B. If the standard procedure is at the centre of the study (p.B one or more arms of a randomised trial are standard), the consent form should include a full description of the procedure and its risks. Registration ClinicalTrials.gov: The FDA has issued a definitive regulation requiring that consent forms for applicable drug and device clinical trials include a specific statement that clinical trial data is entered into ClinicalTrials.gov. The required wording can be found in the Biomedicine and Cancer Consent Model. Participation in the research may result in a loss of confidentiality, but information about you will remain as confidential as possible. Based on your participation in this study, a UCSF medical record will be created. Your consent form and some of your research test results will be included in this file. Therefore, your other UCSF doctors may be aware of your participation. Hospital regulations require all health care providers to keep confidential the information contained in medical records. The following figure shows the five elements identified as key information suggested in the preamble to the revised Final Rule.

The IRB-HSBS General Informed Consent Model has been revised to include new “key information” and other elements required to meet the requirements of the 2018 Common Rule. Download the revised template for your use. Additional templates will be released as soon as they are updated to meet the new requirements. The following guidelines should be used to determine the extent to which standard procedures and associated risks should be described in informed consents: Participation in research may result in a loss of privacy. In this study, you will be asked about drug use and other potentially illegal activities. Researchers will keep your information as confidential as possible, but complete confidentiality cannot be guaranteed. In rare cases, research papers have been subpoenaed by a court. (Word) Two letter templates for the site allow cooperation between U-M and other institutions, organizations, etc. Letters of cooperation must be affixed to U-M`s letterhead and signed by a competent official. These letters are uploaded to the Performance Site section of the eResearch IRB application.

Informed consent documents must be written in plain language at a level appropriate to the professional population, usually at a grade 8 reading level. A best practice is for a colleague or friend to read the consent document to verify its comprehensibility before submitting it with the IRB application. Always: Do not use expressions such as “I have read this form and I understand it” or “Based on this understanding, I hereby consent to participation”, as consent does not guarantee an individual`s understanding, whether legally or otherwise. The standard text explains that the examiner will provide important new information about the subject. Researchers who carry out data collection subject to the General Data Protection Regulation (GDPR) must use this template with a general consent template/document. PDF. Lists the basic and additional elements to be included or included in the informed consent documentation, if any, as well as the citation number [e.B. _0116(b)(1)] in the revised common rule. New items associated with the 2018 Common Rule are in bold. Includes contact information to answer study questions and standard text that asks subjects to contact the Office of Research Protection if they have any comments or questions about the conduct of the study and/or their rights as objects of research. In such cases, you may want to obtain a privacy certificate from the NIH, which can help protect identifiable research information from forced disclosure.

Certificates can be awarded regardless of whether the research is federally funded or not. Name the study sponsor(s). The IRB requires that all consent forms indicate which organizations or institutions (p.B. National Institutes of Health, Department of Defence, government agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors that fund the research or provide drugs or study devices for the study. The mandatory language should only be entered if the study meets the FDA`s definition of a clinical trial. The language must appear verbatim on consent forms for all clinical trials approved on or after March 7, 2012. Simply indicate that if the subject wishes to participate in the study, they must sign the consent form; the signature indicates the consent to participate. You can also provide contact information for other sources of information related to the study (e.g., B local representatives of patients or individuals at other study sites). Routine fMRI study? Refer to the fMRI Guidelines to review the study criteria and download the IRB-HSBS fMRI consent template. In research with children, consent considerations – both process and documentation – become more complex than in adult subjects.

See the IRB`s Research Guide for Children and Minors for information on the documentation required for consent of children and parents, and to use the consent and consent form templates for examples of writing age-appropriate forms. An IRB may approve a consent process that does not include or modify some or all of the elements of informed consent, or waive the requirements for obtaining informed consent if: (Word) Blank template containing the revised 2018 key information of the Common Rule and other required elements of informed consent presented as section headings; contains instructions and the recommended language. It is strongly recommended that you modify this template to create a project-specific consent document for your study for review and approval by the IRB. If you receive a privacy certificate, discuss it at the end of this section using the default certificate trust form. iRIS also requires that each consent document include a release date and version number. Please note that each time you change the consent document, iRIS automatically updates the version number. For example, if you add a revision to version 1.0, then iRIS creates version 1.1. We strongly recommend that you also update the release date when you edit the consent document. Optionally, you can include an internal version number or date in the footer.

However, don`t forget to update the date or number each time you review the document. If it is a biomedical study, a copy of the Statement of Rights of the experimental subject must also be provided. Attach a copy of the current version of the UCSF Bill of Rights to the Declaration of Consent. For a list of the basic and additional elements of the 2018 Common Rule, see the updated document on the basic elements of informed consent. When you upload consent forms to iRIS, you give each consent document a unique name so that the IRB can easily identify the forms (e.g.B. control group consent, parental consent, optional consent to collect samples, fact sheet, etc.). Third party signature: If the study involves subjects who are unable to give consent for themselves (e.g.B. persons with cognitive disabilities, persons who require consent to surrogacy, or children), a separate, properly formulated and labelled signature section may be required for parents or legally authorized representatives for the declaration of consent. The HUB has additional information on clinical trial registration and fda definition. There are several templates of consent forms that are customized for different types of research groups and topics.

Find the templates that best fit your search and use them as a guide for formatting, organizing sections, and standard instructions. As part of the consent process, the consent document is designed to provide potential subjects with information about a research study so that they can make an informed decision about their participation. The use of a form to document the consent process is required unless the IRB expressly waives it. One of the most common reasons for delays in IRB approval is an incomplete, inaccurate or unclear consent form document. Informed consent models (biomedical and social/behavioural versions) are available on the IRB`s Applications and Forms page. You can download a template and adapt it to your research study. One. Unless the standard procedure is explicitly prescribed in the study protocol, the consent form does not need to describe this procedure or its risks. The IRB-HSBS strongly recommends that researchers use one of the informed consent models designed to include the required consent elements (as defined in 45 CFR 46.116) as well as other required regulatory and institutional formulations.

The templates listed below contain the new consent elements outlined in the 2018 Common Rule. Indicate the total amount that the subject receives for participation in the study, as well as any information on the amount of payment if a person does not complete the study or the payment of the premium at the end of the study. Subjects should not be required to complete the entire study in order to be paid. All graduation bonuses should be modest. Replace or define scientific or technical terms in secular language. For example, use “blood sample” instead of “venipuncture.” The NCCN`s Informed Consent Linguistic Database provides standardized descriptions of clinical research risks and events in layman`s language. “Standard” medical procedures included in the study: the declaration of consent indicates whether these procedures are performed for clinical reasons or for study purposes (including whether the procedures are performed more frequently as a result of the study). Will my medical data be treated confidentially? (Confidentiality) A proposed addition to the Exempt Informed Consent Model is the IRB-HSBS Model Exemption Protocol.

Include the reference to the UCSF and information that a research project is discussed in the title of the declaration of consent, for example: B.: Highly recommended for studies involving the collection of biological samples and/or genetic or genomic analysis, especially for government-sponsored clinical trials that must publish a consent document on a public website. .