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The Program for the Protection of Human Subjects (PPHS) is updating their current consent template. This will allow them to incorporate several of the proposed changes to the Common Rule that do not contradict current regulations and which they consider steps in a good direction.
As such, the PPHS office is inviting the research community to participate in an open forum workshop discussion regarding the proposed changes to the template on March 14, 2018, from 10:30-11:30 in Davis Auditorium. Light refreshments will be served between this workshop and the Research Forum at 12:00 in the same location.
Researchers and study staff are encouraged to review the information below and come prepared with comments and any additional suggestions for improving the consent template. Additional information will be broadcast to researchers the week prior to the workshop.
We hope to see you there!
Please consider the following terms for consistent use throughout the template:
Subject vs. participant vs. volunteer
Study doctor vs. regular doctor
Study drug vs. investigational drug vs. experimental agent
Research study vs. research project
While the new common rule is not going into effect yet, the below addition to the consent form is being considered for addition to the new template. It would not be required until the new rule is active, but the concept is worth considering at this time:
The revised Common Rule requires that consent forms begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. The intention of this section is to provide potential research participants with a better understanding of the project’s scope, including major risks and benefits, so they can make a more fully informed decision about whether to participate. This section is not intended as a list of isolated facts, but rather should be drafted to promote comprehension. This section has been likened to an “elevator pitch” or a “small talk” summary of your project that would educate and not bore your dinner guests.
This section should include a summary of the purpose of the study, duration of participation, major requirements of the study and any potential benefits. This section should also contain any significant risks of participating in the study. The information presented in this section may be discussed in greater detail later in the consent form. Ideally this summary should fit on one page – it may not exceed three pages or more than 1/3 of the remaining consent form, whichever is shorter. Proposed draft language for this section is as follows (instructions in blue):
In medicine there are many unanswered questions. A “research study” is when scientists try to answer a question about something that we don’t know enough about. Participation in a research study may or may not directly help you or others,. Participation is entirely voluntary- it is completely up to you whether or not you take part. You can also change your mind at any time and it will not affect your ability to get medical care within the Mount Sinai Health System.
The purpose of this research study is [brief statement of purpose in lay language].
If you choose to participate, you will be asked to [brief overview of the major requirements for participants in lay language, e.g. number of visits, duration of participation, types of procedures].
The main risks to you if you choose to participate are [brief summary of main/most likely and or significant risks in lay language – a complete list of all reasonably foreseeable risks should be included in the body of the consent form].
If there is a potential for benefit: You may also benefit from participation in this research if [brief summary of main/most likely benefits]. If there are alternatives to participation: Instead of participating in this research, you may [list appropriate alternative procedures or courses of treatment, if any – this statement may be deleted if there are no alternatives].
The main risks to you if you choose to participate are [brief summary of main/most likely risks in lay language. Black boxed warnings should be at least mentioned here, too – a complete list of all reasonably foreseeable risks should be included in the body of the consent form].
If you are interested in learning more about this study, please continue to read below.