What's New
Topics:
1. New consent form templates
2. Clinical trial registration required for REB approval
3. Expired Protocols
4. Translation page now updated
- New Consent Templates
- French Consent Template
- Minimal Risk Consent Template (see comment below on when to use)
- Pregnant Partner Release of Information Form (see comment below on how to approach pregnant partner)
- Database research
- Leftover specimens
- Interviews, surveys, focus groups
- Behavioral interventions
- The research participant informs the study doctor or coordinator that their partner is pregnant;
- PI/delegate should ask the participant to inform their partner that they are in a research study (if they haven't already told them);
- The participant should inform their partner that the researcher would like to collect follow up information on the pregnancy, birth and infant health for a specified period of time;
- If their partner is interested in learning more about the data collection, the participant should either:
- Ask their partner to come to the next study visit with them; or
- Provide them with the PI's contact information to contact the researcher directly.
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Clinical Trial Registration
The REB will not provide approval for your clinical trial without proof of registration on a public registry (an example is: clinicaltrials.gov). When you submit your application to the OHSN-REB, please provide the registration number. If your protocol has already been approved, you will be asked for the registration number at the time of continuing review (annual renewal).
For OHRI sponsored protocols, the investigator is responsible for registering his/her protocol. For information about how to register, please refer to the OHRI extranet http://www.ohri.ca/extranet/trials/default.asp.
For UOHI sponsored protocols, the investigator is responsible for registering his/her protocol. For information about how to register, please refer to your institutional policies and procedures.
For Industry sponsored protocols, it is the sponsor's responsibility to register. Please request the registration number from the sponsor or CRO you are dealing with.
TCPS 2
The registration of clinical trials upholds the principles of Respect for Persons, Concern for Welfare, and Justice, by ensuring that the efforts of all participants in clinical trials are acknowledged, and by reducing the potential for endangerment of others through publication bias.
Article 11.3 All clinical trials shall be registered before recruitment of the first trial participant in a recognized and easily web-accessible public registry.
Clinical trial registries are intended to increase transparency and accountability by providing a record of clinical trials at the recruitment stage that can be used to locate publication of trial results (see TCPS 2; Article 11.12). This helps prevent publication bias, that is, the selective publication of only those trials that yield results in support of an intervention. These registries, in addition to agency policies, editorial policies, ethical policy reforms, and revised national and institutional ethics policies and results disclosure requirements, contribute to a multi-faceted approach to eliminate non-disclosure. The collective goal is to reduce publication bias, and prevent the suppression of data in clinical research.
- Expired Studies
- Translation Page
The following new consent form templates have been developed and posted in the �Consent Form� portion of the website:
When to Use the Minimal Risk Template :
TCPS 2: "minimal risk" research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.
For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
This minimal risk consent template was designed to help researchers carrying out research which is considered "minimal risk" according to TCPS 2.
Some examples of minimal risk research would be:
The above are just a few examples of what is typically considered minimal risk research. The above examples may also fall into the higher than minimal risk category depending on the study design or study population (example would be research with a vulnerable population).
Procedure for Obtaining Consent from the Pregnant Partner of a Research Participant :
The Principal Investigator (PI) or their delegate cannot approach the pregnant partner without their expressed consent. It is recommended that researchers follow this process when learning about a research participant�s pregnant partner:
Similar to participant recruitment process, the PI/delegate should not be contacting the pregnant partner without their consent to be contacted.
NOTE : If the pregnant partner is already present in the room during the study visit, you may ask them to consent without following the procedure above.
It is the Principal Investigator's responsibility to ensure that ethical approval does not lapse for a study.
If your REB approval lapses, you are NOT allowed to recruit any new participants (or collect data for retrospective chart review applications) until approval has been reinstated. If you recruit participants into your research study, it is up to the Chair of the REB to determine if you are able to use that information or not in the data analysis.
Some of the consequences you may face if your REB approval lapses:
a) The project cost center associated with the lapsed REB approval may be frozen, in which case any expenses/transfers/payments will not be processed until the renewal has been submitted. Please note this may have an impact on employment contracts.
b) If the project is grant-funded, we will be unable to advance funds to the project cost center associated with the lapsed REB approval until the renewal has been submitted.
c) If the project is industry-funded, industry payments will not be deposited to the project cost center associated with the lapsed REB approval until the renewal has been submitted.
To avoid a lapse in REB approval, please submit your Continuing Review (Annual Renewal) Report at least 4-6 weeks prior to its expiry date.
The Translation section of the application is now active. Please refer to this page for information about translation, the translation SOP and translation costs.