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. ORI Informed Consent Website

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.). Read the GDPR Guidance

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. linkblue CITI login

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!

Click here for more Office Hours dates! 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