Author: bartj

The InfoEd Compliance modules supporting our IRB, IACUC, and IBC processes will be offline on 10/26/2023 from 5:30PM to no later than 9:30PM for database patching. After the completion the Compliance modules will become available again.

Update: Database Patching is complete. The InfoEd Compliance modules are operating normally at this time.

The goal of this webinar is to introduce the audience to the Ethical and Responsible Research (ER2) Program at the National Science Foundation. Research projects funded by the ER2 Program use fundamental research to produce knowledge about what constitutes or promotes responsible or irresponsible conduct of research and why, as well as how to best instill responsible conduct of research into researchers, practitioners, and educators at all career stages. The presentation will include a brief history of the ER2 program, and a brief description of the types of proposals that are supported by the program and the merit review process.

Time: October 10, 2023; 11a-12p
To register and get the Zoom link: https://clemson.zoom.us/meeting/register/tJIoc-mqrjgtEtLdT7SlP0nH7iPTOvAGjVyV

Remember as we start a new school year and you add new staff and students to your lab, you will need to complete an IBC amendment in InfoEd to keep your protocol(s) up-to-date. Access InfoEd to create and amend protocols.

The ORC has unveiled its schedule for the Fall series of RCR Brown Bags. These Brown Bags offer 1 hour of Advanced RCR credit.

Please see our offerings here: https://www.clemson.edu/research/division-of-research/offices/orc/rcr/index.html

Please register for those you are interested in here: https://cucourse.app.clemson.edu/orc/student-index.php

October 11, 2023 – Protecting & Promoting Quality and Integrity in Research

What can we do to create and support an environment where research quality and integrity are at the core of the research endeavor? There are several key principles to building this culture, which promotes and protects quality and integrity in research by generating programs that are inclusive so that all stakeholders can participate; comprehensive, including components that include education, oversight and accountability; multifaceted, providing a holistic approach across all dimensions of research integrity; pragmatic by providing resources and tools that make it easy to do the right thing; and empowering, so that all community members and stakeholders can speak up. Beginning in 2018, Duke began implementing a Research Quality Management Program, a program that embodies these principles, which was implemented to innovate and promote best practices in research quality and accountability. This talk will describe the components that support a research environment where quality and integrity are built into the fabric of the research enterprise to promote excellence accountability.

Presenter – Geeta Swamy, MD, Vice Dean of Scientific Integrity and Associate Vice President for Research Duke University
About the speaker — Dr. Geeta K. Swamy is a professor of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine at Duke University and serves as Associate Vice President for Research for Duke University and the Vice Dean for Scientific Integrity for the School of Medicine. Dr. Swamy works with leaders across campus to provide a consistent University vision for scientific integrity standards and expectations and will drive efforts to ensure the advancement of scientific integrity across Duke University and the School of Medicine. A highly accomplished clinician-scientist, Dr. Swamy specializes in perinatal infection and maternal immunization. She is the principal investigator on numerous grants from the NIH, CDC, and other funding sources and has published more than 100 articles. She received her medical degree from the University of North Carolina at Chapel Hill and completed residency training in obstetrics and gynecology at the University of Pittsburgh and a fellowship in Maternal-Fetal Medicine at Duke University.
Target audience – Faculty, staff, postdocs and students
Location – 10am, Watt Innovation Center Auditorium (In-person only)
Register here: https://cucourse.app.clemson.edu/orc/student-index.php

In December, the NSF published the updated Proposal & Awards Policies & Procedures Guide (PAPPG) which outlined several new compliance requirements.

Effective July 31, 2023, the PAPPG specifies two significant changes to the current RCR training requirements:

1. Any personnel listed on proposals submitted to the NSF on or after July 31 must comply with an expanded RCR training requirement:

a. “An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel who will be supported by NSF to conduct research. As noted in Chapter II.D.1.d(iv), an institutional certification to this effect is required for each proposal.” Chapter IX: Recipient Standards – Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 23-1) | NSF – National Science Foundation

This means that RCR training is no longer limited to students—PIs and other personnel must also complete the RCR requirement.

2. In addition, the RCR training “must include mentor training and mentorship.”

The office of Research Compliance is working to identify means of tracking the training and how to incorporate mentor training and mentorship into existing RCR training offerings.

Please ensure that personnel on your NSF proposals that are submitted on or after July 31 are aware of this requirement. For more information on Clemson’s RCR training requirements and how we provide RCR training, please visit our RCR Training Requirements FAQ, and watch the RCR page for to learn about upcoming offerings.

Many of you are aware that earlier this year, we were instructed by SC DHEC and the DEA to move from a centralized model for obtaining and dispensing controlled substances to one where individual investigators will need to obtain their own licenses and order their controlled substances. If you are using or plan to use cocktails with buprenorphine, ketamine, etc., this change will impact your ability to conduct your procedures until you have obtained licensure and purchased the drugs. We have posted information about the process on the OES website.

We are offering an hour-long webinar on Friday, May 12 at 3pm to explain the responsibilities associated with obtaining and maintaining your licenses, list available resources, and answer any questions you may have. If you cannot attend on Friday, we will record the session and make it available. If you are interested in attending and did not receive an email with details, please email orc@clemson.edu.

Did you know if you will be receiving any of these pathogens, you might need a permit?

These pathogens are considered to be pathogenic to livestock/poultry by the USDA. These permits are required to be obtained only by the receiver (regardless of source or research). Permits are only required if the pathogen will be transported from another state (interstate) or internationally. If receiving from within the state, a permit is not required. These permits cost $150 and are good for 1 year.

For more information, please see: https://www.aphis.usda.gov/aphis/ourfocus/importexport/organism-vectors

The InfoEd Compliance modules supporting our IRB, IACUC, and IBC processes will be offline on 05/01/2023 from 5:30PM to no later than 7:30PM for database patching. After the completion the Compliance modules will become available again.

Update: InfoEd database patching has been completed (7PM EST). You may resume using the IRB, IBC and IACUC compliance modules.

If you work with vertebrate animals, certain anesthetics, analgesics, or euthanasia solutions may be regulated by the South Carolina Department of Health and Environmental Control (SC DHEC) and the U.S. Drug Enforcement Agency (DEA). Your work with these substances cannot resume until you have obtained a registration with SC DHEC and a license with the DEA.

The Office of Occupational and Environmental Safety (OES) is responsible for facilitating this process and have posted resources on their website.
For more information and guidance on how to apply for a registration/license, please visit the OES Controlled Substances page. We have also put this link on the IACUC FAQ page.