. In order to achieve more consistent and uniform reviews for the 27 NIH Institutes and Centers that may address overlapping areas of science, the majority of applications are reviewed by CSR. Specifically, most neuroscience, AIDS-related, and behavioral science applications assigned to NIDA are reviewed by standing peer review groups (Scientific Review Groups) convened by the Center for Scientific Review (CSR). NIDA retains review responsibilities for several specialty areas. Career, training, and center grant applications are reviewed by groups convened by OEA. Applications submitted in response to a Request for Applications (RFA), to some Program Announcements (PA), and using certain mechanisms are also reviewed by NIDA/OEA groups.
Contract proposals are similarly processed to ensure appropriate review. NIDA's Contracts Review Branch staff in the Office of Extramural Affairs work closely with the Contracting Officer to ensure a fair and confidential review of proposals. Contract proposals for Research and Development (R&D) are reviewed by peer review groups convened by the Contracts Review Branch, OEA.
Yes. Although CSR uses established guidelines to refer applications to Institutes, applicant input is welcome. It is best to include this request in a cover letter submitted with the application. In electronic applications this cover letter is not seen by reviewers.
You are encouraged to suggest the review group that has responsibility for reviewing the type of science contained in your application and to identify that group in a cover letter submitted with the application. The referrals are made on the basis of established guidelines, and CSR will take your suggestion into account in making the referral to a review group. If one of the NIDA review groups seems appropriate, indicate that in a cover letter. If you cannot identify a review group, referral officers will assign your application to the most appropriate one. If your application happens to be assigned to the review committee with scientists whom you know well (not an unusual occurrence in specialty fields), they may be in conflict with your application based on close personal, professional or institutional associations, and the SRO will recuse them during the evaluation of your application if the association is considered to be a conflict of interest.
Because contract proposals are reviewed by panels that are constituted for a single review for a specific Request for Proposals, offerors are not able to select a review group. There are no standing committees that routinely review contract proposals.
For most grant applications, the initial or first level review involves a panel of scientific experts who evaluate the scientific and technical merit of the application. This Scientific Review Group (SRG) usually contains 15-30 members who meet three times a year. One of the members is designated as the "Chair," who leads the scientific discussion. As noted above, the Center for Scientific Review refers the application to a scientifically appropriate review group at CSR or to the referral officer at NIDA who assigns them to a NIDA review group. Some applications are reviewed by temporarily constituted groups, or "Special Emphasis Panels" (SEPs), which function as a regular SRG but exist for only one meeting. CSR will notify you when your application has been assigned. After submission, watch for the letter that identifies the SRO, review group, institute assignment, and other information.
For contract proposals, the Contracting Officer/Specialist and the SRO work together to ensure that an appropriate review group is formed to evaluate the proposals.
NIDA and CSR Web sites include the rosters of their respective standing committees. A list of these groups and their membership may be found at: About NIDA for NIDA groups and at public.csr.nih.gov for CSR groups. For Special Emphasis Panels, or committees that are not standing, the SRO will be able to tell you who is on the committee after the committee is formed, and the roster will be posted prior to the meeting.
Offerors may request the names of the contract proposal reviewers by writing the Contracting Officer.
You may provide input to the SRO on the types of science that need to be represented on a review panel, but suggesting specific reviewers is not appropriate. This protects everyone from possible allegations of undue influence in the constitution of the committee.
What can I do if I think that someone on the committee is biased against my work or my application goes to the wrong committee?
The SRO is accustomed to addressing such concerns. You should contact your SRO and discuss the issues with him or her. You should be prepared to provide specific reasons for your concern.
For grant applications, contact the SRO. Your Notice in the Commons from CSR will identify a Scientific Review Official assigned to your application whom you can call or email for help. If you have not been provided with the name of the SRO in eCommons within four weeks after your submission, contact the CSR Receipt and Referral Office at 301 435-0715, or call NIDA at 301 443-2755, or email associated staff.
For contract proposals: Contact the Contracting Officer or Contract Specialist listed in the RFP.
NIH guidelines are that that grant applications should be complete and accurate at the time of submission. Additional or late material places a heavy burden on NIH staff and reviewers, and NIH is under no obligation to accept it. Do not submit late material without prior approval by the SRO. Contract proposals should be complete at submission. For contract proposals, contact the Contracting Officer or Contracts Specialist if you have a concern.
