1. Briefly state the problem, the present knowledge relevant to it, and the aims and significance of the proposed research. Cite appropriate literature.
2. Describe the tasks/tests or procedures participants will be asked to complete.
(Suggestions: explain step by step what the participants will be asked to do and distinguish those which are experimental from those which comprise routine clinical care/services.) Attach copies of all questionnaires, testing instruments or interview protocols; include any cover letters or instructions to participants. Provide references on reliability and validity of published tools and written permission to use copyrighted tests if you have not purchased the test
3. Recruitment Procedures
a. Describe how participants will be identified and recruited. Attach all recruitment information, e.g., advertisements, bulletin board notices, and recruitment letters for all types of media (printed, radio, email, electronic, TV, or Internet).
b. Initial Contact. Describe who will make initial contact. How? If participants are chosen from records, indicate who gave approval for the use of the records. If records are “private” medical or student records, provide the protocol, consent forms, letters, etc., for securing consent of the participants for the records. Written documentation for cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of participants identified through a records search must be made by the official holder of the record, i.e. primary physician, therapist, public school official.)
4. Why are the risks and inconveniences mentioned above reasonable? What is the expected scientific yield from the project? Please justify the risks in relation to the anticipated benefits to the participants and in relation to the importance of the knowledge that may reasonably be expected to result from the research.
C. Confidentiality of Data
1. Describe provisions made to maintain confidentiality of data. How will the data be coded? Who will have access to raw data? Will raw data be made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school officials, medical personnel)? If yes, who, how, and why? Describe the procedure for sharing data. Describe how the participant will be informed that the data may be shared.
2. Where will the data be kept and for how long? How will audio and video tapes be disposed of? (Disposition of audio and video tapes should be included in consent form.)