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 research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
In addition, consent or a waiver of consent is no longer necessary for screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective participants if either of the following conditions are met,:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
The CF Template has been revised as of 1/21/2019 to comply with the revised Common Rule. Most recent updates are highlighted in green text in Times New Roman font below. Consent Forms should be written in simple, plain (non-scientific language). The NYSPI-IRB recommends writing for an eighth-grade reading levels (about 12-years-old). And remember, short and sweet! The following is a general template, but for more specific guidance such as assent, genetics, MRI, PET, and surrogate consent please see the appropriate sub-headings.
Consent Form Template
Informed Consent for Participation in Research
Parental Permission to Participate in Research*
*When enrolling minors Parental Permission (rather than Consent), and Assent are required unless specifically waived by the IRB.
Key information. The consent form (or consent process, if there is no consent form) must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the consent form or process must be organized in a way that facilitates comprehension.
- A statement that the project is research and participation is voluntary
- A summary of the research including Purpose, Duration, and List of Procedures
- Reasonable and foreseeable risks or discomforts
- Reasonable, expected benefits
- Alternative procedures or course of treatment, if any
You can build these elements into the beginning of your consent form, or opt to use the Cover Sheet/Consent Form Summary page (see the NYPSI IRB website under Investigators then Consent) which is already a requirement for more than minimal risk studies.
Title of Project
- Purpose and Overview
This section should state the primary aim of the study. Please present a brief overview of the study, in lay language, in one or two sentences.
If your study is externally funded, name the agency, sponsor, or other source of funding. For example: "This study is funded by a grant from the National Institute of Mental Health."
Participation in this research study is voluntary. If you decide not to participate, or if you later decide to stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not to participate or withdraw your participation will not affect your current or future treatment at the New York State Psychiatric Institute or Columbia University Medical Center.
You may also add information specific to your study regarding the right to withdraw (e.g. samples will be destroyed in the event that you withdraw). If applicable, state that participants will be notified of significant new findings that may relate to their willingness to continue to participate. (This statement is not required for simple interview studies.)
- Alternative Treatments/Alternatives to Participation
This section is necessary for treatment related studies or studies in which known effective treatment is being delayed. This section also may be included for studies that don't offer treatment but where it may be helpful to highlight the available treatment options.
Statements such as, "the only alternative is not to participate," don't convey any meaning and should not be used. The option not to participate is stated in the voluntary section.
The alternatives mentioned should describe the standard of care for the diagnosis, if any, and other frequently used clinical options.
For alternatives relevant to MRI studies, please see the MRI Template Language subheading.
This section should be a brief description of study procedures. Detailed and repetitive descriptions of study visits should be eliminated. Additional information may be included in the appendix.
For blood draws in studies involving children, consider specifying in the PSF and CF that EMLA cream (a topical anesthetic) will be used.
- Risks and Inconveniences
Describe any physical, social, and psychological risks in this section. You should also discuss side effects and their significance here. List the risks in order of frequency and severity. Inconveniences such as the time involved, travel, and other minor inconveniences should also be included.
For studies using PET, the following language is an example of what should be included:
Everyone is exposed to natural background radiation daily from sources such as radon, food, water and the sun's rays. The average exposure of people in the U.S. each year is estimated to be 360 mrem (units for measuring radiation). As a very rough comparison, the amount of radiation you will receive in one PET scan is in the same range as what you would be exposed to in one year from natural background sources. There are no known risks associated with this level of radiation; however, radiation adds up throughout a person's lifetime. It is not possible to tell whether the small additional radiation you will be exposed to by participating in this study will increase your long-term risk for diseases such as cancer.