This is no longer needed, as announced in the NIH Guide of May 1, 2000. However, if your application is to be funded, you will be required to secure IRB approval for studies involving human subjects. Similarly, IACUC approval will be needed for studies involving vertebrate animals.
I've heard that I need to present plans for data safety monitoring in some applications. What is expected?
In the NIH Guide of June 2000 and June 1998 (NIH POLICY FOR DATA AND SAFETY MONITORING), NIH announced that investigators must submit a monitoring plan for phase I, II and III clinical trials to the funding Institute and Center (IC) before the trial begins. Further, a general description of the monitoring plan must be submitted as part of the research plan section of the application. Reviewers will comment on the adequacy of that general plan. They will look to see if it is appropriate with respect to the data management plan and potential medical safety risks. In particular, the general plan will be examined for a description of how Adverse Events will be reported to the IRB, NIH, the Office of Biotechnology Activities (if required) and the FDA. Your NIDA project officer can help you determine the elements you need to address in this general description. Guidelines for developing a data and safety monitoring plan are also available online.
Sometimes grant applications must be moved from one review committee to another. The usual reasons for this are to secure more appropriate expertise and to avoid conflicts of interest in a review group. These moves will cause a computer-generated email notice to be sent to the principal investigator. Sometimes these notices reflect a change in the SRO assignment to a committee or other internal administrative event. If, however, the notice indicates a change to a later Council review date, this indicates your application's review has been deferred for some reason. In such a case, you will probably want to call the SRO for more information.
The review administrator must balance a number of priorities. First and foremost, each application must receive a fair and impartial review from qualified scientists. To accomplish this, the SRO must consider the scientific content of the application, the availability of qualified reviewers, schedules, reviewers' skills (including interpersonal skills), conflicts of interest, and other factors. The SRO must avoid even the appearance of favoritism in selecting reviewers, so that each application is judged on a "level playing field." A variety of perspectives is sought in a review meeting, and this is accomplished by selecting scientists of diverse skills and demographic characteristics. The review group should consist of scientists who have broad knowledge of a number of areas, and it might include others with more specialized and narrow expertise. Finally, in some cases, non-scientists familiar with technological, community, or business issues are included in the review meeting because such expertise is needed.
Dates for CSR review meetings are available at public.csr.nih.gov/RosterAndMeetings, and information is also provided at your eCommons account for applications for which you are Principal Investigator Your Contract Specialist or Contracting Officer can tell you when your proposal will be reviewed.
For grants, the SRO convenes the meeting and reminds those present of applicable regulations, policies, and procedures to be followed to assure all applications receive an appropriate and fair review. After introductions and the review of procedures and policies, the Chair leads the reviews of applications. Each application has two or more assigned reviewers who have the responsibility of writing critiques and formally presenting them to the group. These reviewers present their initial scores and their comments on the scientific and technical merit of the application. For most research applications, the evaluation criteria are: Significance, Investigator, Innovation, Approach, and Environment. The reviewers also evaluate the application for adherence to NIH policies regarding the inclusion of women, minorities, and children. They assess procedures for the protection of animal and human subjects and the appropriateness of the budget. After the reviewers present their comments about scientific merit, the full committee discusses the application to arrive at a decision about scoring. Then, any issues about the budget or other issues not related to scientific merit are addressed. In the revised 1-9 best to worst scoring system, each evaluation criterion is given a score as is the overall Impact. The average of all of the committee’s scores is multiplied by 10 to generate the final overall Impact Score, so this ranges from 10 (best possible) to 90 (worst possible). At most reviews, applications with initial below-average priority scores are streamlined or not discussed. However, even for these applications, the scores as well as the listed strengths and weaknesses of the assigned reviewers remain available to applicants in their summary statements.
Contract proposals are reviewed somewhat similarly, except that the review administrator usually chairs the meeting. Typically, each proposal is assigned equally to all reviewers at the meeting. All reviewers present their scores and comments, which are based on evaluation criteria provided in the RFP, and all reviewers list strengths and weaknesses for each scored criterion, and there are usually 100 total possible points.
