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 is the agreement obtained from a participant, or from an authorized representative, for the participant's participation in an activity. The agreement, written or oral, entered into by the participant, may include no exculpatory language through which the participant is made to waive, or to appear to waive, any of the participant's legal rights, or to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Required Elements of an Informed Consent Form For All Research

Purpose of research

A statement that identifies the purpose of the research so that the participant can make an informed choice regarding participation.

Description of risk & benefits of the research

A description of any reasonably foreseeable risks to the participant and a description of any benefits to the participant or to others which may reasonably be expected from the research. Benefits may not necessarily be experienced directly by the participant, but could take the form of helping to increase knowledge in a particular field of study.

Statement that participation in the research is voluntary and that participation can be discontinued at any time

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 refusal to participate will not affect the prospective research participants relationship to Willamette University or any relevant department. The participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

Statement of confidentiality

A statement describing the extent, to which confidentiality of information identifying the participant will be maintained as part of this portion of the informed consent document. Researchers need to detail how information will be kept confidential (both in the storing of information and in the dissemination of results from their research) and how information will be destroyed or discarded once the data are no longer needed. Please refer to your discipline's standards of practice regarding both storage of information (including length of storage required) and methods of discarding data.

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

All informed consent forms must contain contract information about both the researcher and the IRB chair. 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 Professor Peter Harmer, Chair, Willamette University IRB Committee,, 503-370-6470.

Additional Elements of Informed Consent Forms Under Special Circumstances

When the Research Involves the Collection of 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 participant. 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. The consent form should also include an acknowledgement by the participant that he/she is not allergic to latex gloves; and if the participant does have this allergy, the researcher needs to state how the participant will be protected from this risk.

When the Research Involves Physical Exertion

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 the university is not able to offer financial compensation nor absorb the costs of medical treatment should the participant be injured as a result of participating in this research; (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.

When the Research Includes Children or 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 informed consent by their parent or legal guardian. In addition, participation of children sufficiently old enough to understand their best interests requires that the child him/herself also sign an assent form indicating their willingness to participate. The assent form needs to include the same basic elements found in the informed consent form, but the language of the assent form should be developmentally appropriate given the age of the child. Thus, the researcher should construct an assent form that can be easily understood by the child so that he/she can make an informed choice whether or not to participate in the research project. Even if parental approval is obtained, research ethics requires that children not be coerced to participate in research against their will.

Use of Visual Images (Photos/Videos)

If the researcher plans to take visual images of the participant, an additional release form is required so that participants can give specific permission for their images to be released. In these cases, the researcher should also pay particular attention to issues of risk, confidentiality, and anonymity in their consent form and these become unique issues when visual images of participants are taken.