Informed Consent Process and Documentation

Informed Consent Process and Documentation Heading link

Version	Date Updated	Printable Version
2.3	August 28, 2020	0916

Informed Consent Process and Documentation Heading link

Description

Approved by: Human Protections Administrator and Director of OPRS
AAHRPP REF#: 199
AAHRPP Elements: II.3.F., II.3.G., III.1.F.

POLICY Heading link

POLICY

The UIC IRBs require investigators to obtain prospective informed consent from each research subject or their legally authorized representative before they are included in research, except where a waiver of informed consent is granted by the IRB.
The 2018 Common Rule (45 CFR 46) or “2018 Requirements” went into effect on January 21, 2019 and affected all research, including consent documents and processes, approved on and after this date with the exception of the agencies that have not harmonized with the Common Rule.
1. Research approved prior to January 21, 2019 will continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the “pre-2018 Requirements”) unless documented otherwise by the IRB on or after January 21, 2019.
2. The following federal entities have agreed to follow the 2018 Requirements:
  1. Department of Homeland Security;
  2. Department of Agriculture;
  3. Department of Energy;
  4. National Aeronautics and Space Administration;
  5. Department of Commerce;
  6. Consumer Product Safety Commission;
  7. Social Security Administration;
  8. Agency of International Development;
  9. Department of Housing and Urban Development;
  10. Department of Labor;
  11. Department of Defense;
  12. Department of Education;
  13. Department of Veterans Affairs;
  14. Environmental Protection Agency;
  15. Department of Health and Human Services;
  16. National Science Foundation; and
  17. Department of Transportation.
  1. If the research falls under the purview of multiple entities with one or more entities agreeing to follow the 2018 Requirements and one or more entities who do not agree to follow the 2018 Requirements (e.g., NIH funded research testing FDA regulated products), the research will be reviewed under the pre-2018 Requirements.
  1. The required elements as defined by the Federal Regulations and UIC policy and any additional elements that are deemed appropriate by the IRB are included, and
  2. The research is presented in a language and fashion understandable to the subject or their representative, including:
    1. Presenting key information at the beginning of the consent document, and
    2. Presenting information in sufficient detail that a reasonable person would want to know in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
    PROCEDURE
    1. Informed Consent: IRB Review of the Informed Consent Process.
      1. Submission. Investigators submit the proposed informed consent procedures and consent document(s) with their initial and continuing review applications for IRB review and approval. This documentation is also submitted with amendments when the proposed changes alter the informed consent document or process.
      2. IRB Documentation. The IRB documents their review and determinations involving the consent process in the meeting minutes or, when review occurs under expedited conditions, review guides.
      3. Consent Process. The IRB reviews the submission materials to ensure that:
        
        It identifies who will obtain informed consent and that consent is obtained by IRB-approved research personnel with human subjects protection training;
        
        Modes of communication and materials are appropriate to the targeted subject population, including use of the targeted subject population’s primary language and/or reading level;
        
        Individuals communicating information to the subject or LAR during the consent process will convey that information in language understandable to the subject or representative;
        
        Conditions under which consent is sought provide the potential subject or their representative sufficient opportunity to consider whether or not to participate and minimize possibility of coercion or undue influence;
        
        Informed consent does not include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence (examples of what does and does not represent exculpatory language can be found on the OHRP website).
        
        Federally funded research approved prior to January 21, 2019 will be transitioned to the 2018 Requirements. The consent document will be revised at the time of the next continuing review.
        
        Non-federally funded research approved prior to January 21, 2019 will transition to the 2018 Requirements; however, revisions of the consent document will not be required unless otherwise determined by the IRB.
        
        Regardless of funding, initial reviews approved on or after January 21, 2019 that require a consent form must utilize the most current version of the consent form.
        
        States that the study involves research;
        
        Explains the purposes of the research;
        
        States the expected duration of the subject’s participation;
        
        Describes the procedures to be followed and identifies any which are experimental;
        
        Describes reasonably foreseeable risks or discomforts to the subject;
        
        Describes any benefits to the subject or to others which may reasonably be expected from the research;
        
        Discloses appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
        
        Describes the extent, if any, to which confidentiality of records identifying the subject will be maintained;
        
        The consent must note the possibility that the representatives of the IRB and/or UIC OPRS; representatives of the State and University responsible for ethical, regulatory, or financial oversight of research; and Government Regulatory Agencies, such as the Office for Human Research Protections (OHRP) may have access to the consent form and research records; and
        
        The consent must also indicate anyone else who may have access to the records, including, as applicable, the sponsor and funding agencies.
        