Grant applications can either receive a numerical score, be designated as "not discussed," or be "not recommended for further consideration." Some types of applications, such as training grant applications, are scored on a 1.0 to 9.0 scale, with 1.0 being the most meritorious. However, most applications, including unsolicited R01 research applications and most "R" mechanism applications, are reviewed under a "streamlined" procedure. (See also the question below about "not discussed" applications.) In streamlining, reviewers identify the most meritorious applications, defined as the top half of the distribution, and score them on a scale from 1.0 to about 5.0. Note that under this procedure, a very sound application can receive a score of 5.0 if it is at or near the middle of the distribution of merit for those being considered. Finally, all applications, regardless of mechanism, can potentially be designated as "not recommended for further consideration" (NRFC), which indicates that the application lacks significant and substantial scientific merit.
Contract proposals are scored according to the weighted evaluation criteria given in the RFP.
"Confidential" means that the meeting and its results are not discussed outside the meeting except for legitimate purposes related to conducting NIH business. NIH takes confidentiality very seriously. The integrity of the review system depends on reviewers' confidence that they can provide candid, professional comments. In addition, as an applicant, you want to be confident that the information you submit will be used solely to score and evaluate applications and proposals and that proprietary data and other information will be kept confidential. Reviewers agree not to discuss the applications or proposals outside the meeting itself, either with colleagues, other reviewers, or applicants. If reviewers have questions about an application, they are to call the SRO.
Although the entire review roster is available before and after the meeting, another aspect of confidentiality is that applicants are not told what applications particular reviewers were assigned in evaluating the application (e.g., primary reviewer, discussant, general member of the committee), nor which reviewers were considered to be conflicted and were out of the room during the discussion and scoring of a particular application.
No, please do not contact reviewers either before or after the meeting. Any concerns about the review should be directed to the SRO. You may have professional or personal relationships with some committee members. If relationships are significant, they had conflicts of interest and were not in the room during the review of your application. Even if they lacked conflicts, still don’t ever ask them, and if they offer, decline to listen. Such communications have the potential to compromise both of your professional reputations and the integrity of the review process.
My application was designated "not discussed" or ND or had only **'s instead of a numerical impact score. What does this mean?
The term “Not Discussed” replaces the previous “unscored” term since Enhanced Peer Review changes, even those applications that were not actively discussed at the review meeting, now have numerical 1-9 scores for each of the individual review criteria. “Not Discussed” does not necessarily mean that the application was fatally flawed. Not Discussed means that the review group used a process called "streamlined review," in which approximately half of the applications are designated as "Not Discussed" because the reviewers judged them to be in the lower half of the distribution of applications. This designation requires a committee consensus. These applications are not usually discussed fully in the meeting, but applicants do receive a summary statement with the reviewers' written critiques and numerical scores for each evaluation criterion. The designation of "not discussed" can happen at any stage of the review meeting. For example, as reviewers begin their comments, they may indicate that the application has weaknesses that place it in the bottom half of the distribution, and no further discussion will take place. In other cases, the weaknesses become apparent after discussion. As noted above, a designation of "Not Discussed" is not the same as"not recommended for further consideration." The former means only that the particular application was weaker than most. The latter rarely used evaluation term, means that the application was considered to lack significant and substantial scientific merit.
Even applications with many strengths may be Not Discussed. Since fully half of the applications are expected to be not discussed, if you find that your application has been not discussed, it does not mean that you will never be able to pursue this line of work. The written critiques and individual evaluation criterion scores from reviewers are available in the summary statement also for not discussed applications, and addressing the identified weaknesses is often feasible. As for applications whose numerical scores and other factors also may not warrant recommendations for funding, applicants are encouraged to discuss possible plans for revisions for not discussed applications with the assigned Program Official and with colleagues.
The percentile rank of an application is determined by its position among the reviewed applications within the base of applications reviewed in the current round plus two rounds of review, when the review is associated with a standing review committee and involves a R01 application. The percentile base includes all applications reviewed by a scientific review group regardless of whether the application was scored, not discussed, or not recommended for further consideration. In some cases, the base includes all eligible NIDA-reviewed or CSR-reviewed applications. The use of three rounds minimizes round-to-round variation in addition to providing the stability of a larger sample. The percentile ranking of an application is a major factor, but not the only one, in determining whether it will be funded. Not all types of applications receive percentiles. For example, applications submitted in response to a request for applications (RFA) and non-R01 application’s impact scores are not percentiled.
