Recent Updates and Important Notices
Notice of Revised Wording (Withdrawal of Consent)
This notice is to advise the research community of a change to section 14 of the recommended wording in the BCEHI Clinical Common Informed Consent Template. The change relates to participants’ right to request the withdrawal of their data upon their withdrawal from a research study.
The newly revised section of the template offers two different suggested wordings (highlighted in blue). The first is for Health Canada regulated research. This wording has been revised to reflect the fact that (unlike for US FDA regulated studies) there is no clear legal requirement that data collected to the point of withdrawal must be retained. However, and despite the lack of a clear legal requirement, the recommended wording does state that such data will be retained and explains that this is to ensure data integrity and subject and patient safety.
The second recommended wording applies to studies that are not regulated by Health Canada and reflects the principle articulated in the TCPS2 that participants have the right to request the withdrawal of their data and biological samples and to be advised of the circumstances where this would not be possible.
The template has been posted on the new BCEHI website and can be accessed using this permanent link. The link has also been posted on the Templates page of the UBC/C&W REB website.
If you have any questions, please contact Nina Preto, Research Ethics Analyst: firstname.lastname@example.org (604-827-5597) or the UBC / C&W REB office. (09/17/14)
|Important notice re: pre-submission ethics applications from before 2012 |
Do you have a human ethics study in RISe that is in a pre-submission state and was created on or prior to December 31, 2011? Please note that on August 16, 2013, these studies will be inactivated.
Inactivated studies will continue to be accessible in the Principal Investigator’s inactive tab, but will no longer be on the system as a pending submission.
Researcher Information Services at UBC is inactivating old pre-submission applications in order to free up space on RISe. If you have any questions or concerns contact the UBC / C&W Research Ethics Board (REB) at 604-875-3103 or email@example.com.
|Due to recent staffing changes, some of your contacts at the Research Ethics Board (REB) have changed. |
- Maryam Ghafouri has now returned from leave, so for questions or concerns related to screening of post-approval activities and submissions or pre-review of renewal applications please email Maryam at firstname.lastname@example.org.
- For general inquiries, please continue to email email@example.com.
Changes to the delegated review process at the C&W REB
The UBC C&W Research Ethics Board has recently implemented changes to the review of minimal risk studies. Previously, all studies, regardless of risk, had to adhere to full board submission deadlines. Now that the board is three years old with a more established group of reviewers, we have made some changes to this process that will speed up the review of minimal risk studies.
Any study submitted to the REB that is deemed to be minimal risk will now be reviewed via a separate process. THERE ARE NO DEADLINES. Studies will be reviewed and provisos/approvals sent out as they come in. Please note that if the REB reviews your submission and decides that it is more than minimal risk, it will have to be reviewed at the next full board meeting and that will delay the approval process. UBC guidance on what constitutes minimal risk can be found here. (07/24/12)
Mandatory ICF wording for applicable US clinical trials in effect March 7, 2012
The Food & Drug Administration has issued guidance to help IRBs, investigators and sponsors with understanding and implementation of the new informed consent requirement set forth in 21 CFR 50.25(c), which states that the following statement must be incorporated verbatim into all informed consent documents for applicable clinical studies initiated on or after March 7, 2012.
“A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
You can access the complete guidance document here.
Please also note this wording appears on page 18 of the UBC Informed Consent Form Template, found here. (02/13/12)
New guidance notes and consent form for biobanking studies
In response to the growing number of studies involving biobanking (any collection of human biological material—organs, tissue, blood, cells and other body fluids—that contains at least traces of DNA or RNA that would allow genetic analysis) the C&W Research Ethics Board has developed guidance notes on the subject to assist researchers in the preparation of their ethics application. Biobanking guidance notes and a sample consent form can be found in the templates section of our website.
These documents will continue to be updated as national and international guidance and regulations come into effect. Please feel free to email the REB with any questions, concerns, or suggestions for these documents. (9/13/11)
Draft UBC Clinical REBs Consent Form Template Posted
Please note that the Draft UBC Clinical REBs Consent Form Template has been posted in the templates section. It is accompanied by a Memo introducing it and asking for feedback. Researchers are encouraged to use it and provide feedback. The template will be finalized May 15, 2011.
