The Final Rule includes a new definition of research and identifies scholarly and journalistic activities as categories deemed not to be research. The new definition of research excludes “scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected… It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups… For example, a medical case report could fall within this category, if the point of the report were to describe an unusual and interesting case-specific medical complaint and its treatment.” In contrast, if a purpose of a project is to gather information from individuals in order to understand the beliefs, customs and practices, not only of those individuals, but also of the community or group to which they belong, the project would be deemed research according to the new definition.
The Revised Common Rule for the protection of human subjects in research includes new consent requirements. Key Information (information that presents the most important information to consider if you are thinking about enrolling in a research project) must be presented at the beginning of the consent document.
Find the new templates and samples
Lois Zitzow, director of University Research Animal Resources, is leaving UGA and a search is underway for a new director. During the interim period, URAR asks that researchers with animal use needs allow extra time for requests. Chris King, associate vice president for Research Integrity and Safety, and Leanne Alworth, director of the Office of Animal Care and Use, will share leadership responsibilities during the transition.
Substantial revisions to the
What does this mean for UGA researchers?
The Common Rule changes were designed to reduce administrative burden and to enhance the protection of human subjects. The UGA Human Research Protection Program is working to implement the revised regulations. The revisions will include changes to the IRB Portal, policies, and some procedures. There are some specific changes that may be of interest to many UGA researchers. These changes are described below and on the IRB website.
New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The revised Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 21, benign behavioral interventions conducted with adults may be determined to be exempt. Also, the collection of identifiable, sensitive information from adults may be determined to be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place. Submission to the IRB office to obtain the Exempt determination is still required.
Continuing Review Changes
Some minimal-risk research will no longer require continuing review (renewal). A general progress report will be requested at a period determined by the IRB during initial review, but research activities can continue as approved without waiting for the IRB to acknowledge the report. Such projects will not be assigned an expiration date.
Consent Form Changes
Consent forms must begin with a concise and focused presentation of the key information that is most likely to assist in understanding why one might or might not want to participate in the research. Consent forms must now include information regarding the potential for future use of de-identified data and biospecimens.
Additional information is available at the links below.
- UGA Human Research Protection Program website: https://research.uga.edu/hrpp/
- CITI training basic information: https://about.citiprogram.org/en/final-rule-resources/#irbimpact
- Department of Health and Human Services revised Common Rule educational materials: https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html
Contact the Human Subjects Office to schedule in-person group sessions (email@example.com or 706-542-3199)
The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule). The revised Common Rule will become effective Jan. 21, 2019. See the UGA Human Research Protection Program website for additional information, including an FAQ with information specific to UGA.
The UGA Human Subjects Office will conduct post-approval assessments of active projects beginning January 2019 to ensure the educational needs of investigators are met and human research is compliant with regulations and institutional policies.
Projects that will be assessed are identified through the IRB Portal. Post-approval monitoring will be conducted on non-exempt federally funded studies. The goal is to assess up to 10% of active federally sponsored projects each quarter. These will be selected at random from our database of active studies.
Please contact Angela Bain at 706-542-3821 for questions about this new program.
University of Georgia’s Human Research Protection Program recently received accreditation from the Association for the Accreditation of Human Research Protection Programs. This accreditation demonstrates that UGA has a high-quality human research protection program and is a public affirmation of UGA’s commitment to protecting research participants. The Human Subjects Office takes great pride in this accomplishment and thanks you for your continuing support of its mission.
Brandon Jordan has been named the university’s new radiation safety officer. Jordan has worked at UGA as an assistant radiation safety office with responsibilities such as administering wipe surveys of sealed sources, providing hazardous waste analysis, conducting package testing and managing laboratory quarterly reports. He received his Bachelor of Science from Oklahoma State University and complements his radiation safety experience with professional instruction taken in applied health physics and radiation safety officer training. Jordan supports research groups who use radioactive isotopes, X-rays, lasers or high magnetic fields, and he is open to any comments or improvement suggestions regarding services provided by the Office of Research Safety.
For more information, contact Brandon Jordan at firstname.lastname@example.org or 706-542-0526.
The Human Research Protection Program (HRPP) has issued revised policies for the Use of External Sites in Research and for research involving External Collaborating Sites. The revised materials can be found on the HRPP website: https://research.uga.edu/hrpp/policies-and-procedures/.
The Office of Research Safety (ORS) is launching an optional fee-for-service program, complete with a fee schedule and one-stop service. The program goal is to remove the burden from researchers and administrators who face issues getting their laboratory space ready for operations with safety compliance assurance.
ORS can help with:
1) missing/lost safety items (i.e., spill kits)
2) legacy chemicals (i.e., shelf full of waste-like/unwanted chemical reagents)
3) decontamination of abandoned equipment/instruments (i.e., freezer relocation).
Certain compressed gases are no longer allowable purchases with a P-Card. Any compressed gas that exhibits additional hazardous characteristics such as flammability, corrosivity, toxicity or strong oxidizing properties must be purchased through UGA Mart. See list of gases prohibited from P-Card purchases. Compressed gases such as nitrogen, carbon dioxide, inert gases and cryogenics are allowable purchases with a P-Card.
The Research Safety Committee and the Office of Procurement collaborated on this effort to better track the quantity of hazardous compressed gases on campus.