This page covers NIAID Human Subjects Resources.
Table of Contents
- General Human Subjects
- Planning a Human Subjects Application
- Planning an Investigator-Initiated Clinical Trial
- Human Subjects Documentation
- Human Subjects Research Plan
- Data Sharing Plan
- Human Subjects Protocol
- Data and Safety Monitoring Plan
- Phase III Clinical Trials
- Target Study Enrollment
- IND or IDE Requirements
- rDNA Requirements
- Before Enrolling Participants
- Revising a Human Subjects Application
- Human Subjects Reporting Requirements
- Have I gone through the Decision Trees for Human Subjects Requirements to make sure my research falls under the rubric of human subjects? Have I used the other Decision Trees for Human Subjects Requirements?
- Have I gone to Does your human subjects research study meet the NIH Definition of a clinical trial? to determine whether my research qualifies as a clinical trial?
- Have I read through the application instructions?
- If my research qualifies as a clinical trial, are clinical trials either optional or required by the notice of funding opportunity (NOFO) to which I’m applying?
- If I am planning to conduct an investigator-initiated clinical trial, have I contacted my program officer to confirm whether I should go through the NIAID investigator-initiated clinical trials process?
- 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 application?
- Regardless of any exemptions, have I addressed the inclusion of women, minorities, and people of all ages in 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, importance of the knowledge to be gained, and data and safety monitoring for clinical trials?
- 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 the designated box on the Research and Related Other Project Information page in my grant application?
For more information, go to our Research Using Human Subjects section.
- Have I carefully read the human subjects section of the 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 contracting officer's representative 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 contracting officer's representative?
- Have I reviewed Investigator-Initiated Clinical Trial Resources and Investigator-Initiated Clinical Trial Awards: General Questions and Answers?
- Have I contacted an NIAID program officer for prior consultation?
- Have I checked “yes” for either Clinical Trial or Agency Defined Phase III Clinical Trial (as applicable) in Section 2 Human Subjects of the PHS 398 Cover Page Supplement of my application?
- Does my application have a Research Plan, one that includes the protocol (if required by the division)? Note: Some NOFOs require complete protocols as other “Attachments.”
- Does it include a data and safety monitoring plan (for clinical trials)?
- Does it include a Planned Enrollment Report? (Check optional box on the face page of the Grant application.)
- If proposing mutli-site studies, do I comply with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research and have I submitted written documentation that the sIRB 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 application?
For more information, go to our Research Using Human Subjects section.
- Have I given this section a heading called Human Subjects Research and placed it as an attachment in the appropriate place with the application?
- Do I have a separate attachment describing how I will protect subjects from research risks?
- Do I have a separate attachment on the inclusion, analysis, and outreach for women and minorities?
- Do I have a separate attachment 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)?
- If I plan to conduct clinical trials, do I have a subsection certifying I've completed the required submissions to ClinicalTrials.gov?
- 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 and justification if not using people of all ages? 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 application instructions?
- Have I checked with my program officer or contracting officer's representative to see if the NIAID division I'm applying to requires my protocol in the application?
- Have I 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?
For more information, go to our Research Using Human Subjects and Inclusion of Special Populations: Women, Minorities, and All Ages sections.
- If my application is requesting more than $500,000 in direct costs in any year, does it include a data sharing plan?
- Have I consulted my program officer at least ten weeks before submitting my application to determine whether NIAID will accept my application?
- If responding to an RFA, PA or RFP, have I read the announcement carefully for instructions about my data sharing plan?
- Did I discuss my data sharing plan with my program officer when I contacted him or her?
- Have I included a data sharing plan 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?
- 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?
For more information, go to our Research Using Human Subjects and Inclusion of Special Populations: Women, Children, Minorities sections.
- Have I discussed my data and safety monitoring plan with my program or contracting officer's representative?
- 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 the Food and Drug Administration (FDA)?
Follow the guidance in the SF424 (R&R) General Application Guide.
- 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 approved my DSMB?
- Did I send my program or contracting officer's representative 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 description of the research conduct training?
For more information, go to Design Your Data and Safety Monitoring Plan in our Research Using Human Subjects section.
- 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?
- 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?
For more information go to Meet Requirements for IND or IDE in our Research Using Human Subjects section.
- Has my application been reviewed by my institutional biosafety committee, FDA, and my IRB?
- Did I send written documentation, including comments, of those reviews and approvals to NIAID?
For more information read our Research Using Human Subjects section.
- 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 ensured that all clinical trial staff completed Good Clinical Practice training and that each person will refresh his or her training at least every three years?
- Have I reviewed NIAID's Sample Letter To Document Training in the Protection of Human Subjects 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 and certified to NIAID that I completed the required submissions?
- Has NIAID approved my protocol, IRB or IEC approval, data and safety monitoring plans, IND or IDE information, 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 Patients in our Research Using Human Subjects section.
- Have I contacted my program or contracting officer's representative 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 If Reviewers Have Concerns on Research Using Human Subjects.
- 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 Cumulative Inclusion Enrollment Report?
- Have I completed the Planned Enrollment Report form?
- Have I included the Cumulative Inclusion Enrollment Report table as part of my annual progress report?
- Have I certified to NIAID that I completed the required ClinicalTrials.gov submissions?
- 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 to Document Training in the Protection of Human Subjects for documenting training?
For more information read Manage Your Award.
- 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 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 unforeseen or uncontrollable circumstance caused a delay in my clinical trial? Have I checked the Investigator-Initiated Clinical Trial Administrative Extension SOP and Extention of Investigator-Initiated Clinical Trials Questions and Answers to see if I am eligible for an extension?
- Have I included the Cumulative Inclusion Enrollment Report as part of my annual progress report?
For more information go to Manage Your Award.
- Have I had the IRB and all relevant 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 contracting officer's representative 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 Responsibilities in our Research Using Human Subjects section.
- 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 contracting officer's representative 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 contracting officer's representative within 24 hours of FDA notification?
- For IND reports of adverse device effect, have I sent a copy to my program or contracting officer's representative within 24 hours of FDA notification?
For more information go to Report Adverse Events Promptly in our Research Using Human Subjects section.
- Have I sent NIAID a copy of the continuing approval of my institutional biosafety committee?
For more information go to Reporting Requirements in our Research Using Human Subjects section.
To find an NIAID program officer, see our Contacting Program Officers and Grants Management Specialists.