Informed Consent Process and Documentation- PRO113   

Definitions
 

In this procedure, the term research includes clinical investigation. The terms subject and participant are used interchangeably.

In this procedure, the term legally authorized representative (LAR) includes parents and guardians as well as legally authorized representatives and is used to represent both singular and plural usage as appropriate to the context.

procedure
 

Investigator Responsibilities

• Completes the appropriate sections of the FOR200 Human Subjects Protocol (HSP) for initial review, the FOR225 Investigator's Progress Report (IPR) for continuing review, or the FOR224 Project Revision/Amendment Form for review of modifications to research, if applicable, describing:
  • The timing of obtaining informed consent and any waiting period between informing the participant and obtaining consent (Adequate time should be provided for the potential participant to read the informed consent document, ask questions, and consider the risks and benefits prior to signing.);
  • Persons proposed to obtain informed consent;
  • Steps in informed consent process;
  • Any information to be disclosed to participants to meet the requirements for informed consent process that is not exhibited in the proposed informed consent documents. The informed consent process requirements, independent of use of written consent documents, include:
    • Obtaining legally effective informed consent from the participant or legally authorized representative (LAR)
    • Circumstances that provide the participant or LAR sufficient opportunity to decide whether or not to participate
    • Circumstances that minimize the possibility of coercion or undue influence
    • For research conducted within the Bureau of Prisons (BOP), additional elements of disclosure must be included (see GUI341)
    • Information given to the participant or LAR be in a language understandable to the participant
    • No use of exculpatory language through which the participant waives or appears to waive or release a participant’s legal rights
    • Specified elements of informed consent process (see GUI304 Statement on Elements and Disclosures for Informed Consent Process);
  • Additional safeguards added to the informed consent process to protect special populations from undue influence and coercion, if applicable (see, as appropriate, POL032 policy on, PRO132 procedure for pregnant women and fetuses; POL033 policy on, PRO133 procedure for prisoners GUI341; POL008 policy on, PRO108 procedure for children; PRO125 procedure for decisionally impaired adults; POL039 policy on, PRO139 procedure for subject selection and recruitment); and
  • Other measures, if any, to minimize undue influence and coercion in the informed consent process.
• Requests a waiver or alteration of informed consent requirements, including documentation, when appropriate (see POL036 policy on, PRO153 procedure for waiver or alteration of informed consent process, including documentation).
• Identifies and requests exceptions to informed consent process, as appropriate, for clinical investigation subject to FDA regulation (see, as applicable, POL021 policy on, PRO151 procedure for emergency use of test articles; POL019 policy on, PRO119 procedure for exception from/waiver to informed consent process in research planned for emergency settings; GUI339 Guidance for Department of Defense (DoD) Component Sponsored Research Being Conducted by UAB).
• Submits informed consent documents with the IRB Application eForm (includes any applicable oral scripts, short forms and written summaries, and assent forms), with HIPAA authorization if applicable (or combined informed consent/HIPAA authorization form), in IRB-recommended format (see FOR206 Sample Consent Form with HIPAA Authorization, Sample Consent Form without HIPAA, FOR207 Sample Assent Form, Boilerplate Consent Form Language, FOR223 Sample Short Form Written Consent Document), which includes the following requirements for informed consent process unless a waiver or exception of informed consent process requested:
  • Written in language at the appropriate reading and comprehension level for the targeted population (eighth-grade reading level is recommended for adult consent documents). For non-English-language informed consent documents, see Additional Responsibilities for Informed Consent Process Involving Non-English Speaking Participants, below;
  • Indicating that the participant is not waiving any legal rights by signing the informed consent document.
• Including the elements and disclosures for informed consent process (see GUI304 Statement on Elements and Disclosures for Informed Consent Process).
• Includes all disclosures and requirements pertaining to informed consent when following ICH-GCP guidance (E6) (see GUI342).
• Verifies at the time of consent, when applicable, that an LAR meets the order of priority for granting permission for participation of the proposed research participant (see POL015 UAB Policy on Definition of Child, Parent, Guardian; POL025 UAB Policy on Definition of Legally Authorized Representative for Decisionally Impaired Adults).
• Obtains signatures and the dates of signature on informed consent documents (including assent forms) for the following individuals unless the IRB has waived documentation of informed consent process.
  • Participant or LAR, if applicable;
  • Investigator or other person approved by the IRB to obtain informed consent.
• Gives a copy of the signed and dated valid (stamped) IRB-approved informed consent (permission) document to the individual who signed the form (participant or LAR, as applicable, unless waived by the IRB).
• Supplies copy of signed informed consent document to performance sites in accordance with the performance sites’ policy.
• Submits any revisions to the informed consent process or documents to the IRB for review and approval using the amendment/modification procedure (See PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB).

Additional Responsibilities for Documentation of Informed Consent Process with Oral Presentation Using Short Form

Investigator:

• Submits a short form for IRB approval stating that the elements of consent have been presented orally to the participant, or the parent, guardian, or LAR, if applicable (see FOR233 Sample Short Form Written Consent Document)
• Submits a written summary for IRB approval of the information including the elements of informed consent process for oral presentation (see GUI304 Statement on Elements and Disclosures for Informed Consent Process)
• Uses the IRB-approved short form and written summary (equivalent to the informed consent document)
• Obtains consent in the presence of a witness:
  • When a participant or LAR does not speak English, the witness should be conversant in both English and the language of the participant
• Obtains signatures and the dates of signatures unless the IRB has waived documentation of informed consent in the following manner:
  • Has the witness sign and date both the short form and a copy of the written summary; and
  • Has the participant or the LAR sign and date the short form; and
  • Has the person obtaining consent sign and date a copy of the written summary of the information that is presented orally (the person obtaining consent may not be the witness to the consent).

