See the Glossary for more terms.
Table of Contents
Investigators conduct human subjects research if they obtain data by intervention or interaction with a living person or obtain individually identifiable private information about a living person. Click on the glossary links for definitions of these terms.
Look at the following in our Private Information or Biological Specimens in Human Subjects Research questions and answers:
Yes. See How Human Subjects Applications are Reviewed in NIAID's human subjects tutorial.
See the following:
No. Since NIH clarified what it considers to be human subjects research, the six human subjects exemptions rarely apply to NIAID applicants. Most research at NIAID is now either human subjects or not human subjects. For more details, see NIAID's Is Your Research Exempt?
Exemptions usually don't apply to NIAID research. However, do the following if you have used the Human Subject Regulations Decision Charts, reviewed NIH and NIAID guidance, and still believe your study may be exempt:
For more information, read What is a human subjects exemption? in NIAID's Private Information or Biological Specimens in Human Subjects Research questions and answers.
See the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, and visit our Private Information or Biological Specimens in Human Subjects Research questions and answers.
Also go to NIH's FAQs About Research Using Human Specimens, Cell Lines or Data at Office of Extramural Research.
Yes. All human subjects applications must also comply with the NIAID Clinical Terms of Award. Investigators should read it to see what NIAID expects in the application and after award. They are are in addition to, not in lieu of, requirements in the PHS 398 or funding opportunity announcement.
For research in China, follow the instructions in NIAID Clinical Terms of Award Restriction for China.
For further details, see the Human Subjects SOPs.
NIAID has a mandatory process for investigator-initiated clinical trials. For more information, go to Investigator-Initiated Clinical Trial Planning and Implementation Awards.
Read and follow the instructions in either the funding opportunity announcement (for electronic applications) or the PHS 398 (for paper applications) in addition to the NIAID Clinical Terms of Award.
For more help and advice, visit our NIAID Human Subjects Application and Grant Handbook on our NIAID Human Subjects Resources portal.
No, it's not essential. For example, if a grantee has subcontracted the human subjects research, the project leader at the subcontractor site might be listed on the relevant protocols instead of the PI. The subcontractor project leader is not required to add the PI's name.
If you are involved in human subjects research with your sponsor, you must be covered by his or her IRB approval.
Yes. Read Obtain a Federalwide Assurance in our NIAID Human Subjects Application and Grant Handbook and see our Human Subjects SOPs.
Yes. The Federalwide Assurance is the only valid human subjects assurance. See the Human Subjects SOPs for more information.
See Is it ok if I do not yet have my Federalwide Assurance number when I apply?
Yes. The Office for Human Research Protections provides these features in its Electronic Submission System. To register, go to File a New Federalwide Assurance (FWA) or Filing a New Registration for an Institutional Review Board (IRB) by an Institution or Organization (IORG).
Yes, an FWA is not necessary for peer review. Your FWA is due just-in-time, i.e., when your application is within a range of possible funding.
However, make sure you can obtain it in time. Typically, it takes OHRP two weeks or less to approve an FWA application. However, if OHRP spots a problem, it will probably take longer. See OHRP for more information.
Though your certification of IRB or IEC approval is due just-in-time, i.e., when your application is within a range of possible funding, you should start the approval process well before the application's due date because revisions and final approval can take time.
If the certification is ready, include it in the application. Read more in Get IRB or IEC Approval. Also see the Human Subjects Certifications: IRB or IEC SOP.
Yes, if you're planning to use a Web site to advertise for subjects. When a site goes beyond listing basic descriptive information, IRB approval is usually required. For details, read OHRP Guidance on Institutional Review Board Review of Clinical Trial Websites.
Go to the following resources:
See Investigating Foreign Populations.
Yes. Your application must show mandatory training in the responsible conduct of research for all key personnel on the grant.
For more information read:
Yes. In addition to the regular review criteria, reviewers use additional criteria to judge human subjects research applications. Read more in How Human Subjects Applications are Reviewed.
The overall program and each project using human subjects need a Human Subjects section, unless any project is using the cell lines only. On the face page, indicate Yes for human subjects.
