The consent form must be written in a clear and concise language so an average person who has little experience in science or scientific terminology may understand.
Informed consent must be obtained under circumstances in which the subject (or legally authorized representation) has sufficient opportunity to consider whether or not to participate and that minimizes the possibility of subject coercion or undue influence. No informed consent, whether verbal or written, may include an exculpatory language through which the subject or their legally authorized representative is made to waiver, or appear to waive. The subjects' legal rights include any release of the university or its agents from liability for negligence.
An inadequately or improperly prepared consent form may delay approval of a protocol.
In seeking informed consent, the following information shall be provided to potential subjects:
- Explanation: An explanation of the purpose of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any experimental treatments or procedures.
- Risks and Discomforts: A description of any reasonable predictive risk or discomfort to the subject including possible results of the experimental treatment or intervention should prove ineffective when the subject is a recipient of treatment for an illness or dysfunction.
- New Information: A disclosure of new appropriate alternative procedures or course of treatment that becomes available during the course of the study and that may be advantageous to the subject's condition or well-being.
- Benefits to be Expected: A description of any benefits to the subject or to others which may be reasonably expected from the research, including compensation (if any) offered to the subject.
- Confidentiality: A description of the extent to which confidentiality of records identifying the subject will be maintained.
- Contacts: A description of whom to contact for answers to any questions the subject may have about the research, the subject's rights, or other matters. A 24-hour phone number is preferable.
- Freedom of Consent and Approval: A description stating participation is voluntary, and that refusal to participate will not result in a penalty of loss of benefits to which the subject is otherwise entitled. Also it includes a statement that a subject may discontinue participation at anytime.
- Voluntary Participation Medical Treatment: For all studies involving human subjects following statement must be included:
My signature below acknowledges my voluntary participation in this research project. Such participation does not release the researcher, the University of Mary, or other agencies from their professional and ethical responsibilities to me. Potential risks from participation in this research project have been disclosed to me. I acknowledge that unforeseeable and/or unknown risks or discomfort may occur. In the event that medical treatment occurs as a result of normal participation in this research project, the University of Mary, or other agencies will be responsible for my medical costs or other damages incurred in the absence of fault on their behalf.
If appropriate, the following content may also be provided on the Informed Consent Form:
- A statement that the specific intervention or treatment may involve unforeseeable risks to the subject or embryo or fetus, if the subject is or may become pregnant.
- Foreseeable circumstances under which the subject's participation may be terminated by the investigator with regard to the subject's consent.
- Additional costs that subject may incur as a result of participation in the research project.
- Important consequences of a subject's decision to withdraw from the research and procedures for organized termination of participation by the subject.
The Instructional Review Board may approve an informed consent procedure that alters some or all of the elements of informed consent provided the Board finds and documents all of the following:
- The research protocol involves no more than minimal risk to the subjects.
- Sufficient information will be disclosed to inform the subject fairly to decide whether or not to participate in the research project.
- Withholding or altering part of the description of the procedures will not materially affect the ability of the subject to evaluate the harm or discomfort caused by the research.
- The project cannot practically be carried out without the withholding or alteration of the information, but with the assurance that the study's design ensures protection of the rights and safety of each individual subject with the alteration.
- The information is not altered or withheld for the goal of eliciting participation of the subjects.
