The following statement should be added to ALL consent forms:
The Michigan Tech Institutional Review Board (Michigan Tech-IRB) has reviewed my request to conduct this project. If you have any concerns about your rights in this study, please contact the Michigan Tech-IRB at 906-487-2902 or email IRB@mtu.edu.
Elements of Informed Consent
Voluntariness - an investigator must provide the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate without coercion or undue influence.
Comprehension - the information that is given to the subject or the subject's representative shall be in language understandable to the subject or the representative.
Information - includes specific items for disclosure intended to assure that subjects will be given sufficient information (procedures, purposes, risks, anticipated benefits, alternative procedures (if applicable), person(s) conducting the research, and a statement offering the opportunity to ask questions and to withdraw at any time from the research.
No informed consent, whether oral or written, may include any language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Information Required on Consent Forms
Federal regulations require that the following information must be provided to each subject as part of the informed consent process:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or others, including scientific benefits which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject.
- A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, an explanation as to whether any compensation, or medical treatments are available if injury occurs, and, if so, what they consist of, and whether subjects are expected to pay for treatment of research-related injuries or illness.
- A statement of whom to contact for (a) answers to pertinent questions about the research, (b) research-related illness or injury, and (c) the rights of research subjects.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional elements as required:
- A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research as well as the procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
- The approximate number of subjects involved in the study.
Written Documentation of Informed Consent
In most cases, federal regulations require that informed consent is to be documented in writing. Documentation usually involves the use of a written consent form containing all of the information to be disclosed and signed and dated by the subject (or the subject's legal representative) and by the person obtaining the consent. One copy should be given to the subject (or representative), and one copy should be retained by the investigator for at least three years.
Federal regulations require that IRBs give special consideration to protecting human subjects who are particularly vulnerable. These subjects include children, prisoners, pregnant women, cognitively impaired individuals, traumatized or comatose individuals, persons who are terminally ill and those who are economically or educationally disadvantaged. With the exception of research involving children, investigations using special populations are approved only when the research objectives cannot be met using populations outside this special category and when there is only minimal risk involved or when the research will directly benefit the subjects.
In rare instances, the IRB may waive written documentation of the consent process (but not the process itself) for research presenting no more than minimal risk. In certain instances of research involving no more than minimal risk where the research could not be practically carried out if written documentation were required ( such as telephone surveys), the IRB also may waive the requirement for written documentation of the consent process.
In some cases (if the subject is unable to read or if written consent is found to be culturally disrespectful or inappropriate), the information about consent may be presented verbally. In these cases, the researcher reads the consent form to the subject, and a short written consent document is substituted. This document should state that the elements of informed consent have been presented orally to the subject. When a short form is used, there should also be a witness to the oral presentation. All parties should sign the short written consent document.
Constructing the Consent Document
The consent document should have three parts: beginning, middle, and end.
- Who is doing the experiment
- The nature, purpose, and duration of the research
- The uses to be made of the data
- The methods to be employed
- The hazards, inconveniences, discomforts, and any potential risks to which the subjects will be subjected
- The availability of compensation and treatment, if injured
- The benefits that might be expected
- Disclosure of alternate procedures the subject may choose, if applicable
- The conditions of participation if any
- A statement that the data are confidential and a description of the procedures to be employed in maintaining confidentiality
- The facts that subjects are at liberty to withdraw their consent prior to the experiment or to discontinue participation in the experiment at any time without prejudice or penalty
- An offer to answer any questions
- Instructions for who to contact should questions arise later, as well as who to contact in case of a research related injury or illness
- Contact information for questions regarding research subjects rights
- A place for the date of signing and the signatures of the subject and investigator