The following language is required in consent forms for PET studies that include the insertion of an intra-arterial catheter:
Risks of Intra-arterial Catheters: The placement of a catheter in your artery may cause discomfort. There is a very small chance of complications from this catheter such as bleeding, infection, or blood clot. There is an extremely low risk (0.09%) of cutting off circulation to your hand, which could result in a need for surgical repair, or in rare instances, could result in the loss of use of part or all of the hand. These complications are rare and usually occur in medically ill patients who have catheters in their wrists for several days. In contrast, the catheter will remain in your arm for about eight hours for this study. If you have a history of a bleeding disorder or are taking certain medications that affect blood clotting, you will not be asked to participate in this study.
State clearly whether there is or is not potential direct benefit to the participant. If no benefit is expected, simply state that this study was not designed for the benefit of the participant. Briefly state whether there is expected societal benefit.
Monetary compensation may not be listed as a benefit.
- Confidentiality (Please see the Confidentiality Subheading under Investigator then Consent)
For applicable clinical trials the following statement 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.
- Study Compensation
Compensation is provided for time, effort, and reimbursement of transportation costs. The total possible compensation should be clearly stated.
For compensation of $600 or more the following paragraph is necessary:
We are required by law to report your earnings to the IRS. Therefore, your Social Security Number and amount earned will be reported, and you will receive the appropriate IRS form at the end of the year in which you were paid. Please note that payment for this study may affect your eligibility for Medicaid and other city and state support services. No information about which study you participated in will be provided to the IRS.
- In Case of Injury
For ALL studies:
Federal regulations require that we inform participants about our institution's policy with regard to compensation and payment for treatment of research-related injuries.
(Minimal risk studies only)
If you believe that you have sustained an injury as a result of participating in a research study, you may contact the Principal Investigator at (___) ___-_____ so that you can review the matter and identify the medical resources that may be available to you.
For more than minimal risk studies conducted at NYSPI (the Principal Investigator is at NYSPI) and funded through RFMH (no procedures or funding through CUMC), please add the following standard language:
In case of injury, New York State Psychiatric Institute will provide short term emergency medical treatment, which has been determined to be necessary by New York State Psychiatric Institute's doctors, and which is within the capability of New York State Psychiatric Institute to provide. In addition, we will provide assistance in arranging follow up care in such instances.
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide compensation or payment for treatment of research related injuries. However, you should be aware that you do not give up your legal right to seek such compensation through the court by participating in this research.
- (In Case of Injury continued)
For more than minimal risk studies conducted at or funded through Columbia University Medical Center, the following language is needed:
Please be aware that:
The New York State Psychiatric Institute, Columbia University and New York Presbyterian Hospital will furnish that emergency medical care determined to be necessary by the medical staff of this hospital
You will be responsible for the cost of such care, either personally or through your medical insurance or other form of medical coverage.
No monetary compensation for wages lost as a result of injury will be paid to you by *the New York State Psychiatric Institute, Columbia University or by New York Presbyterian Hospital.
By signing this consent form, you are not waiving any of your legal rights to seek compensation through the courts.
*If funding is through Research Foundation, this should say, "....Research Foundation for Mental Hygiene, the New York State Psychiatric Institute, Columbia University and New York Presbyterian Hospital."
State that the investigator will answer to the best of his/her ability any questions that the participant may have now or in the future about the research procedures, or about the subject's response to the procedures. Please include the principal investigator's name and telephone number participation in the study, the participant may call the Principal Investigator.
If applicable, state that participants will be notified of significant new findings that may relate to their willingness to continue to participate. (This statement is not required for simple interview studies.)
Include the following text:
If you have any questions about your rights as a research participant, want to provide feedback, or have a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a committee that protects the rights of participants in research studies). You may call the IRB Main Office at (646) 774-7155 during regular office hours.
- Documentation of Consent
I voluntarily agree to participate in the research study described above.
Print name: __________________
I have discussed the proposed research with this participant including the risks, benefits, and alternatives to participation (including the alternative of not participating in the research). The participant has had an opportunity to ask questions and in my opinion is capable of freely consenting to participate in this research.
Print name: ________________
Person Designated to Obtain Consent
You will be given a copy of this consent form to take with you.
* Consent may only be obtained by persons named in the PSF as being authorized to obtain consent.