Consent Template Language
The CF Template was 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. The latest version 7/8/19 includes the most recent Certificate of Confidentiality suggested language from NIH.
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 in the Consent menu bar. The Confidentiality section below is limited. For the full Confidentiality section, either see the Consent/Confidentiality section in the menu bar, or go directly to the CF template.
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.
Title of Project
- 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 research. This part of the consent form or process must be organized in a way that facilitate 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 treatment, if any
You can build these elements into the beginning of your consent form, or opt to use the Cover Sheet/Consent Summary page (see Consent) which is already a requirement for more than minimal risk studies.
- 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 Irving 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.
For videotapes that may be viewed at professional conferences, etc.:
There may, however, be unforeseen risks related to professional audience members viewing tapes and recognizing you by sight. Prior to viewing videotapes, audience members will be instructed to excuse themselves from the room if they recognize the participants in the tapes by sight. The audience will also be told that they may not use audio taping or cameras of any kind while the video is being shown.
- 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 Joint Commission on Radiation Exposure (JRSC) has developed language for three categories of risk:
Minimal Risk (<3mSv). For effective doses under 3 mSv, the risk can be described as "minimal" and the consent form language is rather brief. Provide a numeric value for the effective dose use the following consent form language:
This research study involves exposure to radiation. This radiation exposure is not required for your medical care and is for research purposes only. The radiation exposure is necessary to obtain the research information desired. The total amount of radiation that you may receive in this study is approximately X mSv, which is less than that is typically received from natural sources of radiation in a year. At these very low levels, scientists are uncertain as to the actual risk and there may be no risk at all.
Low Risk (3 mSv to 100 mSv). For effective doses between 3 mSv and 100 mSv, the risk can be described as "low" and slightly more consent form language is recommended. Provide a numeric value for the effective dose and a numeric estimated risk of future cancer incidence. Doses to individual organs should be discussed if dose from administered radiopharmaceuticals to any individual organ is greater than 1 Sv. Consent form language:
This research study involves exposure to radiation. This radiation exposure is not required for your medical care and is for research purposes only. The radiation exposure is necessary to obtain the research information desired. The total amount of radiation that you may receive in this study is approximately XX mSv. The additional cancer risk from this research study is estimated to be up to Z%. At these low levels, scientists are uncertain as to the actual risk and there may be no risk at all.
Acceptable Risk (> 100 mSv). For effective doses above 100 mSv, the risk can be described as "acceptable" and more extensive consent form language should be provided. Provide a numeric value for the effective dose and a numeric estimated risk of future cancer incidence. Doses to individual organs must be discussed if the dose from administered radiopharmaceuticals to any individual organ is greater than 1 Sv. Use of the effective dose concept may not be appropriate for therapeutic application of radiation, and special risk language should be developed for this on a case-by-case basis. Consent form language:
This research study involves exposure to radiation. This radiation exposure is not required for your medical care and is for research purposes only. The total amount of radiation that you may receive in this study is approximately XXX mSv. The additional cancer risk from this research study is estimated to be up to ZZ%. The Human Use Subcommittee of the Joint Radiation Safety Committee has approved the use of radiation in this research study. Please tell the research team if you have taken part in other research studies or have recently received any medical care involving radiation.
Additional consent form language for studies with a potential for tissue reactions. In addition, the procedures involving radiation in this research study might increase the possibility of skin injury, hair loss and/or cataracts.
SKIN (Peak Skin Dose > 3 Gy): Skin injuries seldom occur and are usually limited to a small area of reddening of the skin surface that was irradiated. They rarely result in an ulcer.
HAIR (Only if skin information is also given; may not be necessary if target area does not have much hair): If hair loss occurs, it is usually temporary, but could be permanent.
EYES (lens dose > 0.5 Gy to either or both eyes): Cataracts occur rarely and appear many years after the exposure of the eyes to large doses of radiation.
Risk Calculations for Low and Acceptable Risk Radiation Exposure:
With respect to the % risk calculation for dose levels exceeding 3 mSv, for studies involving only adults, the youngest subject who could be enrolled in the study should be used to calculate risk. The risk to a female subject should be used unless the study is limited to only males. For all pediatric subjects, JRSC recommends using the risk to a 10-year old female subject unless the study is directed at younger children, in which case an appropriate age should be used.
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 Consent/Confidentiality Subheading under Investigator menu bar)
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.") A statement about whether subject's private information or biospecimens could be used for future research studies or distributed to another investigator for future search study, with or without identifiers.
Also include the following standard language:
Records will be available to research staff, and to Federal, State and Institutional regulatory personnel (who may review records as part of routine audits.)
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.
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.