Informed Consent - Yale University：知情同意-耶鲁大学.pptVIP

Information Technology Services * (C) Copyright, 2000 Yale University. All rights reserved. * Should be signed/dated copy of it- easiest way to do this is to print two copies for each subject and have them sign both- Sensitive populations- Domestic violence victims- one could see where a consent lying around related to research in this arena might be dangerous for participant so do not force them to take a copy-may want to consider requesting a waiver of documentation of informed consent Correct version- We have had studies where there have been amendments to CF done between initial and annual approvals and then the wrong version of the consent (unamended consent) is submitted at the time of reapproval) use version control (in header/footer of document)—see template Amendments and renewals that effect consent documents-- Search and destroy missions to destroy old, unsigned consent forms (keep one in HIC file for records) In addition, be sure to use the RIGHT consent for the RIGHT population or study arm No crossing out- DO NOT cross out parts of the CF that “don’t apply to you” for example, you may have a study that involves two groups- one that will and one that will not receive MRIs—it is NOT OK to just cross out the part about the MRIs- each different population requires its own consent form (or a good description of who will and who will not receive the MRI) Information Technology Services * (C) Copyright, 2000 Yale University. All rights reserved. * Waiver of written consent is different from waiver of informed consent- we are just talking about the documentation of inf. Consent here. This would most likely be a minimal risk non-treatment type of study or that involves no procedures for which consent would be required outside of the research context. So, for example, the HIC would consider waiving written consent if only thing linking subject to the study is the consent form (eg anonymous surveys) Sometimes this would require an information sheet that