        Explains 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;
        
        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
        
        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.
        
        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;
        
        Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
        
        Any additional costs to the subject that may result from participation in the research;
        
        Consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
        
        Statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject;
        
        Approximate number of subjects involved in the research;
        
        A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit [45 CFR 46.116(c)(7)];
        
        A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions [45 CFR 46.116(c)(8)]; and/or
        
        For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) [45 CFR 46.116(c)(9)].
        
        For research meeting the definition of a clinical trial, the consent must include a statement that the results of the research will be posted on clinicaltrials.gov [21 CFR 50.25(c) and 42 CFR 11].
        
        Contain the basic and, when appropriate, additional elements of consent in I.E. and F.;
        
        Contain a statement noting the possibility that the FDA may inspect the records;
        
        Per UIC requirements, inform subjects that a purpose of the study includes an evaluation of the safety of the test article. Statements that test articles are safe or statements that the safety has been established in other studies are not appropriate when the purpose of the study includes determination of safety;
        
        Inform subjects, for studies that also evaluate the effectiveness of the test article, of that purpose, but should not contain claims of effectiveness;
        
        If the research involves an investigational drug, device, biologic, or Humanitarian Use Device (HUD), states the regulatory status of the agent using explanations designed to be understood by the targeted subject population. For example, “the use of drug/biologic/device [insert name] in this study is considered investigational, meaning it has not been approved by the FDA for marketing in the US for the use being tested in this research”;
        
        For FDA regulated clinical trials, the informed consent document cannot give the subject the option of having their data removed from the study database when they withdraw from the study.
        
        If subjects who withdraw from the interventional portion of a clinical trial will be asked to allow continued follow-up of clinical outcome information, their informed consent for this limited participation must be obtained on an IRB-approved consent document.
        
        When subjects withdraw and do not consent to continued follow-up, the investigator must not access for purposes related to the study the subject’s medical record or other confidential records.
        
        The UIC informed consent templates provide investigators with standard formatting and language for sections (e.g., voluntary participation, other alternatives, new information, privacy and confidentiality, compensation for injury, answers to question) of the consent documents and supplemental documents, guidance, and/or policies.
        
        Any deviation from the standard formatting and informed consent template language may be approved at the discretion of the IRB.
        
        The consent document should be written in the second person (i.e., “You have been invited to participate…” or “Your participation in the research is voluntary”) to help convey the message that the subject is choosing to participate. The first person should be used only in the final section of the consent form, indicating the subject’s agreement to participate.
        
        The consent document for funded research should indicate the name of the sponsor or funding agency and that they are providing funds (or test article or other support) for the conduct of the research.
        
        Investigator discloses any conflicts of interest in the consent document following the COI disclosure agreement, Significant Financial Interest – Disclosure and Management Plan (SFI-DMP), worked out with the COI office. The IRB reviews and approves the disclosure language in the consent document.
        
        If a Certificate of Confidentiality has been granted or obtained, the consent states the terms and limitations provided by the Certificate (Refer to UIC HSPP document Guidance for Investigators: Certificates of Confidentiality).
        
        The consent document must inform the subject of their responsibilities during the study.
        
        The consent document must include the name, department and contact information for investigator.
        
        A waiver of consent by the IRB means the entire requirement for consent is waived, including the consent process and required disclosures. On the other hand, when an alteration of consent is granted, consent is still obtained but the process or elements of disclosure differ from what is normally required.
        
        IRB approval is required for any case where the consent process is waived or altered.
        
        When research involves public benefit and service programs conducted by or subject to the approval of state or local officials and involves a waiver or alteration of consent [45 CFR 46.116(e)]:
        
        The IRB may waive the requirement to obtain informed consent for research or may approve a consent procedure that omits some, or alters some or all, of the basic or additional elements of informed consent given that the IRB finds and documents that:
        
        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; and
        
        The research involves no more than minimal risk to the subjects;
        
        The research could not practicably be carried out without the 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;
        
        The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
        
        When appropriate, the subjects will be provided with additional pertinent information after participation.
        
