Prior Version: 7.2007

Last Revised: 10.2015

Prior Version: 7.2007

Informed Consent

General Guidelines

Introduction

The CWRU IRB Informed Consent Policy is based upon the essential principles established in The Belmont Report: respect for persons, beneficence, and justice; and is in accordance with the Department of Health and Human Services (DHHS) (45 CFR 46.116). Informed consent (respect for persons) is one of the primary ethical requirements governing research that involves human subjects. The concepts of informed decision-making and that of voluntary participation are essential elements of the informed consent process. To ensure an effective informed consent process, the consent form should express the realistic expectations of participation in the research study, avoiding inducement by raising false hopes.

Individuals must be given all of the relevant information about the research, in order to decide whether they wish to participate or continue to participate, in a research study. The informed consent process should also include opportunities to allow potential participants to ask questions and to exchange information freely with the study staff. Moreover, investigators have an ethical and contractual responsibility to keep research participants fully informed of any new information that may affect their willingness to continue to participate. The consent document should therefore be the basis for a meaningful exchange between the investigator and the potential research participant.

Definitions

Adult is a person who has attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. The specific treatments or procedures involved in the research and the jurisdiction in which the research will be conducted may determine who is considered an adult.

Assent means a child’s affirmative agreement to participate in research. Failure of a child to object to participation cannot be construed as assent. Assent is a process involving communication with the child. A signature on an assent document, a physical gesture of affirmation, or a verbal assent are not, in and of themselves, assent.

Child is a person, who has not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. For example, in most American states, a child is someone age 17 and younger; however, in Taiwan, a child is someone age 19 and younger.

Guardian is an individual, who is legally authorized under applicable state or local law, to consent on behalf of a child to general medical care. Foster parents cannot provide parental permission for their foster children to engage in research, only emergency medical care.

Incapacity means to lack the ability to make health care decisions or the ability to understand the benefits and risks of the proposed health care/research, or to understand possible alternatives, and to make and communicate a decision.

Informed Consent is an individual’s voluntary agreement, based upon adequate knowledge and understanding of the relevant information, to participate in research either for themselves or for a child for whom they are the parent or guardian.

Legally Authorized Representative or LAR means an individual, judicial or other entity authorized under applicable law to consent on behalf of a prospective participant to the participant’s participation in the procedure(s) involved in the research. The term legally authorized representative may include a person properly appointed by an advanced directive (such as a living will or declaration) or a durable power of attorney for health care, certain court appointed guardians, and next of kin. Documentation of a person’s status as a legally authorized representative for a research participant is required and must be carefully evaluated to determine the validity of the appointment and scope, if any, of authority granted to make decisions regarding procedures involved in the research. For example, the existence of a durable power of attorney for health care or advanced directive for health care may not create a legally authorized representative for any or certain kinds of research decisions. The University’s General Counsel’s Office shall be consulted by the IRB and investigator if there are any questions related to legally authorized representative’s consent.

Deception Research is a study in which participants are intentionally misinformed or information is purposely withheld, as part of the research design, and therefore not all elements of informedcan be provided. All required elements, except those that would expose the deception (that are purposely withheld), need to be included in the original informed consent document. All deception studies must include a clear and detailed debriefing process and a request to altered informed consent.

Policy

It is the policy of the IRB to assure that for research involving human subjects, provisions are made to obtain legally authorized informed consent from each prospective participant or legally authorized representative. However, the IRB may grant a waiver of informed consent if conditions presented are in accordance with the requirements for a waiver or alteration of informed consent. Any such waiver or alteration must be consistent with applicable Federal and Ohio state laws and regulations.

The IRB also requires that documentation of informed consent be obtained from all participants unless alternate procedures are approved by the IRB. The IRB will review all informed consent documents to assure the adequacy of the information contained in the consent document and adherence to federal regulations regarding the required elements of informed consent.

All approved informed consent forms will be stamped via iRIS. Stamps include the protocol number, IRB approval date, and the IRB expiration date. All pages will be stamped. The IRB requires that the most recently approved and non-expired consent documents be used when obtaining consent from participants.

The CWRU IRB standard research consent language must also be included at the end of the consent unless waived (45 CFR 46.116(d)) or altered by the IRB. The standard consent template is available at the CWRU IRB website.

