Welcome to the start of our Informed consent article series! Solutions IRB is excited to bring you weekly articles covering the different types of consent, informed consent, waiver of consent documentation, waiver or consent, alteration of consent and broad consent. For this initial article we are going to go over the basic elements of informed consent described in the CFRs as well as elements that Solutions IRB look for.

CFR Informed Consent Elements

1. 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;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. 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;
7. 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;
8. 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; and
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
   1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
   2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Things Solutions IRB requires/looks for.

1. Two forms of contact for the PI/research team
2. A statement similar to the following. “If you have questions about your rights as a research subject, you may contact Solutions IRB at (855) 226-4472 or participants@solutionsirb.com.”
3. Solutions IRB’s contact information listed after the PI’s
4. A consenting statement at the end of the consent form, such as “by clicking continue you give your consent to participate” or “By signing you consent to participate”
5. If audio recorded during the interview, and a statement that they can or cannot participate if they do not agree to be audio recorded.
6. If a study will have audio or video recordings, a check box to agree to be audio recorded during the interview, and a statement that they can or cannot participate if they do not agree to be audio recorded.
7. Clear withdrawal instructions, e.g, how, who to contact, what happens to their data if they withdraw.
8. If applicable, how will participants receive payment, e.g. electronic email, or by mail?
9. If applicable, in what form will compensation be received, e.g. cash, or by gift card?
10. If applicable, When will potential participants receive compensation?
11. If applicable disclosure of any conflicts of interest
12. Consent forms must be paginated
13. Must be at an appropriate reading level for the population, general population is an 8^th grade reading level.

We are excited to bring this series to you! If you have any questions please reach out to us at reviews@solutionsirb.com or 855-226-4472.

Author: Cora Crawford

It is the responsibility of IRB members to thoroughly review a research plan and decide whether to approve a protocol. When reviewing research Solutions IRB’s guidelines address three ethical principles that are fundamental to human subject protection, these being: respect for persons (respect for the right of self-government), beneficence (do no harm, maximize benefits, and minimize harms), justice (equal distribution of research burdens and benefits).

An IRB assures that adequate safeguards are incorporated into research design such as: frequent monitoring, the presence of trained personnel who can respond to emergencies, or coding of data to protect confidentiality are examples. For a study to be deemed minimal risk, the probability and magnitude of harm or discomfort in that study must be no greater than those ordinarily encountered in daily life.

Any study may contain diverse types of risk, such as: physical risks, psychological risks, social/economic risks, loss of confidentiality, and legal risks. Researchers are expected to take steps to minimize any potential risks. These include:

• Using procedures that are consistent with sound research design
• Not exposing subjects to unnecessary risk
• Using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Prescreening to identify and eliminate high-risk participants,
• Providing participants with as much information as possible during informed consent and debriefing.

Researchers must be sure that any risks involved in the research are reasonable in relation to the protocols anticipated benefits.

Authors: Ayn O’Reilly and Bridgette Moralez