        An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
        
        The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
        
        The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
        
        FDA-regulated minimal risk clinical investigations, when:
        
        The clinical investigation involves no more than minimal risk [as defined in 21 CFR 50.3(k) or 56.102(i)] to the subjects;
        
        The waiver or alteration will not adversely affect the rights and welfare of the subjects;
        
        The clinical investigation could not practicably be carried out without the waiver or alteration; and
        
        Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
        
        Investigations meet the criteria for exemption from the Investigational Device Exemptions regulation at 21 CFR 812.2(c)(3);
        
        The study uses leftover specimens (e.g., remnants of specimens collected for routine clinical care or analysis that would have been discarded), specimens obtained from specimen repositories, or leftover specimens that were previously collected for other research purposes;
        
        The specimens are not individually identifiable (i.e., the identity of the subject is not known to and may not readily be ascertained by the investigator or any other individuals associated with the investigation, including the sponsor);
        
        The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor;
        
        The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation; and
        
        The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information.
        
        IRB may document a waiver of the requirement for the investigator to obtain a signed consent form if it finds any of the following:
        
        That the only record linking the subject to the study is the signed informed consent and the principal risk is harm resulting from breach of confidentiality. Each subjects will be given the opportunity to say whether they want documentation linking them to the research and their wishes will govern;
        
        That the study presents no more than minimal risk of harm to subjects and involve no procedures for which written consent is normally required outside of the research context, or
        
        If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, that the study presents no more than minimal risk of harm to subjects and provided there is an appropriate mechanism for documenting that informed consent was obtained.
        
        The IRB may require that the subjects be provided a written summary (information sheet) of the research.
        
        The information sheet must include all required elements of consent unless an alteration of consent is granted by the IRB.
        
        The UIC IRB requires that the written consent form and/or information sheet approved and stamped with the approval date or approval period (whichever is applicable) by the IRB be utilized for the consent process. Informed consent is documented via the signature and date by the subject or their legally authorized representative and the research personnel obtaining consent, except when the IRB has approved a waiver for obtaining written informed consent or a waiver of documentation of informed consent.
        
        The investigator provides a copy of the informed consent document (whether paper or electronic) to the participant or the participant’s representative.
        
        When signatures (whether wet or electronic) are obtained, the investigator should keep the original signed informed consent document as part of the research file.
        
        When signatures are not obtained (i.e., verbal consent), the investigator should keep a log of when subjects are consented, if possible,
        
        When consent is obtained without signature or identifiers, the investigator should track the number of subjects enrolled.
        
        A written consent document (i.e., long form):
        
        that embodies the elements of informed consent required by 45 CFR 46.116 and/or 21 CFR 50.25;
        
        this form may be read to the subject or the subject’s legally authorized representative; and
        
        the investigator must give either the subject or the representative adequate opportunity to read it before it is signed.
        
        Refer to the UIC HSPP document, Guidance: Involvement of Non-English Speaking Subjects in Research for a description of the consent process when utilizing the short form.
        
        OPRS approved (but unstamped) short forms are available for utilization during enrollment of an unexpected potential subject who does not speak English. Available forms are posted on the OPRS website.
        
        Investigators who utilize short forms must follow the processes and procedures outlined on the Guidance document above, including reporting the use of the short form via a Protocol Exception form within 10 business days.
        
        Investigators who wish to utilize electronic consent (e-consent) for their research should ensure the following:
        
        all elements of informed consent are present unless an alteration of consent is granted;
        
        the consent should be easy to navigate with the ability to proceed forward and backward;
        
        if appropriate and as determined by the IRB, the consent should be available in paper format (including the printing of hyperlinks) for subjects who are unfamiliar or unable to utilize the e-consent.
        
        Electronic Signatures. The UIC IRB allows electronic signatures to document informed consent as long as the regulatory requirements under 21 CFR parts 11, 50, and 56 for FDA regulated studies and DHHS regulatory requirements under 45 CFR 46 are met.
        
        As per 21 CFR 11.100, UIC notified the FDA of its intention to accept electronic signatures as the legally binding equivalent of the traditional hand-written signatures of individuals whose identity the UIC has verified.
        
        The preferred method to obtain the electronic signature is Adobe Sign. If this is not possible, then other methods may be considered by the UIC IRB provided the PI submits documentation and assurance that the proposed method is 21 CFR 11 compliant.
        
        Investigators who wish to pursue the use of the COVID MyStudies app will need to contact the CDER Real-World Evidence Program at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov, reference their pre-IND or IND numbers (as applicable), and provide the IRB-approved informed consent document for uploading to the COVID MyStudies app.
        
