SEKESC-IRB Informed Consent
Informed consent is the process by which potential participants are provided important information about the research study. Human subjects can only be involved in your study if they voluntarily agree to participate after having been adequately informed about the research. If the human subjects in your study are part of a vulnerable population (children, students, prisoners), special protections may be required. See also the Informed Consent Checklist.
Consent documents must be clearly written and understandable to subjects. The language must be non-technical (comparable to the language in a newspaper or general circulation magazine). Scientific, technical, and medical terms must be plainly defined. The reading level of the consent document should be appropriate to your targeted subject population. The same recommendation applies to the assent forms for minors and study recruitment materials. Informed consent may not include language that appears to waive subjects’ legal rights or appears to release the investigator or anyone else involved in the study from liability or negligence.
This information and recommendation when filling out forms is directly taken from the Code of Federal Regulations, Department of Health and Human Services for the Protection of Human Subjects §46.116.
Who, What, Why
- Specify who is conducting the research and their affiliation with SEKESC.
- Include a statement that the study involves research.
- Explain the purpose(s) of the research.
- Describe the procedures to be followed and the duration of participation.
- Identify whether any procedures are experimental
- When appropriate, describe any additional costs to the subject that may result from participation in the research.
- When appropriate, state the approximate number of subjects involved in the study.
- Include a statement that participation is voluntary
- Include a statement indicating that the subject may refuse to participate or may discontinue participation at any time during the project without penalty or loss of benefits to which the subject is otherwise entitled.
- Describe any compensation the participant will receive and, if appropriate, procedures to prorate compensation for those who withdraw prior to completion of the study.
- When appropriate, include a statement that “the decision to participate, decline, or withdraw from participation will have no effect on the subject’s grades at, status at, or future relations with SEKESC.”
- When appropriate, state any anticipated circumstances under which the subject’s participation may be terminated by the research without regard to the subject’s consent.
- When appropriate, state the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
Risks & Benefits
- Include a description of any reasonably foreseeable risks or discomforts.
- Include a description of possible benefits to the subject or to others, which may reasonably be expected from the research.
- If research involves treatment, disclose any appropriate alternative procedures or courses of treatment that might be advantageous.
- When appropriate, a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
- When appropriate, a statement that significant new findings developed during the course of the research which may related to the subject’s willingness to continue participation will be provided to the subject.
- When applicable include the statement “SEKESC does not provide medical or hospitalization insurance coverage for participants in this research study nor will the SEKESC provide compensation for any injury sustained as a result of participation in this research study, except as required by law.”
- Describe the extent, if any, to which confidentiality of records will be maintained. If you cannot assure privacy or confidentiality, state that explicitly.
- State how results will be disseminated.
- The name(s), title(s), and contact information (phone and email) of the person(s) to contact for answers to questions about the research and the name, title, and contact information of the responsible principal investigator, if different.
- Add the following SEKESC-IRB contact statement, “If you have any questions about your rights as a participant in this study or any concerns or complaints (including a research related injury), please contact the IRB Chair at 620-724-6281 or via email at IRB greenbush.org”
- The name, title, and telephone number of the person to contact in the event of a research-related injury or to voice a concern or complaint.
Near the Signature Line
- State that the subject will be given a copy of the consent form or may print a copy if consent is online
- Include a statement such as “I have read and understand the above consent form and voluntarily agree to participate in this study.”
- When appropriate, include a statement that “I am 18 years of age or older.”
- An area to mark “yes” or “no” to being audiotaped, videotaped, or photographed (if such recording is optional and has not already been specified as a requirement for participation).
Retention of Informed Consent Documents
- Documentation of informed consent of subjects must be retained for at least three years after the research is completed.
- During those three years, records must be accessible for inspection and copying by authorized representatives of the SEKESC-IRB Board, should the need arise.
- Once the three year period has passed, informed consent records should be sufficiently destroyed, such as by shredding. Recycling or throwing away the documents does not meet the SEKESC’s standard of “sufficiently destroyed.”
- If the IRB waived the requirement for informed consent or the requirement for documentation of informed consent, the above requirements do not apply.