Table 1.

Common language and regulatory interpretation required in the MRA

1“Uncheck the box”	Must “uncheck the box” on FWA Adopt policies specific to noncompliance and reporting, where reporting to OHRP is required only for federally funded research Institution retains right to report nonfederally funded noncompliance to OHRP
2Subject injury language	Agree to common subject injury language (or substantially equivalent language) Informed consent document cannot compel one institution to provide treatment or payment by another institution, without prior agreement
3.Insurance coverage	Commit to appropriate and sufficient insurance coverage
4.Privacy compliance (HIPAA, HITECH, etc.)	Not all institutions covered by HIPAA regulations All institutions must be able to comply with HIPAA, HITECH, and related privacy laws when reviewing for another a covered entity