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Checklists for Planning and Writing a Human Subjects Grant Application

These checklists have been updated for electronic application and are based on NIAID's All About Grants tutorials. Throughout, we provide links to the tutorials for more complete information.

This covers Human Subjects. For other grant application topics, see the general Checklists for Planning and Writing a Grant Application.

General Human Subjects

Have I gone through the decision trees to make sure my research falls under the rubric of human subjects? Have I used the other decision trees?
Have I read through the Grant Application Guide (for an electronic application) or the human subjects section of the PHS 398 (for a paper application)?
If I am planning to conduct an investigator-initiated clinical trial, have I contacted my program officer to confirm whether my study requires a Clinical Trial Planning Grant (R34)?
Although exemptions rarely apply to NIAID research, is mine an exception that's exempt from some of the application and reporting requirements? (Research of fetuses, pregnant women, prisoners, or children is never exempt.)
Have I justified any exemption in the human subjects section of my Research Plan?
Regardless of any exemptions, have I addressed the inclusion of women, minorities, and children in the Research Plan of my application?
Have I taken into account that my application will also be reviewed for risks to subjects, adequacy of protection against risks, potential benefits to the subjects and others, and importance of the knowledge to be gained?
Have I made it clear to reviewers that I've thought through all issues and shown explicitly how I will comply with all regulations?
Has my institution filed a human subjects assurance online with the Office for Human Research Protections?
Have I made sure that my protocol includes everything required?
Have I checked "yes" for human subjects research in box 4 of the PHS 398 face page (for paper applications)
Have I checked "yes" for human subjects research in the designated box on the Research and Related Other Project Information page in my Grant Application Package (for electronic applications)?

For more information, go to our How to Write a Human Subjects Application tutorial, starting with Are You Conducting Human Subjects Research. Next, read Planning and Writing Your Research Application, beginning with Know the Requirements for Investigator-Initiated Clinical Trials. Under Before You Enroll Participants, read Include the Federalwide OHRP Assurance.

Also see Investigator-Initiated Clinical Trial Planning and Implementation Grants questions and answers.

Planning a Human Subjects Application

Have I carefully read the human subjects section of the PHS 398 (for a paper application) or Grant Application Guide (for an electronic application)?
Have I followed all of its instructions?
Have I asked for help from my business office and experienced grantees?
Have I checked the NIAID Clinical Terms of Award to see what Institute-specific requirements I'll need to fulfill?
Have I called an NIAID program officer or project officer for advice about the terms?
Am I planning ahead for the populations I'll need to include in the application, and for the reporting I'll do after I get the award?
Have I started the process of getting my IRB or IEC to certify my Research Plan?
Have I discussed my data and safety monitoring plan with my program or project officer?

For more information, go to Planning and Writing Your Research Application, in our How to Write a Human Subjects Application tutorial, starting with Know the Requirements for Investigator-Initiated Clinical Trials.

Planning an Investigator-Initiated Clinical Trial

Have I reviewed the Investigator-Initiated Clinical Trials Resources page and the Investigator-Initiated Clinical Trial Planning and Implementation Grants questions and answers?

Human Subjects Documentation

Does my application have a Research Plan, one that includes the protocol (if required by the division)?
Does it include a data and safety monitoring plan (for clinical trials)?
Does it include a Targeted/Planned Enrollment Table?
If several institutions are involved, have I submitted written documentation that each institution's IRB or IEC approved the protocol? Have I included a copy of the approved informed consent document and shown the version number or dates for which it is valid?
Have I sent NIAID full documentation from all IRBs or IECs (both national and local)?
If I have a Federalwide Assurance number at the time of application, did I include it?
If it's ready when I submit my application, have I included a letter documenting that the investigators involved in human subjects research have been educated in research conduct? Does that letter include a list of key personnel, the title, and a one-sentence description of the training?
Have I placed all of my human subjects documentation in the human subjects section of my Research Plan?

