eResearch will be updated March 26, 2011 to incorporate recommendations from the University's recent AAHRPP review.
The following changes will be implemented in eResearch Regulatory Management:
Changes to Informed Consent Templates – IRB Contact Information for International Research
For research projects conducted outside the U.S., the University of Michigan IRBs have
revised their consent templates and guidance materials to include the U.S. international
country code as part of the U-M IRB telephone number. If a local IRB or ethics
committee has reviewed the project, the U-M IRB will now require that the contact
information (email, telephone number and address, as applicable) for the local IRB or
ethics committee be included in the consent document. For studies not reviewed by a
local IRB or ethics committee, the IRB may require that the investigator provide contact
information for a local individual or organization that can assist subjects in relaying
questions or complaints to the IRB, particularly for projects involving more than minimal
risk to subjects.
Sponsored Projects - Special Agency Requirements
Projects receiving funding from certain federal agencies may have additional regulatory
requirements for research with human subjects. Links to information about these special
requirements for the Department of Defense, Department of Education, Department of
Justice, and the Environmental Protection Agency have been added to Section 02
(Sponsor Information).
Request for Waiver of Documentation of Informed Consent
For projects requesting a waiver of documentation of informed consent, Question 10.1.2
(in Section 10 – Informed Consent), has been revised to request a justification for the
use of the waiver of documentation.
Clarification of Requirements for Parental Permission in Research with Children
In Section 10.2 (Informed Assent – Children), Question 10.2.2, the following information
has been added in the eResearch application HELP section regarding requirements for
parental permission and/or child assent for each category of research:
a) For research under regulatory category 45 CFR 46.404 or 45 CFR 46.405, the IRB
may determine that the permission of one parent is sufficient if adequate provisions
have been made for soliciting the assent of the children and the permission of their
parents or guardians.
b) For research under regulatory category 45 CFR 46.406 or 45 CFR 46.407, if
permission is to be obtained from parents, both parents must give their permission
unless one parents is deceased, unknown, incompetent, or not reasonably available,
or when only one parent has legal responsibility for the care and custody of the child.
Investigators must include information regarding their plan to seek permission of one or
both parents in their response to Question 10.2.2.
Conflict of Interest Disclosure
The IRB COI questions have been enhanced to require disclosure by any member of the
study team responsible for the design, conduct, or reporting of the research. To assist
the IRB review, COI Committee staff will now upload management plans into eResearch
applications via posted correspondence.