Please direct your comments to the consent form working group. Their emails are outlined in the attached memo.
UBC fee structure for annual renewals
Please review the attached document regarding the new UBC fee structure for annual renewals. (3/4/11)
Clarified Guidance for Minimal Risk Studies
Please review the clarified guidance for minimal risk studies. It is not the final official guidance document as it is missing the appropriate links and references but should be helpful in determining whether your study qualifies for delegated review. A notice will be distributed when the official UBC guidance has been completed. Read the guidelines. (2/25/11)
Important Announcement regarding the Tri Council Policy Statement and TCPS Tutorial
The second edition of the Tri Council Policy Statement on Ethical Conduct for Research Involving Humans has now been formally released and is available through the Interagency Advisory Panel on Research Ethics website at the following link: Ethical Conduct for Research Involving Humans.
All non-Faculty personnel who are associated with a research project and who will have contact with the research subjects are expected to have completed the TCPS online tutorial before the application is submitted to the REB. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, research coordinators, etc. The REB requires that all Principal Investigators be familiar with the TCPS and recommends that Principal Investigators also complete the TCPS tutorial, especially when the Principal Investigator supervises or teaches classes for graduate students or medical residents.
Read the full memo. (12/9/10)
As a result of the US OHRP audit of the UBC Clinical Research Ethics Board (CREB) this past year; all UBC ethics boards have had to implement changes to stay in compliance with US regulations. All studies that need to comply with FDA requirements (indicated by an affirmative answer to question 7.12 of the RISe application form) such as US-sponsored clinical trials and any study that is funded by a US government agency (NIH, DHHS) must be reviewed by the full board regardless of risk to the subjects. In addition, all related amendments and annual renewals must also be reviewed at the full board meeting.
Read the full memo. (7/12/10)
Course in Human Research Participant Protection (CHRPP)
UBC has partnered with Queen's University to provide a free, made-in-Canada educational resource for faculty, staff and students at UBC and affiliated sites who are engaged in research with human participants, or who teach undergraduate and graduate research methods courses.
The Course in Human Research Participant Protection (CHRPP) is an interactive online course that equips participants with a deeper knowledge of the ethical treatment of human research participants. It also provides guidelines that are helpful in preparing applications for research ethics approval.
Tutorials are oriented towards research in the social sciences, health sciences and humanities and can be completed at your leisure. A certificate of completion is provided at the end of the course. Faculty, staff and students are encouraged to register for CHRPP at: http://www.chrpp.ca/UBC/login. A valid UBC or affiliated site email address (e.g. @cw.bc.ca, @bccancer.bc.ca, @providencehealthcare.bc.ca, @vch.ca) is required for registration.
For additional information concerning this educational opportunity, please contact Kirsten Bell (Kirsten.Bell@ors.ubc.ca), Research Ethics Analyst. (7/8/10)
Fraser Health REB now accepting UBC REB applications
UBC Principal Investigators affiliated with Fraser Health may now submit their UBC application form to Fraser Health for approval. This will enable researchers to use the same application form for both UBC and Fraser Health approvals. Read the letter outlining the new agreement. (3/31/10)
New toll free number for the UBC Research Subject Information Line
Please add this number to your standard wording when submitting amended consent forms. The new number is 1-877-822-8598. See Guidance Note 39.7.6 for further information. (2/16/10)
The new serious adverse events reporting method is now up-and-running on RISe.
PLEASE DO NOT SEND any paper copies and ensure that you follow the Guidance notes for the reporting of SAE’s that are listed on our website. All SAE’s that do not meet the UBC C&W REB guidance notes will not be accepted. (11/16/09)
Changes to the RISe Application: New Requirement to Complete Question 4.6
UBC has agreed to participate in a Canada-wide collaborative effort to expedite research studies that are time-sensitive in nature and related to public health emergencies such as pandemics (including H1N1). In order to facilitate this process, researchers are now required to complete question 4.6A of the research ethics application form, so that the Board and Research Ethics Administration can ensure that these studies are dealt with in accordance with the collaborative review process. This requires that all applicants must complete question 4.6A. If you do not complete this question, when the application is submitted you will be required to go back to complete the field. (9/10/09)