Section 5: Informed Consent

5.1 Obtaining Informed Consent From Research Subjects

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent.


2.0 Policy

It is the policy of the Organization that:


3.0 General Requirements


4.0 Elements of Informed Consent


5.0 ICF and Information Sheet Templates

All investigators are required to utilize one or more of the templates in RSS as applicable:

6.0 Process of Informed Consent


7.0 Documentation of Informed Consent


8.0 Documentation in the Research and Medical Records



10.0 Requirements for Re-Consent of Subjects


11.0 Telephone Consent

Refer to HRPP policy 5.3 (Use of a Telephone Consent Process).


12.0 Short Form

Refer to HRPP policy 5.5 (Use of the Short Form Consent Document).


13.0 Waiver or Alteration of Informed Consent

Refer to HRPP policy 5.2 (Waiver or Alteration of Informed Consent and HIPAA Authorization).


14.0 Waiver of the Requirement to Obtain a Signed ICF

Refer to HRPP policy 5.4 (Waiver of the Requirement to Obtain Signed Consent Form).


DOCUMENT HISTORY:

 Written: 2/5/2016 (Approved: 2/5/2016) - original author not documented

 Revised: 1/26/2018 - revision not documented

 Revised: 5/24/2021 - Clarified that documentation of consent may be obtained thru an electronic signature per HRPP Policy 5.3, and made multiple revisions throughout concerning process of e-consent and e-signature; deleted requirement that only licensed physicians or dentists are authorized to obtain and document consent for “clinical studies involving significant risk”; clarified and simplified available informed consent and information sheet templates; clarified and expanded description of vulnerable subjects who may need additional protections during the consent process; expanded methods suitable for contact of subjects to disclose new information (and affirm willingness to continue); clarified situations where re-consent might be required; clarified that agreement for continued follow-up does not require written consent; deleted reference to LAR since section 2.3 states “For this policy reference to ‘subject’ also refers to a subject’s LAR, or a minor subject’s parent or legal guardian, as appropriate”.

 Revised 8/15/2022 - specifics concerning who constitutes as a qualified interpreter, addendum added - {Approved: 6/27/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 9/8/2022 – moved section 9 (Special Consent Circumstances…) to HRPP Policy 5.7 {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/9/2022

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for granting an IRB waiver or alteration of informed consent with or without waiver of HIPAA authorization requirements in research.


2.0 Policy


3.0 Criteria for Waiver or Alteration of Consent under HHS regulations and HIPAA regulations


4.0 Criteria for Waiver of Parental/Guardian Consent (Permission) under HHS regulations at 45 CFR 46.408(c)

The following are the IRB requirements that must be met in order to approve a waiver of parental/guardian consent (permission) under HHS regulations at 45 CFR 46.408(c):


5.0 Criteria for Waiver or Alteration of Consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials


6.0 Criteria for Waiver or Alteration of Consent for FDA Regulated Minimal Risk Research


7.0 Process of Review


DOCUMENT HISTORY:

 Written: 1/11/2016 (Approved: 1/11/2016) - original author not recorded

 Revised: 1/29/2018 - revision not documented

5.3 Use of a Remote Consent Process

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for use of remote informed consent process. For the purpose of this policy remote consent includes telephone, video-conferencing, or use of desktop, mobile or web-based applications or similar technologies.


2.0 Policy


3.0 Process for Utilizing Remote Consent


DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not documented

 Revised: 7/27/2018 - revision not documented

 Revised: 6/11/2020 - previously titled policy: Use of a Telephone Consent Process

 Revised: 1/19/2021 - clarify authority of convened IRB, expedited reviewer and IRB Executive Chair in authorizing use of remote consent (sections 2.1.1 and 2.1.2)

5.4 Waiver of Requirement to Obtain Signed Consent Form

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s process for IRB waiver of the requirement to obtain a signed ICF.


2.0 Policy


3.0 Criteria for IRB Approval of a Waiver of Requirement to Obtain a Signed ICF


4.0 Process of Review


DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 1/25/2018 - revision not documented

5.5 Use of the Short Form Consent Document

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for use of a short form written consent document for enrollment in research.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Use of the Short Form


DOCUMENT HISTORY:

 Written: 2/5/2016 (Approved: 2/5/2016) - original author not recorded

 Revised: 6/18/2018 - revision not documented

 Revised: 5/13/2021 - Revised to state request form available thru RSS; added BMC staff as eligible interpreter or witness; deleted list of short form available languages; deleted requirement to record time spent in the process of consent; deleted requirement that interpreter separately document the process of consent; corrected references to revised Common Rule; minor stylistic changes

 Revised 10/14/22 – added definition of “Qualified interpreter” to harmonize with HRPP 5.7; clarified that approval to use short form is only valid for 2 weeks and may only be used for one subject; stylistic changes; correction of typographic errors. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/29/2022

 Revised 11/30/2022 - corrected 4.1.2 from: "IRB-approved short forms are available in a variety of languages on the IRB website in the following languages, along with an English translation of the short form.", to: "IRB-approved short forms are available in a variety of languages on the IRB website, along with an English translation of the short form." (Robert Lewis - IRB Assoc)

5.6 Exceptions from Informed Consent Requirements for Emergency Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of an exception from informed consent requirements for emergency research.


2.0 Policy


3.0 Definition


4.0 Requirements


DOCUMENT HISTORY:

 Written: 1/8/2016 (Approved: 1/8/2016) - original author not recorded

 Revised: 3/5/2018 - revision not documented

5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent for non-English speaking persons, or persons with additional needs or vulnerabilities participating in human subject research. For general considerations of informed consent see HRPP 5.1 (Obtaining Informed Consent from Research Subjects).


2.0 Policy

It is the policy of the Organization that:


3.0. Specific Protections and Requirements


Addendum A

Minimal Requirements for Translation of Informed Consent Documents

Translation of Consent forms into a language other than English must be performed by qualified persons, with adequate competence in English and the language of the translation, and preferably with knowledge of research methodology.


Addendum B

Minimal Requirements for Interpretation

Interpretation must be performed by qualified persons, who are fluent in both English and the language of the subject, and preferably with knowledge of research methodology.

If a prospective subject wishes to designate his/her own interpreter, a Qualified Interpreter must also be present to ensure the quality and accuracy of the interpretation.

A minor cannot be used as an interpreter.


DOCUMENT HISTORY:

 Written: 11/2/2022 - Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair), {Approved: 11/8/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 12/2/2022

 Revised: 1/27/2023 - updated hyperlinks for HRPP references 5.1, 5.3, and 5.5 (Robert Lewis, IRB Assoc)