HackensackUniversityMedicalCenter
Institutional Review Board
GUIDELINES FOR WRITING A PROTOCOL
Many investigators submitting research projects to the Institutional Review Board (IRB) are unsure of the information to include in the protocol. Below is an outline, which can be modified, as necessary. Not all headings will be applicable to each study, but a review of the material should prove helpful. If the protocol is sponsored by an outside source, i.e. a pharmaceutical company, manufacturer of medical device, etc., the sponsor’sprotocol should be used, and should not be rewritten.
I. Objectives of the Study
The rationale for the study, the investigator’s goals, and/or the hypothesis to be tested should be stated here.
II.Background Material
Describe and provide the results of animal studies, laboratory studies and pilot studies done here or elsewhere, and clinical studies conducted abroad.
III. Drug Information
If the protocol involves drugs, drug information should be provided: the chemistry, molecular formula, description, structure, human toxicity, synonyms, pharmaceutical data, storage and stability (if available (if available). The dosage, administration and mechanism of action should also be noted, as well as the name of the supplier.
IV. Inclusionary Criteria
Patient eligibility criteria should be listed. (Medical criteria, age, demonstration of disease, ailment, etc., proof of failure using standard therapy, laboratory assessments for eligibility, etc.).
V.Exclusionary Criteria
Age limits, if applicable; minors, pregnant women, mental incompetents, if applicable; use of other medications concomitantly, if applicable; subjects with other diseases, severity of illness, etc.
VI. Recruitment Procedures
The investigator should indicate where patients will be recruited, (e.g. walk-in clinic, emergency room, ICU, asthma clinic, etc.). If normal controls are to be used, this should also be noted. Recruitment methods (e.g. advertisements) should also be noted. A copy of the ad should be submitted along with the protocol. If monetary compensation is to be offered, the PI should state the amount the subject is to receive.
VII. Methodology
Investigator should explain the treatment plan. Baseline diagnostic tests, initial laboratory assessments for eligibility, any EKGs, physical exams, etc., should be noted. Any drug washout period should be explained. If the study is double or single blind, if placebo is to be used, and/or if randomization is involved, this should also be explained in detail. The use of patient diaries should be noted, the number of visits, dose modification or adjustments, and the route of administration of drugs should be included. The PI should indicate if subjects are to be hospitalized for any part of the study.
The PI should list measures to be used, tests, interviews, videotaping, and the amount of time the patient will be involved in the study.
The PI should make clear which methodologies are standard clinical care and which are experimental: e.g. if lumbar punctures are to be performed, it should be clear which, if any, would have been performed off study.
Any monitoring should be described. The PI should also discuss reasons for dropping any participant from the study. (Relapse, lack of patient compliance, etc.).
VIII.Discomfort and Risks
The PI should detail the possible risks to the subject and whether side effects are reversible. Any discomfort should also be carefully noted.
IX.Benefits
The PI should explain what benefits might be derived from participation in the study, noting in particular, the benefit over standard treatment (e.g. a once-a-day administration instead of four times a day, an oral formulation over an IV administration).
X.Criteria for Evaluating Response
The investigator should indicate determinations of response to therapy: laboratory assays, biopsies, bone marrow aspirations, absence of symptoms, normal blood levels, etc. The definition of partial response and failure should be noted.
XI. Confidentiality
The investigator should explain how patient confidentiality will be preserved, how data will be kept confidential and used for professional purposes, whether charts will be coded, kept in locked files, etc.
All protocols require one of the following:
- A HIPAA Authorization
- A Request to Waive Authorization
- A Data Use agreement (for use with limited data sets)
- HIPAA De-Identified Data Certification Form (protocol must be specific in this area and address what data is to be collected).
XII.Credentials, Training
Any training (observation of a new surgical technique, etc.) should be addressed. Any additional investigators should be mentioned specifically.
XIII.Bibliography
The investigator should provide a reasonable list of references directly related to the study. Any diagrams for new medical devices or brief reprints from journals might also pr