CREB Retreat / Educational Workshop 17 Oct 2012

From UBC Wiki

Update from CREB REBA & Educational Session 09:00-10:00 (Pia Ganz, Suzanne Richardson, Sarah Bennett)

Annual Report 2011 UBC CREB Annual Report 2011

Workshops presented:


Criteria for minimal risk (Peter Loewen, John Russell)

  • Does TCPS2 evolve our understanding of "minimal risk" at all?
  • Do studies involving changing pressure and oxygen qualify?
  • What about cluster-randomized trials? Can individual consent be waived for these when minimal risk is involved?
  • What should CREB members consider in making this judgment?
  • Table of Minimal Risk Studies referred to Full Board

Please see

Data & Safety Monitoring Boards (Peter Loewen, Stephen HoptionCann)

  • Who decides when they're required?
  • When is it reasonable for the REB to request one be formed?
  • What standards for their composition and conduct exist?

Wording we have used in the past if it is determined that DSMB details are required:

  • Please elaborate on the Data Safety Monitoring Board (DSMB) plan details – in particular:
  • Details of monitoring the progress of the study and the safety of participants
  • Describe the mechanism for reporting adverse events and safety reports
  • Plans for assuring data accuracy and protocol compliance


CIHR has recently changed its procedures and no longer makes the decision regarding when a DSMC is required: "peer review may make the recommendation, but it will be up to the applicant and their institutional REB to determine if a DSMC is required" as per the TCPS2 Chapter 11 Section C

NIH Data and Safety Monitoring Guidelines and Policies
NIH POLICY FOR DATA AND SAFETY MONITORING
FDA’s 2006 guidance document on DSMBs, Data Monitoring Committees

CREB radiation guidance and next steps (Peter Loewen, Stephen HoptionCann)

Oversight of protocols submitted by graduate students and other trainees (John Cairns)

UBC Clinical Guidance Notes June 29, 2012 Guidance Note # 8 Page 29
Article 8.1: Requirement for a Research Protocol or Proposal

All of UBC’s REBs mandate that a research protocol MUST be submitted for all research applications regardless of the type of study. These must be submitted as separate documents attached to box 9.1 of the RISe application form. Research proposals submitted to granting agencies may be used to meet this requirement. Protocols must include the following components although some variation is allowed in the discretion of the reviewing REB.

  1. A background literature review (with accompanying references) that includes an explanation of the need/justification for the study.
  2. The study purpose
  3. Hypotheses
  4. Objectives
  5. Specification of endpoints/outcomes (if applicable)
  6. Research design including statistical analysis plan (if applicable) and
  7. Detailed research procedures

Important Note: The requirement for a research protocol is a UBC-wide REB policy. Your application will be sent back, and approval delayed, if a protocol is not submitted with your application. Ensure that ethical issues as implicated by the research design are addressed within in the protocol.

Need for peer review (John Cairns)

UBC Clinical Guidance Notes June 29, 2012 Guidance Note # 8 Page 29

Article 8.2: Peer Review
For all research, UBCs REBs must be satisfied that the value and the scientific validity of the study warrant it being conducted such that study participant’s time and effort regardless of level of risk of the study, is not being expended with no corresponding benefit to either society or to the participants. Peer review (sometimes referred to as scholarly or scientific review) is generally understood by UBC’s REBs as a review of the importance of the research question and the validity of the methodology. Traditions for scholarly review vary between disciplines or fields of research.

Minimal Risk Research:
Clinical Research that poses no more than minimal risk may not require peer review. The REB must be satisfied about both the value and scientific validity of the study. Research in the humanities and social sciences that poses no more than minimal risk does not normally require peer review.(TCPS2 Article 2.7)

More-than-minimal-risk research:
Clinical Research posing more than minimal risk must have undergone some prior peer review, for example, review by a funding sponsor, or by some other peer review mechanism. UBC’s REBs must be satisfied about both the value and the scientific validity of the study. If clinical research which is more than minimal risk has not undergone some level of peer review, the REB must be provided with an explanation concerning why such a review has not be undertaken/is not possible to obtain. UBC’s REBs may conduct peer review of studies, if there is no other available mechanism and they have the appropriate scholarly expertise. If the REB does not have the appropriate scholarly expertise, it can establish an ad hoc peer review committee to conduct such a review. The ultimate responsibility to provide some level of review in more than minimal risk clinical studies, however, lies with the Principal Investigator.

Independent peer review:
Scholarly review by an independent group of experts who are not affiliated with the institutional department conducting the research, or with the company sponsoring the clinical drug/device trial is preferable to peer review by experts who are not independent.

UBC’s REBs Requirements:
All more than minimal risk studies submitted to UBC REBs require a peer review or scholarly review, or an accepted argument about why one has not been obtained. Your application will be sent back to you, if you do not provide appropriate peer review information on page 4 of the RISe application. If you make an argument that one is not necessary and the REB does not agree, you may be asked to submit one as a condition of study approval.

TCPS2 Article 2.7
Relationship between Research Ethics Review and Scholarly Review
As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research.

Application
The primary test to be used by REBs in evaluating a research project should be ethical acceptability and, where appropriate, relevant disciplinary scholarly standards.
Traditions for scholarly review vary among disciplines or fields of research, including the stage at which scholarly review occurs, and this needs to be taken into account by REBs. The extent of the scholarly review that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out. Research in the humanities and the social sciences that poses, at most, minimal risk shall not normally be required by the REB to be peer reviewed.
REBs should normally avoid duplicating previous professional peer-review assessments unless there is a good and defined reason to do so. It is to be noted that for specific types of research (e.g., clinical trials) REBs should respect the relevant guidelines that require REBs to evaluate the scientific aspects of the research as part of their research ethics review.
Researchers have a role to play in demonstrating to their REB whether, when and how appropriate scholarly review has been or will be undertaken for their research. REBs may request that the researcher provide them with the full documentation of scholarly reviews already completed.
Where scholarly review is required,

  • an REB should consider what scholarly review has been applied to a particular research project (e.g., by a funder or sponsor, or for student research by the research supervisor or thesis committee, or by a permanent peer review committee where it exists);
  • if scholarly review as indicated by the relevant disciplinary tradition has not yet been done, and there is no body available to do it, the REB should consider the following mechanisms in satisfying itself that scholarly review of the research is completed:
- establish an ad hoc independent peer review committee;
- if the REB has the necessary scholarly expertise, assume complete responsibility for the scholarly review. In assuming this responsibility, the REB should not be driven by factors such as personal biases or preferences, and should not reject proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups.

Who can recruit research participants? (John Cairns)

UBC Clinical Guidance Notes June 29, 2012 Guidance Note #10

Requirements for deidentification and anonymization of personal data to be obtained from registries and other databases (John Cairns)

Constraints on samples being used for genetic/genomic/DNA analysis (John Cairns)

  • Why is a separate consent required?
  • Create a shared / common understanding of the process etc.

Social Media (Kirsten Bell)

Harmonization (Laurel Evans, Sarah Bennett)

Reimbursement / differential compensation / timing of compensation (Peter Loewen & Pia Ganz)

  • does the REB have a role in advocating that subjects be reimbursed in a timely fashion?
  • plasma televisions for aboriginal participants and cash for non-aboriginals?

Updates: Health Canada Clinical Trial Agreements, Drugs vs. Devices

Require clarification in terms of new devices and HC regulatory requirements.

Differences in review of Studies with FDA oversight vs. Canadian oversight (John Cairns)

Policy changes which may have an impact on our proceedings (Peter Loewen)

New Guidance Notes

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