What's New? (2010)
This page offers some of the most recent 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 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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- 12/3/10: IRB Review Newsletter [PDF]
- Holiday Schedule
- 2010 ORI Staff Additions
- Human Research Related Educational Video or Broadcast Recordings
- 10/14/10: IRB Review Newsletter [PDF]
- Informed Consent Form Template Revisions
- New Item Requested on the IRB "Form A" - General Information Sheet
- 9/10/10: Genetic Information Nondiscrimination Act (GINA)
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), requires that investigators include appropriate language in the informed consent documents for genetics research (genetic testing and/or collection of genetic information). See "Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA)" [PDF] on ORI's Educational Materials, Regulations and Policy Guidance web page for more information. Sample language that can be modified based on the nature of the research and the types of human subjects involved can be found in the instructions for documentation of informed consent (Medical or Nonmedical).
- 8/23/10: Recruitment Materials and Compensation Amount
There has been a slight modification to the verbiage regarding compensation to subjects. The new verbiage is in the guidance document “A Principal Investigator’s Guide to Identification and Recruitment of Human Subjects for Research” [PDF] which can be found on ORI's Educational Materials, Regulations and Policy Guidance web page. The original verbiage was driven by biomedical research and a modification has been made in consideration of social/behavioral type research.
The new verbiage reads:
Recruitment materials should not promise “free medical treatment”, when the intent is only to inform subjects that they will not be charged for taking part in the investigation. Recruitment materials may state that subjects will be paid to compensate for their time and/or travel. For Phase I-III clinical trials and other significant risk research it is not permissible to state the amount to be paid to potential subjects. For all other research protocols the IRB will make the decision of whether amount to be paid may be posted in the recruitment materials on an individual protocol basis. Payment should not be emphasized in recruitment materials.
- 7/30/10: IRB Review Newsletter [PDF]
- Continuation Review...& HIPAA too
- Education Opportunity Announcements: Regional Conference & VA Updates
- 5/11/10: IRB Review Newsletter [PDF]
- Nonmedical Meeting Schedule Update
- Informed Consent Process Quick Quiz
- Upcoming Event: NIH Requirements for Responsible Conduct in Research
- 4/26/10: IRB Review Newsletter [PDF]
- AAHRPP Reaccreditation
- Navigating the IRB Process
- Be Waiver Wise
- 3/9/10: Important Message from UK Dept. of Biological Safety
For clinicians, only research involving testing and analysis of human blood, tissue, or samples from other parts of the body in a research laboratory on the University of Kentucky’s campus is required to be registered with the IBC. If samples are sent off-site to another laboratory or to the clinical laboratory at the hospital for analysis, the research is exempt from registration. Again, IBC registration of research involving laboratory analysis of human tissue/materials is only required if carried out on campus in a research laboratory.
- Any research involving any infectious agents, potentially infectious materials or recombinant nucleic acids is required to be registered with the Institutional Biosafety committee as established by University policy and the NIH Guidelines for Research Involving Recombinant DNA Molecules. Because the University receives funding from NIH grants, ALL research conducted at the University must comply with NIH Guidelines and University policies. Biohazardous materials which are considered worthy of registration can include:
- Infectious agents (virus, bacterial, fungal)
- Recombinant DNA (ex: plasmids with inserts, viral vectors)
- Recombinant proteins
- Infected animal blood and/or tissues
- Human blood, blood products, fluids and /or tissues
- Human cell lines
- Live vaccines
Registration forms can be accessed online at:
http://ehs.uky.edu/biosafety/forms.html
- Any research involving the use of the following US Department of Health and Human Services and USDA listed infectious agents or toxins is required to be registered with the UK Department of Biological Safety. Proper usage, amount and storage as required by the Code of Federal Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) must be documented as established under the guidelines of the Centers for Disease Control and Prevention and University of Kentucky policy. Please see the list below for the complete list of agents and toxins. Please directly contact Holley Trucks, Biosafety Specialist Sr. (859-257-8655), for further assistance.
For further information or assistance, please do not hesitate to call the University of Kentucky Department of Biological Safety:
Marcia Finucane, Biological Safety Officer 859-257-1049
Holley Trucks, Biosafety Specialist Sr. 859-257-8566
Eric Rouse, Biosafety Specialist 859-323-5728