GUIDELINES FOR WRITING RESEARCH PROTOCOLS

(From the website http://research.louisville.edu/UHSC/)

This information sheet provides guidelines for writing research protocols that contain all the necessary information for IRB review.

1. The primary responsibility of IRBs is to safeguard the rights and welfare of human research subjects. Therefore, a PI must provide enough information for the IRB to determine that human subjects will be adequately protected and that the research will be conducted in full compliance with the MPA. In order to approve a research activity involving human subjects, an IRB must assure that all of the following requirements are satisfied:

a. Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.

b. Risks to subjects are reasonable in relation to (1) anticipated benefits, if any, to subjects, and (2) the importance of the knowledge that may reasonably be expected to result.

c. The selection of subjects is equitable. In making this assessment, the IRB must take into account the purposes of the research and the setting in which the research will be conducted. It must be particularly attentive to the special problems which may arise in research involving vulnerable populations, such as children, pregnant women, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons. If any of the subjects is likely to be vulnerable to undue influence or coercion, the IRB may require additional safeguards to protect such subjects.

d. Informed consent will be sought from each prospective subject, or the subject's legally authorized representative, generally by means of a written consent document that the IRB has carefully reviewed to assure that it contains the required elements of informed consent and that it is understandable to a lay person.

e. The research plan makes adequate provisions for ensuring the safety of subjects.

f. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

2. Specific Protocol Content -
Headed Sections

a. Summary - In 400 words or fewer, provide a description of the objectives, study population, design, and outcome parameters.

b. Introduction. Describe the background and references that are relevant to the design and conduct of the study.

c. Objectives. State the objectives of the study, whenever possible, as hypotheses.

d. Study Design and Methods. Describe the involvement of human subjects (see section (h), below) including initial evaluation procedures and screening tests, phases, procedures and sequence of the study.

e. Inclusion and exclusion criteria: These must be included in the protocol.

f. Analysis of the Study. Delineate the precise outcomes to be measured and analyzed. Describe how these results will be measured and statistically analyzed. Delineate methods used to estimate the required number of subjects. Describe power calculations if the study involves comparisons.

g. Human Subject Protections. Protocols without this section will not be accepted for IRB review.

(1) Rationale for Subject Selection:

The protocol must include (a) a rationale for research subject selection based on a review of gender/ethnic/race categories at risk for the disease/condition being studied; (b) strategies/procedures for recruitment (including advertising, if applicable); and (c) justification for exclusions, if any.

Explain the rationale for the involvement of special classes of subjects, if any, such as fetuses, pregnant women, children, cognitively impaired individuals, prisoners or other institutionalized individuals, or others who are likely to be vulnerable. Reference the appropriate Clinical Center Medical Administrative Series or Federal Regulations Subparts as necessary when discussing the research involvement of these subjects. Discuss what, if any, procedures or practices will be used in the protocol to minimize their susceptibility to undue influences and unnecessary risks (physical, psychological, etc.) as research subjects.

(2) Evaluation of Benefits and Risks/Discomforts:

Describe the potential benefits to subjects or to others that may reasonably be expected from the research. If paid healthy volunteers are involved, or if subjects are to be paid, specify the amount of compensation.

Describe any potential risks -- physical, psychological, social, legal, or other -- and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects. Describe the procedures for protecting against or minimizing any potential risks, such as violations of confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects.

Discuss why the risks to subjects are reasonable in relation to the anticipated benefits and in relation to the importance of the knowledge that may reasonably be expected to result.

h. Adverse Event Reporting and Data Monitoring.

Provide a plan for reporting adverse events to the IRB. Also, describe the provisions for monitoring the data collected to ensure the safety of subjects.

i. Consent and Assent Processes and Documents

Describe the consent procedures to be followed, including the circumstances in which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.

Children are generally not legally empowered to give consent, but depending on their age, they may have the ability to give assent ("assent" means a child's affirmative agreement to participate in research). Every protocol involving children (those individuals under age 18) should include a discussion of how assent will be obtained for the particular study. If an assent is to be obtained, use the IRB template.

j. References. Include selected references, which highlight methods, controversies, and study outcomes.