Seeking Informed Consent
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Pre-screening in the study population is occasionally required in advance of the informed consent discussion. The method used “to pre-screen” is part of the over all subject selection strategy, and must be described in the recruitment section of the research protocol. If the pre-screening script used to determine eligibility exists separate from the protocol, it must be submitted as a study document for REB review.
If pre-screening requires contact with a prospective subject, only a health care professional known to the person is permitted to make the initial contact. However, in circumstances where the required approach is not practicable, correspondence with a statement of “agreement to be contacted” or a “request to contact the Investigator”, may be signed at the discretion of the MUHC Director of Professional Services (DPS) or delegate. With permission the Investigator may send correspondence signed by the DPS according to the study recruitment design. Pre-screening for secondary use of existing identifiable data may go forward if the original written informed consent signed by the subject allowed future research use of the data collected.
Written consent to pre-screening is obtained separately from the informed consent document used in the study. If a “consent to pre-screening” document will be used, it first must receive REB review and approval. The written consent to pre-screening must contain the choice to “opt-in” or “opt-out”.
Respect for the privacy of the person and for the confidentiality of information collected during the pre-screening process is of utmost importance. The absence of a reply from a prospective subject does not imply agreement to be contacted. Explicit permission to be contacted must be given by the individual to the Investigator. Actual pre-screening may take place in person, or via mail, telephone or electronic communication.
The MUHC DPS or delegate may give permission to pre-screen medical records of prospective subjects when no contact with the person is required and research ethics approval is provided for the study.
The pre-screening plan must include arrangements to dispose of the information collected for every person who refused the invitation, or did not meet the study entry criteria. The pre-screening data collected from study subjects are “essential documentation” subject to research retention rules.
MUHC policy requires the Principal Investigator to provide to each person participating in research with a therapeutic component, a “wallet-size information card” including the MUHC or IRB study code, name of study drug(s) or medical device, and emergency contact number.
You may use the appropriate wallet card template below that is designed for printing on “Avery Business Card Stock 5371”. The template may be printed as a single card or a single page.
We suggest the cards be printed double-sided in English and in French versions to allow the subject to carry bilingual information on a single wallet card.
MS Word documents
- Drug Study Template [.doc]
- Medical device study template [.doc]
- Carte medicaments [.doc]
- Carte instruments [.doc]
PDF documents
- Drug Study Template [.pdf]
- Medical device study template [.pdf]
- Carte medicaments [.pdf]
- Carte instruments [.pdf]
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