Confidentiality Language for Informed Consent Agreements
Language to avoid
Inaccurate and overly restrictive promises in the informed consent agreement can limit an investigator's ability to share data with the research community. For example, some agreements promise that data will be seen only by the research team, or displayed only in aggregate form in tables. This language will make it difficult or impossible to disseminate data to the research community.
Investigators should tell study participants that they are scientists with an obligation to protect confidentiality while sharing study findings with the broad scientific community. Many effective means exist to do this. Data can be modified to eliminate risk of disclosure while preserving their value for science.
Here are two model statements that investigators may use to describe protection of confidentiality in an informed consent agreement.
Sample 1. We will make our best effort to protect your statements and answers, so that no one will be able to connect them with you. These records will remain confidential. Federal or state laws may require us to show information to university or government officials [or sponsors], who are responsible for monitoring the safety of this study. Any personal information that could identify you will be removed or changed before files are shared with other researchers or results are made public.
Sample 2. The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. Your participation in this study is confidential. Federal or state laws may require us to show information to university or government officials [or sponsors], who are responsible for monitoring the safety of this study.