Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...

Participant = Minor Participant = Incapacitated / Incompetent Adult Outpatient Psychotherapy Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian† See...