WebThe HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. WebRequest for Waiver of Authorization or Consent Form Recruitment Templates When using direct patient contact as a recruitment method, you need to include information in your proposed protocol to the IRB. Once you have IRB approval you may then contact DataCore to obtain a list of patients.

Federal Register, Volume 62 Issue 92 (Tuesday, May 13, 1997)

http://www.irb.emory.edu/forms/waivers/index.html WebIf you wish to apply for a Waiver of Informed Consent from the IRB, please complete this form by addressing each of the 5 criteria. The IRB will carefully consider your request and inform you of its decision in a timely fashion. All five criteria must be met in order to grant a Waiver of Informed Consent. Thank you very much. michaela boehm

eCFR :: 21 CFR 56.105 -- Waiver of IRB requirement.

WebWaiver or Alteration of HIPAA The IRB may approve a waiver or alteration of HIPAA provided that the research meets the criteria outlined in 45 CFR 164.512 (i) (2) (ii) (see below). The requirements overlap but are not the same as those for waiver of consent and waiver of documentation of consent. WebContact us at [email protected] 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800 A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams. IRBMED ROSTER, OFFICE PERSONNEL, AND EMERGENCIES/ON-CALL Informed Consent Templates Education WebWaiver of IRB Requirements for Drug and Biological Product Studies Guidance For Sponsors, Clinical Investigators, and IRBs October 2024 Download the Final Information Sheet Final … michaela blume