For more information, go to Planning and Writing Your Research Application, in our How to Write a Human Subjects Application tutorial, starting with Plan for Registering an IRB or IEC and Obtaining an FWA. Also read Document Training in Research Conduct and Include the Federalwide OHRP Assurance under Before You Enroll Participants.

Human Subjects Research Plan

Have I given this section a heading called "Human Subjects Research" and placed it after the "Research Design and Methods" section of my PHS 398 (paper application) or included the necessary attachments for human subjects in the PHS 398 Research Plan form of my Grant Application Package (for an electronic application)?
Do I have a subsection describing how I will protect subjects from research risks?
Do I have a subsection on the inclusion, analysis, and outreach for women?
Do I have a subsection on the inclusion, analysis, and outreach for minorities?
Do I have a subsection on the inclusion, analysis, and outreach for children, demonstrating the expertise to study children, suitability of my facilities, and how I will recruit enough children?
Do I have a subsection on data and safety monitoring?
Do I have a subsection on the detection of differences in the intervention effect for women and minorities (for NIH-defined phase III clinical trials only)?
Have I described my method and criteria for selecting subjects, dates of enrollment, and outreach and retention plans?
Have I stated how I will ensure adequate numbers of minorities, children, and both genders, including outreach mechanisms? Have I justified any exclusions?
Have I built this information into the project design?
Did I use the racial and ethnic categories defined in the PHS 398 (for a paper application) or Grant Application Guide (for an electronic application)?
Have I checked with my program officer or project officer to see if the NIAID division I'm applying to requires my protocol in the application?
Have demonstrated that I've thought through all issues and shown explicitly how I will comply with all regulations?
Have I clearly stated how I will include diverse groups and protect subjects from study-related risks?
Have I described the benefits of my research to patients and public health?
If it is appropriate to the research for some groups to be excluded or poorly represented, have I described the issue in terms of the study's size, disease characteristics, and feasibility of accruing subjects?
For inclusion of children, have I included a plan or justification for not studying them unless there are scientific or ethical reasons for not doing so?
If there are scientific reasons for examining minority groups abroad, have I designed studies to accommodate their participation and data analysis?
Have I made sure that my collaborators have their assurances with OHRP in place if they're working with human subjects?
Have I included a data sharing plan, if appropriate?

For more information, go to Planning and Writing Your Research Application, in our How to Write a Human Subjects Application tutorial, starting with Special Guidance for Domestic and Foreign Applicants.

Data Sharing Plan

If my application is requesting more than $500,000 in direct costs in any year, does it include a data sharing plan?
If responding to an RFA or RFP, have I read the announcement carefully for instructions about my data sharing plan?
Have I contacted my program officer at least six weeks before submitting my application to determine whether NIAID will accept my application?
Did I discuss my data sharing plan with my program officer when I contacted him or her?
Have I included a data sharing plan in the Research Design and Methods section of my PHS 398 (paper application) or in the PHS 398 Research Plan form of my Grant Application Package (for an electronic application) or explained why data sharing is not possible?
Have I made sure I am complying with the privacy rule of the Health Insurance Portability and Accountability Act (HIPAA) by removing any information that could be used to identify human subjects before sharing data?

Human Subjects Protocol

Does my protocol include a study design?
Does it include interventions?
Does it include patient eligibility?
Does it include criteria for excluding any populations?
Does it include plans to manage side effects?
Does it include plans to assess and report adverse events?
Does it include plans to monitor the data and safety of the trials, pharmacy, and laboratory?

Data and Safety Monitoring Plan

Have I discussed my data and safety monitoring plan with my program or project officer?
Do I monitor trials to ensure safety and effectiveness and recommend their conclusion?
Have I minimized risks to a practical extent?
Does the degree of monitoring correspond to the level of risk?
Does my data and safety monitoring plan provide an independent, objective review of the conduct of the research, interim safety and efficacy data, and progress towards achieving study goals?
Does it cover policies and procedures for reporting adverse events to the IRB, NIH Office of Biotechnology Activities (for studies involving rDNA), and FDA?

