The minimum basic elements of informed consent include:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the 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 participant; a statement indicating what assistance, if any, is available if the discomfort is too great for the participant;
- A description of any benefits to the participant or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
- A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. In keeping with this requirement, web-based surveys must be designed so that participants are not forced to respond to a question before moving to the next one; and
- A statement that the research study has been approved by the IRB and who to contact: Please include the following statement, “This study has been reviewed and approved by UA Little Rock’s Institutional Review Board (IRB). The IRB has determined that this study meets the ethical obligations required by federal law and University policies. If you have questions or concerns regarding this study, please contact the Principal Investigator (provide university email and university phone number if available) or Advisor (If there is an advisor, provide university email and phone number if available). If you have any questions regarding your rights as a research participant, please contact the Research Compliance Officer at 501-916-6209 or firstname.lastname@example.org.”
Informed consent is documented by the use of a written consent form or survey cover letter and approved by the IRB. The informed consent process should not begin until IRB approval has been received by the researcher. The consent form must be signed by each participant or the participant’s legally authorized representative. A copy must be given to the person signing the form, and a copy is retained by the PI. The PI must retain the original consent forms for three years following completion of the study. A blank, unsigned consent form that the researcher intends to use during the research study should be included in the submission materials.
Informed Consent and Assent of Minors
When seeking informed consent, special considerations must be given in the case of children and adolescents under 18 years of age. Only the parents or legal guardians of minors may give legal consent on behalf of their children (or wards). School officials, including teachers, may never give informed consent for the students in their school or school district.
In cases where minors are involved, the parent or guardian must sign the letter of consent, but it is also desirable to receive assent from the minor. The age that child assent is required differs according to the type of research that will be conducted. It is generally considered appropriate to introduce child assent when dealing with minors that have reached the age of 7. Researchers should create and use an assent form to explain the research project to the minor and get their verbal agreement or “assent” to participate in the study. All care must be taken to explain their participation in the project at a language level they can understand.
For researchers conducting a study that involves surveys of minors in a group setting, please include the following elements in your survey cover letter: clearly emphasize the voluntary nature of participation, that there are no penalties for non-participation, and if applicable, that student grades will not be affected in any way by non-participation. At the bottom of the survey document, please include the following choices for the minor participant: __ Please include my answers in your study, __Please do not include my answers in your study.
Waiver of Consent Documentation
The IRB may waive documentation of informed consent if it determines:
- That 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. Each participant will be asked whether they want documentation linking them with the research, and their wishes will govern; or
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
In the IRB Request for Review form, the PI must include the verbal script that is proposed for use with each participant in lieu of documentation of informed consent. When documentation is waived, the IRB may require that the PI provide the participants with a written copy of the consent form.