General Consent Requirements

The IRB requires that all informed consent documents include the eight basic elements of informed consent listed below (45 CFR 46.116(a)). The IRB may also require any or all of the six additional elements of informed consent (45 CFR 46.116(b)), depending on the nature of the research.

There may not be discrepancies within the informed consent documents, the IRBapplication, the sponsor’s or investigator’s protocol, the investigator’s brochure, the grant and/or the contract regarding the purpose, risks, and benefits of the research. The IRB Manager or designated IRB staff will work with the Investigator to ensure the informed consent document is consistent with the grant and/or contract. The Informed Consent document must be in a language understandable to the participant or the participant’s legally authorized representative (45 CFR 46.116). The IRB recommends that readability should not exceed eighth grade reading levels.

Verbal or telephone consent is not acceptable unless the IRB has specifically waived the requirement for a written consent (45 CFR 46.11(c)). Consent must be obtained before initiation of any study procedures unless delayed consent is approved by the Board through a waiver of consent. The investigator must provide a detailed description of the intended method for obtaining informed consent in the protocol. All informed consent documents (full written documents, oral scripts, assent forms, short form, etc.) must be submitted for review and approval by the IRB prior to use. Any changes in the informed consent documents – post-IRB-Approval – must be submitted as an amendment to the IRB for review and approval prior to use.

Eight Basic Elements of Informed Consent

1)Research Statements –The research statements must include the following:

a)A statement that the study involves research;

b)An explanation of the purposes of the research;

c)An explanation of the expected duration of the participant’s participation;

d)A description of the procedures involved; and

e)Identification of any procedures that are experimental.

It is important to explicitly state that the individual is being asked to participate in a research study so as to clearly differentiate the relationship between subject and researcher from student and teacher (for example); and (ii) informed consent for participation in a program or non-research activity from the informed consent for research.

2)Risks and Discomforts

A description of any foreseeable risks and discomforts.

3)Benefits

A description of any benefits to the participant or others that may reasonably be expected from the research. Payment for participation is not considered to be a benefit. If the participants are remunerated for participation, the details must be included separately from benefits. Remuneration includes both reimbursement for expenses and incentives for time and discomfort. Most Social Behavioral studies do not include direct benefits. It is required to state that there are no direct benefits, if applicable. If uncertain, contact the IRB office.

4)Alternatives

A disclosure of appropriate alternative procedures or courses of treatment, if any, including those that might be advantageous to the participant. It is appropriate to state that an alternative is to not participate in the study.

5)Confidentiality

A statement describing the extent, if any, to which confidentiality of the records identifying the participants will be maintained. Specific language can be found in the consent template.

6)Compensation and Research-Related Injury

Research involving more than minimal risk must include an explanation as to whether any compensation and an explanation as to whether medical treatments are available if injury occur and, if so, what they consist of, or where further information may be obtained.

Included in the standard language required by the CWRU IRB is the obligation of the investigator to direct a research participant experiencing physical injury or illness as a result of participating in a study to appropriate medical care.

If compensation for injury is available from the study sponsor or funding agency, this should be explained in the body of the consent form. This must be consistent with any contracts that might exist.

7)Contact Person

An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to participants.

8)Voluntary Participation and Right to Withdraw

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 theparticipant is otherwise entitled. If applicable, student subject populations must be told that their grades or class standing would not be adversely affected. If applicable, employees must be told that their supervisors may be aware of their participation during work hours but would never learn of their responses.

Six Additional Elements of Informed Consent

When applicable, the additional elements of informed consent must be included in the consent document. Below is a description of each of the elements, as well as guidance to when they are required. The main determination is whether the additional information will have an impact on a participant’s willingness to voluntarily participate in the research; and whether the information is meaningful and protects their rights and welfare. Please contact the IRB Office for guidance.

1)Unknown Risks

A statement that the particular treatment or procedure may involve risks which are currently unforeseeable to the participant (This is required if the research involves any procedures that are not well known).

2)Termination of Participation

Investigators must describe any anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent. This is usually only done when the safety and welfare of the participant is in question. (This is required if there are any anticipated circumstances under which a participant’s participation may be terminated without the participant’s specific concurrence).

3)Costs

Any additional costs to the participants that may result from participation in the research. This is only required if there are any anticipated additional costs directly related to the research. This should be consistent with any grants or contracts that might exist.

