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Human Subjects

Questions and Answers

Table of Contents

How do I determine if I am conducting human subjects research?

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.

Who can help me determine if my study is considered human subjects research?

Look at the following in our Private Information or Biological Specimens in Human Subjects Research questions and answers:

Will the peer reviewers evaluate my application's human subjects determination?

Yes. See How Human Subjects Applications are Reviewed in NIAID's human subjects tutorial.

Does FDA's Interim Final Rule on Medical Devices; Exception From General Requirements for Informed Consent affect my human subjects determination?

See the following:

Is it common for NIAID research to be exempt from human subjects requirements?

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?

How can I find out if my research is one of the rare studies at NIAID that may be exempt from human subjects requirements?

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:

  1. Consult with your institution: It's up to institutions to instruct applicants how to follow the Office for Human Research Protections' Guidance on Research Involving Coded Private Information or Biological Specimens and obtain approval.
  2. Contact your program officer or contracting officer's representative for additional assistance.

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.

Where can I find guidance on research involving coded private information or biological specimens?

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.

Does NIAID have special procedures and instructions for human subjects applications?

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.

Where do I find information and advice on preparing a human subjects application?

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.

Is it necessary to list the name of the PI grantee on each of the grant's protocols?

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.

For fellowship and career awards, is it necessary to be covered by an IRB approval?

If you are involved in human subjects research with your sponsor, you must be covered by his or her IRB approval.

Do I need an institutional assurance to conduct human subjects research?

Yes. Read Obtain a Federalwide Assurance in our NIAID Human Subjects Application and Grant Handbook and see our Human Subjects SOPs.

Do I need to replace my Single Project Assurance with a Federalwide Assurance?

Yes. The Federalwide Assurance is the only valid human subjects assurance. See the Human Subjects SOPs for more information.

When should I start working on obtaining or renewing a Federalwide Assurance?

See Is it ok if I do not yet have my Federalwide Assurance number when I apply?

Can I obtain, update, and renew a Federalwide Assurance, IRB or IEC registration online?

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).

Is it ok if I do not yet have my Federalwide Assurance number when I apply?

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.

When should I start getting IRB or IEC approvals?

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.

Do I need IRB approval for a clinical trial Web site?

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.

Where can I find information about IRB and IEC requirements for foreign applications?

Go to the following resources:

Where can I find information about research in foreign populations?

See Investigating Foreign Populations.

Do all investigators on a human subjects application have to show training in the protection of human subjects?

Yes. Your application must show mandatory training in the responsible conduct of research for all key personnel on the grant.

For more information read:

Are human subjects applications reviewed differently?

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.

If we are preparing a multiproject application where one core is using human subjects to generate cell lines that will be used by our five projects, which sections on the face page should be Yes for Human Subjects?

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.

If my description of human subjects protection is inadequate, how will it affect the review of my application?

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.

Can a human subjects concern lead to a bar to award?

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.

Can I get an award if I have a bar?

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.

Can I begin accruing subjects before my start date?

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.

Are independent data and safety monitoring boards required for all clinical trials?

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:

Am I responsible for acquiring informed consent?

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).

What are informed consent requirements for research involving in vitro diagnostic devices?

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).

Do I need to register my clinical trial with ClinicalTrials.gov?

If you are conducting an applicable clinical trial, you must register with ClinicalTrials.gov. For more information, see Before You Enroll Patients.

If I want to submit my clinical study for publication, do I need to register early in the process?

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?"

Could not registering affect my ability to publish?

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?"

Must I send NIAID the IRB-approved protocol before accruing patients or enrolling participants?

Yes. See NIAID Clinical Terms of Award, page 3. Also, see Can I begin accruing subjects before my start date? on this page.

Do T32 grants need IRB approval before an award is made?

No. T32 grants are one exception to the rule, though they still must show approval before you start research that involves human subjects.

Do I have to inform my program officer or the contracting officer's representative of my reports to FDA?

Yes. See Ongoing Reporting Requirements in Guidance for Complying with NIAID Clinical Terms of Award, page 5.

As an investigational new drug sponsor, must I notify FDA and NIAID about adverse events?

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.

For a clinical trial, how often must I send an Cumulative Inclusion Enrollment Report form?

Send an Cumulative Inclusion Enrollment Report form annually. See Guidance for Complying with NIAID Clinical Terms of Award, page 7. For more information, see Send NIAID the Cumulative Inclusion Enrollment Report Form in our human subjects tutorial.

Can NIH help me protect the confidentiality of my research subjects?

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.

Does NIH have requirements for HIPAA?

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.

If I can't complete a clinical trial within the performance period of my current award, can I apply for an extension?

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.

Do you have a resource that explains and compares clinical research regulations in foreign countries?

Yes. Go to ClinRegs for country-specific clinical research regulatory information, including comparison information, presented in plain language.

If I have other questions about human subjects, is there another good source of information?

Yes. Go to the HHS Human Research Protections Frequent Questions (FAQs) and NIH's Research Involving Human Subjects.

What if my question wasn't answered here, or I'd like to suggest a question?

Email deaweb@niaid.nih.gov 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.

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Last Updated October 03, 2014

Last Reviewed May 23, 2012