NIAID Funding News, July 20, 2016

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July 20, 2016 NIAID Funding News

Feature Articles

Use a Single Institutional Review Board for Multisite Protocols Beginning With May 2017 Applications

Opportunities and Resources

In The News

Advice Corner

A Useful Reminder: Contact Us Early, Write a Letter of Intent
Reader Questions
- Can I use the training-related expenses category of an institutional research training grant to cover costs of previously appointed trainees?
- For a Research Program Project (P01) grant application, can a subcontractor who will carry out one of the projects hire a subcontractor to complete an aspect of that project?

New Funding Opportunities

See the list

Use a Single Institutional Review Board for Multisite Protocols Beginning With May 2017 Applications

Starting next year, all domestic sites participating in multisite studies using the same protocol involving nonexempt human subjects research will use a single institutional review board (sIRB) to conduct the reviews required for protecting human subjects. NIH launched the new policy to enhance and streamline the process of IRB review.

As the applicant or offeror, you will be responsible for assuring that the sIRB is qualified since your actual plan for using a single IRB will not be evaluated in peer review. In order to coordinate the various sites, you may need to develop an Authorization Agreement with all the sites to harmonize the approach to roles and responsibilities for the single IRB—see our NIAID Reliance (Authorization) Agreement Toolkit.

The sIRB can belong to the primary awardee institution, a subawardee institution, or be an independent IRB or NIH intramural IRB.

To be clear, the policy will apply only to studies where the same research protocol is being conducted at more than one site; it does not apply to multisite studies in which the sites have different roles in carrying out the research.

Finally, this policy is not limited to clinical trials. All nonexempt human subjects research is subject to the policy. For help in determining whether your research is nonexempt, take the human subjectsInfopath Questionnaire.

Timeline and Applicability

The policy applies to grants, cooperative agreements, contracts, and NIH intramural research. Career development, training, and fellowship award applications are not included in the sIRB policy.

When the policy goes into effect in May 2017, grantees with ongoing, noncompeting awards will not be expected to comply until they submit a renewal application. However competing applications for research grants and cooperative agreements with due dates on or after May 25, 2017, must follow the policy.

For contracts, solicitations issued on or after May 1, 2017, will require offerors to follow the sIRB policy.

NIH will grant exceptions to the policy if using an sIRB is prohibited by federal, state, or tribal laws, policies, or regulations. NIH will also consider granting exceptions when a request is made and a compelling justification provided for why an exception is needed.

Foreign sites are not included in the sIRB policy. For example, a multisite study with three domestic sites and two foreign sites should use an sIRB for the domestic components as well as a local IRB at each of the two foreign sites.

NIH’s acceptance of submitted sIRB plans will be incorporated in contract awards or as a term and condition in the Notice of Award for grants.

Determining the Costs

When you apply, you need to determine which IRB activities are “primary” and which are “secondary.”

Primary activities are those associated with conducting the review of the proposed research protocol that will be carried out at all of the participating sites as well as the review of the informed consent document template describing the study.

Secondary activities are those associated with the review of site-specific considerations for all of the participating sites, including investigator qualifications, institutional capabilities, state/local regulatory requirements, and community ethos. This includes fulfilling IRB oversight responsibilities, such as receiving and reviewing any complaints that arise about the conduct of the study.

In the budget section of your application or proposal, you should list primary activities as indirect costs. NIH will consider secondary activities to be direct costs only with adequate justification.

From there, you’ll also need to identify which institution(s) will be a primary awardee, who is hosting the sIRB, and the hosts of the participating sites. Once you know your configuration, review this June 21, 2016 Guide notice to find a scenario that matches your proposed research for further guidance on which activities should be charged as direct or indirect costs to which institutions.

Additional Information

The sIRB policy generated a significant volume of community feedback when first proposed in a December 2014 request for information. Those responses are summarized in the June 21, 2016 Guide notice announcing the final sIRB policy.

Many of the comments were concerned with the logistics of establishing an sIRB, such as what information applicants should include in an sIRB plan and what NIH views as the ideal relationship, roles, and responsibilities shared between the sIRB and participating sites.

Over the next year, NIH will issue additional guidance and resources on the new IRB Review website to address those topics not already discussed in the final policy.

Fulfill NIAID’s Need for Structural Genomics Centers

NIAID is recompeting its Structural Genomics Centers for Infectious Diseases (SGCID) program, which works to determine three-dimensional (3D) structures of protein targets of biomedical interest and share the targets’ structure information, including expression clones and peptide materials, with the scientific community.

Successful offerors will support the SGCID program by:

Generating 3D structures for targets derived from bacterial, viral, eukaryotic, and other human pathogens using high-throughput technologies and methodologies
Conducting studies to characterize molecular functions and biochemical properties of selected targets
Conducting studies for structure-guided design and functional evaluation of drug targets and vaccine candidates
Providing a 3D structure determination service to the external scientific community
Disseminating contract-generated resources, including all 3D structure information and reagents

To read the full request for proposals, go to the May 25, 2016 FedBizOpps.gov solicitation. Be sure to also review Amendments One and Two, listed on the same webpage, which provide NIAID’s responses to several questions about the opportunity.

