National Institutes of Health (NIH) has issued a final Policy for Data Management and Sharing. UGA investigators engaged in research involving human subjects must provide additional information during the consent process pertaining to sharing of data and may need to formalize the exchange of data between collaborators through Data Use Agreements. Additional information related to required consent information can be found on the Human Research Protection Program website. Queries regarding Data Use Agreements can be directed to the Office of Research Legal Advisors.
Due in large measure to COVID-19-related concerns about the safety of participants and research staff, IRB reviews and decisions are often taking longer than they did pre-pandemic. IRBs are reviewing some studies they would not have reviewed in the past, contributing to delays. If a study is deemed to pose a significant risk of COVID-19 exposure without offering any benefit to participating subjects, the IRB may elect to not approve the study. The Human Subjects Office asks for researchers’ patience and cooperation as everyone strives to ensure that safety is first and foremost. For more information, contact HSO at email@example.com or 706-542-3199.
NIH’s Office of Laboratory Animal Welfare (OLAW) has notified institutions that the new 2020 AVMA Guidelines on Euthanasia of Animals are to be implemented October 1, 2020. After October 1, 2020, grant applications and contract proposals must be consistent with the AVMA 2020 Guidelines.
The main change that will affect the most researchers is the method of CO2 exposure for rodents. The new required CO2 displacement rate is 30-70% of the chamber volume/minute.
Note that the UGA IACUC Policy on Rodent Euthanasia Using Carbon Dioxide has already been updated to reflect the new requirements.
Instructions posted at CO2 euthanasia stations should no longer reflect the old flow rate range, and must reflect the new required flow rate range.
The Office for Human Research Protections (OHRP) has posted on its website a set of decision charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule). The decision charts are necessarily generalizations and may not be specific enough for particular situations. The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments. These decision charts can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html.
The Human Research Protection Program (HRPP) has developed a Toolkit for researchers who are planning to resume in-person research activities involving human participants. Please look for forms and materials on the HRPP website or in the IRB Portal Library. Contact IRB@uga.edu if you have any questions.
Attention human research investigators: We recognize and value UGA investigators’ experience and expertise in conducting research projects. Further, we understand the demands on researchers’ time, and we strive to create systems and infrastructure that provide a high level of research project management support. However, the PI is ultimately accountable for ensuring that individual research projects meet all reporting and approval requirements. While the IRB portal is programmed to send courtesy reminders at 90, 60, and 30 days prior to a study’s expiration date, this system does not replace the responsibility of PIs to be aware of the approval period for research studies.
We strongly urge investigators to have multiple tools and safeguards to ensure that they meet regulatory and institutional requirements pertaining to continuing review and maintaining approval of human research projects. Setting up calendar reminders for 30 days prior to study expiration is one possible method.
Please remember that all human research procedures related to the approved project must stop when approval expires until a new approval period is granted. When research activities are complete, the PI is responsible for closing the project in the IRB portal, even if the project was for a student’s thesis or dissertation.
Please contact the Human Subject Office at IRB@uga.edu or 706-542-3199 if you have any questions about continuing review and expiration of IRB approval. More information is available in our Policies and Procedures and on the Human Research Protection Program website https://research.uga.edu/hrpp/.
In order to improve animal welfare and research outcomes, the IACUC will require specific online training, beginning July 1, 2019, for all persons on protocols that involve rodent surgery and/or general anesthesia.
What researchers need to know about this mandatory training:
- Starting July 1, 2019, training will be required for all personnel on Animal Use Protocols (AUPs) that include survival surgical procedures on rodents and/or general anesthesia of rodents.
- Training validation will be required for approval of new AUPs and Annual Renewals.
- For amendments adding new personnel, the new personnel will need to complete this training to be added to the AUP.
- The required training is the online training module, “LAT 13: Aseptic Technique and Surgical Support and Anesthesia”, in the Professional Education Portal (PEP).
- Individuals only need to complete this training module one time. There will be no expirations or repeat expectations for this course.
This course is already available via PEP for anyone that would like to take this training proactively. You can find the course by searching for “LAT 13” or “surgical support” from the search bar in the upper right corner of the PEP dashboard. Principal investigators can assign this course in PEP to personnel on their AUPs effective immediately. For assistance with assigning training to your personnel, please contact the Office of Research Integrity and Safety Support Services at firstname.lastname@example.org.
The Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services released a new informational video that describes social and behavioral health research (SBER) and explains how it is different from biomedical research. The video is for potential participants and is designed to help them consider whether or not they want to participate in research. Researchers may also find this helpful when designing consent processes and materials. View the SBER in English. Watch video: www.youtube.com/watch?v=CGOYerqfsNc&feature=youtu.be
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.
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