Research Cores - Clinical Research Unit

CRU-3-01 Obtaining and Maintaining Informed Consent and HIPAA Authorization

SOP: 听Obtaining and Maintaining Informed Consent and HIPAA Authorization

Number:
CRU-3-01		 Date:
Version 5.0,
06/Mar/2026		 Supersedes:
Version 4.0,
19/Jul/2023		 Responsible Authority:
CRU Director		 Page 1 of 4

  1. PURPOSE

    The purpose of this document is to define the process of obtaining and maintaining informed consent and HIPAA authorization with participants prior to and throughout their participation in human subject research. This SOP describes the informed consent and HIPAA authorization process for each participant in a research study approved by the IRB.

  2. REVISIONS FROM PREVIOUS VERSION

    2.1Version 3.0, 09/Mar/2020, updated the date and version number.

    2.2听 Version 5.0, 06/Mar/2026: reviewed the SOP, updated the version number and date, removed Assistant Director from this SOP, removed using a translator for the informed consent, removed scanning signed informed consent forms to the CRU drive, added CRU staff to the SOP.

  3. POLICY

    3.1 听DOR Policy 10.3.10 Informed Consent Policy.

  4. RESPONSIBILITIES

    4.1 听Principal Investigators (PIs)

    1. 4.1.1Designate and authorize study staff qualified by education and training to obtain informed consent and HIPAA authorization from participants prior to enrollment in clinical research; ensure that delegation of consent duties complies with any sponsor- or protocol-specific requirements (i.e. person obtaining consent must be MD, RN, etc.).
    2. 4.1.2Ensure required ICF and HIPAA authorizations are properly obtained, documented, and maintained for all participants.
    3. 4.1.3Ensure that PI and study team follow good clinical practices (i.e. explain all items on ICF, ensure comprehension, etc.) throughout the IC process (before and during participation).
    4. 4.1.4Provide potential participant/authorized representative sufficient time and opportunity to consider whether or not to participate in the research study, acknowledging his/her right to withdraw at any time during the study.
    5. 4.1.5 听Minimize the possibility of coercion or undue influence on the potential participant to participate or continue participating in the research study (ICH4.8.3).
    6. 4.1.6 听Ensure ICF and HIPAA authorizations are translated and available in other culturally appropriate forms, including appropriate language, based on study population.
    7. 4.1.7 听If providing ICFs in languages other than English, provide trained staff that can communicate in specific language and has knowledge of the population's culture.
    8. 4.1.8 听Ensure IRB approval of all study ICFs (i.e. main, HIV, genetic, etc.) and HIPAA authorization forms. Revise ICF whenever important new information that may be relevant to the research participants' consent (i.e. new risks, change in emergency contact information, new procedures, etc.) becomes available.
    9. 4.1.9 听Ensure IRB approval of all revised study ICFs and HIPAA authorization forms.
    10. 4.1.10 听Ensure process is in place to reconsent study participants using IRB-approved amended study ICFs and HIPAA authorization forms, when applicable.

    4.2 听Clinical Research Professional (CRP)/CRU staff:

    1. 4.2.1 听In collaboration with the PI and other study team members (as appropriate), obtain, document, and maintain ICF and HIPAA authorization forms for all study participants.
    2. 4.2.2 听Provide potential participant/authorized representative sufficient opportunity to consider whether or not to participate in the research study, acknowledging his/her right to withdraw at any time during the study.
    3. 4.2.3 听Minimize the possibility of coercion or undue influence on potential participants to participate or continue participating in the research study (ICH4.8.3).
    4. 4.2.4 听Ensure that the informed consent process and HIPAA authorizations are fully documented in progress notes or consent process notes.
    5. 4.2.5 听Maintain documentation of informed consent process and HIPAA authorizations.
    6. 4.2.6 听Ensure the use of the most current IRB-approved ICFs and HIPAA authorizations.

  5. PROCEDURE

    5.1 听Confirm the use of the most current IRB-approved ICF and HIPAA authorization form prior to initiating the informed consent process.

