(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. (b) (2) and (b) (3). This listing refers only to research that is not exempt.) Full board review—more than minimal risk, potential for harm to participants. This includes, but is not limited to collection of sensitive information, invasive medical procedures, and research on special populations. There have been only few full board projects at Maricopa. Type of review is suggested by Principal Investigator (PI) but ultimately determined by IRB or CRRC. It is not permissible for a PI to declare their research to be exempt and bypass review. Training Certificate for IRB Members and PIs NIH – National Institutes of Health training - http://phrp.nihtraining.com/users/login.php Free to the person taking the training Certificate must be within two years of date of completion CITI certificate is accepted as well What Goes Where CRRC –Expedited or exempt research conducted only by students from that campus will be reviewed by the CRRC. This speeds up the process and makes it easier for PIs to get quick advice. Some campuses also require students in research methods classes to undergo IRB review. IRB (District) All protocols that require full-board review All research conducted by non-students (including internal and external PIs) All research involving the DO or the entire district (all students and/or employees) All grant proposals Consortium protocols (e.g. Maricopa and NAU) Requests from district personnel eProtocol Online IRB management software in use at MCCCD. Provides for electronic submission and review of protocols. Allows for consistent record keeping, and provides central location for all files related to each submission. Has advantages and disadvantages and a “learning curve” especially for reviewers. Makes submissions and revisions more manageable, and keeps a good record of activities. IRB Application Process Determining if research is about human subjects;
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. (b) (2) and (b) (3). This listing refers only to research that is not exempt.) Full board review—more than minimal risk, potential for harm to participants. This includes, but is not limited to collection of sensitive information, invasive medical procedures, and research on special populations. There have been only few full board projects at Maricopa. Type of review is suggested by Principal Investigator (PI) but ultimately determined by IRB or CRRC. It is not permissible for a PI to declare their research to be exempt and bypass review. Training Certificate for IRB Members and PIs NIH – National Institutes of Health training - http://phrp.nihtraining.com/users/login.php Free to the person taking the training Certificate must be within two years of date of completion CITI certificate is accepted as well What Goes Where CRRC –Expedited or exempt research conducted only by students from that campus will be reviewed by the CRRC. This speeds up the process and makes it easier for PIs to get quick advice. Some campuses also require students in research methods classes to undergo IRB review. IRB (District) All protocols that require full-board review All research conducted by non-students (including internal and external PIs) All research involving the DO or the entire district (all students and/or employees) All grant proposals Consortium protocols (e.g. Maricopa and NAU) Requests from district personnel eProtocol Online IRB management software in use at MCCCD. Provides for electronic submission and review of protocols. Allows for consistent record keeping, and provides central location for all files related to each submission. Has advantages and disadvantages and a “learning curve” especially for reviewers. Makes submissions and revisions more manageable, and keeps a good record of activities. IRB Application Process Determining if research is about human subjects;
5962-nov-2016-overview-irb.docx