        Once the investigator has received notice from the CDER Real-World Evidence Program that they can utilize the app for their trial, the investigator will need to submit an amendment to indicate the change in the consent process (including an indication that the IRB-approved version of the consent document will be uploaded to the app), and to provide the related documentation from CDER. If the informed consent requires revisions prior to uploading to the app, the investigator will be required to obtain IRB approval via an amendment prior to contacting CDER.
        
        Full information is available on the FDA COVID MyStudies Application (App) website (https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudies-application-app).
        
        a waiver of documentation of consent needs to be granted by the IRB;
        
        an introductory script/screen or virtual consent should be used to present the consent information to the participant;
        
        The script/screen or virtual consent should include language indicating that the subject agrees to participate in the research by completing the survey/data collection tool or the subject would have the ability to indicate consent by selecting a button to proceed with their participation.
        
        Investigators using the RedCap, Qualtrics, or other systems under the University license do need not provide specific information about the data security regarding long term storage.
        
        Investigators planning on using systems which are not licensed by the University should provide information about the electronic system, explain their plans for document retention, including data backup if applicable, and provide a copy of the executed Business Associate Agreement (BAA).
        
        Retain the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (i.e., are competent), and
        
        Are able to indicate approval or disapproval to study entry.
        
        The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.
        
        The IRB Chair, Vice Chair, or convened IRB may appoint an unbiased individual as a third party to observe the informed consent process on behalf of the IRB.
        
        The individual may monitor the process of informed consent conducted by the PI (or a member of the IRB-approved research staff delegated this role by the PI) with the prospective research participant or the participant’s legally authorized representative.
        
        The third party may collect data on the informed consent process by employing a variety of methods, including but not limited to, a physical presence (monitoring) during the consent process and/or employing written and verbal questionnaires to evaluate the effectiveness of the consent process.
        
        The IRB Chair, Vice Chair, or Convened IRB may appoint an unbiased ombudsman specializing in a vulnerable population to oversee the consent process, typically a scientist or an individual with expertise in the research area. This individual would observe the ongoing consent process and study conduct if the subject has become incapacitated during his or her research participation; or
        
        The IRB Chair, Vice Chair, or Convened IRB may also appoint an unbiased ombudsman to oversee that a subject who is particularly vulnerable receives equitable and ethical treatment throughout the course of the research study. This type of ombudsman should have experience with the vulnerable population at issue or may also be a group of people with an interest in the safety of human research subjects, generally with a particular research focus. This type of ombudsman is permitted to be an IRB member.
        
        For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site (http://ClinicalTrials.gov) that will be established as a repository for such informed consent forms.
        
        If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
        
        The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
        
        Informed consent is a continuous process. It starts with the initial presentation of a research activity to a prospective subject and continues until the subject ends their participation or the study closes. The Investigator must assure that an ongoing exchange of information between the research team and subjects (including persons giving consent or permission for others) are maintained throughout the course of the study.
        
        The investigator describes the informed consent process in the protocol and/or IRB application.
        
        The UIC IRB requires that the investigator or other study personnel who conduct the consent process present the information accurately and in a manner minimizing the possibility of coercion or undue influence.
        
        The consent process must allow prospective subjects sufficient time to consider whether to participate in the study, consult with others and have all their questions answered.
        
        The IRB may require investigators to develop a formal plan to assess and confirm that the subject understands the consent. This may include the use of a written tool, requiring a friend or family member to be present, requiring a waiting period or observation of the consent process by a representative of the IRB.
        
        Delegation of Responsibility for Obtaining Consent: If the Principal Investigator is delegating the responsibility for conducting the consent interview and obtaining informed consent to someone else on the research team, the PI must formally delegate this responsibility to this person or persons by naming them in the research records (i.e., delegation log). All individuals who are delegated to conduct the consent interview and obtain informed consent must have received the applicable UIC Investigator training and be up to date on UIC Investigator continuing education requirements to perform these functions..
        
        Providing Subjects with Notice of Additional Reporting Requirements. Investigators and the IRB should be aware of when the informed consent document must include a statement explaining that confidentiality might be breached due to Illinois reporting laws, including for positive HIV status, elder and child abuse, cancer, and certain infectious diseases. (Refer to UIC HSPP policy Ethical Standards and Legal Principles.)
        
        Any changes in the informed consent documents or processes after IRB approval must be submitted as an amendment to the IRB for review and approval prior to implementation, with the exception of the short form.

Informed Consent Process and Documentation

Informed Consent Process and Documentation Heading link

Informed Consent Process and Documentation Heading link

Description

POLICY Heading link

POLICY

PROCEDURE