Is the activity a systematic collection or analysis of data with the intent to generate new knowledge?
If living humans are involved in a systematic collection or analysis of data with the intent to generate new knowledge IRB review is required. The IRB must determine if the activity constitutes human subjects research or human subjects research that is eligible for exemption from approval. Unless there is a specific agreement in place to accept the review of another institution’s IRB, MDCH IRB review is required whenever: • The research is sponsored by the Department, or • The research is conducted by or under the direction of any employee or agent of the Department in connection with his or her institutional responsibilities, or • The research is conducted by or under the direction of any employee or agent of the Department using any facility of the department, or • The research involves the use of the department’s non-public information to identify, or contact, human research participants or prospective participants. No human subjects research is permitted without current MDCH IRB ap
