All initial studies approved on or after January 20, 2019 are governed by new IRB regulations (the Revised Common Rule). One of the new requirements is the addition of a section at the beginning of the consent form that provides key information for the potential participant. This section should give a brief overview of the study and is intended to provide the prospective subject with enough information for them to understand why they may or may not want to participate in the research.
The Concise Summary is included on the templates downloaded from IRBIS. The header and box format should not be removed or altered.
The key information should include the following:
- A summary of the purpose of the study
- Duration of the subject’s participation
- Main requirements of participation
- Potential for direct benefit. If there is none, please state so.
- A summary of significant risk(s) of participation, please include risk of breach of confidentiality for all studies if no other risks are applicable.
Here is an example of a Concise Summary that addresses all required elements:
The purpose of this study is to determine how the characteristics of the cartilage that makes up our ear affects the ear’s ability to hear sounds as we age. In the course of your clinical operation, it is planned to take cartilage from one area and use it in another. When we do this, there is often a small amount of excess cartilage that is normally discarded at the end. Participation in this study would grant us permission to take the cartilage that is normally discarded and to examine it under a microscope to determine the structural makeup of the cartilage. We hope to use these samples to further our understanding of why some individuals develop difficulty hearing where other’s do not.
It is important to know that your surgical care now and in the future is in no way dependent on your participation in this study. There is no alteration in your surgical plan and if there is no cartilage remaining as part of the standard surgical procedure, we will not take any extra for research purposes. We will only be utilizing your specimen after the consenting process. In participating in this research, although precautions have been taken by the study team such as keeping all confidential information on a secure server and following UNC policy, there is always a chance that your information may be inadvertently shared. You will receive no direct benefit from participating in this study, but you may enable physicians to better counsel and treat future patients.
You can find more examples on our website: https://research.unc.edu/wp-content/uploads/2018/01/Concise-Summary-Examples.pdf