The administrative core does not need a Human Subjects section. Basically, any part of the application that uses human subjects must have a Human Subjects section, otherwise the application will receive a bar to award.
During peer review, the panel will discuss whether the human subjects protection described in your application is adequate. That information will be stated in your summary statement and may affect the overall impact score, depending on the nature and severity of the inadequacies.
In addition, your application will get a code to reflect any human subjects concerns, which you must address before we can make an award. For more information, read our After Peer Review questions and answers.
Yes. If the scientific review group has human subjects concerns, it will assign a code to your application that may bar or restrict your award. A code 44 indicates a bar to award.
Under normal circumstances, we cannot fund your application until you address the issues. If you see a code, contact your program officer right away.
At the end of the fiscal year, we may issue an award with a restriction that prevents you from spending funds on the parts of your project that are barred. Check your Notice of Award for specifics, and go to Your Notice of Award, Know Your Terms of Award in the Strategy for NIH Funding. Also see our Human Subjects SOPs.
No. Before you enroll any subjects, NIAID staff must approve your protocol and have your IRB approval and other documents on file. Read Before You Enroll Patients in our human subjects tutorial and Must I send NIAID the IRB-approved protocol before accruing patients or enrolling participants? on this page.
No, the type of monitoring depends on the clinical trial. Phase III clinical trials must have an independent data and safety monitoring board (DSMB). Others may also require DSMB oversight.
For details, see our:
See Get IRB or IEC Approval and Submit Documents Before Enrollment in our human subjects tutorial.
Also see the HHS Informed Consent and Investigator Responsibilities sections of Human Research Protections Frequent Questions (FAQs).
Look at If I use leftover human specimens to conduct an in vitro diagnostic device study, do I need to get informed consent? in our Private Information or Biological Specimens in Human Subjects Research questions and answers.
For additional information, see the HHS Informed Consent section of Human Research Protections Frequent Questions (FAQs).
If you are conducting an applicable clinical trial, you must register with ClinicalTrials.gov. For more information, see Before You Enroll Patients.
Registering early with ClinicalTrials.gov may be necessary if you want your study to be considered for publication in a journal governed by the International Committee of Medical Journal Editors (ICMJE). For phase III clinical trials, ICMJE's publication policy requires registration before you enroll your first patient.
This may also be required for other types of clinical trials. For details, read "Is This Clinical Trial Fully Registered?"
Yes. If you want your study results to be published in a journal governed by the International Committee of Medical Journal Editors (ICMJE), make sure you understand its registration policy.
That policy may require that you register your clinical trial before you enroll your first patient. To see how it applies to your research, read "Is This Clinical Trial Fully Registered?"
Yes. See NIAID Clinical Terms of Award, page 3. Also, see Can I begin accruing subjects before my start date? on this page.
No. T32 grants are one exception to the rule, though they still must show approval before you start research that involves human subjects.
Yes. See Ongoing Reporting Requirements in Guidance for Complying with NIAID Clinical Terms of Award, page 5.
Yes. See Guidance for Complying with NIAID Clinical Terms of Award, page 7. Also look at Report Adverse Events Promptly in our human subjects tutorial.
Send an Inclusion Enrollment Report form annually. See Guidance for Complying with NIAID Clinical Terms of Award, page 7. For more information, see Send NIAID the Inclusion Enrollment Form in our human subjects tutorial.
Yes, with a certificate of confidentiality. See our Certificates of Confidentiality SOP and NIH's Certificates of Confidentiality Kiosk; follow Detailed Application Instructions for Certificate of Confidentiality to apply.
No. NIH doesn't ask applicants to address the Health Insurance Portability and Accountability Act because NIH is not a covered entity. You can read the HIPAA Privacy Rule to see if the requirements apply to you.
You may be able to apply for an extension. To learn more, read the NIAID Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
Also see our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions questions and answers.
Yes. Go to ClinRegs for country-specific clinical research regulatory information, including comparison information, presented in plain language.
Yes. Go to the HHS Human Research Protections Frequent Questions (FAQs) and NIH's Research Involving Human Subjects.
Email firstname.lastname@example.org with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.
Last Updated September 09, 2014
Last Reviewed May 23, 2012