This means that the institution, whether a public university or a private sponsor, must establish a human research participant protection program (HRPPP) with multiple levels of responsibility and accountability, from the IRB (which, by federal law, prospectively reviews all federally
funded human subjects research protocols) to the chief administrator (Chancellor or CEO) to the investigator, staff, and students, to the research participants.
Not exact matches
My familiarity with TRE helped me shape an NIH grant proposal entitled «Scientists and
Subjects» (SAS)-- an online seminar on the ethics of research with human subjects, now in its second year of
Subjects» (SAS)-- an online seminar on the ethics of
research with
human subjects, now in its second year of
subjects, now in its second year of
funding.
Currently, researchers who use
human subjects or records must receive external approval from review boards before their
research can proceed or before they can receive federal
funding.
Courses often cover legal issues, like how to handle
research involving
human subjects, rather than examining how
funding may influence scientists or how cutting - edge
research such as genetic engineering may affect society at large.
Response: We generally agree with the commenters on the need to provide protections to all
human subjects research, regardless of
funding source.
Response: Although we share the concern raised by commenters that the option for the documentation of privacy board approval for an alteration or waiver of authorization may perpetuate the unequal mechanisms of protecting the privacy of
human research subjects for federally -
funded versus publically -
funded research, the final rule is limited by HIPAA to addressing only the use and disclosure of protected health information by covered entities, not the protection of
human research subjects more generally.