Frequently Asked Questions
Q: Can our institution use Copernicus Group IRB (CGIRB) to review some of our research studies, while maintaining local oversight for other studies?
Yes. After discussions between CGIRB and your institutional representatives, a program can be customized to fit the specific needs of your institution. This may allow for a subset of studies to be reviewed by CGIRB (ie, Industry Sponsored studies) or may allow CGIRB to review research at specific sites within your institution (ie, your outpatient research facility).
Q: For what type of research does CGIRB have experience in providing IRB oversight?
CGIRB has experience in the review of the following:
- FDA and OHRP Regulated Studies
- Phase I-IV Drug Studies in all therapeutic areas
- Device Studies
- Biologic Studies
- Observational/Registry Studies
- Social-Behavioral Studies
Q: How do I submit documents to CGIRB securely online?
You will first need to contact CGIRB to obtain a username and password. Once you receive this, you will be able to login to Intralinks. When you login, you will see a folder there with your company name and you may upload your information directly to this folder. CGIRB will be notified that there is an item waiting to be picked up and we will go out and retrieve the information. Future preferences and shared folders may be developed at this time.
Q: Would using an external IRB require adding additional institutional administrative staff?
Partnering with CGIRB should reduce the workload of your existing IRB. However, an individual at your institution will need to be designated to work with CGIRB to assist with issues such as tracking of submissions, review of periodic reports, investigator questions, and payment of invoices. In current models, this role is usually held by an individual who is involved with or at least familiar with your existing IRB process.
Q: Can we come to visit CGIRB to see the facility and look at SOPs?
In order to best protect human subjects at your institution we want to build an honest working relationship with open communication every step along the way. To foster this culture, we encourage representatives from your institution to visit our facility in North Carolina. During your visit we would be able to provide a tour of our facility, let you review our SOPs and Policies, and introduce you to our staff and board members to give you an idea of the experience and expertise of CGIRB.
Q: How would CGIRB consider the local concerns of our institution's subject population?
Local considerations regarding the acceptance of research within the potential subject population is of importance for every review. CGIRB may obtain this information in a variety of ways, such as consultation with your institutional officials and via the Investigator Site Questionnaire, among others. (see forms)
Q: Our institution does not have an Federalwide Assurance (FWA) filed with The Office of Human Research Protection (OHRP). Could we still use the ethical review services of CGIRB?
Yes. CGIRB can provide ethical review and oversight for institutions who do not hold an FWA as well as for institutions who currently have an FWA filed with OHRP. In each case a written agreement between the institution and CGIRB will be executed clearly stating the type of service being delegated to CGIRB. This agreement will also state that CGIRB will follow their own internal SOPs for any review being done for the institution and it's investigators.
In addition to the written agreement mentioned above, the following will be required prior to submitting proposals to CGIRB.
If you have an FWA:
- You must update your FWA to include CGIRB (Registration #IRB00001313) and submit to OHRP
- You must execute an IRB Authorization Agreement with CGIRB (see forms)
If you do not currently have an FWA filed with OHRP:
- You must complete documentation to waive jurisdiction for IRB review. This must be signed by the IRB Chairperson, Institutional Official or other authorized individual. For your convenience, CGIRB has an IRB Authorization Agreement form on our website.
Q: How much time would it take to set up a human research protection partnership between CGIRB and our institution?
As you might imagine, the answer to this question will vary. A conservative estimate would be to allow 3-6 months from initial discussions to the first review conducted by CGIRB. Variables that may impact this timeline would be:
- Level of acceptance from institutional officials for the transfer of IRB obligations
- Availability of a liaison to customize your work flow plan
- Education and training of investigators on the new submission process
Q: What are some of the benefits we could realize by partnering with CGIRB for the support of our human research protection program?
- Excellent Research Oversight
- Decrease Local IRB Workload
- Multiple Meetings per Week to Better Meet Timelines
- Partnership with an IRB who has received Full AAHRPP Accreditation of its Human Research Protection Program
- Adaptable Processes
- Large and Knowledgeable CGIRB Support Staff
- Easy Transfer Process
- Education and Training Resources
|
Company