For more information, go to Planning and Writing Your Research Application, in our How to Write a Human Subjects Application tutorial, starting with Create a Data and Safety Monitoring Plan.

Phase III Clinical Trials

Have I addressed inclusion, depending on whether I expect clinically important differences in the intervention effect by gender, or between racial or ethnic subpopulations?
Have I designed analyses that can reveal intervention differences between men and women and between minorities and non-minorities, or show that such differences do not exist?
Do my plans provide for subset analyses? Have they been approved by my IRB with the final protocol?
If previous studies offer no strong evidence for or against differential effects, are my sample size and analysis plans sufficient for a "valid" analysis (unbiased, but not necessarily with high statistical power) of possible differences in intervention effect between subgroups?
If previous studies strongly support the existence of differential effects, does the sample size and analysis answer the primary question separately for men and women, and for each racial or ethnic subgroup?
Do I have a data and safety monitoring board (DSMB)?
Has NIAID appproved my DSMB?
Did I send my program or project officer a description of the board, its charter or operating procedures (including proposed meeting schedule and plan for review of adverse events), roster, and CVs of all members? Did I include a sentence describing their research conduct training?

For more information, go to Create a Data and Safety Monitoring Plan under Planning and Writing Your Research Application, in our How to Write a Human Subjects Application tutorial.

Target Study Enrollment

Have I planned for the populations I'll need to include in the application?
Have I planned for the reporting I'll do after I get the award?

IND or IDE Requirements

Does my research involve a new medical intervention?
Have I obtained an investigational new drug application (IND) or investigational device exemption (IDE) from FDA? Or does FDA consider my research exempt?
Have I let NIAID know the name, institution, and address of the IND or IDE sponsor, date filed with FDA, IND or IDE number, written comments from FDA, and written responses to those comments?
Have I included risk information from the investigator's brochure, a review of the published literature, or other credible sources?
Have I notified NIAID if the FDA has put my study on hold, and sent NIAID copies of all correspondence with FDA, including documentation that the hold has been lifted?
For interventions studies, have I obtained regulatory oversight by either FDA (under an IND or IDE) or the regulatory body of the country where the research is to be conducted?
For a foreign regulatory body, have I sent NIAID written documentation from the regulatory body showing I am in compliance with local regulatory laws?
Have I looked over the IND or IDE reporting requirements checklist?

For more information go to Meet Requirements for IND or IDE under Before You Enroll Participants, in our How to Write a Human Subjects Application tutorial.

rDNA Requirements

Has my application been reviewed by the NIH rDNA advisory committee (RAC)?
Have I then had it reviewed by my institutional biosafety committee, FDA, and my IRB?
Did I send written documentation, including comments, of those reviews and approvals to NIAID?
Have I had a public RAC review?
Have I sent NIAID a copy of the letter from the Office of Biotechnology Activities either stating the protocol has been exempted from public review, or summarizing the RAC suggestions and PI response to the recommendations?
Have I looked over the rDNA reporting requirements checklist for requirements after my application is funded?

For more information read Show Recombinant DNA Advisory Committee Approval under Before You Enroll Participants, in our How to Write a Human Subjects Application tutorial.

Before Enrolling Participants

If I didn't send it with my application:
- Am I ready to submit a letter documenting that investigators involved in the human subjects research have been educated in research conduct?
- Have I reviewed NIAID's sample letter for documenting training?
- Does my letter include a list of key personnel, the title, and a one-sentence description of the training? Am I prepared to send it in with the rest of the just-in time information?
If I didn't have a Federalwide Assurance number at the time of application, or if my number has changed since my last submission, am I prepared to send it in with the rest of the just-in-time information?
If I didn't have my certification of IRB or IEC approval ready when I applied, is it ready to go with the rest of the just-in-time information?
If I am conducting clinical trials, have I registered them on ClinicalTrials.gov?
Has NIAID approved my protocol, IRB or IEC approval, data and safety monitoring plans, IND or IDE information, RAC approval, and training in research conduct?
Have I addressed any concerns to their satisfaction?
Has my IRB or IEC approved any changes to the protocol?

