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Fall 2021 Newsletter

In This Issue:

Using REDCap in Tracking and Evaluation of Occupational Health for an Animal Care and Use Program

A vital part of an Occupational Health Program (OHP) is to address employee occupational risks within their respective research environments safely and effectively.  To do that, having an effective and efficient software program is critical. Over the past year, the Office of Research Compliance and the IACUC office has collaborated with the University’s REDCap team to transition the OHP paper-based procedures to the web-based platform REDCap. 

REDCap allows for the utilization of electronic forms for encrypted data collection, submission, and sharing of occupational health information. This process helps to provide a streamlined approach for healthcare providers in the evaluation of an employees' potential occupational exposure risks, along with the aim to minimize in-person office visits. REDCap will facilitate communication of OHP enrollment to the employee, their supervisor, and the IACUC office. The employee's Personal Health Information (PHI) is not shared or accessed by anyone other than the employee and the healthcare provider. 

With a streamlined approach to data collection, timely health assessments and improved communications, the implementation of REDCap for the OHP will narrow the barriers for research personnel and administrative offices.  For additional information on the OHP and enrollment instructions, please see the Animal Care & Use website

REDCap is administered by the Strategic Initiative's Department at the Biomedical Library.  We would like to acknowledge Clista Clanton, Thalia Shaw, and Jessica Medema for their hard work and collegial support.  

IRBNet: Updating Your User Profile

To manage your User Profile, log in IRBNet and click “user profile” at the top right corner of the page above the satellite dish.  You may access this page at any time to update your account information, change your password, manage your affiliations and training records.  It is important that this information be up-to-date and the use of a correct email address to prevent possible deactivation of your account. You are encouraged to always use a southalabama email account as a contact. 

Additionally, the “User Profile” feature allows users to link training documentation to their IRBNet projects by clicking the blue script at the bottom of the page “Add a New Training & Credential Record”.

IRBNet allows you to track and share your training records and certifications. Once added to your profile, your training and credentials can be easily linked to your projects from the Designer menu, are accessible by your project teams and can be quickly accessed and tracked by the regulatory committees that review your projects. For more details see Link Training Records to IRBNet Account.

Educational Outreach for Clinical Research Staff

The Office of Research Compliance (ORCA) has worked with the Clinical Trial Office (CTO) to develop a training program for newly hired clinical research coordinators, data managers, and other ancillary staff. This program follows the competency framework developed by the Joint Task Force for Clinical Trial Competency. According to their website. “The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.”

 We have built a robust program that uses a mix of lectures, exercises, observing, and other methods to ensure a multi-mode approach. The ORCA and CTO each work to assess the new hires at set intervals in order to build their skills in each competency domain. This program is in a pilot stage and reassessment of its validity will occur over the next several months. We welcome any feedback on this program. 

2021-2022 Responsible Conduct of Research Training 
Update and Registration

Responsible Conduct of Research (RCR) training sessions will now be offered through Classroom Instruction and USA Canvas (online) Platform beginning October 2021 through May 2022.  RCR education is an important aspect of the Office of Research Compliance and Assurance training curriculum. 

All Faculty engaged in research and other sponsored and unsponsored projects are required to attend, at minimum, two hours of instruction/sessions each fiscal year (October-May).  Faculty must complete specified core sessions within a five (5) year period.
For more information, please review our RCR Policy

Registration is required for all sessions, Classroom Instruction and USA Canvas.
 
CLICK TO REGISTER!

Did You Know?
Travel Laptop Loaner Program

 

University employees who travel internationally to teach or conduct research should be aware of the possibility of export license requirements for items, materials, or equipment that they carry with them. Hand-carrying items, materials, or equipment outside of the U.S. (even temporarily) is considered an export. 

To reduce data insecurity and identity theft risks associated with international travel, the University offers loaner laptops to employees traveling abroad. Traveling with a loaner laptop ensures that employees will have the
applications and information they need, while minimizing cybersecurity risks.  Travel Laptop Loaner Form

Online Training is Available for Shipping of Biological Substances and Dry Ice

Training certification for shipping biological materials and dry ice should be completed through the online CITI platform.  To register for the online training, create a CITI account at https://about.citiprogram.org/ and when prompted from training module select the course entitled “Shipping and Transport of Regulated Biological Materials”.  This course is designed as initial training and refresher training for employees who package and ship diagnostic and clinical human or animal specimens, human or animal pathogens, and other regulated biohazards.  After you complete the course and pass the online quiz, you will be certified to ship Biological Substances and Dry Ice for two years. For additional information click here.
Failure to comply with international and federal transportation regulations when shipping hazardous materials can result in civil and criminal penalties.

Questions and Answers Corner

I receive PHS funding and involved in international collaborations, what do I need to disclose for conflict of interest?  If you receive income or any type of reimbursement from a foreign entity (includes companies, foreign institutions/ universities and foreign governments) in the prior twelve-month time period, you must disclose at the time of the annual conflict of interest reporting period.  Contact dlayton@southalabama.edu with any additional questions.

Am I required to annually disclose my service as a section reviewer on federal projects if I receive financial payment for this service?  No, income from service on advisory committees/review panels for any federal, state or government agency, or institutions associated with higher education, etc. is exempt from reporting. 

If lecturing outside the U.S., how shall I remain compliant with the Fundamental Research Exclusion (FRE) for purposes of export control regulations?   When attending professional meetings, etc. abroad, there is no license required, so long as the information shared is the result of FRE anticipated for publication. Keep in mind that the FRE exclusions would no longer be applicable if there any restricted or proprietary information set by the sponsor’s terms and conditions.  However, defense services will require an export license.  

Should you disclose financial interests in a presentation or publication?  Being open and transparent is critical and therefore recommended financial interests related to the research study and source of funding be disclosed in presentations, publications, and the research team. 

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