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Office of Extramural Affairs



Frequently Asked Questions

How do I start to apply for support?

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 and addiction. Talk to a Program Official about your interests and specific aspects of NIDA's mission. To find a Program Official, explore the organization of NIDA on our home page to 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 your specific scientific areas. Also, look on the home page under Funding, then List of All NIDA Program Announcements and RFAs, for information on grant opportunities. Look under Funding, then Contract Requests for Proposals, for contractual possibilities. These funding opportunities may also be found in the NIH Guide for Grants and Contracts.

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.

Where can I get application forms?

You will need the PHS 398 Grant Application for research grants, research career awards, and institutional training grants. You will need the PHS 416-1 for training fellowships. These forms may be obtained from your Office of Sponsored Programs or Research Development, or from the NIH website at: www.grants.nih.gov/grants/forms.htm.

Or you may call the Grants Information Office, Office of Extramural Research (OER) at NIH: 301 435-0714. The e-mail address is: grantsinfo@nih.gov.

For contracts, the forms are found at: www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm.

What does "extramural" mean? What does "intramural" mean?

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.

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 cadre of NIDA-supported researchers who receive extramural funds. NIDA supports extramural research primarily through grants, but contracts and other mechanisms are used also.

What are the roles of various NIDA extramural staff?

There are four classes of professional staff that you are most likely to encounter in your interactions with NIDA. They are the Scientific Review Administrator (SRA), the Program Official (or Project Officer), the Grants Management Officer (or Specialist), and the Contracting Officer (or Contract Specialist). Their roles are complementary and interlocking, as each assists at different points in the application or proposal development, submission, review, and funding processes.

What is the role of the Scientific Review Administrator?

The SRA 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 SRA assesses the scientific content of an application or proposal to determine the types of expertise needed for its review. The SRA 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 SRA 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 summary, or "summary statement," is often referred to as a "pink sheet" because summary statements used to be printed on pink paper.) The SRA can also assist you by providing general information on NIH review policies, procedures, and related issues. Much of the SRA's logistical support is provided by the Grants Technical Assistant (GTA).

From the time you submit a grant application until completion of its review, the SRA is your point of contact. For contract proposals, the Contract Specialist and Contracting Officer are the point of contact.

What is the role of the Program Official?

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 make presentations at scientific meetings and organize conferences and workshops to disseminate information about Institute scientific priorities. Through discussions of the applicant's research concepts and provision of information on NIDA's help investigators develop their applications. After the summary statement is received by the applicant, the PO is the applicant's point of contact for scientific and technical aspects of assigned applications and grants. The PO 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. 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.

What is the role of Grants Management?

Grants management personnel include Grants Management Officers (GMOs), Grants Management Specialists (GMS), and Grants Technical Assistants. 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 requests for NIH prior approval or for 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 an agent of the GMO 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.

What are the roles of the Contracting Officer and Contract Specialist?

The Contracting Officer receives and acts on contract proposals, and the Contract Specialist is an agent of the Contracting Officer 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) should be 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. PAs define areas that an institute is particularly interested in funding. Applications for grant support may cite a PA, but this is not necessary. Indeed, some of the most innovative research ideas are not drawn from announcements. A Request for Applications (RFA) indicates a specific interest in receipt of applications and solicits applications. 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 come in with their bids and proposals. PAs, RFAs, and RFPs are published in the NIH Guide to Grants and Contracts.

How much money should I request?

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 get prior approval from a Program Official.

Whom should I contact if I need help completing the application or proposal?

A NIDA Program Official familiar with your area of science can give general advice on whether aspects of your research are relevant to NIDA's mission and on procedural aspects of preparing and submitting a grant application. Program Officials can often help you locate investigators doing work similar to yours, and they can help you understand the intent 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.

The SRA can explain review processes, review procedures, review-related policies, and review group expertise. Some applicants find this information useful in thinking about their applications. SRAs can also explain the intent and purpose of government 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.

