What's New? (2008)
This page offers news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research in the year 2008. Note that due to the nature of web page evolution, some links may be broken. For the most current document links, search for the name of the document using the following search tool:
In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-323-2446 or e-mail Belinda.Smith@uky.edu and provide your name, e-mail address, department, campus address and phone number.
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- 12/9/08: IRB Review Newsletter [PDF]
- All Things Considered– Part II - Waiver of Documentation of the Informed Consent Process at Continuation Review (CR)
- Protection through Destruction - References for appropriate destruction of private information or confidential data
- 11/24/08: Research Offices Holiday Hours
The Office of Sponsored Projects Administration (257-9420), the Proposal Development Office (257-2861), the Office of Research Integrity–IRB & IACUC– (257-9428), and the Survey Research Center (257-4684) will be closed Wednesday, December 24 through Friday, January 2 and will reopen on Monday, January 5, 2008. If you anticipate a need for services provided by any of these offices during this time, please call the appropriate office(s) before December 15.Thanks and from all of us, we wish you a safe and happy holiday season!
- 11/10/08: IRB Review Newsletter [PDF]
- Attention Research Investigators – moving or change of address?
- All Things Considered – new stamp for survey cover letters or phone scripts.
- Continuation Review – 3 cues to use!
- 10/29/08: On March 20, 2008, the Cancer Therapy Evaluation Program (CTEP) issued a memorandum to NCI/CTEP-sponsored cooperative groups explaining implementation of revised CTEP procedures for handling amendments to cooperative group protocols. The procedure involves temporary cessation of enrollment of new subjects pending IRB review of amendments in which new or modified risk information alters the overall risk-benefit relationship for subjects.
OHRP has posted its September 29, 2008 memorandum to Dr. Jeffrey Abrams, Acting Associate Director, Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) in the belief that others may find useful OHRP’s clarifications regarding several issues related to the implementation of changes to protocols and informed consent documents for NCI/CTEP-sponsored clinical trials.
- Investigators of NCI/CTEP-sponsored cooperative group studies are required to temporarily stop enrollment pending IRB review, when a protocol/consent amendment involving new or modified risk information is issued.
- CTEP will include in the action letters that are issued to the investigators, their opinion as to whether the changes proposed to the protocol or consent form, in response to new or modified risk, are minor and therefore eligible for expedited review.
We are recommending that investigators include copies of these action letters with their submissions to the IRB for review of new or modified risk information.
- 10/27/08: IRB Review Newsletter [PDF]
- MANY HATS: the multiple roles and requirements of Sponsor-Investigators conducting FDA regulated clinical research
- Device Advice – an assortment of essential information regarding research or clinical use of investigational devices
- NIH Conflict of Interest Web Training
- 9/22/08: The Office of Research Integrity (ORI) provides administrative support for UK’s Institutional Review Boards and provides guidance to faculty, staff and students engaged in the conduct of research with human subjects. We utilize a number of tools including email announcements, newsletters and websites to timely inform researchers regarding news, regulatory guidance, form updates, etc.
If you are interested in receiving announcements and the newsletter by email, please forward your name and email address to Larry Iten at aliten@uky.edu. In addition, you may view announcements and the newsletter on the ORI website at http://www.research.uky.edu/ori/WhatsNew2008.htm.
- 9/12/08: New Informed Consent Templates: A recent VAMC Research & Development site visit from the Department of Veterans Affairs Office of Research Oversight (ORO) has necessitated revisions to the UK consent template (8/27/08). Per VA ORO requirements, references to VA have been removed and included in a VA specific consent template on VA Form 10-1086. The VA consent form will be used for studies that recruit subjects from the VAMC. VA R & D has held a series of education sessions for researchers currently conducting studies at the VAMC. A general audience session is being planned for December in conjunction with the CR-DOC Clinical Research Updates. Contact VA Research & Development for additional guidance at (859)-281-4927.
