Reference no: EM133848239
Study - Healthcare literacy in the digital environment: The ways younger generations seek medical services.
IRB review is required for most activities that constitute engagement in human subjects research, as federally defined.
At DMSC/DHSC, researchers are permitted to self-determination their exempt research without confirmation from the IRB. This tool is intended to help you determine and document whether the human subject research qualifies for exempt self-determination or requires DMSC/DHSC IRB Review.
INSTRUCTION:
1. To get started, review Parts A & B to determine if the research is eligible for exempt self-determination.
2. If the research is eligible for exempt self-determination, maintain a copy of the completed Exempt Self-Determination Tool and any supporting documentation in your records. IMPORTANT! Do NOT submit the Exempt Self-Determination Tool to the IRB.
a. Sign the Lead Researcher (LR) Assurance statement at the end of the Exempt Self-Determination Tool. Obtain the Faculty Sponsor's signature as appropriate. Hire best assignment help now!
3. If DMSC/DHSC IRB Review is required, please submit a review through Cayuse
PART B: VERIFY EXEMPT CATEGORIES ELIGIBLE FOR SELF-DETERMINIATION
1. Please review the following Exempt categories that are eligible for self-determination.
2. Check the category(ies) that apply to the research.
IMPORTANT! If one or more category below are not applicable then the research is not eligible for exempt self-determination and IRB review is required.
SECTION 1: STUDY INFORMATION
SECTION 2: STUDY TEAM
SECTION 3: WHAT IS YOUR RESEARCH QUESTION?
SECTION 4: SUBJECT POPULATION
SECTION 5: RECRUITMENT METHODS
SECTION 6: PARTICIPANT COMPENSATION
SECTION 7: INFORMED CONSENT PROCESS
SECTION 8: RESEARCH PROCEDURES
SECTION 9: CONFIDENTIALITY OF RESEARCH INFORMATION
SECTION 10: LEAD RESEARCHER ASSURANCE