Where do I submit my application?

For new, revised, and competing renewal grant applications, follow the instructions in the PHS 398 or other application kit. The application will be submitted to the Center for Scientific Review, which 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.

What is the Center for Scientific Review?

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 grants. More information on CSR can be found at: www.csr.nih.gov/.

What happens after submission?

For grants, 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. The CSR also makes about 50 copies that are distributed to review group administrators, grants management staff, program staff, and others. You will receive a letter from CSR approximately one month to six weeks after submission, and this letter will tell you the institute assignment and the name and contact information for the NIH official (i.e., the Scientific Review Administrator) responsible for the review of your application.

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). Most applications related to the development of medications for drug abuse, drug abuse treatment, and drug abuse services are reviewed by groups convened by NIDA's Office of Extramural Program Review (OEPR). Fellowship, career, training, and center grant applications are also reviewed by groups convened by OEPR that focus on NIDA's applications. Applications submitted in response to a Request for Applications (RFA), to some Program Announcements (PA), and using certain mechanisms are also reviewed by NIDA/OEPR groups.

Contract proposals are similarly processed to ensure appropriate review. Staff in NIDA's Contracts Review Branch, Office of Extramural Program Review, 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, OEPR.

May I suggest an assignment to NIDA or another Institute?

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.

Who will review my application or proposal?

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) consists of peers of the applicant and usually contains 15-18 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 an appropriate review group either at CSR or NIDA. 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 SRA, review group, institute assignment, and other vital information.

For contract proposals, the Contracting Officer/Specialist and the SRA work together to ensure that an appropriate review group is formed to evaluate the proposals.

How do I find out who is on the review panel?

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: www.nida.nih.gov/organization.html for NIDA groups and at www.drg.nih.gov/refrev.htm for CSR groups. For Special Emphasis Panels, or committees that are not standing, the SRA will be able to tell you who is on the committee after the committee is formed.

Offerors may request the names of the contract proposal reviewers by writing the Contracting Officer.

May I choose where I want my application to be reviewed?

You are encouraged to suggest the review group that best matches the aims of your application and 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.

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.

May I suggest reviewers?

You may provide input on the types of science that need to be represented on a review panel, but suggesting names is not appropriate. This protects you 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 SRA is accustomed to addressing such concerns. You should contact your SRA and discuss the issues with him or her. You should be prepared to provide specific reasons for your concern.

Suppose I have questions after submission?

For grant applications: Although the Program Official is your point of contact prior to submission, you should communicate with review staff after submission in order to protect the integrity and independence of the review system. Your letter from CSR will identify a Scientific Review Administrator assigned to your application whom you can call for help. If you have not received a letter from CSR notifying you of the SRA within six weeks of your submission, contact the CSR Receipt and Referral Office at 301 435-0715, or call NIDA at 301 443-2755.

For contract proposals: Contact the Contracting Officer or Contract Specialist listed in the RFP.

How do I submit additional information?

The PHS 398 states 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 SRA. Contract proposals should be complete at submission. Contact the Contracting Officer or Contracts Secialist if you have a concern.

Do I need Institutional Review Board (IRB) approval for my application?

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.

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, NIH announced that investigators must submit a monitoring plan for phase I and II 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 potential risks, the complexity of the study, and the methods. 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.

What does it mean if I get a notice of grant application reassignment?

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 notice to be sent to the principal investigator. Sometimes these notices reflect a change in the SRA 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 SRA for more information.

What does an SRA consider in setting up a meeting?

The review administrator must balance a number of concerns. First and foremost, each application must receive a fair and impartial review from qualified scientists. To accomplish this, the SRA must consider the scientific content of the application, the availability of qualified reviewers, schedules, reviewers' skills (including interpersonal skills), conflicts of interest, workloads, and other factors. The SRA 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 a sufficient number of senior 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.

When will my application or proposal be reviewed?

