NEW: Spring 2019: Siena has a new (required) consent form! There have been several changes to the consent process, and changes to the requirements for informed consent as described in the revised Common Rule. The changes include but are not limited to:
Use the template when preparing your application, as the form has been designed to meet the new regulations and offer suggestions for language. Please tailor it to best suit the needs of your studies and target populations. Most of the elements of the former consent form have not changed, but they have been restructured and the language has been adjusted.
Below the template links is a more detailed description of the new requirement of “Key Information” as well as a description of basic elements of the consent form.
This is designed to include instructions and suggested language within the form, itself. It requires you delete instructions and information you are not using.
This is designed to include instructions and suggested language within the form, itself. It requires you delete instructions and information you are not using.
An informed consent document is used to provide subjects with the information they need to make a decision to volunteer for a research study. New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study.
Below are the five elements identified in the preamble to the revised Common Rule as “key information”:
At Siena, if your consent form (using the template provided) exceeds two pages, you will need to include this “Key Information” before the body of your consent. The template already states your project is research and participation is voluntary, so it only asks you address items 2-5.
This checklist is also on your application form.
| Required Elements of Informed Consent | ✓ | |
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1. If application is more than 2 pages: Key information containing brief
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| 2. Explanation of purpose of the research and the expected duration of the subjects’ participation | ||
| 3. Description of procedures to be followed | ||
| 4. Description of any foreseeable risks or discomforts to the participant | ||
| 5. Description of any benefits to the subject or to others that may reasonably be expected from the research | ||
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6. Additional study information:
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| 7. Statement listing the types of personally identifying information that will be collected and why it is necessary to do so. | ||
| 8. Explanation of where/how the data are stored (data security) and how long it will be kept | ||
| 9. Description of the extent, if any, to which confidentiality of records identifying the subjects will be maintained and a listing of who will see the data and the type of data they will see | ||
| 10. Contact information for PI(s), Faculty Supervisor, IRB Chair. | ||
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11. IRB # and approval date (write “TBD” when you submit application and replace after receiving approval letter)
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In some cases, the IRB may approve a consent procedure that does not include, or that alters, some or all of the required elements of informed consent, or may waive the requirement to obtain informed consent. Requests for informed consent waivers, alterations, exceptions, and substitutions must be explicitly requested on the application form, with a rationale of why the change is warranted in accordance with the policy.