This section should describe steps to protect privacy and the limits of confidentiality. State where records will be kept, who will have access to them, and how privacy will be protected.
Note that “confidential” does not mean “anonymous.” “Anonymous” means that all identifiers (names, numbers, clinical data, etc.) are stripped from the sample/data. Only use the term anonymous when there is no way to link information/sample/data back to a person.
If the study is covered by a certificate of confidentiality
If it is a drug company sponsored study, indicate that drug company personnel may also review the research records.
- As of March 7, 2012, consent forms for studies that are clinical trials must include the following text, exactly as shown here
"A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time":
For studies involving an MRI, include the following statement and highlight it in discussion with prospective participants:
“Your MRI will be interpreted and the results will be shared with you or a physician who you may designate. Your MRI report will be maintained as part of the clinical database at the New York State Psychiatric Institute or the Columbia University Medical Center along with your name and will be accessible to clinicians at the Medical Center. Your psychiatric diagnosis will not be a part of the report.” [delete last sentence for controls]
In addition to the confidentiality protections described in this consent form, a federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance or by adoption agencies. GINA also does not protect you against discrimination based on an already diagnosed genetic condition or disease. If you would like to know more about it you can discuss this with the principal investigator of this study or you can go to the following website www.genome.gov/10002328
Describe any other limitations to the confidentiality participants can expect:
For example: “If your answers indicate a serious problem that may jeopardize your safety or health, then the researchers will contact your parents and appropriate school personnel to see how they can help you, unless there is a very good reason not to contact them. Research staff may not be able to discuss this with you first.”
For example "Suspected or known neglect or sexual or physical abuse of a child, or threatened violence to self or others will be reported to the appropriate authorities."
For example: “Because you will take part in a group interview, the other people in the group interview will also hear your responses. We ask that everyone respect the confidentiality of the other participants....