Informed Consent Requirements
Informed consent is one of the cornerstones of the ethical treatment of research subjects. For expedited and full review application, obtaining informed consent is almost always required. This page contains information about informed consent, including:
- how to determine whether your research project requires obtaining informed consent;
- general requirements regarding obtaining informed consent;
- specific requirements for obtaining written informed consent; and
- specific requirements and tips for obtaining oral informed consent.
Does my research project require informed consent?
If your project is designed to obtain information about a person that is not anonymous, and if that person is neither an elected or appointed official nor a candidate for public office, then your project probably requires informed consent from participants.
Information about a person is anonymous if (i) it is not possible to identify the person either directly or through identifiers that link the person with their responses, and (ii) disclosure of the person's responses outside the research project would not place the person at risk of criminal or civil liability, and (iii) disclosure of the person's responses outside the research project would not damage the person's financial standing, employability, or reputation.
If your project is designed to obtain information about a person who is under the age of 19, then your project probably requires informed consent from the person's parent or legal guardian.
If your project is not exempt from review, then your project requires informed consent from participants unless your project meets at least one of the following two conditions:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality.
2. The research presents no more than minimal risk of harm to participants, and the research involves no procedures for which written consent normally is required outside of a research context.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance or routine physical or psychological examinations or tests.
Consult the Waiver of Informed Consent to determine if your research is eligible for not requiring informed consent despite not being exempt from review. Note that you must provide justification for waiving consent.
Records of informed consent must be stored in a way that maintains participant confidentiality.
Information about a person is confidential if at least one of the following conditions is met:
(a) it is possible to identify the person either directly or through identifiers that link the person with their responses but the investigator takes reasonable precautions to ensure that those not involved in the research are unable to identify the person, or
(b) disclosure of the person's responses outside the research project would reasonably place the person at risk of criminal or civil liability but the investigator takes reasonable precautions to ensure that the person's responses are not disclosed outside of the research project, or
(c) disclosure of the person's responses outside the research project would damage the person's financial standing, employability, or reputation but the investigator takes reasonable precautions to ensure that the person's responses are not disclosed outside of the research project.
Basically, participant information is confidential if it is not anonymous but the investigator takes reasonable precautions to ensure that those outside of the research project are both unable to identify the participants and unable to access the participants' responses.
How do I obtain informed consent?
When you obtain informed consent, you must do so only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence.
The language you use to obtain informed consent must be understandable to the participant or the participant's representative. (For adults, this means that it does not require comprehension beyond an eighth-grade level.)
You cannot request, in writing or orally, the participant or the participant's representative to waive any legal rights or release the investigator, the sponsor, the institution or its agents from liability for negligence.
You cannot include any language (written or oral) that makes it seem as if you are requesting the participant or the participant's representative to waive any legal rights or release the investigator, the sponsor, the institution or its agents from liability for negligence.
Written Informed Consent
For written informed consent, you must have each participant sign a form that contains the following elements:
(a) a statement that the study involves research;
(b) an explanation of the purpose of the research;
(c) a statement about the expected duration of the person's participation;
(d) a description of the procedures the study will use to obtain information from the participant;
(e) an indication of which procedures in the study, if any, are experimental;
(f) a description of any reasonably foreseeable risks or discomforts to the subject;
(g) a description of any benefits to the participant or to others which reasonably may be expected from the research;
(h) an indication of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
(i) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
(j) a statement of whom the participant may contact for answers to pertinent questions about the research and research participant's rights, and whom the participant may contact in the event of a research-related injury to the participant;
(k) a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which he or she is otherwise entitled.
If your project involves participants in more than minimal risk, the written informed consent form must also contain the following element:
(l) an explanation of whether compensation and/or medical treatments are available to the participant if injury occurs and, if so, what the compensation or medical treatment includes and/or where the participant may obtain more information
When applicable, the written informed consent form must also contain:
(m) a statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
(n) a description of the anticipated circumstances under which participation may be terminated by the investigator without regard to the participant's consent;
(o) an indication of any additional costs to the participant that may result from participation in the research;
(p) an indication of the consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant;
(q) a statement that significant new findings developed during the course of the research which may relate to the participant's willingness to continue participation will be provided to the participant;
(r) a statement of the approximate number of participants involved in the study.
You must make available to whoever provides the written informed consent a copy of the consent form.
Oral Informed Consent
For oral informed consent, you must (1) read to each participant (and their legal representative, if any) a statement that contains all of the elements required for written informed consent, (2) have a witness to the oral presentation of this information, (3) obtain prior written approval from IRB concerning the content of what is to be read, (4) have the participant or legal representative (as applicable) sign a short form giving consent for participation, (5) have the witness sign both the short form and a copy of what is read to the participant, (6) have the person obtaining the consent sign a copy of the what is read to the participant, and (7) provide a copy of the short form and what is read to whoever provides the informed consent.
The IRB recommends that you also use a recording device to create a record of oral consent. On the device, and for each participant, record an oral reading of the consent form to the participant, and record the participant's oral consent to be part of the research.
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