[NOTE: IF ANY STUDY SUBJECTS ARE CONSIDERED VULNERABLE BY THE FEDERAL GOVERNMENT, PLEASE EXPLAIN ADDITIONAL MEASURES YOU ARE TAKING TO PROTECT THEIR RIGHTS.] How are subjects recruited and selected? [ATTACH RECRUITMENT What incentives will be offered, if any? Are you associated with the subjects (e.g., your students, employees, patients)? Yes ___ No ___ If yes, please explain the nature of the association and what measures you are taking to protect subjects’ rights, including safeguards against any coercion. Will subjects be minors (under 18) or otherwise not fully competent to consent? Yes ___ No ___ If yes, explain: Will this research be conducted with subjects who reside in another country, or who reside in the U.S. but in a cultural/ethnic context different from traditional U.S. society/culture (including language speakers)? ___ Yes ___ No If yes, explain. If yes, will there be any corresponding complications in your ability to minimize risks to subjects, maintain their confidentiality and/or assure their right to voluntary informed consent? ___ Yes ___ No If yes, what are these complications and how will you resolve them? C. Informed Consent 1. Describe briefly how and to what extent participants will be informed about the research before they give their consent. Please attach a copy of the informed consent letter you will use. (It should be at the 8th grade reading level, or lower as dictated by the needs of the subjects.) 2. Does your investigation involve incomplete disclosure of the research purpose or deception of subjects? ___ Yes ___ No [NOTE: DESCRIBE ANY DECEPTION, IF ANY, TO BE USED WITH HUMAN SUBJECTS.] If yes, be sure to include copies of your debriefing procedures for subjects. 3. Indicate how subjects can, if they wish, withdraw from the study. [IF PROCEDURES ARE POTENTIALLY HARMFUL, DESCRIBE ARRANGEMENTS FOR MEDICAL REFERRAL OR OTHER ASSISTANCE. IF EXPECTED CULTURAL OR LANGUAGE PROBLEMS, DESCRIBE PROVISIONS TO BE MADE FOR CONSENT.] D. Privacy/Confidentiality 1. Does the project involve protected health information as defined by HIPAA?
[NOTE: IF ANY STUDY SUBJECTS ARE CONSIDERED VULNERABLE BY THE FEDERAL GOVERNMENT, PLEASE EXPLAIN ADDITIONAL MEASURES YOU ARE TAKING TO PROTECT THEIR RIGHTS.] How are subjects recruited and selected? [ATTACH RECRUITMENT What incentives will be offered, if any? Are you associated with the subjects (e.g., your students, employees, patients)? Yes ___ No ___ If yes, please explain the nature of the association and what measures you are taking to protect subjects’ rights, including safeguards against any coercion. Will subjects be minors (under 18) or otherwise not fully competent to consent? Yes ___ No ___ If yes, explain: Will this research be conducted with subjects who reside in another country, or who reside in the U.S. but in a cultural/ethnic context different from traditional U.S. society/culture (including language speakers)? ___ Yes ___ No If yes, explain. If yes, will there be any corresponding complications in your ability to minimize risks to subjects, maintain their confidentiality and/or assure their right to voluntary informed consent? ___ Yes ___ No If yes, what are these complications and how will you resolve them? C. Informed Consent 1. Describe briefly how and to what extent participants will be informed about the research before they give their consent. Please attach a copy of the informed consent letter you will use. (It should be at the 8th grade reading level, or lower as dictated by the needs of the subjects.) 2. Does your investigation involve incomplete disclosure of the research purpose or deception of subjects? ___ Yes ___ No [NOTE: DESCRIBE ANY DECEPTION, IF ANY, TO BE USED WITH HUMAN SUBJECTS.] If yes, be sure to include copies of your debriefing procedures for subjects. 3. Indicate how subjects can, if they wish, withdraw from the study. [IF PROCEDURES ARE POTENTIALLY HARMFUL, DESCRIBE ARRANGEMENTS FOR MEDICAL REFERRAL OR OTHER ASSISTANCE. IF EXPECTED CULTURAL OR LANGUAGE PROBLEMS, DESCRIBE PROVISIONS TO BE MADE FOR CONSENT.] D. Privacy/Confidentiality 1. Does the project involve protected health information as defined by HIPAA?
IRB_Full_Form_for_Faculty_PI_in_Word%20_Template_with_CATEGORY_Definitions(0).docx