June 2019
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The IRB Review
A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

Updated Informed Consent Templates


ORI released updated versions of informed consent templates to incorporate suggested edits, improve readability, and deter potential compliance issues relative to the investigator signature.

  • The National Institutes of Health (NIH) certificate of confidentiality (CoC) frequently asked questions, indicates that the NIH sample CoC consent language may be altered as long as the main points of the policy protections and limitations are addressed. We revised the NIH CoC section to reduce the readability by 7 grade levels.

  • IRB policy requires the research participant (or their legal representative) to sign and date the informed consent form. The authorized study personnel conducting the consent process prints his/her name and dates the form. This is consistent with federal regulations and Good Clinical Practice (GCP) guidelines. Regulations do not require an investigator to sign the consent form; therefore, the investigator signature line was removed from the medical consent templates. Researchers may add the signature line to their consent forms as desired or as required by sponsoring agencies.

Templates are available on the ORI Informed Consent Website or by choosing "All Templates" under Application Links within your E-IRB protocol application.
The Road to Re-accreditation
The Step 1 application for re-accreditation of the UK Human Research Protection Program was submitted June 5th.

The review process will continue through 2019, culminating with a site visit. The Association for Accreditation of Human Research Protection Programs (AAHRPP) will randomly select and interview researchers, staff, IRB members, and others involved in human subject research. In preparation for the site visit, ORI will launch a new AAHRPP webpage comprised of training resources, policy updates, and education event announcements.

NEW


General Data Protection Regulation (GDPR) Guidance

The GDPR regulation provides significant data protection and privacy provisions for data exported from the European Economic Area (EEA). Research utilizing personal data from participants located in the EEA, must adhere to the GDPR (e.g., de-identification, privacy notice, informed consent, sensitive data protections, etc.).
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Clinical Investigator Training

ORI has purchased the new Biomedical Investigator course on CITI. The course provides guidance, tips, and downloadable tools to equip clinical investigators with knowledge on responsibilities and supervision.

The course is available under the Additional Optional Courses of Interest menu on the CITI platform.

Save the Date for the 21st Annual
Human Subject Protection Conference!

Human Subject Protection: I Will Survive September 5, 2019
Northern Kentucky Convention Center

  Join us Thursday, September 5, for our annual human subject protection conference, entitled "Human Subject Protection: I Will Survive." This year's event will address issues of significant importance to human subject protections, including:   

  • Comparative effectiveness research
  • Research involving biorepositories
  • Participant perspective
  • Big data
  • Research compliance
  • Research study team management
This year's conference will also feature an "Ask the IRB Chair" panel discussion during lunch. Conference brochure coming soon!
Next ORI
Office Hours
June 12, 2019
1:30-2:30 pm
Health Kentucky Research Building (HKRB), Room 210

July 18, 2019
11 am - 12 pm
Whitehall (CB),
Room 331