The application for Institutional Review Board (IRB) approval has been submitted and is still under review.
As part of the process, I have fielded questions and made adjustments to portions of the application as necessary. For the most part, this has consisted of changes to the Informed Consent Form.
Informed Consent is an important aspect of a research project as it helps human subjects understand the study they are participating in. In fact, obtaining Informed Consent is federally regulated by the U.S. Department of Health and Human Services.
In Part 46 of the HHS 2018 Common Rule, the parameters of Informed Consent are outlined and include, in part, the following:
- “Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.”
- “The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.”
- “The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.”
- “No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”
To accomplish this, the Informed Consent form must include, in part, the following:
- “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 that 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 that may reasonably be expected from the research;”
- “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.”
Specific to my Informed Consent Form, I hadn’t written it in language that was simple enough. I had to make it easier to read and understand as a way to provide clarity.
I made those changes and resubmitted. Now I wait for the official word about whether or not the alternations were enough to achieve approval so I can start collecting data.