For more information, read Before You Enroll Participants, in our How to Write a Human Subjects Application tutorial, up through Resolve Peer Review Concerns.

Revising a Human Subjects Application

Have I contacted my program or project officer to determine how to resolve any concerns the review group had?
Have I resolved any problems or concerns reviewers had with my application?

For more information read Resolve Peer Review Concerns under Before You Enroll Participants, in our How to Write a Human Subjects Application tutorial.

Human Subjects Reporting Requirements

General

Have I determined what the basic reporting requirements are for an NIH award?
Am I collecting data during the award, including data for minority subgroups, to complete the Inclusion Enrollment Report Table?
Have I completed the Targeted/Planned Enrollment Table form?
Have I included the Inclusion Enrollment Report table as part of my annual progress report?
Am I getting re-certification of IRB approval every year of my award?
If I've hired new staff, have I submitted documentation in my annual progress report that they were trained in the protection of human subjects? Have I reviewed NIAID's sample letter for documenting training?

For more information read Maintaining Your Award, in our How to Write a Human Subjects Application tutorial, up through Other Reporting Requirements.

When to Report to Your Program or Project Officer

Have I requested prior approval for any amendments or changes to the protocol before implementing them?
Have I had a protocol termination?
Have I had any changes in informed consent or IRB approval status?
Have I had a temporary suspension or permanent termination of patient accrual?
Have I had any other problems or issues that could affect participants?
Have I had any reports to or communications with FDA?
Has an unforseen or uncontrollable circumstance caused a delay in my clinical trial? Have I checked the Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions questions and answers to see if I am eligible for an extension?
Have I included the Inclusion Enrollment Report Table as part of my annual progress report?

For more information go to Maintaining Your Award in our How to Write a Human Subjects Application tutorial, starting with Amendments, Suspensions, and Terminations.

IRB and IEC

Have I had all relevant IRBs and IECs review the protocol and analysis plans as often as specified (at least once a year and whenever changes occur in my procedures)?
When sending NIAID documentation of IRB or IEC continuing reviews, have I included the following information for each investigative site: IRB or IEC registration number; OHRP federalwide assurance number for the site; IRB or IEC continuing review and approval; IRB or IEC approved consent form and protocol, each identified by version number, date, or both; and any documents related to protocol amendments, suspensions, or termination?
Have I reported any changes in informed consent or IRB approval status to NIAID?
Have I also sent my program or project officer a copy of my IRB letter of renewal, latest IRB- or IEC-approved protocol identified by version number or date, or my latest IRB- or IEC-approved informed consent document identified by version number and dates it is valid?

For more information go to IRBs and IECs Have Ongoing Requirements under Maintaining Your Award, in our How to Write a Human Subjects Application tutorial.

IND or IDE

Am I notifying NIAID in writing if FDA places my study on hold?
Are the IND and IDE sponsors notifying FDA about adverse events through safety reports? Are they providing copies to the NIAID program or project officer within 24 hours of FDA notification?
Am I reporting other adverse events I document during the trial in my annual IND or IDE report?
For seven-day IND telephone or fax reports or 15-day IND written reports, have I sent a copy to my program or project officer within 24 hours of FDA notification?
For IND reports of adverse device effect, have I sent a copy to my program or project officer within 24 hours of FDA notification?

For more information go to Report Adverse Events Promptly under Maintaining Your Award, in our How to Write a Human Subjects Application tutorial.

rDNA

Have I sent NIAID an annual report, as well as reports of adverse events not included in expedited reports to the Office of Biotechnology Activities?
Have I sent NIAID a copy of the continuing approval of my institutional biosafety committee?

For more information go to Other Reporting Requirements under Maintaining Your Award, in our How to Write a Human Subjects Application tutorial.

To find an NIAID program officer, see our Contact Staff for Help

For more information, see NIAID's NIH Grant Cycle: Application to Renewal. Find more checklists at All About Grants tutorials.