Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject. Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.
• Federal regulations describe the required elements of consent.
- A statement that the study involves research, an explanation of the purposes and the expected duration of the subject’s participation, and a description of the procedures, noting any procedures which are experimental;
- A description of reasonably foreseeable risks or discomforts;
- A description of benefits to the subject or others that may reasonably be expected;
- Disclosure of appropriate alternative procedures or courses of treatment;
- A statement of the degree to which confidentiality of records identifying the subject will be maintained;
- For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
- Who to contact for answers to questions about the research, about research subjects’ rights, and about research-related injury;
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled
• There are additional elements that must be included if appropriate.
- A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
- Anticipated circumstances under which the subject’s participation may be terminated without the subject’s consent;
- Additional costs that may accrue to the subject as a result of participation;
- Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
- A statement that any significant new findings that may relate to the subject’s willingness to continue will be provided;
- The approximate number of subjects involved in the study.
• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:
- The research involves no more than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- When appropriate, subjects will be provided with additional pertinent information after participation.
Confidentiality (also Certificates of Confidentiality)
Consent Form Template: Confidentiality section
- General Guidance
Describe how identifiable data will be stored, who will have access, how long it will be kept, and measures to be taken to ensure confidentiality of electronically stored/transmitted data (e.g. "All records will be stored in locked files and will be kept confidential to the extent permitted by law")
Also include our standard language regarding confidentiality:
Records will be available to research staff, and to Federal, State and Institutional regulatory personnel (who may review records as part of routine audits).
Describe measures to be taken to ensure confidentiality of electronically stored/transmitted data.
For individuals recruited and seen at NYSPI, include the following electronic medical record disclosure: Your name and other personal identifying information will be stored in an electronically secure database at New York Psychiatric Institute.
If it is a drug company sponsored study, indicate that drug company personnel may also review the research records.
- Clinical Trials
If your study needs to register in ClinicalTrials.gov, the following language is required:
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.
- Certificate of Confidentiality
For any other applicable limitations to confidentiality, or if your study involves genetics, of if you have a Certificate of Confidentiality, please see below.
If the study is covered by a Certificate of Confidentiality, describe the protections and limitations afforded by the certificate. Although required language may vary, depending on which agency will be granting the Certificate, the essential point is that it protects the researchers from having to release any research data - including the names of participants, even under court order or subpoena.
•(Certificate of Confidentiality cont)
This research is covered by a Certificate of Confidentiality issued by the [AGENCY NAME HERE (e.g., Department of Health and Human Services (DHHS))]. With this Certificate, the researchers cannot be forced to release any research data in which you are identified, even under a court order or subpoena, without your written consent. The Certificate does not prevent the researchers from reporting suspected or known neglect or sexual or physical abuse of a child, or threatened violence to self or others. Such information will be reported to the appropriate authorities.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.
The PSF confidentiality section should describe where scans, associated clinical and identifying data, and clinical readings will be stored and how confidentiality will be maintained. If results are to be maintained on a widely available database (e.g. Webcis) this information should be noted and described in the consent form.
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]
Depending on the location of scanning and interpretation, one of the following statements should be included:
A. The results of your MRI scan will be maintained in an electronically secure database at NYSPI or CUMC and accessible only to the members of the research team. or,
B. The results of your MRI scan will be maintained on the clinical information system at Columbia University Medical Center and will be accessible to hospital clinicians.
- Genetic Information Nondiscrimination Act (GINA)
Genetic studies require a Certificate of Confidentiality
Consent forms for genetic studies must describe new protections under the Genetic Information Nondiscrimination Act (GINA). Please review the Genetics CF template available on the IRB website. Consent forms for existing studies may be revised at the time that they are submitted for continuing review or modification.
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
- Suspected abuse or threatened violence
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.
- Focus Groups
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....