The summary statement is intended to summarize the merit of the application and, if scored, to present committee recommendations related to time and amount of resources needed to do the work proposed. The summary statement contains reviewers' evaluations based on the review criteria, including evaluation of compliance with NIH policies related to human subjects, animal welfare, composition of the sample, etc. The summary statement always contains the written critiques of the reviewers, which are provided to assist NIDA staff and the Council in their deliberations. If an application is scored, its score, recommended budget and period of support, and a summary of the discussion are included.
The priority score is always an average of the full review committee’s scores, not only the scores of the reviewers assigned to provide detailed written critiques. If the score was percentiled against a committee, that percentile is included.
The review committee's charge does not include making suggestions for revisions or tutoring. Thus, summary statements should not be expected to contain specific guidance for resubmissions, except to the degree that the remedy is obvious from the comment about a weakness.
The critiques of reviewers are presented essentially verbatim, with editing to assure anonymity, correct minor mistakes (e.g., typographical errors), and clarify sentences. Each critique is an independent opinion, so congruence between or among them is not required. Therefore, applicants should not necessarily expect internal consistency, especially since, even after discussion, reviewers may hold different views.
A summary statement is not intended to identify every strength and weakness of an application. Some parts of the application may not be addressed by any assigned reviewer or be mentioned in the discussion.
Summary statements for contract proposal review meetings are internal documents, and are not released to the offerors. However, unsuccessful offerors may contact the Contracting Officer to arrange for a debriefing.
If your application is not discussed or did not receive an impact score that is likely to be funded, look for what can be remedied and what cannot. If weaknesses can be readily addressed, do so and revise and resubmit. Be sure to address the concerns raised in the summary statement. You do not have to agree with these concerns, but you will need to note your response to them. Work with your program officer to revise your application.
NIH now makes scores available to applicants in their personal and private eCommons account which is established during the application process. For grant applications, scores are usually available within several working days after the review meeting. If your score has not appeared one week after the review date, please call or email the assigned SRO.
The results of your contract proposal's review will be provided by your Contracting Officer or Contract Specialist as soon as they are available.
Summary statements are available after the review group meets. They are prepared and posted at eCommons for access by the Principal Investigator as quickly as possible. If your summary statement is not available by six weeks after the meeting, contact your assigned Program Official or the SRO.
Summaries of contract proposal reviews are considered internal documents within NIDA and are not released to offerors. The summary statement is used to establish the competitive range and to negotiate with offerors who stand a reasonable chance for obtaining a contract award. While the summary statement will not be released to offerors, the Contracting Officer may use this document to debrief unsuccessful offerors.
Contact the Program Official listed in the upper left-hand corner of the summary statement obtained from eCommons. This specialist can usually discuss the likelihood of your application being funded, whether or not you should revise, approaches to revisions, etc.
In general, differences of scientific opinion between applicants and reviewers are to be expected and are not considered evidence of a flawed review. A flawed review occurs when there are substantial errors of scientific fact in the review and it appears likely that these errors significantly affected the score. Also, a flawed review occurs if persons with a conflict of interest participated in the review. Contact your Program Official to discuss this. Program and Review staff work together and will work with you to clarify and explain the issues raised in the summary statement.
Yes. However, first discuss your issues with the assigned Program Official and the SRO. If NIH staff concur that there are significant errors in procedure and/or inappropriate reviewer expertise, Review will delete the initial flawed review and arrange a second independent review of the application. If NIH staff do not agree that the review was flawed, the applicant can still initiate an appeals process, and the applicant’s appeal is presented to the NIDA Council. If the Council agrees with NIH staff that the review was correct, the appeal is denied. If the Council agrees with the applicant that the review is flawed based on procedure or lack of expertise, the application is reviewed without modification in a subsequent cycle. Pursuing an appeal in the absence of support by NIH staff should be carefully considered, since even a successful appeal leads only to another review of an unmodified application.
