Human Subjects Research Review Sample
SAMPLE
Informed Consent
Principal Investigator:
Title of Project:
Purpose of the Study
You are invited to participate in a research study of [state what is being studied]. We hope to learn [state what the study is designed to discover or establish] [Identify any procedures that are experimental]. You were selected as a possible participant in this study because [state why the subject was selected]. You must be [list all inclusion criteria] in order to participate. There are approximately [number] of subjects expected to be involved in the study.
Description of Study Procedures
If you decide to participate, we [or, name of the person] will [describe the procedures to be followed, including their purposes, how long they will take, and their frequency]. [Describe the discomforts and inconveniences reasonably to be expected].
Potential Risks
[Describe the risks reasonably to be expected]. [A statement that the particular treatment or procedure may involve risks to the subject, which are currently unforeseeable (if applicable)]. [A statement that if the subject is or becomes pregnant, the particular treatment or procedure may involve risk to the embryo or fetus, which are currently unforeseeable (if applicable)].
Potential Benefits
[Describe any benefits reasonably to be expected]. [If there are no benefits, state so]. We cannot and do not guarantee or promise that you will receive any direct benefits from this study.
Alternative Procedures (if applicable)
There are no known alternative procedures. The only alternative is not to participate [or, describe appropriate alternative procedures that might be advantageous to the subject. Any standard treatment that is being withheld must be disclosed].
Confidentiality and Access to Records
[A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained]. [Description of how the records collected will be kept and stored]. If you give us your permission by signing this document, we plan to disclose [state the persons or agencies to whom the information will be furnished, the nature of the information to be furnished, and the purpose of the disclosure]. [For FDA-regulated research: A statement that notes the possibility that the Food and Drug Administration may inspect the records]. [A statement that informs the subjects of mandatory abuse reporting]. This research will remain confidential unless we are required by New York State Law to report harm to yourself or your children.
[For DNA research that is solely being conducted to obtain human specimens, please use the DNA informed consent samples]. Your DNA material will be securely stored under controlled conditions as specified by New York State Law and the Department of Health. Under no circumstances will we identify the individuals, who participate in the research, except as required by law. A risk in the future is that new technologies will be developed with potentially important implications for genetic research; however, we will nonetheless endeavor to maintain the confidentiality of your data and DNA material to the greatest extent possible. [We consider this personal risk to be minimal, as information linking your personal identification information and data obtained during this study will be destroyed at the conclusion of the study (de-identification of data)]. [If DNA is not de-identified, describe procedures for re-consenting].
Participant Payment
[If the subject will receive a fee for participating, or services in lieu of a fee, describe the amount or nature]. [Any additional costs to the subject that may result from participation (if applicable)].
When an IRB approves payment for a human subject activity, the Consent Form distributed to each subject must include information regarding the Internal Revenue Service requirements for 1099 reporting. In addition, if it is known that the total payment is anticipated to be $600 or more, the Consent Form must include the subject's social security number. If it is anticipated that the subject will receive payment of $600 or more during the calendar year, include space for the subject's full legal name, address, and social security number. Space should be provided for the subject to sign and date the Consent Form. The project director must retain all signed and dated Consent Forms.
The following statement must be included in the Consent Form:
"By accepting payment(s) for participating in this study, certain identifying information about you may be made available to professional auditors to satisfy federal and state reporting requirements, but confidentially will be preserved. Please note that if you earn $600 or over in a calendar year as a research subject, these earnings will be reported to the Internal Revenue Service."
Emergency Care and Compensation for Injury
[An explanation as to Binghamton University’s compensation policy, “If you are injured as a result of participating in this study you and your insurance carrier are assuming full financial responsibility for any injury that you may suffer as a result of participating in this study. No other form of compensation is being offered but that does not mean you are giving up any of your legal rights.” Also state any medical treatments that are available if injury occurs, and if so, what they consist of or where further information may be obtained]. [A statement of whom to contact in the event of a research related injury to subject (may not be omitted just because the research involves no more than minimal risk)].
Voluntary Nature and Withdrawal
Your decision whether or not to participate will not affect your relations with the investigators, Binghamton University, and [cooperating institution/organization (if applicable)]. Your participation is completely voluntary. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without any penalty. [Describe any consequence of the subject’s decision to withdraw from the research (if applicable)]. [Include procedure for early termination of participation by the subject (if applicable)]. [Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent (if applicable)].
Any significant new findings developed during the course of the research that may affect your willingness to continue participation will be provided to you in a timely manner.
Conflict of Interest (when appropriate)
[A sample statement can be found here: https://www.binghamton.edu/research/compliance/humansubjects/irbpacs.html]
Questions and Contact Information
Before you sign the form, please ask questions on any aspect of the study that is unclear to you. If you have any additional questions, concerns, or complaints or wish to report a research related problem later, [name(s) of the investigators and include their contact information] will be happy to answer them. If at any time you have questions concerning your rights as a research subject or you have questions, concerns, or complaints about the research, you may contact Binghamton University's Human Subjects Research Review Committee (HSRRC) at (607) 777-3818 or .
You will be given a copy of this form to keep.
YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE. YOUR SIGNATURE INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE HAVING READ THE INFORMATION PROVIDED ABOVE.
Date ______
Signature ______
[For parents/legal guardian giving permission. The line below should not appear if subjects are consenting for themselves]
Relationship to subject ______
[For FDA-funded research]
Signature of Witness ______
Signature of Investigator ______
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