Provide information about the primary researcher and co-researchers:
Include a sheet containing the names (with phone numbers and addresses, credentials, job titles, divisions, and/or agency names) and signatures of the primary researcher, each co-researcher, and the appropriate program director).
State the purpose of the research (e.g., its significance, expected impact).
Describe the methodology of the project:
- Describe procedures for subject recruitment, selection, and screening. Identify the number and characteristics (e.g., age, sex) of subjects to be included, and any exclusionary criteria.
- Describe all procedures to be performed (i.e., how data will be collected); describe criteria or procedures for assigning subjects to different "treatment" groups (e.g., control, experimental).
Provide expected start and end dates for the project.
State any risks or benefits to subjects and any potential benefits for mankind.
Describe provisions for any medical care required as a result of participation in the research study.
Describe procedures for safeguarding confidentiality.
Describe (if applicable) manner by which subjects are to receive compensation (e.g., cash, special benefits or services, etc.)
Develop and provide a consent form (not all projects require this). To determine if a consent form is necessary, view the DHHS website. ohrp.osophs.dhhs.gov - 46.116
Consent forms must be in language easily understood by the subject, and must contain all pertinent information in sufficient detail to allow the subject to make an informed decision to participate or not to participate in the study.
Include copies of survey instruments or other forms to be used in data collection with proposal submission.
Include a copy of approval from other Human Subject Review Boards. This is required if study is done collaboratively with a university or other external institution.
See sample Human Subjects Protocol.