Dual review describes the process for most grant reviews. An initial review for scientific and technical merit is done by the Scientific Review Group administered by the SRO. Then, there is a second level review for most grant applications. This review is conducted by the National Advisory Council on Drug Abuse if the application is assigned to NIDA as the primary funding institute.
The Council provides NIDA staff with input on programmatic priorities and the appropriateness of the initial SRG review (this is sometimes called “second level” of review). Council members must concur with the initial review results before funding of most research applications can occur. A list of NIDA's Council members may be found under "Committees" on our Organization page.
The Council does not fund applications. Funding decisions are the responsibility of the Director, NIDA.
Funding decisions are made by the Director of NIDA after consideration of the Institute's program priorities, the availability of funds, and the review groups' comments on the scientific and technical merit of applications and proposals.
Your assigned Program Officer and Grants Management Specialist are your points of contact.
Read the summary statement, and discuss possibilities (revision, new direction, etc.) with the Program Official.
This frequently includes greater levels of details about the budget, human subjects or vertebrate animal issues, and similar information that helps to assure that your research plans follow NIH guidelines.
This can be done either before submission or after the grant application has been reviewed. The grant application must be approved by the IRB and/or IACUC before it can be funded.
When do I need to submit a detailed data and safety monitoring plan? What information should I include in the detailed DSM plan?
The purpose of the DSM plan is to ensure the safety of study participants in clinical trials and the validity of trial results. A detailed DSM plan is required for all clinical trials of all phases for which grant support is sought. A clinical trial is a prospective study to test the effect of a biomedical or behavioral intervention in human subjects. It includes testing medications, herbal/nutritional supplements, physical interventions, behavioral interventions, prevention interventions, and/or diagnostic tools that affect the outcome of the study participants. Read the guidelines for developing a detailed DSM plan.
A DSMB is generally required for Phase III clinical trials. For earlier medication trials (Phase I or II) and some behavioral clinical trials, a DSMB may be appropriate if the study has multiple clinical sites, is blinded, tests a high-risk intervention, or is conducted in vulnerable populations. Generally, Phase III trials involve larger numbers of subjects, but size is not a specific criterion for this designation. NIDA provides guidelines for establishing and operating a DSMB.
In general NIH is committed to sharing resources generated with NIH funding, and for research projects with budgets $500,000 and over annually, a specific plan is required to indicate related data sharing plans. This typically includes a time table and the likely route(s) of data or other resource disseminations. These typically include publications and scientific meeting presentations, and plans for making data, animal models or batteries of samples available to other researchers.
Work with the business office of your organization and with your assigned Grants Management Specialist and Program Official at NIDA to get all the required documents before receiving the funds.
First, congratulations. You will typically first make sure that all administrative and budget questions have been resolved, typically by working with the assigned Program Official and Grants Management specialist and your institution’s budget office. You will then be expected to conduct the described research. If early studies or other factors make it necessary to significantly change a research plan or a given aim, this will need to be approved. You will be expected to provide annual Progress Reports and this is an opportunity to check whether key milestones have been achieved. Related publications should cite the specific grant, which will help to document progress. If unusually positive data and significant publications result, the Program Official will also be interested in learning about this, and the NIDA Office of Communications may help to disseminate your findings e.g. through a summary within NIDA Notes or in reports to Congress. It is expected that NIDA-funded research will lead to significant advances with important basic and applied implications. Successful grants are expected to generate publications with high impact, and renewal applications often follow up on the new findings from a successful grant. If results have “real world” implications, patents and/or Small Business plans may be feasible, and Program Officials can also discuss related options.
The process of developing an idea, preparing an application or proposal, awaiting the results of reviews, and possibly preparing a revision can seem overwhelming. Nevertheless, both experienced investigators and those just beginning a research career do successfully secure funding. Don’t give up easily.
Take advantage of the resources available to you: there is substantial information on the NIH and NIDA websites about funding opportunities. Additionally, review, program, and grants and contract management staff are available to assist you. Don’t hesitate to contact them.
NIDA's mission of bringing the power of science to bear on drug abuse and addiction is realized through the high quality of the research it supports. We hope that you will work with us to fulfill that critical public health mission.
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