What needs to be included in the human subjects section of a grant application (Section E for NIH Grants)? 

Protection of Human Subjects 

This section should include: 

• Responsibilities of Principal Investigator (See UVA Investigators Agreement for a listing of the responsibilities)
• State it has been reviewed by an IRB compliant with 45CFR46/*21CFR50/ICH/HIPAA
• State that all subjects will sign an informed consent compliant with 45CFR46/ *21CFR50/ICH/HIPAA
• State inclusion/exclusion criteria that will protect an inappropriate subject from participating
• State how you will protect confidentiality (very important in specimen banking/genetic testing protocols)
• Recruitment-State how you plan to recruit subjects
• Obtaining consent- How you will provide an informed consent process
• Verification of UVA Federal Wide Assurance # 00006183

 *Note- only those protocols being done under an IND or IDE should reference 21CFR50. 

Inclusion of Women/ Minorities/Children 

Women, minorities and children must be included in all NIH biomedical and behavioral research involving human subjects in clinical research.  If you are not including them in your protocol make sure you document valid reasons why they will not be included in the protocols affiliated with this grant, even if the protocol has been deemed exempt. 

Clinical Research 

NIH defines human clinical research as: 
(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human specimen that cannot be linked to a living individual.   Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. 
(2) Epidemiologic and behavioral studies. 
(3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subject research are not considered clinical research by this definition. 

Clinical Trial 

A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).   Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective.  

Data and Safety Monitoring Plan - required only if there is an intervention

Data and Safety Monitoring Plans should include: 

• Adverse Event Reporting
• Safety Monitoring
• Safety Data to be Collected 

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. 

Adverse Event Reporting 

This section should include: 

• How will adverse events be collected?
• What is an adverse event for your protocol?
• What information will be recorded about the adverse event?
• Reporting requirements to IRB/sponsor. 

Safety Monitoring 

This section should include: 

• Designate who is responsible for overall safety monitoring (PI/DSMB).
• How often will review of adverse events be done?
• How will this review be done?
• How will results of review be shared? 

Safety Data to be Collected 

This section should include a list of labs/tests that will be done to protect subject.  Example: If an investigational drug is being given that is excreted in the kidneys - what tests/labs will be done to monitor kidney function. How often will they be done? Who will monitor results? 

Data and Safety Monitoring Boards (DSMB) 

DSMBs are required by most NIH Institutes for Phase III trials- check with your funding institute to determine their requirement. The IRB-HSR can determine if a DSMB is required. 

Data and Safety Monitoring Board/Committee (DSMB/DSMC) 

If your protocols will require a DSMB/DSMC, include the following information: 

• Member names with their affiliation/experience
• Frequency of meetings
• Frequency of reports 

Feedback 

The IRB-HSR staff would greatly appreciate any feedback you get from funding agencies regarding the human subject section of your grant application.  Please email feedback to us which will help keep this information current.