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 the NIH Grant Cycle.
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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
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
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.
Also see the Trans
NIAID Clinical Research Toolkit.
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?
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 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?
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?
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
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. |