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.
Genetics Consent Form
The New York State Psychiatric Institute -- Institutional Review Board Resources for Investigators
Genetics Research Consent Form Guidelines
To make an informed choice, the subject must be made aware of the study purposes, risks, benefits, and alternatives to study participation. The Consent Form is an important part of this process and is meant to guide both investigator and potential subject in the consent process.
The following guidelines are meant to help investigators create clear, concise and ethically sound consent documents for psychiatric genetics research.
Studies involving DNA require special permission from participants and special consideration by the IRB, because:
-Genetic test results can be used to predict future health risks that might be of interest to insurers or employers.
-Genetic test results apply to a whole family and therefore are of interest to others, not solely the individual subject.
-Information from a genetic test can be kept in many different places and under many sets of rules over which an individual has no control and, in fact, little or no knowledge.
-DNA is fundamentally linked to identity, individuality, and an individual's relationship with kin.
This section is essential to the "discuss and document" rule of thumb of informed consent. This documentation should provide some sort of statement that the participant has read and understood the material presented and that all of their questions have been answered to their satisfaction. Documentation of consent should also be clear in that by signing the form, participants have not waived any legal rights that they would otherwise have. If more than one level of participation is available to the participant, list each one clearly and separately (perhaps with boxes to check) so that they can agree to any or all parts individually and explicitly. There should be places for the printed name of participant, the signature of the participant and the date, the printed name of the physician discussing and documenting consent, in addition to this physician's signature and the date signed. If an independent of assessment of a potential participant's capacity is made, this should also be documented. See additional guidance regarding capacity of participants.
Sample language: I have read and understand the preceding information describing this medical research study. The study doctor or the study staff has explained it to me in detail and all of my questions have been answered to my satisfaction.
I understand that I will receive a signed copy of this consent form for my records. I voluntarily agree to participate in the research study described above.
Printed Name of Subject
Signature of Subject Date
If the study provides an opportunity for subjects to agree to one component of the study and not another, please consider adding on a section following the signature of the subject that describes the subject's options for participation. Use boxes and bolding to clarify your point. Example follows:
Part 1: Dr. X MAY /MAY NOT use my DNA for research relating to bipolar disorder and/or mania or to lithium.
Part 2: Dr. X MAY /MAY NOT use my DNA for research on other disorders.
Part 3: Dr. X MAY /MAY NOT create cell lines from my DNA for storage at a National repository. Once the trial ends, I will not be able to request the destruction of the sample because the link of my DNA Sample to my identity will have been removed.
The individual performing consent should also sign the consent form. For example,
"I have discussed the proposed research with this subject and, in my opinion, this subject understands the benefits, risks, and alternatives (including non-participation) to study participation and is capable of freely consenting to participate in this research."
Printed Name of Consent Physician
Signature of Consent Physician
As with any study, you can choose to begin the consent form with a brief introduction that states that participation is the decision of each individual and an invitation to ask questions about any terms that are unknown or confusing. Some investigators choose to include language such as,
"Research studies only include people who choose to be involved in the study. Please read this consent form carefully and take your time making your decision. This consent form may contain words that are hard to understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand."