SOP 012: Informed Consent Requirements

1. Purpose

This SOP describes the informed consent process, the required and additional elements of informed consent, waiver/alteration criteria, and regulatory and legal requirements required in obtaining informed consent from participants.

2. Overview

Investigators are required to obtain informed consent as a legal and ethical obligation. Informed consent is an essential part of ethical human subjects research. IRBs and investigators are responsible for ensuring that researchers provide informed consent to participants before research participation unless the requirement for informed consent is waived or altered by the IRB.

Please note: IRB-approved consent forms must be used when recruiting human subjects for research under the auspices of WVU. Upon review and approval, the electronic system will watermark each page of the PDF file uploaded as the consent documents. The watermark will contain the approval date and the expiration date, along with the protocol number.

3. General Information

3.1. The requirement to obtain the informed consent of individuals before involving them in research is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. Respect for persons requires that individuals are treated as autonomous agents, the rights and welfare of persons with diminished autonomy are appropriately protected, and potential research participants are “given the opportunity to choose what shall or shall not happen to them” (Belmont Report).

3.2. The consent process involves more than a consent form. Informed consent has been described as an “interactive process that involves the researcher informing potential participants of the purposes and procedures of the research, the risks and benefits associated with the research, and how the data provided by the participant will be protected and stored” (AAA Statement on Ethnography and Institutional Review Boards). This discussion must be culturally and linguistically appropriate for the population under study.

3.3. In addition to the language and content of the consent process, the nature and circumstances of the process are also important aspects of informed consent. Circumstances such as, who will conduct the consent discussion, who will provide consent, and the timing of obtaining consent (including any waiting period between informing the participant and obtaining consent), are critical to facilitating the participant’s understanding of what has been disclosed and promoting the voluntariness of the participant’s decision about whether or not to participate in the research.

3.4. Informed consent is an ongoing process. Even in the absence of new information or changes to research procedures, periodic review or confirmation of a participant’s consent is often desirable (e.g., in studies that take place over a long period, particularly complex studies, or longitudinal studies involving progressive disorders or aging populations). Participants must be able to freely decide whether to withdraw or to continue participating in the research at all times.

3.5. Projects involving deception or incomplete disclosure of material aspects of the research must meet the criteria for a waiver or alteration of informed consent. When appropriate, participants should be given additional pertinent information (debriefed) after participating in the research. Debriefing procedures and materials must be submitted to the IRB. If investigators believe a debriefing is not an appropriate procedure for the proposed study or that debriefing could cause participants more harm than the deception/incomplete disclosure itself, appropriate justification must be provided to the IRB. The IRB will make the final determination about whether debriefing is necessary and whether the proposed process is sufficient.

4. Consent Process Requirements

The consent process must have all of the following attributes to comply with federal regulations for informed consent:

4.1. The circumstances of the consent process will provide the participant or legally authorized representative sufficient opportunity to consider whether to participate.

4.2. The circumstances of the consent process will minimize the possibility of coercion or undue influence.

4.3. The information provided during the consent process will be presented in language understandable to the participant or the participant’s legally authorized representative.The consent discussion should not include complex, technical, or highly specialized language or medical jargon that would not be understandable to potential participants.

4.4. The information communicated during the consent process is free of exculpatory language through which the participant or legally authorized representative is made to waive or appear to waive any of the participant’s legal rights or to release (or appear torelease) the investigator, sponsor, or the university (or its agents) from liability for negligence.

5. Informed Consent Components

5.1 Concise Summary

Lengthy and/or complex consent documents must begin with a concise and focused summary of the key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research and to encourage discussion about the pros and cons of research participation. The following items may be addressed in this summary:

• Purpose of the research;
• Expected duration of the research:
• Research procedures to be followed;
• The most critical risks or discomforts (i.e., highest frequency or greatest severity);
• Reasonably expected benefits;
• Appropriate alternative procedures or courses of treatment;

Other additional information may be needed based on the study design and the intended participant population. Information listed in the concise summary need not be repeated later in the consent form unless that information is necessary to help ensure the consent remains understandable to the participant.

5.2 Required Elements

The information provided during the consent process must be consistent with the federal requirements. Unless informed consent is waived or altered by the IRB (see “Waiver or Alteration of Informed Consent” below), the consent process must include the following basic elements:

• A statement that the study involves research, explanation of the purposes of the research, expected duration of participation, description of the procedures to be followed, and identification of any experimental procedures;
• A description of any reasonably foreseeable risks or discomforts to the participant;
• A description of any benefits to the participant or to others that may reasonably be expected from the research;
• 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;
• Explanation of whom to contact for answers to pertinent questions about the research and the participant’s rights and whom to contact in the event of a research-related injury to the participant; and
• 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 that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
• One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
• 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 participant or the legally authorized representative, if this might be a possibility; or
• A statement that the participant’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.
• For research involving greater than minimal risk, an explanation about whether:
• Medical treatments are available if injury occurs and, if so, what they will consist of or where future information can be obtained;
• Compensation is available if injury occurs and, if so, an explanation as to what it consists of or where further information can be obtained
• For research regulated by FDA:
• A statement that informs the participant of the possibility that FDA may inspect the records;
• For applicable clinical trials, the following statement notifying the participant that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by the U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”

5.3 Additional Elements

One or more of the following elements will also be provided to potential participants during the consent process, when appropriate:

• A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable;
• Anticipated circumstances under which the investigator may terminate participation without regard to the participant’s consent;vbbvv
• Any additional costs to the participant that may result from participation in the research;
• Consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant;
• A statement that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue participation will be provided;
• The approximate number of participants involved in the study;
• A statement that participants biospecimens (even if identifiers are removed) may be used for commercial profit and whether or not the participant will share in this commercial profit;
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions;
• Whether the research will (if known) or might include whole genome sequencing for research involving bio-specimens.

Please note: Additional information beyond the basic and additional elements of consent (above) may also be required when the IRB determines that this information would meaningfully add to the protection of research participants.

6. Special Considerations in Informed Consent

The circumstances of the consent process must provide potential participants or their legally authorized representatives sufficient opportunity to consider whether to participate and minimize the possibility of coercion or undue influence. Additional safeguards are required to provide the rights and welfare of participants when some or all of the participants are likely to be vulnerable to coercion or undue influence (e.g., prisoners, children, students, employees, educationally or economically disadvantaged individuals, or individuals with impaired decision-making capacity). Additional requirements for obtaining informed consent (or assent) in specific populations are described in the following WVU OHRP policies:

• Pregnant women, fetuses, or neonates (SOP 048: Research Involving Pregnant Women, Neonates, and Fetuses)
• Prisoners (SOP 047: Research Involving Prisoners)
• Students or Employees (SOP 013: Vulnerable Populations)
• Adults with impaired decision-making capacity (SOP 013: Vulnerable Populations)
• Economically or educationally disadvantaged individuals (SOP 013: Vulnerable Populations)
• Non-English-speaking individuals (See “Short Form Written Consent Document below”)

7. Observations of the Consent Process

According to the federal regulations, the IRB has the authority to observe or have a third party observe the consent process. Observation of the consent process can provide additional protections to research participants (e.g., in studies involving adults with impaired decision-making capacity or studies with complex interventions). Observation can be performed by members of the IRB, WVU OHRP staff, or other individuals designated by the IRB, investigator(s), or sponsor.

8. Waiver or Alteration of Informed Consent

In the limited circumstances described below, the IRBs can approve a consent process that does not include, or alters some or all of the elements of informed consent.

8.1 Research on Public Benefit or Service Programs

The IRB can waive or alter the requirements for informed consent for non-exempt research examining state or local public benefit or service programs or certain features of those programs if all of the following criteria are met:

• The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs;
• The research could not practicably be carried out without the waiver or alteration; and
• The research is not FDA-regulated.

8.2 Minimal Risk Research

The WVU IRB can waive or alter the requirements for informed consent for non-exempt research that meets all of the following criteria:

• The research involves no more than minimal risk to participants;
• The waiver or alteration will not adversely affect the rights and welfare of participants;
• The research could not practicably be carried out without the requested waiver or alteration;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
• Whenever appropriate, participants or legally authorized representatives will be provided with additional pertinent information after participation.

8.3. Research Designed to Study Conditions in Children
The IRB can waive or alter the parental or guardian permission requirements for certain non-exempt research involving children. For more information, please see SOP 015: Assent and Parental Permission.

8.4. Planned Emergency Research
The IRB can approve a waiver of the requirements for informed consent for non-exempt research in life-threatening situations when it is not possible to obtain informed consent from participants or their legally authorized representatives. For more information, see SOP 054: Planned Emergency Research.

8.5. Emergency Use of Investigational
For more information about exceptions to the requirements for informed consent in “emergency use” (life-threatening) situations in which it is not possible to obtain informed consent from patients before using an investigational drug, biologic, or device when no other standard acceptable treatment is available, please see SOP 053: Emergency Use of Investigational Drugs, Biologics, or Devices.

9. Use of Short Form Written Consent Document

Federal regulations require that the informed consent process is conducted in “language understandable” to research participants, and, with certain exceptions, that informed consent is documented in writing by the use of a written consent form approved by the IRB and signed and dated by the individual or individual’s legally authorized representative. In limited situations, the regulations permit the informed consent process to be conducted orally, with a written “short form” consent document. This process may be used to obtain the informed consent of non-English speaking participants or their legally authorized representatives, as described below.

The short form consent document may be used only in the following circumstances:

• The participant or legally authorized representative does not speak/understand English;
• The participant or legally authorized representative speaks only a language(s) that was not anticipated in the study population or location (i.e., unexpectedly encountered);
• The IRB has not approved an appropriately translated consent form in the participant’s language; and
• There is not adequate time for preparation and IRB review and approval of a translated consent form.

When the study population or location includes people who speak a language other than English, or where the circumstances of participant enrollment provide sufficient time for preparation and IRB review and approval of translated documents, the short form should not be used.

9.1 Short Formed Procedures

• The PI may request to use a short form written consent document stating that study personnel have presented the elements of informed consent (as required by 45 CFR 46.116) orally to the participant or their legally authorized representative.
• The IRB reviews the request and may approve the short form option for documentation only if the study meets all of the requirements outlined above and in 45 CFR 46.117(b), and as applicable, in 21 CFR 50.27(b).
• When the IRB approves use of the short form written consent:
• The PI ensures there is a witness to the oral presentation. For participants who do not speak English, the PI ensures the witness is conversant in both English and the participant's language
• The IRB approves a written summary of the oral consent presented to the participant or the participant’s legally authorized representative, which embodies the basic and appropriate elements of disclosure;
• The participant or participant’s legally authorized representative signs the short form. For FDA-regulated research, the participant or the participant’s legally authorized representative signs and dates the short form;
• The witness signs both the short form and a copy of the summary;
• The person obtaining consent signs a copy of the summary; and
• The person obtaining consent gives a copy of the summary to the participant or the participant’s legally authorized representative, in addition to a copy of the short form.

10. Exception to Informed Consent Requirement

Information or biospecimens can be obtained for screening, recruiting, or determining eligibility of prospective participants without informed consent (and without the need for the IRB to waive informed consent) if eitherof the following conditions is met:

• The investigator will obtain information through oral or written communication with the prospective participant or legally authorized representative; or
• The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored (existing) identifiable biospecimens.

11. Posting of Clinical Trial Consent Forms

For clinical trials conducted or supported by a federal department or agency, the Final Rule (Revised Common Rule) requires that a copy of an unsigned, IRB-approved consent form be posted on a publicly available federal website (ClinicalTrials.gov). The funding awardee or federal department/agency is responsible for posting the form after recruitment is complete but no later than 60 days after the last participant visit. Proprietary or institutionally sensitive information may be redacted; only one consent form per research project must be posted regardless of the number of participant groups or research project sites.

12. References

WVU Policies:
SOP 013: Vulnerable Populations
SOP 014: Research Involving Children
SOP 015: Assent and Parental Permission
SOP 047: Research Involving Prisoners
SOP 048: Research Involving Pregnant Women, Neonates, and Fetuses
SOP 053: Emergency Use of Investigational Drugs, Biologics, or Devices
SOP 054: Planned Emergency Research
SOP 055: Electronic Informed Consent

Federal Regulations:
21 CFR 50.20
21 CFR 50.25
21 CFR 56.109
21 CFR 56.111
45 CFR 46.111
45 CFR 46.116

AAHRRP:
Element II.3.F.