NIAID anticipates awarding one or more cost-reimbursement, level-of-effort type contracts with a one-year base period of performance beginning on or around June 1, 2017. The awards will likely include four one-year option periods, for a maximum period of performance of five years.

NIAID estimates the base level of effort requirement at 35,360 labor hours for each contract year, equating to 17 full-time employees (FTEs) with an FTE being defined as 2,080 hours. In addition to the base level of effort, NIAID anticipates each year of performance to contain an option quantity for up to 6 additional FTEs.

For this solicitation, you are required to submit your proposal using NIAID's electronic Contract Proposal Submission (eCPS) website by 3:30 p.m. EST on August 15, 2016. For directions on using eCPS, go to How to Submit an Electronic Proposal.

Loan Repayment Programs: New Notices, New Application Items

As it usually does in July, NIH reissued notices for its various Loan Repayment Programs (LRP), which can ease some of the burden from your student loans.

You may want to consider applying if you're an eligible doctoral-level clinician or researcher who's committed to conducting qualified research for at least two years. You can get up to $35,000 to offset your educational debt each year.

The current LRP cycle opens for applications September 1 and ends November 15. For details on the two programs NIAID supports, read the July 5, 2016 Guide notices for the Clinical Research LRP and Pediatric Research LRP.

Be sure to note some changes that affect you and your application. For example:

You must have an eRA Commons ID to submit your LRP application.
All online application, colleague, and institutional support documents must be submitted by November 15.
The length of your application is bound by page limits instead of character limits to be consistent with NIH practices.

See NIAID's Loan Repayment Programs for an overview. NIH's Loan Repayment Program offers these resources:

Application Process Interactive Roadmap covers key decision points and guidance at each juncture.
Tips for Writing a Competitive LRP Application provides helpful pointers as well as reasons applications aren't funded so you can steer clear of potential mistakes.
LRP's Ambassador Network puts you in touch with LRP alumni who can share their experiences and advice for preparing a strong application. To get more information, find an ambassador, or become one, email lrp@nih.gov.

If you have questions, touch base with Dr. Shawn Gaillard, NIAID's LRP contact.

Recap of June Council

NIAID's advisory Council meeting on June 6 covered a lot of ground, including two hot topics: the budget and Zika virus.

If you couldn't attend in person or online last month but want to know what transpired, watch videocasts of remarks from NIAID Director Dr. Anthony Fauci and Vaccine Research Center (VRC) Director Dr. John Mascola as well as the subcommittee sessions. Links are below.

Budget

As always, Dr. Fauci updated attendees on "one of our favorite subjects—the NIH budget."

After talking about the funding trend for NIAID since FY 2000, comparing the FY 2016 operating budget with that of FY 2015, and covering the Institute's financial management plan for FY 2016, Dr. Fauci addressed The President’s Budget for Fiscal Year 2017.

It requests an overall increase to NIH of 2.6 percent or $825 million over the FY 2016 level. NIAID—like most institutes and centers—would have a flat budget, which means the Institute will need to continue its conservative approach to setting paylines.

The President also requested $1.9 billion in emergency funding for Zika virus-related initiatives, with $277 million directed to NIAID to support development of diagnostics, vaccines, therapeutics, and vector control strategies for Zika and other vector-borne diseases.

On a side note: If you are a Zika researcher, you may want to check out the following Guide announcements and notices:

Other Noteworthy Items

Dr. Fauci's remarks also included:

Key appointments—several people have new roles at NIH, such as:

Dr. Maureen Goodenow, director of NIH's Office of AIDS Research (See Appointment of Dr. Maureen M. Goodenow as Associate Director for AIDS Research, NIH)
Eric Dishman, director of the Precision Medicine Initiative Cohort Program

Dr. Matthew Gillman, director of the Environmental Influences on Child Health Outcomes Program, perhaps better known as ECHO

Meetings and events, including the Global Vaccine and Immunization Research Forum in Johannesburg, South Africa
Staff legislative activities, for example, appearing at hearings about the Zika virus before several Senate and House of Representative committees

Go to NIAID Advisory Council-June 2016 to watch the entire Council presentation, including Dr. Mascola's report on VRC's accomplishments and ongoing activities.

Subcommittee Synopses

Learn more about NIAID's priorities and initiatives from Council subcommittee meetings, where NIAID staff discuss extramural research programs with advisory Council members.

See below for video of these subcommittees' open sessions:

Approved Concepts

The subcommittee meetings also covered concepts for clearance.

As you may know, Council must approve a concept before we can announce it as a possible initiative: request for applications, program announcement, or request for proposals.

To see a list of approved concepts, go to Concepts: Potential Opportunities. Find our most recent concepts on the following pages:

It's important to check out concepts since you can use them as clues to NIAID's research interests and potential topics for future investigator-initiated applications. Find out more at Use Our Concepts List, Blend Approaches in our Strategy for NIH Funding.

