Guidelines for Submitting Appendix B to the COHS Human Subjects Review Committee
Complete Appendix B (DOC). Please fill in all relevant parts.
Create a Study/Research Protocol and attach it to Appendix B This should contain:
Cover page with your name and the name of all co-authors.
Abstract: 125 words or less.
Statement of purpose (3-5 sentences).
Background/literature review (under 2 pages).
Research questions and hypotheses.
Methods
Research design
Data Source
Sampling strategy (if applicable)
Data collection instruments such as the survey or data abstraction forms (if applicable)
Any study documents (flyers, letters, screening form, cover letters, etc).
A letter from the owner of the data authorizing its use (not needed for public datasets such as those from the CDC or NCHS). For example, if you are getting your data from a hospital, you need a letter certifying that you have access to the data.
A statement about data management: If collecting data: The data will be stored in a secure and locked location (you need to name the location). It will be destroyed five years after completion of the project. If using public datasets: The data are from an existing dataset so the decision to destroy the data is not in the hands of the principle investigator.
Human subject certification (NIH certificates) from the Responsible Primary Investigator (RPI) - this must be a faculty member. You also need the NIH certificates from all Co-PI's.
References
Submit one electronic copy of Appendix B and the Study/Research Protocol to the Chair of the COHS Human Subjects Review Committee (janeff@odu.edu). Provide one copy of the full protocol (if you have one) to the chair of the COHS Human Subjects Review Committee.