- 9/2/08: IRB Review Newsletter [PDF]
- New & Improved Modification Request Form
- Emergency Contact Numbers
- Investigator Signature on Informed Consent Forms
- 7/28/08: IRB Review Newsletter [PDF]
- UK Regional Human Research Protection Conference
- Unanticipated Problem/Adverse Events (UP/AE) involving prisoners
- 6/16/08: The Office of Research Integrity developed a guidance document for enrolling K-12 students as research subjects, particularly when conducting research into teaching methods, curricula and other areas related to the scholarship of teaching and learning. The guidance promotes methods to reduce risk of undue influence and outlines the necessary steps for obtaining facility approvals; requirements for parental permission, student assent or consent waivers; applicable privacy regulations and other protections for consideration when conducting research in this population. Investigators should refer to this guidance when submitting protocols that will enroll K-12 students: "Guidance for Enrolling K-12 Students as Research Subjects" [PDF].
- 6/9/08: The following addition was made to the Informed Consent SOP per recommendations from the Association for the Accreditation of Human Research Protection Programs (AAHRPP):
When the long form of consent documentation is used, the VA investigator enters a progress note in the subject’s medical record documenting when the subject’s participation is terminated. This is in addition to the VA progress note requirements already outlined in the SOP, for when the "Written Consent Document (Short Form)" is utilized. See the Informed Consent SOP [HTML] for detailed progress note requirements applicable to Veterans Affairs Medical Center research studies.
- 5/23/08: IRB Review Newsletter [PDF]
- New Form B
- International Ethics Resources Available
- Report of the Public Responsibility in Medicine Research (PRIM&R) Human Tissue/Specimen Banking Working Group
- 5/21/08: Four Standard Operating Procedures (SOP) were revised and put into production (Initial Full Review; Continuation Review; Generation, Use, & Revisions of SOPs; Mandated Reporting to External Agencies), and a section pertaining to research involving prisoners was added to the first page of the instructions in the Unanticipated Problem/Adverse Events Internal Prompt Reporting Form [WORD] [RTF].
- 5/18/08: Based on recommendations in the final report by the AAHRPP Council, the Informed Consent Process section of the Research Description (Medical "Form B" and Nonmedical "Form B") was revised to include a request for a description of other written materials that may be provided to participants or legally authorized representatives. Researchers should be sure to replace any previously saved versions of "Form B" with the one provided in the online IRB application.
- 4/7/08: Three revised documents were posted to ORI's Educational Materials, Regulations and Policy Guidance web page. Two documents entitled "Summary FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug" [PDF] and "Summary Of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices" [PDF] are under the topic heading Investigational New Drugs/Devices. One document entitled "Sponsor-Investigator Clinical Trials with FDA Regulated Products" [PDF] is under the topic heading Investigator Responsibilities. The "Determination of Activities That Need IRB Review SOP" [WORD] [PDF] was also revised and posted to ORI's Standard Operating Procedures web page.
- 4/7/08: The availability of the IRB Survival Handbook as an easy to navigate indexed web-manual was announced. Contents of the IRB Survival Handbook focus primarily on UK policies and procedures for human research review, and the IRB application process. The A-Z indexed manual provides one-click access to topics from Adverse Events to VA Research. The Survival Handbook is located at http://www.research.uky.edu/ori/IRB-Survival-Handbook.html. Book copies of the handbook are still available upon request but the web-based version allows for real-time updates and access to the latest guidance and information.
- 3/1/08: Effective immediately, the ORI/IRB requires a complete list of study personnel to be submitted: 1) at Continuation Review (CR) time (regardless of whether a change is being requested), and 2) upon submission of a Modification Request (MR) if the request involves a change to study personnel.
The SP list should include designation of responsibilities including who is authorized to obtain informed consent and whether the individual listed has completed the mandatory human research protections training. To ensure all pertinent information is included, it is strongly recommended that the IRB/ORI Study Personnel List Template [WORD] [RTF] be utilized (alternately, the SP List found at the end of “Form A”/General Information Sheet of the IRB application can also be used as it is the same format). For more details, see the February 2008 "Study Personnel List Requirement" listserv announcement: [PDF].