University of Iowa Human Subjects Office / IRB

Guidance and Regulation Updates

OHRP News

SACHRP Recommendation: Consideration of the Principle of Justice 45 CFR part 46
SACHRP Recommendation: Attachment B - New Challenges in Interactions among Sponsors, Clinical Trial Sites, and Study Subjects
SACHRP Recommendation: Attachment A - IRB Authority to Restrict Use of Data Collected and Developed in Research
HHS and 16 Other Federal Departments and Agencies Issue a Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period
HHS and 16 Other Federal Departments and Agencies Announce a Notice of Proposed Rulemaking Proposing to Delay for an Additional 6 Months the General Compliance Date of the Revisions to the Common Rule
International Social-Behavioral Research Standards
Interim Final Rule Delays Both the Effective Date
Use of Electronic Informed Consent (Final Guidance issued with FDA)
DRAFT Guidance: Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
OHRP and FDA Announce the Availability of a Draft Guidance Document on IRB Meeting Minutes
OHRP Announces Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects NPRM
OHRP Notice Requesting Public Comment on Whether FDA’s Draft Guidance Document on Electronic Informed Consent in Clinical Investigations would be Appropriate for Research Regulated under 45 CFR part 46
OHRP releases draft guidance on assessing risks to human subjects involved in research that compares "standard of care" medical practices
OHRP Announces the Availability of Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
OHRP Determination Letters
May 8, 2014 -- OHRP Webcast on "Conducting Internet Research: Challenges and Strategies for IRBs"
New interactive video aims to better protect research subjects and reduce research misconduct in clinical research
OHRP revises its response to the question “When does compensating subjects undermine informed consent or parental permission?”
OHRP Announces the Availability of a Draft Guidance Document on Transferring a Previously-Approved Research Project to a New IRB or Institution

FDA News

NIH Notices