Informed Consent Issues
Obtaining Informed Consent
Informed consent is at the heart of the IRB application, review and research process for human participants. IRB applications will not be considered by the IRB committee until an adequate informed consent document is submitted with the application.
Informed consent will be sought from all prospective research participants (or their legally authorized representatives) unless waived by the IRB. Investigators should be sensitive to the possible need of an interpreter- translator for participants who do not speak English and/or prepare a consent form in the person's native language. The IRB may waive the requirement of a signed consent form if:
- this consent form is the only record linking the subject with the research and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- the research presents no more than minimal risk of harm to participants, involving no procedures for which written consent is normally required outside the context of the research. Such a waiver might be appropriate where the research involves minimal risk, the rights and welfare of the participants are not adversely affected, and the research would not be feasible without the waiver.
Informed consent is the agreement obtained from a subject, or from an authorized representative, for the subject's participation in an activity. The agreement, written or oral, entered into by the subject, may include no exculpatory language through which the subject is made to waive, or to appear to waive, any of the subject's legal rights, or to release the investigator, the sponsor, the institution or its agents from liability for negligence.
The Written Consent Document
Unless the IRB provides special approval for an oral informed consent procedure, documented informed consent will consist of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. The signed consent forms shall be kept in the investigator's file. The consent form may be either of the two following document styles:
- A written consent document that embodies the elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
- A "short form" written consent document stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short form."
Basic Written Consent for Adult Participant (DOC). For very low risk projects, mostly social sciences and humanities.
More Formal Consent for Adult Participant (DOC). For projects with possible risk, typically physical sciences.
Photo/Audio/Video Release (DOC). Release form only.
Required Elements of an Informed Consent Form
Purpose of research
A statement that identifies the exercise as a research activity, provides an explanation of the purpose(s) of the research, estimates the duration of the subject's participation, details procedures to be followed, and identifies any procedures which are experimental.
Description of risk & benefits of the research
A description of any reasonably foreseeable risks or discomforts to the subject and a description of any benefits to the subject or to others which may reasonably be expected from the research.
Any research that involves physical exertion or activity, needs to include the following components in the Informed Consent form when discussing risks and benefits: (a) a statement noting that Willamette will not pay for medical treatment should injury to the participants occur; (b) an acknowledgement by the participant that he/she does not have any known relevant medical condition that would put him/her at risk for participating in the study; and (c) an acknowledgement by the participant that he/she has medical insurance (either Willamette student insurance or private health insurance). The researcher needs to articulate that a potential participant with either a known medical condition that would place him/her at risk of participating or failure to acknowledge medical insurance would disqualify the person from participating in a research study involving physical exertion or activity.
Statement that participation in the research is voluntary
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and refusal to participate will not affect the prospective research participants relationship to Willamette University or any relevant department.
Statement that participation can be discontinued at any time
The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Statement of confidentiality
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
Statement regarding debriefing
For research studies in disciplines that require debriefing of participants at the conclusion of the research, a statement of how and when debriefing will take place should be articulated.
Researcher and IRB chair contact information
A statement such as the following might be used: "Questions about the research and any concerns that arise from participating in the research should be directed to (PI name & telephone number; also include Faculty Advisor name and telephone number if PI is a student) or Dr. Meredy Goldberg Edelson, Chair, Willamette University IRB Committee, irbchair@willamette.edu, 503-370-6133)."
Informed Consent When Collecting Body Fluids
If you are planning to collect body fluids or tissue, a statement (sample statement below) is required that indicates that any persons at increased risk for Hepatitis B or C or HIV (AIDS) infections should not donate blood or other body fluids. In order to locate source participants quickly, the informed consent document should also contain the current address and telephone number of the subject. Compulsory screening of source participants for infections should not be done except where such screening is required to protect the validity of the research data. In those cases where an investigator asserts that screening is necessary, the need for such testing must be justified to the IRB.
A sample statement to include in informed consent documents when body fluids will be collected follows:
Preventing Transmission of Infections
The IRB has developed guidelines for preventing the transmission of infections in University research laboratories. The purpose of the guidelines is to establish procedures to protect laboratory workers and source participants from exposure to infectious or potentially infectious human materials in University research laboratories.
Persons who have ever had hepatitis B or C, who have tested positive for HIV or any AIDS virus, or persons who have AIDS should not donate body fluids or tissues. Persons at risk for getting and spreading any AIDS virus also should not donate body fluids or tissue and should not participate in this investigation. You are at risk if:
- you are a man who has had sex with another man since 1977, even one time.
- you have shared a needle, even one time, to inject drugs or medication.
- you have taken clotting factor concentrates for a bleeding disorder such as hemophilia.
- you have ever had a positive test for any AIDS virus or hepatitis B or C or any AIDS antibody.
- you have had sex with any person described above.
- you have had sex with a male or female prostitute since 1977.
Consent and Assent Forms for Child (or Developmentally Disabled) Participants
Children and mentally or developmentally disabled participants are a protected group. Research involving such individuals will only be approved in special situations and when risk to participants is very low. Participation of children under the age of 18 or disabled individuals requires signed consent of their parent or legal guardian. In addition, participation of children sufficiently old to understand their best interests (typically pre-teens and teens) requires that the child themselves also sign a form of �assent� indicating their willingness to participate. Even if parental approval is obtained, research ethics requires that children not be coerced to participate in research against their will.