Consent Requirement, Key Elements
Revised Common Rule requirements effective January 21, 2019
** Only studies approved or altered after 1/21/19 will be governed by the new rule. The IRB will not require re-consent except when other significant changes are made to the consent form.
The revised Common Rule requires the addition of Key Elements. The consent form (or consent process, if there is no consent form) must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant in understanding the reasons why one might or might not want to participate in the research. To comply, you may discuss the Key Elements at the beginning of page 1 of the consent form (before the Purpose/Overview section) OR you may utilize the Consent Summary Page template below.
The Key Elements include the following 5 elements:
- A statement that the project is research and participation is voluntary
- A concise summary of the research including purpose, duration, and list of procedures
- Reasonable, foreseeable risks or discomforts
- Reasonable, expected benefits
- Alternative procedures or course of treatment, if any.
Consent Summary Page
A consent form cover sheet should be included at the front of all more than minimal risk studies' consent forms. This allows prospective participants to get a quick look at the basics of what the study entails, what their choices are, and what the risks and benefits are, without having to read a lengthy, in-depth description. It allows them to determine quickly if they think they will be interested in participating. It also assists them in understanding the more complex consent discussion.
Below is a summary of the study that you are asked to participate in. This outline is meant to be a guide for you to use while considering the study and reading the consent form. It is not meant to replace the consent form, which you will have to sign if you decide to participate in the study. The consent form contains detailed information about the study and about the risks which you will need to consider before making your decision. Read the consent form carefully and discuss it with others before deciding to take part. And remember that, even if you agree to participate, you can change your mind at any time.
As with all research, this is a voluntary study, and you do not have to participate if you do not want to. Also, you may stop participating at any time.
- Alternative Treatments/Alternatives to Participation
This section is only required for treatment studies. Name available alternative treatments, including the option of not receiving treatment.
Describe the basic procedures only, not every blood test and questionnaire. Use a bulleted format.
- Risks and Inconveniences
This study includes some risks and discomforts (please refer to the consent form for further details and explanations of these risks). These include (list only the most important risks, in order of severity and frequency)
This research study is not meant to benefit you directly. If there are benefits, you may add "although some benefit is possible," and name the possible benefit(s).
You may contact the study doctor, ____________ at _________ with any questions.
Independent Assessment of Capacity
The following template language should be used:
I have examined [Name of participant] on [date] for the purpose of determining whether the individual is capable of understanding the purpose, nature, risks, benefits, and alternatives (including non-participation) of the research, making a decision about participation and understanding that the decision about participation in the research will involve no penalty or loss of benefits to which the individual is otherwise entitle, for Dr. [Name of Principal Investigator]'s research project, [Title of project]. On the basis of this examination, I have arrived at the conclusion that:
- ____This individual has capacity at this time.
- ____There is a question about this individual's capacity at this time.
- ____This patient clearly lacks this capacity.
Print Name _____________________________
(MD or PhD, not a Co-Investigator or on the study team)