Basic Elements on Informed Consent Document (ICD)
As part of the initial research submission application, researchers are required to include an Informed Consent Document. When working with minors or other special populations, an assent form may also be required. Contact the IRB for more info on assent requirements.
Note – Lack of information or clarity on the informed consent document is the main reason why the IRB approval process gets delayed. Keep in mind that both the IRB committee and potential participants have no knowledge of your project. The ICD should be written clearly, so that potential participants know what they are expected to do, and it needs to be written in plain language so that a “lay” person would understand (typically written at an 8th grade reading level for adult participants).
The IRB document should include:
- 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 to others, which may reasonably be expected from the research.
- If there are no direct benefits, the researchers may tell subjects what they hope to learn, how that knowledge will contribute to the field of study or how the knowledge might benefit others if such a case can be made.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- This requirement is primarily relevant for biomedical research. However, it might be applicable to social and behavioral research if behavioral interventions, such as novel teaching or therapeutic methods, are proposed.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- The description must include a full disclosure of any state-mandated reporting requirements, such as suspicion of child abuse and/or neglect or harm to others, when warranted by the topic under investigation. State requirements vary, so IRBs and researchers must be aware of state-specific information.
- For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, what compensation will be provided, and where further information may be obtained. For example, if using a survey that contains questions about attempted suicide in a WLU student population, it would be appropriate to include the contact information for the WLU counselor.
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.
- Typically this is the email of the P.I. (and faculty sponsor if applicable). In some field research, there may not be any way for subjects to call or email anyone about their questions and concerns. Alternative means of communication must be established, such as a local contact on the research team.
- 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 the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- Most researchers in the social and behavioral sciences are not in a position to impose penalties. However, specific study-related assurances that there will be no negative consequences associated with choosing not to take part might be appropriate. For example, parents may need to be assured that if they choose not to participate in a school-based, school-approved study their children’s grades or placement will not be affected. Students should be assured that their course grade will not be affected in any way by not participating.
Example of a General Consent:
- Different disciplines and projects may require different information (i.e. Biomedical, Educational research, Health Related Research)
The below word document is an example of a general consent form which includes guidelines and comments. Researchers should remove the comments etc. before submitting their ICD as part of the research proposal.