Keep in mind that there's no guarantee that a concept will become a published initiative. For more on the planning process, go toConcepts May Turn Into Initiatives.

Learn More

To find out more about the activities of our advisory Council, go to:

Advisory Council portal
Advisory Council section of our Standard Operating Procedures
Advisory Council section of our Questions and Answers

News Briefs

Meet Us in Orlando for HHS SBIR/STTR Conference This November.

The 18th Annual HHS SBIR/STTR Conference

will take place in Orlando, Florida, from November 15 to 17, 2016. Attendees will benefit from interactive workshops, networking opportunities, and seminars on topics ranging from understanding indirect costs to completing animal welfare assurances.Register

before August 31 to take advantage of the discounted early bird registration fee.

Continue Using Application Form Packages Despite Listed Expiration Dates.

You may have noticed that certain federalwide forms, such as the SF 424 R&R, have an expiration date of June 30, 2016. Don’t worry though: NIH has already been approved to continue using the forms through October 31, 2018. Use them until further notice. For more details, read the June 30, 2016 Guide notice.

Application Due Date for Transplantation Tolerance Study Group Extended One Week.

Applicants to the Nonhuman Primate Transplantation Tolerance Cooperative Study Group U01 and U19 funding opportunity announcements have an extra week to complete their applications, which are now due on August 10, 2016.

The FOAs will expire the following day.

A Useful Reminder: Contact Us Early, Write a Letter of Intent

Contact a program officer early in your grant application preparation process, since NIAID staff can help determine whether your proposed idea is responsive to the funding opportunity announcement (FOA) or if there is a better fit with a different FOA.

Several factors can lead to your application being deemed nonresponsive, as can certain preapplication requirements if not completed on time.

For example, most NIAID FOAs do not allow clinical trials. If you assess that your research proposal is not a clinical trial, but NIAID does, then your application will not be reviewed. As a second example, NIAID requires applicants to seek prior approval at least six weeks before submitting a big grant, which is a grant that requests direct costs of $500,000 or more in any one year of the project. Were you to overlook this requirement, we would not review your grant.

As a rule of thumb, you should reach out to a program officer 10 to 12 weeks before applying. While optional letters of intent are due 30 days before you submit the grant application, one month isn't likely to be enough time to address any major issues NIAID staff identify.

This doesn't mean you should bypass the letter of intent, as we often use the letters to help anticipate the volume of incoming applications and identify any unique expertise that needs to be included on a peer review panel.

Note that the letter of intent has no effect on your score in peer review. Still, if you provide the correct information, our program staff can further advise you on how to best direct your effort. Here are some additional details you could include:

What to Discuss/Include	What We May Spot for You
Concise description of your proposed project. Do not send us your entire application.	Whether your research would be a good fit for NIAID, and if not, which other NIH institute or center might be more appropriate Whether it sounds responsive to the announcement If there’s a better funding opportunity for your idea than the one you had in mind Other concerns worth addressing before you apply
Whether your plans touch on special policy areas, such as human subjects, clinical, or animal research.	Whether your analysis of the NIH definitions or exceptions seems to match Whether your human subjects research might also be classified as a clinical trial If there are special rules restricting your choice of animal species or animal-related plans Other possible limits that could affect your planned avenue of research
Name of pathogens you plan to study, if any.	Whether your research plan fits any opportunity-specific requirements about the type of pathogen For example, perhaps your choice must be listed as a NIAID Category A, B, and C Priority Pathogen or an Additional Emerging Infectious Disease/Pathogen at NIAID Emerging Infectious Diseases/Pathogens

The advice you get from program staff can keep you focused on the best path forward. Without program advice, you could waste your only chance to respond to a request for applications.

Letter or not, we always recommend touching base with program staff sooner rather than later so that you have sufficient time to use their advice to improve your application; see When to Contact an NIAID Program Officer. This advice is particularly important when applying to opportunities with only one remaining application receipt date.

To learn more about how NIAID staff can help you at other stages of the funding process, see Communicating With NIAID—How to Get Help.

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

“Can I use the training-related expenses category of an institutional research training grant to cover costs of previously appointed trainees?”—anonymous reader

Training-related expenses (as well as any funds received under a training grant) must be used for costs incurred in the budget period to which the grant is allocated. If the trainee is appointed during the budget period that the funds are allocated to then it would not be a problem. However, if the trainee is not appointed during that budget period then the costs should be covered by training-related expenses from the budget period under which the appointment was made.

See Advice on Research Training and Career Awards for more information about training grants and training-related expenses.

“For a Reseach Program Project (P01) grant application, can a subcontractor who will carry out one of the projects hire a subcontractor to complete an aspect of that project?”—anonymous reader

No. In accordance with NIH grant policy, all subawards must be with the prime grantee institution. Thus, the subawardee cannot enter into a third tier subaward agreement.

Instead, the prime grantee should create subawards directly with both the first and second subawardees.

To learn more, read Subawards (Consortium Agreements) for Grants SOP.