Additional Responsibilities for Informed Consent Involving Non-English Speaking Participants

Investigator:

• Describes research and other personnel (e.g., PI, staff, translator) who will conduct the consent procedures/discussion, communicate other information, and be available to answer questions in a language understandable to the participant
• Submits translations of the informed consent documents for targeted populations for review and approval. (The IRB strongly encourages the use of a full translation of the entire informed consent document.)
  • For international research with local IEC/IRB review this requirement applies to locally approved documents
  • For the UAB IRB to grant approval, informed consent documents must include, at a minimum, the required elements of informed consent and the signatures of the participant, or LAR if applicable, and the person obtaining consent
• Provides certification that verifies that the informed consent document has been properly translated into the non-English language
• Provides the qualifications of the individual or the service that was used to translate the informed consent documents (e.g., credentials, certifications, education, or native language fluency)
• Provides participants with the IRB-approved non-English-language informed consent document as part of the informed consent discussion and gives them an opportunity to read and discuss the document with a fluent translator present

OIRB Responsibilities

Reviewing Staff:

• Reviews submission (HSP, IPR, or amendment/revision form, as applicable) to assess if sufficient information on the proposed informed consent process and documentation for informed consent has been provided for IRB review and requests additional information as necessary.
• Examines submission for requests for waiver of informed consent, waiver of documentation of consent, or indication of exception to informed consent.
  • Reviews all informed consent documents submitted for IRB review for required and additional elements, as appropriate (see GUI304).
• Requests additional information, as needed, to the HSP or informed consent documents.
• Assigns minor modifications to the informed consent documents for review by the expedited procedure or schedules for review by the convened IRB (see PRO148).
• Issues the informed consent documents with the current IRB approval stamp and date of expiration.

Administrative Staff:

• Drafts correspondence to the investigator requesting modifications to the informed consent process and/or documents
• Issues stamped approved informed consent documents, along with documentation of approval

IRB Responsibilities

The Primary Reviewer reviews and presents the following:

• The nature of the proposed participant population including vulnerable targeted populations
• Proposed information for disclosure in relation to the required and additional elements of informed consent
• Whether the purpose, risks, and benefits in the informed consent accord with the research protocol
• The circumstances under which the consent process will occur:
  • Personnel involved
  • Manner and setting
  • Timing of consent and any waiting period involved
  • Opportunities for exchange of information
• Use of additional protections for informed consent for vulnerable populations
  • For non-English-speaking participants, plans for involvement of a translator fluent in both English and participant's language
  • Incorporation of consent procedures in accordance with policies, procedures and guidance documents, as applicable, for pregnant women and fetuses, prisoners, children, and decisionally impaired adults, as applicable
• Any other procedures proposed to minimize coercion and undue influence.

The Convened IRB or Experienced IRB Reviewer for the Expedited Procedure:

• Reviews the informed consent process including manner, timing and any waiting period between presentation of information and granting of consent, place, and personnel that will be used to obtain informed consent from all participant populations including vulnerable targeted populations unless the IRB waives informed consent (see POL036 policy on, PRO153 procedure for waiver of informed consent)
• Reviews the informed consent documents to make the determinations below unless the IRB waives documentation of consent (see PRO153)
• Determines whether an exception to informed consent applies in accordance with applicable policies (see POL019 policy on, PRO119 procedure for waiver to informed consent process in research planned for emergency settings; POL021 policy on, PRO151 procedure for emergency use of FDA-regulated test articles); GUI339 Guidance for Department of Defense (DoD) Component Sponsored Research Being Conducted by UAB)
• Approves the research only if the IRB determines and documents that the requirements for informed consent are satisfied by making the following findings unless the IRB waives or alters informed consent:
  • The informed consent process appears legally effective
  • The informed consent process provides the participants ample opportunity to consider whether or not to participate
  • The information given to the participant will be in language understandable to participants
    • For non-English-speaking participants, this requires confirmation that translations of informed consent documents are certified by qualified personnel
  • No exculpatory language is present in which the participant waives or appears to waive legal rights
  • The informed consent process minimizes risk to coercion and undue influence including use of additional protections for vulnerable targeted populations
• Information disclosed in the informed consent process and documents, if applicable, is in accordance with federal regulations and UAB policy (see GUI304)
  • Informed consent disclosures accurately portray the purpose, risks, and benefits of the study protocol
• Approves the research only if the IRB approves the written informed consent documents after determining that the requirements for documentation of informed consent are satisfied unless the IRB waives documentation of informed consent. The IRB must:
  • Find the written informed consent documents embody the elements and disclosures of informed consent
  • Find the informed consent documents provide for the document to be signed and dated by the participant or the LAR and the investigator or person obtaining consent
  • Find the study gives the participant adequate time to read the consent
  • Find an included statement that a signed and dated copy will be given to the person signing the form
  • If a short-form consent document is used, the IRB must:
    • Find that the short-form document states the elements of consent have been presented orally to the participant or the LAR
    • Require a witness to be present during the oral presentation
    • Require, when a participant or LAR does not speak English, the witness should be conversant in both English and the language of the participant
    • Approve a written summary of what is said to the participant or LAR
    • Provide for the short form to be signed and dated by the participant or LAR, and the witness
    • Provide for the summary to be signed and dated by the person obtaining consent and the witness
    • Require a copy of the short form and the summary be given to the participant or the LAR
• Reviews all amendments to the informed consent process or documentation of informed consent process that potentially change the risk-benefit ratio to participants and determines whether information affects participants’ willingness to participate and, if so, the appropriate manner to inform participants.