    5.2 听Provide an environment for the consent process that will ensure participant privacy.

    5.3 听Provide an IRB-approved ICF and HIPAA authorization form in a language that the participant comprehends fluently.

    5.4 听Provide sufficient time for participant/authorized representative to read, review, and discuss ICF and HIPAA authorization forms.

    5.5 听Provide witness for ICF process, if required by IRB policies and procedures.

    5.6 听Ensure the person obtaining consent speaks the participant's language fluently and understands the participant's culture to ensure comprehension.

    5.7 听Discuss each item in the ICF and HIPAA authorization form as a part of the entire informed consent process.

    5.8 听Discuss ICF and HIPAA authorization form with cultural appropriateness.

    5.9 听Encourage participant/authorized representative to ask questions throughout the entire consent process, as well as throughout study participation.

    5.10 听Describe the research in an informative manner without using persuasive techniques.

    5.11 听Ask participant/authorized representative to print his/her own name and sign and date the ICF and HIPAA authorization form if he/she agrees to participate in the research.

    5.12 听If a witness was used, ask him/her to print his/her own name and sign and date the ICF.

    5.13 听Ensure person obtaining consent prints his/her own name and signs and dates the ICF.

    5.14 听Ensure ICF and HIPAA are signed and dated prior to performing any protocol-specific activities.

    5.15 听Provide a copy of the signed ICF and HIPAA authorization form to the participant/authorized representative.

    5.16 听Document the consent process in a progress note or consent process note (see section 6 of this SOP).

    5.17 听Store original signed ICF(s), HIPAA authorization forms, and other consent documentation in the study participant binder.

    5.18 听Revise ICF, obtain IRB approval, and reconsent (if applicable, per IRB instructions) all enrolled participants as soon as possible when changes are made to the consent documents that have the potential to affect future study participation (i.e. new risks) or continued participation.

    5.19 听Exceptions to the standard informed consenting process:

    1. 5.19.1 听Refer to FAU Research Integrity/IRB or central IRB policies and procedures (i.e. waiver or alteration of consent process, waiver of documentation of consent, short form consent).

    5.20 听Document the informed consent process with the following information:

    1. 5.20.1 听The statement that consent was obtained prior to any study-specific procedures being performed.
    2. 5.20.2听 Individuals present for the consent discussion.
    3. 5.20.3 听The statement that consent process was performed in a language that the participant or authorized representative comprehended fluently.
    4. 5.20.4 听The statement that consent was fully explained, including all of the required and additional (as applicable) elements of informed consent, and all questions were answered to the satisfaction of the participant and/or legally authorized representative.
    5. 5.20.5 听Document specific questions asked by the participant or legally authorized representative.
    6. 5.20.6 听Document that participant or legally authorized representative receive a signed copy of the ICF and HIPAA authorization forms.
    7. 5.20.7 听Document that a copy of all ICFs and HIPAA forms were provided to supporting programs/units/entities.

    5.21 听Maintenance

    1. 5.21.1 听Store original signed ICF(s) and HIPAA authorization form(s) in the study participant binder.
    2. 5.21.2 听Store revised signed ICF(s) and HIPAA authorization form(s) in the study participant binder.
    3. 5.21.3 听Store documentation of consent process with the ICF in the study participant binder.

  6. MATERIALS

    6.1 听Templates

    1. 6.1.1 听FAU IRB Consent and HIPAA Authorization Templates 鈥� Research Integrity, IRBNet.
      http://www.fau.edu/research/research-integrity/how-to-submit-via-irb/
    2. 6.2.1 听CRU Consent Process Note

  7. REFERENCES

    7.1 听International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry. March 2018

    7.2 听Research Integrity/Institutional Review Board Policies and Procedures. 吃瓜网, Division of Research, Research Integrity
    /research-admin/research-integrity/human-subjects-irb/irb-policies-and-procedures/

    7.3 听Western Institutional Review Board

    7.4 听Advarra Center for IRB Intelligence (CIRBI) Platform

    7.5 听U.S. Department of Health & Human Services, Agency for Healthcare Research and Quality. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

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