Protocol Outline

Institute for Health Research IRB Guidelines Excerpt
HHS Web Page with Decision Charts to Help You Decide
A. Components of a Research Protocol
B. Research Protocol Outline
C. Sample Protocol 

Appendix A

Components of a Research Protocol Proposal

The IHRIRB’s assessment of your research proposal involves a series of steps:  (1) identifying the risks associated with the research, as distinguished from the risks the participants would experience even if not participating in the research; (2) determining that risks will be minimized; (3) identifying the probable benefits to be derived from the research; (4) determining that risks are reasonable in relation to the benefits to the participants, if any, and the importance of the knowledge to be gained; (5) ensuring that potential participants will be provided with an accurate and fair description of the risks or discomforts of the anticipated benefits; and (6) determining the intervals of periodic review.

To ensure that the IHRIRB completes their review in a timely manner, your proposal must include the following information, as applicable:

¨       Cover letter with a list of all investigators and a contact person and telephone number

¨       Detailed protocol of study design, sampling, analyses, timelines, evaluation, and community involvement

¨       Informed consent and assent forms

¨       Other attachments, such as a copy of scripts or survey that will be used, materials that will be distributed, etc.

If your proposal is missing any required items, review of your proposal will be delayed.


Research Protocol Outline

Your research Protocol should discuss in detail how you plan to carry out the research, how you will analyze the data that you collect, and what you plan to do with the results.  The following are points that you should address in your protocol.

Introduction and Background

¨       Provide relevant research background and explain why this activity is necessary or important.

¨       Describe the potential impact of the proposed research.

Study Design

¨       Provide a complete description of the study design, sequence, and timing of all study procedures that will be performed.  Provide this information for pilot, screening, intervention, and follow-up phases.  Include all materials that will be used in the procedure, such as surveys, scripts, questionnaires, etc.  Attach flow sheets if they will help the reader understand the procedures.

¨       Describe how study procedures differ from standard care or procedures (e.g., medical, psychological, educational, etc.).

¨       If any deception or withholding of complete information is required, explain why this is necessary and attach a debriefing statement.

¨       Describe where the study will take place

¨       A letter of approval and cooperation from each participating site is needed.  For example, if the study will be conducted in the local school system, an approval letter from the School Board and Superintendent are necessary.


¨       Explain how the nature of the research requires or justifies using the participant population.

¨       Provide the approximate number and ages for the control and experimental groups.

¨       Describe the gender and minority representation of the participant population.

¨       Describe the criteria for selection for each participant group.

¨       Describe the exclusion criteria exclusion for each participant group.

¨       Describe the source for participants and attach letters of cooperation from agencies, institutions, or others involved in the recruitment.

¨       Explain who will approach the participants and how the participants will be approached.  Explain what steps you will take to avoid coercion and protect privacy.  Submit advertisements, flyers, contact letters, and phone contact protocols.

¨       Explain if participants will receive payments, services without charge, or extra course credit.

¨       Explain if participants will be charged for any study procedures.

Risks and Benefits

¨       Describe the nature and amount of risk of injury, stress, discomfort, invasion of privacy, and other side effects from all study procedures, drugs, and devices.  Describe the amount of risk the community may be subjected to.

¨       Describe how due care will be used to minimize risks and maximize benefits.

¨       Describe the provisions for a continuing reassessment of the balance between risks and benefits.

¨       Describe the data and safety monitoring committee, if any.

¨       Describe the expected benefits for individual participants, the community, and society.

Adverse Effects

¨       Describe how adverse effects will be handled.

¨       Discuss if facilities and equipment are adequate to handle possible adverse effects.

¨       Explain who will be financially responsible for treatment of physical injuries resulting from study procedures (e.g., study sponsor, subject, organization compensation plan, etc.).

Confidentiality of Research Data

¨       Explain if data will be anonymous (no possible link to identifiers).

¨       Explain if identifiable data will be coded and if the key to the code will be kept separate from the data.

¨       Explain if any other agency or individual will have access to identifiable data.

¨       Explain how data will be protected (e.g., computer with restricted access, locked file, etc.).

Consent Forms and Assent Forms

¨       If the consent form is written, submit copies of all consent and assent forms for each participant group.  If an oral consent or assent script will be used, submit written scripts for each group.

¨       If you will not use a consent form or script, submit written justification of waiver of consent.

Drugs, Substances, and Devices

¨       List all non-investigational drugs or other substances that will be used during the research.  Include the name, source, dose, and method of administration.

¨       List all investigational drugs or substances to be used in the study.  Include the name, source, dose, method of administration, IND number, and phase of testing.  (INDs must be registered with the appropriate institutional pharmacy.)  Provide a concise summary of drug information prepared by the investigator, including available toxicity data, reports of animal studies, description of studies done in humans, and drug protocol.

¨       List all investigational devices to be used.  Provide the name, source, description of purpose, method, and Food and Drug Administration IDE number.  If no IDE is available, explain why the device qualifies as a non-significant risk.  Attach a copy of the protocol, descriptions of studies in humans and animals, and drawings or photographs of the device.

Additional Information

¨       Describe how materials with potential radiation risk will be used (e.g., X-rays and radioisotopes).

¨       If you will use materials with potential radiation risk, describe the status of annual review by the Radiation Safety Committee.  If the annual review has been approved, attach a copy of the approval.

¨       Describe the medical, academic, or other personal records that will be used.

¨       Describe the type of audio-visual recordings, tape recordings, or photographs that will be made.

¨       Explain if the Scientific Instrument Division will test all instruments.  If not, describe the safety testing procedures.

¨       Do the PI or sponsor have relevant insurance coverage? If so, state company name and policy number.

This excerpt should be read in conjunction with the Guidelines.

Appendix C

Sample Protocol Outline



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