May 6, 2019
RPO Staffing News | Consent Template Changes | IRB Policies and Procedures Manual Changes | Training Reminders | IRB Update
RPO Staffing News
Join us in welcoming Carolyn Marsden, new IRB Analyst, to the IRB team. Carolyn is a Post-Doctoral Fellow joining us from the Department of Microbiology and Molecular Genetics (MMG) here at ¶¶Òõ̽̽. Carolyn received her Bachelor's degree in Biology from SUNY Stony Brook and her Ph.D. in Biomedical Sciences from Tulane University.
Consent Template Changes
We have updated our consent template in the following ways:
- Included Network language to use when applicable
- Revised MRI language in relation to pregnancy testing
- Noted that Substance Abuse Programs have different standards in HIPAA
- Future research in HIPAA section
- Participant payments revised language
These changes apply to new protocol submissions. All ongoing submissions must ensure that they have incorporated all of the Common Rule requirements.
IRB Policies and Procedures Manual Changes
- 9.0 Consent – added link to instructions regarding posting consents on Clinical Trials.gov per the Common Rule requirement and added guidance on documentation of the consent process
- 14.6 Fees for Committees on Human Research Review of Sponsored Trials - IRB Fee Schedule Change
- 17.0 Closing or Reopening a Protocol – updated process to reopen a closed protocol
- 19.1 Standards and Language for Studies Involving MRI – removed requirement for pregnancy testing for MRI’s without contrast and moved MRI consent language into consent template
CITI Training Reminders
Refresher training for both Human Subjects in Research and Good Clinical Practice is every three years. The reminders will be coming from CITI going forward 90, 60, and 30 days in advance of the expiration. Expiration reminders will be generated and sent from the email address noreply@citiprogram.org with a subject line reading: "CITI Program – Course Completion for {Member Name} Will Expire Soon". Please do not ignore these messages.
**Please remember that if the last time you took your human subjects training was prior to 12/15/16, you are not receiving reminders to complete refreshers in CITI. Incompletion of training results in removal from protocols and an increase in work for everyone.
>>>View the latest Tip Sheet with study specific requirements<<<
Reminders About the Continuing Reviews Post Common Rule Change
As you know, continuing review is no longer required for some minimal risk research. However, to allow for a protocol to transition to the new Common Rule requirements, the consent must be revised to align with the new Common Rule changes before the IRB is able to cease further continuing reviews. A few things you can do to expedite this process is to
- When you receive your first continuing review reminder, identify if your approved protocol requires full or expedited review. If you are not sure contact your IRB Research Analyst.
- If expedited, and you are still enrolling participants, you must submit a modification to revise the consent to align with the new requirements. It would be helpful if you could submit this modification as early as possible after your first reminder. This will enable us to review and approve prior to your last continuing review submission.
Single IRB Update
The institution has successfully ceded 10 NIH funded non-Cancer Center projects to other IRBs. We continue to fine-tune the process and appreciate those initial submitters’ patience. To date, all projects have fallen into the minimal risk research category. However, in the future, we do anticipate requests to rely for studies that include higher risk populations and procedures which would typically require a full Committee review here at ¶¶Òõ̽̽.
Often times, during convened meetings, knowledgeable members notice local context issues such as state law, feasibility, etc. Additionally, with local IRB oversight we are more apt to identify compliance and safety issues through our ongoing communications with the PI and research team.
Since the ¶¶Òõ̽̽ IRB will not be reviewing these projects, the institutions have to develop a mechanism to ensure that local context issues continue to be considered prior to research activity. The IRB will work with stakeholders at both institutions to develop a process for that to continue. The IRB will also be developing a specific program to demonstrate local researcher compliance with the external IRBs’ SOPs as well as the approved protocols. More information to come on these.