The most important concerns of the Human Subject Review Committee (HSRC) are to assure subjects’ safety, preserve subjects’ anonymity and confidentiality, and assure that participation is voluntary. Provide enough clarity, detail and specificity in this application for HSRC to determine that the researcher has put in sufficient time and attention planning this project, is trained and equipped to manage the project responsibly.
Application for Review
In order to facilitate approval of the application for use of human subjects in research, it is necessary for all relevant information to be included in the application. It is of equal importance that the document present a clear and concise explanation of the proposed research project.
1. Project Abstract (500 words)
2. Bibliography Please attach the bibliography from the review of the literature for this study.
3. Risks and Benefits
Please describe the possible risks to human subjects. Specify possible kinds and degrees of risks, e.g., minimal, emotional risk in the form of distress or embarrassment. Outline the precautions that will be taken to minimize these risks, and how the benefits outweigh the risks.
a) Specific level of risk to subjects
b) Benefits of the research
4. Purpose and Research Design
5. Problem Statement (300 words) Provide the HSR a clear description of what the research aims to examine)
6. Research Questions
7. Selection and recruitment of participant
How will the recruitment of human subjects for your proposed project be carried out? Include your recruitment criteria and procedures. Attach copies of any advertisements, flyers, announcements, or messages you will use to recruit participants.
8. Data collection process and protocols
Include the procedures and protocols to which humans will be subjected, (i.e., questionnaires, interviews, audio or video recording). Provide detailed description of when, where, and how data will be collected and the procedures and protocols used. Please attach a copy of all the questions you will be asking.
9. Debriefing Procedures (For studies that use deception or pose more than minimal risk)
It is possible that the research may produce psychological difficulties for a subject; therefore, it may be necessary to make arrangements for those difficulties to be dealt with by a professional. For example, in one study of people with chronic illness, the Investigator provided all subjects with a list of mutual-help organizations in the local area.
10. Confidentiality and Anonymity
Explain whether the participants will be protected through confidentiality or anonymity and how this protection is appropriate for the level of risk and how this protection will be managed. Include how information from this study will be distributed, and how will the promise of confidentiality be kept or carried out in the final product.
11. Data Management and Storage
Explain how the data will be managed (transferred, used, shared) and stored once it is collected. Include how long the data will be kept, and why that amount of time is necessary.
12. Informed Consent Process and Form
Explain how informed consent will be obtained and attach the specific informed consent form for this study. (See sample sections for informed consent)