The protocol narrative (or "protocol") is submitted with the original submission of the protocol and revised versions, as necessary, with amendments. It must be sufficiently detailed to permit the IRB to evaluate the soundness of the procedures proposed and the potential risks and benefits to research subjects. For clinical trials, the latest version of the protocol and investigator brochure must be provided for review. 

The protocol should be typed and the pages numbered. Sponsor protocols are sometimes extremely lengthy and detailed; a summary should be prepared to aid in the committee’s review.

As a general guideline, the following sections are appropriate: 

1. background and prior pertinent experimental findings or animal data, if any.  This is especially important in protocols for studies of investigational drugs or investigational devices; 

2. purpose or hypothesis of the study, including potential knowledge to be gained; 

3. description of protocol methodology; 

4. probable duration of protocol; 

5. exact location where research is to be conducted (building, room number, etc.); 

6. special precautions to be taken by researchers, including dose modifications; 

7. description of experimental controls and use of placebos; 

8. type and number of experimental subjects, including method of subject selection, randomization, and inclusion and exclusion criteria, if any; 

9. description of the statistical analysis to which the data will be subjected.  This allows the IRB to ensure that study will produce statistically valid conclusions to justify the research on human subjects; 

10. potential risks and benefits to subjects;

11. monitoring of safety of subjects: The protocol should outline the steps to be taken to monitor the safety of all subjects, including a plan for reporting adverse events to the IRB, sponsor, and the FDA, as applicable. If a Data Safety Monitoring Board (DSMB) will be utilized, this should also be described;

12. payment to subjects:  Normal volunteers, research subjects acting as control group subjects, or research subjects who do not directly benefit from the experimental investigation, may be offered a reasonable, but not coercive, payment to participate in the protocol.  All projects that promise to provide payments to subjects must include details regarding the payment amount, as well as the prorated payment plan, within the protocol and consent form. The reasonableness of the amount offered will depend on the degree of discomfort the subjects experience, the invasiveness of the procedure or investigation, the character of the research, the population likely to be attracted by the protocol, the method in which the protocol will be advertised, the amount of time a subject is expected to devote to the protocol, and related considerations.  In addition, such protocols and consents should either (1) describe the plan for pro-rated payment to subjects if subjects withdraw voluntarily from the protocol or if, upon the suggestion of a physician or investigator, early withdrawal is necessary or (2) provide justification as to why prorated payment is not being offered to subjects; 

13. procedures to obtain and record informed consent; 

14. procedures which will be used to maintain confidentiality of research and study subject materials; 

15. bibliographic references to support the hypothesis and the justification for the use of human subjects and in particular the inclusion of any vulnerable populations; 

16. description of recruiting methods (i.e., advertisements, patient records, primary physician referrals).  If ads are to be used, indicate where ads will be placed and who will handle responses to the ads.  In addition, indicate whether patients are being recruited through clinicians or primary physicians; 

17. description of how the subject's primary physician will be notified of and, as appropriate, involved in the proposed research; 

18. description of anticipated coordination between appropriate inter-departmental faculty, and where necessary inclusion of those faculty as participants; 

19. if applicable, the protocol should clarify whether subjects will be asked to take a pregnancy test before and, as applicable, during the study. The IRB suggests the following guidelines for testing: presence or absence of serum HCG (pregnancy test) should be determined no earlier than the seventh day of the luteal phase (i.e., not earlier than day 21 in women with 25 day cycles, not earlier than day 22 in women with 29 day cycles, not earlier than day 23 in women with 30 day cycles, etc.); 

20. as applicable, a rationale for excluding women, minorities and/or children from participation. It is a policy of National Institutes of Health that all research involving human subjects includes women, minorities and children.  All protocols that explicitly exclude any of these populations must provide sufficient rationale for the exclusion of such.  Sufficient rationale might include a discussion of the inappropriate study population with respect to the health of the subjects or the purpose of the research.  The expectation that additional costs may be incurred by including women, minorities and children cannot be a reason for excluding these populations. 

 Please note: protocols involving children must first conform to the requirements of 45 CFR 46 subpart D, Additional DHHS Protections for Children Involved as Subjects in Research. The Principal Investigator must indicate the level of risk and the proposed benefit to the children for this research study on Supplemental Form C.  For the purpose of the NIH policy, “child” is defined as an individual under the age of 21 (http://www.nih.gov/grants/funding/children/children.htm).