May 7, 2008

News Articles

• Human Subjects? It's Yes or No
• Council Member Represents NIAID on NIH AIDS Advisory Committee
• Mentored Ks and Concurrent Support: Revised Policy Kicks In
• Send Your Suggestions for HIV/AIDS Vaccine Research
• New Director of Office of Clinical Research Affairs in DMID

Opportunities and Resources

• Step Up to Use STEP Specimens
• Learn How to Protect Human Subjects
• Make Transient Molecular Complexes Less Complex

Advice Corner

• Reader Questions
  • Progress Reports Copies
  • The Last Year's Progress Report
  • P01 Review by Different Study Sections
  • New Investigator Status and SBIR Subcontracts

New Funding Opportunities

• See the list.

	News Articles

Human Subjects? It's Yes or No

We have been seeing applications that are incorrectly marked human subjects, which slows the processing of applications and awards.

Since the Office for Human Research Protections (OHRP) clarified what it considers as human subjects research, the six human subjects exemptions rarely apply to NIAID. Almost all research supported by NIAID is either "human subjects" or "not human subjects." See OHRP's Guidance on Research Involving Coded Private Information or Biological Specimens for more information.

So are you conducting human subjects research? Mark your application as "No Human Subjects Research" if your research involves human specimens or data from subjects and it meets all of the following conditions:

• You are using coded private information, data, or specimens.
• You are not collecting samples by interacting or intervening with living people.
• None of the investigators or collaborators can identify subjects through coded private information or specimens (e.g., an investigator's access to identity is prohibited by a written agreement).

Follow the instructions for Scenario A: No Human Subjects Research in Part II of the Grant Application Guide. In the Protection of Human Subjects section of the Research Plan, remember to justify your claim that no human subjects are involved.

If you're not sure if your application proposes human subjects research, follow the decision tree for Research Involving Private Information or Biological Specimens or talk to your institutional review board.

For more information, see Are You Conducting Human Subjects Research? in our How to Write a Human Subjects Application tutorial.

Council Member Represents NIAID on NIH AIDS Advisory Committee

Christel H. Uittenbogaart, M.D., a member of NIAID's main advisory Council, is the Institute's new representative to the Office of AIDS Research Advisory Council (OARAC), an analogous Council for the NIH Office of AIDS Research.

Dr. Uittenbogaart is professor of pediatrics and microbiology, immunology, and molecular genetics at the University of California, Los Angeles. Read more about her and other NIAID Council members at Biographical Sketches of NIAID Council Members.

Mentored Ks and Concurrent Support: Revised Policy Kicks In

Good news for anyone on a mentored career development award (K01, K08, K22, K23, K25).

Thanks to a new NIH policy, you may now receive concurrent salary support from a peer-reviewed grant from any federal agency during the last two years of your award. Previously, the grant had to be from NIH. If you're eligible, you may reduce your K award's time and effort to no less than six person months.

To take advantage of the change, you must meet the following criteria:

• Be the PI on a competing research project grant or director of a subproject on a multicomponent grant from NIH or another federal agency.
• Have an active K award.

For more information, read the April 10, 2008, Guide notice.

Send Your Suggestions for HIV/AIDS Vaccine Research

Following up on the Summit on HIV Vaccine Research and Development, two Requests for Information (RFI) in the NIH Guide give you the chance to shape the Division of AIDS' funding opportunities:

• To Solicit Input and Ideas on Priorities in Basic Vaccine Discovery Research
• Public Comment on Development of a Funding Opportunity Announcement on Highly Innovative Tactics to Interrupt Transmission of HIV

For both RFIs, remember to limit your response to five pages and respond before May 20, 2008.

NIAID encourages responses from the community, including junior investigators and new faculty. See each RFI for questions to answer and contact information.

New Director of Office of Clinical Research Affairs in DMID

Dr. Shy Shorer has been appointed Director of the Office of Clinical Research Affairs in the Division of Microbiology and Infectious Diseases (DMID), which he served as acting director of since October 2006.

Before joining DMID in 2004, Dr. Shorer trained in anesthesiology and intensive care medicine and worked for three biotechnology companies.

	Opportunities and Resources

Step Up to Use STEP Specimens

If you're an HIV/AIDS researcher, you've heard about the STEP study by the HIV Vaccine Trials Network (HVTN). But have you heard about opportunities surrounding the STEP trial results?

