Researchers wishing to open multi-center, industry-sponsored research utilizing Western Institutional Review Board (WIRB) need to submit the appropriate paperwork to the Carilion Clinic Institutional Review Board (CC IRB). If the CC IRB authorizes the WIRB review, the WIRB may then become the IRB of record. Researchers may visit the WIRB website for more information. Follow the steps below to submit research to WIRB.

STEP 1

WIRB Submission Form Updated 9/20/2013

Use this form to submit your protocol to the CC IRB. The information from this form will be reviewed to determine if your study can be submitted to WIRB. Please note that the principal investigator must sign this form. You must submit the following to the CC IRB with this form:

  • Copy of completed WIRB submission application
  • Copy of protocol
  • Copy of consent form
  • Copy of recruitment material
  • Completed Research Financial Disclosure Questionnaire for all team members
  • Current CV (within two years) unless already on file with CC IRB (send via e-mail)

The CC IRB requires that investigators and key research personnel must complete on-line education and training before a research study can be submitted to WIRB. Please refer to the section on this web page on required education for more information.

Please make sure that the consent form includes a section called "CC Research Compliance Survey." The CC Research Compliance Survey section is as follows:

To help protect the rights of research subjects, the Carilion Clinic Institutional Review Board (CC IRB) surveys people who have recently taken part in a research project. This is done to make sure the research was done in a way that was respectful to you, the subject. To help do this, the CC IRB would like to send you a survey about your experiences while taking part in research. While your name and address will be given to the CC IRB staff in order to mail the survey, they will destroy the list of names and addresses as soon as the survey is mailed. The survey itself will be anonymous. You do not have to allow the CC IRB to send you this survey. Please check below if you would like the CC IRB to send you the survey or not:

_____ Yes, I agree to the CC IRB sending me a survey about my experiences while taking part in research.

_____ No, I do not want the CC IRB to send me such a survey.

STEP 2

Once the CC IRB has received the WIRB Submission form and all required documentation, it will review the study and verify that necessary elements are included. If all information is complete, the CC IRB will send the investigator an approval letter that authorizes the study to be submitted to WIRB. Keep this letter for your files. You will need to attach a copy when you submit to WIRB.

STEP 3

Investigators must submit to WIRB all continuing reviews, amendments, unanticipated problems/serious adverse events, and protocol deviations and violations. Any reports to WIRB should be submitted using WIRB forms.

The CC IRB requires investigators to submit copies of all local protocol violations and local unanticipated problems/serious adverse events. Remember that an unanticipated problem is defined as an incident, experience or outcome that is

  1. Unexpected in terms of nature, severity or frequency
  2. Related or possibly related to the research
  3. Suggests the research places subjects or others at a greater risk of harm than was previously known.

All three criteria must be met in order to meet the criteria of an unanticipated problem/serious adverse event. See the Carilion Clinic Standard Operating Guideline 2.9 for further information.

The CC IRB also requires submission of copies of reports or letters from monitors or auditors concerning the local site. In addition, any change in local research personnel also must be submitted to the CC IRB. New personnel must submit a CV to CC IRB and must have completed a Research Financial Disclosure Questionnaire and required on-line education and training. Any reports involving local issues or study personnel should be submitted on CC IRB forms.