For grant applications, dates for upcoming SRG meetings at NIDA can be obtained under the Committee Meetings section of the NIDA Web site www.nida.nih.gov/MeetProg2.html. Dates for CSR review meetings are available under Meeting Schedules at www.drg.nih.gov/refrev.htm. Your Contracts Specialist or Contracting Officer can tell you when your proposal will be reviewed.

What happens in a review meeting?

For grants, the SRA 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, Approach, Innovation, Investigator, 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 concerns about the budget or other issues not related to scientific merit are addressed.

Contract proposals are reviewed similarly, except that the review administrator 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.

What scoring scale is used?

Grant applications can either receive a numerical score, be designated as "unscored," or be "not recommended for further consideration." Some types of applications, such as training grant applications, are scored on a 1.0 to 5.0 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 "unscored" 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 3.0. Note that under this procedure, a very sound application can receive a score of 3.0 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.

I've heard that meetings are confidential. What does that mean?

"Confidential" means that the meeting and its results are not discussed outside the meeting except for legitimate purposes related to conducting business. NIDA 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 SRA. NIDA staff also are instructed to maintain confidentiality. Applications/proposals and review materials are destroyed as soon after the meeting as possible.

Another aspect of confidentiality is that applicants are not told which roles reviewers were assigned role in evaluating the application (e.g., primary reviewer, discussant, general member of the committee).

Can I talk to my reviewers before or after the meeting?

There is no circumstance under which you should attempt to contact reviewers either before or after the meeting, nor under which reviewers should contact you. Any concerns about the review should be directed to the SRA.

My application was designated "unscored." What does this mean?

Most grant application review groups use a process called "streamlined review," in which approximately half of the applications are designated as "unscored" 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. The designation of "unscored" 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 "unscored" is not the same as "not recommended for further consideration." The former means only that the particular application was weaker than most. The latter means that the application lacked significant and substantial scientific merit.

How are percentiles calculated and what do they mean?

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. The percentile base includes all applications reviewed by an SRG regardless of whether the application was scored, unscored, 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 an RFA are not percentiled.

What should I expect in my summary statement?

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. 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.

How can I find out my score?

NIH policy is to mail scores to the applicant. For grant applications, notices are normally sent about two weeks after the meeting. Please do not call for scores unless you have reason to suspect that your score was not sent.

The results of your contract proposal's review will be provided by your Contracting Officer or Contract Specialist as soon as they are available.

When and how do I receive my summary statement?

Summary statements are mailed about eight weeks after the review group meets, depending on how quickly they can be prepared. Some are mailed directly by the Center for Scientific Review, while others are mailed by the NIDA Program Official. If you do not receive your summary statement in a timely manner, contact your assigned Program Official. NIDA review staff can locate the name and number of the Program Official if you do not know whom to call.

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.

Whom do I contact after I receive the summary statement?

Contact the Program Official listed in the upper left-hand corner of the summary statement. This individual can discuss the likelihood of your application being funded, whether or not you should revise, approaches to revisions, etc.

If I don't agree with the criticisms in the summary statement, what should I do?

Contact the Program Official to discuss your concerns. 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.

What is "Dual Review"?

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 SRA. 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.

What is NIDA's Council's role in grant reviews?

The Council provides NIDA staff with input on programmatic priorities and the appropriateness of the initial SRG 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" at this URL: www.nida.nih.gov/organization.html.

How is it decided if my application will be funded?

Review of applications and proposals is advisory. Funding decisions are made by NIDA staff after they consider the Institute's program priorities, the availability of funds, and the review groups' comments on the scientific and technical merit of applications and proposals.

What else should I know?

The process of developing an idea, preparing an application or proposal, awaiting the results of reviews, and possibly preparing a revision can be daunting and seem overwhelming. Nevertheless, both experienced investigators and those just beginning a research career do successfully secure funding. About 30 percent of applications submitted to NIDA, across all mechanisms, are eventually funded, and NIDA's budget has continued to grow.

NIDA's mission of bringing the power of science to bear on drug abuse 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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