NIAID wants to fully understand the STEP results, which can help guide future HIV vaccine efforts. NIAID and HVTN are seeking ideas about how we can learn as much as possible, especially the reason some volunteers who received the vaccine appeared to be at increased risk of acquiring HIV, and what impact, if any, their induced immune responses have on the virus.

If you're interested in using specimens from the STEP trial, submit a concept proposal to HVTN. Because quantities of some specimens are limited, a scientific review panel external to HVTN and NIAID will set research priorities.

You can get funds to support your study in the following ways:

• Use funds from an existing grant if it has the necessary scope of work and budget.
• Request funds from the HVTN for your proposed study.
• Submit a new research application to NIAID.

To learn how to submit your concept proposal for access to specimens, see Establishing a Scientific Agenda for Laboratory Studies to Seek Better Understanding of the STEP Trial Results.

HVTN and Merck & Co., Inc. are discussing how and when the full data set from the STEP trial will be released to the research community. For more information on the STEP study, see The Release of New Data from the HVTN 502 (STEP) HIV Vaccine Study and About the STEP Study.

Learn How to Protect Human Subjects

If you are looking to satisfy the human subjects training requirement for NIH awards, check out Protecting Human Research Participants from the NIH Office of Extramural Research.

This Web-based training presents basic concepts, principles, and issues explaining the obligations of researchers and institutions.

Although the course replaces the National Cancer Institute's Human Participant Protections Education for Research Teams training, it does not recognize login information from that course, so you'll need to complete the User Registration.

See the February 29, 2008, Guide notice for more information.

Make Transient Molecular Complexes Less Complex

Have an idea for a tool or process to study transient molecular complexes? Check out these small business funding opportunities:

• New Technologies for Transient Molecular Complex Characterization (SBIR [R43/R44])
• New Technologies for Transient Molecular Complex Characterization (STTR [R41/R42])

Your proposed research should develop new or extend existing technologies to enhance understanding of the effects of subtle mutations or environmental factors in the development and progression of diseases.

For more information, see the NIH Guide notices and contact Diana Finzi at dfinzi@niaid.nih.gov.

	Advice Corner

Reader Questions

Aisha Shabazz, Virginia Commonwealth University, asks:

"Do I need to submit a copy of our progress report along with the original?"

No. You do not need to send a copy of a paper progress report.  Please be aware that most people send noncompeting progress reports through the electronic streamlined noncompeting award process (eSNAP) if the award is eligible for SNAP.

If your grant has automatic carryover authority, you can submit a SNAP, which is shorter than a standard progress report. Check your Notice of Award to see if you qualify for SNAP, and ask your business office whether eSNAP is enabled for your institution.

For more information, read Send Us an Annual Progress Report and subsequent pages in  Part 11a. Managing Your Grant of the NIH Grant Cycle: Application to Renewal, and see the PHS 2590 instructions.

Zarinah Aquil, University of Michigan, asks:

"Do I need to submit a final progress report for my grant if I am applying for a renewal?"

No. You no longer need to submit a final progress report since you must document progress in your renewal application.

If you are closing out your grant or your renewal application does not get funded, you will need to submit a final progress report as well as a final financial status report.

Ted Fitzgerald, Family Health International, asks:

"If we submit a multidisciplinary multiproject grant application to NIAID, will different study sections review the research components?"

No. P01s are reviewed as a single application in NIAID. We establish special emphasis panels to ensure that all necessary expertise is represented in the review group.

An anonymous reader asks:

"If I will be a PI on a subcontract to a Small Business Innovation Research award, will I lose my new investigator status?"

No. A subcontractor is not the official NIH PI for a grant. For more information on new PI status, go to Are You "New"?

	New Funding Opportunities

• RFA-DA-09-004, Functional Characterization of Genetic Variants and Interactions: The Genes, Environment and Health Initiative (R03)
• RFA-DA-09-003, Functional Characterization of Genetic Variants and Interactions: The Genes, Environment and Health Initiative (R21)
• RFA-AI-08-044, Methods for Prevention Packages Program (MP3)
• RFA-AI-08-018, Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP)
• PA-08-151, Midcareer Investigator Award in Patient-Oriented Research

See these and older announcements on our NIAID Funding Opportunities List.