4)Consequences of Withdrawal

The consequences of a participant’s decision to withdraw from the research must be described by the investigator if there are any potential adverse consequences for a participant; and the specific procedures for orderly termination of participation by the participant (which must also be described in the protocol).

5)New findings will be given to Participants

If applicable, a statement that significant new findings developed during the course of the research which may relate to the participants willingness to continue participation will be provided to the participant.

6)Number of Participants

The approximate number of participants to be involved in the study. If the study is amulti-center study, indicate how many sites are involved, how many participants will be included overall and how many will be included at this site.

Additional Consent Requirements

1)No Exculpatory Language

No informed consent, whether written or oral, may contain any exculpatory language through which the participant or their legal authorized representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

CWRU IRB Consent Requirements

1)Standard Research Consent Language

It is the requirement of the IRB that the Standard Research Consent Language be included in all written consent forms unless specifically waived by the IRB.

2)Authorization to Use and Disclose Protected Health Information (PHI) for Research Purposes

All research studies enrolling patients or collecting protected health information (PHI) must abide by the Health Insurance Portability & Accountability Act (HIPAA) enacted April 14, 2003. This regulation, also known as the “Privacy Rule”, establishes conditions under which researchers may have access to and use an individual’s PHI to for research purposes. Clinical HIPAA Authorization DOES NOT cover use or disclosure of PHI for research purposes. Permission must be obtained via signed Authorization for use and disclosure of PHI for research purposes. The IRB requests that the language relating to HIPAA and authorization for use and disclosure is included in the consent document. Please reference the HIPAA Authorization template for the approved language.

3)Signature Section

The signature section of the Standard Research Consent Language has signature blocks for the following study categories: adults able to provide informed consent; adults with decisional impairment; minors where the IRB has determined that the permission of one parent is sufficient; and children where the IRB has determined that the permission of one parent is not sufficient unless the other parent is deceased; unknown; incompetent; not reasonably available; or one parent as legal responsibility for the case and custody of the child. The person obtaining consent must both sign and print his or her name. If the principal investigator does not obtain consent, he or she must confirm the eligibility of the participant and verify that consent was obtained by signing and dating the consent form within one month of when consent was obtained.

4)No Omission of Required Elements unless Waiver Approved

The investigator must indicate in the protocol application the type of consent used withthe study including whether a waiver of consent is being requested, and the assent plan for children (if applicable). Required elements of informed consent may not be omitted unless waived by the IRB. Requests for waivers need to be justified in the protocol.

5)Use of First or Second Person Language

The language of the consent document should be consistent throughout with the use of either the first person pronoun (i.e., “I, me, my”); or second person pronoun (i.e., “you, your”). The IRB strongly encourages the use of second person; however, first person consent forms are allowed.

6)Language Level

Informed consent documents must be written in language that is at the appropriate reading and comprehension level for the targeted population. The target language level for consent forms must read at no greater than an 8th grade reading level. Further, the language has to be age-appropriate and understandable. The IRB encourages investigators to use the IRB Consent template when developing consent documents.

7)No Complex Technical Language/Jargon

All consent and study documents must be in lay language and should not includecomplex language that would not be understandable to all participants. Technical and scientific terms should be adequately and clearly explained using common or lay terminology. The IRB prefers the use of only the lay term. For example, “tooth decay” or “cavities” instead of “caries”; “germs” instead of “bacteria”; “heart attack” instead of “myocardial infarction.”

Generic names are preferable when describing certain items unless the brand name is more commonly known and understood. Regardless of which name is preferred, it should be used consistently throughout the informed consent documents. Devices and procedures should also be described consistently throughout the documents and explained in simple language. The IRB would allow the use of technical jargon depending on the study population. An example would be using medical terminology for a study population consisting of medical/dental students or professionals.

8)Waiver or Alteration of Informed Consent Requirements

The IRB may approve a consent procedure that eliminates or alters the required elements of informed consent, or to waive the requirement to obtain informed consent altogether. An Alteration or Waiver of Informed Consent is defined as a variation from the traditional informed consent process. However, this process still includes a considerate and thorough discussion of the study with the participant and verification that the participant understands the study and will participate voluntarily.

The IRB may alter or waive the requirement for informed consent of participants. In order to approve such a waiver or alteration, the IRB must find and document all of the following: