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

 Revised 1/8/2025 – clarified information which must be included in “concise and focused summary” [excluded “duration of participation”, and specified “brief” description of procedures] in section 3.7.1; revised section 4.2.14 to delete information present in other sections, or not relevant to this policy; simplified and clarified list of “types of consent forms” (section 5.0); revised section 6.4 to delete information already present in other policies; revised sections 6.8 and 6.9 to require provision of “Rights of Research Subjects” and “What Do I Need to Know before being in a Research Study?” in the subject’s language as available; added that documentation of consent for studies involving an FDA unapproved product may also be provided by Advanced Practice Professionals (including Certified Nurse Midwives, Certified Registered Nurse Anesthetists, Nurse Practitioners, Physician Assistants) acting within their scope of practice (section 7.7); deleted requirement that PI must notify the ORA when all subjects have been contacted due to new information could potentially have a significant impact on the health and welfare of subjects (section 10.3.2): revised to delete redundant references to changes made at Continuing Review (section 10.4); stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

1.0 Purpose

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


2.0 Policy

It is the policy of the Organization that:


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)


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. Responsibilities of IRB/ORA


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

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

 Revised: 3/17/2023 – stylistic revisions {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 2/7/2024 – sections 2.4 and 6 revised to allow for waiver or alteration of consent for FDA regulated research as per revised 21 CFR 50.22 (final rule January 22, 2024). {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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

It is the policy of the Organization that


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)

 Revised 2/9/2024 - Revised to allow use of remote consent for all research (regardless of level of risk); revised to delete difference in requirements for clinical vs non-clinical research; added requirement that for research posing greater than minimal risk, the investigator must also obtain in-person written informed consent at the first opportunity if the research interventions take place on the premises of the Organization (section 3.1.2.1), or must utilize video remote consent if the research interventions do not take place on the premises of the Organization (section 3.1.2.2); clarified research interventions may begin immediately when remote consent is obtained electronically (sections 3.1.3.6 and 3.1.3.7); deleted requirement to document the rationale for use of remote consent. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

5.4 Waiver of Requirement to Obtain Signed Consent Form

1.0 Purpose

The purpose of this policy is to describe the Organization’s process for waiver of the requirement to obtain a signed Informed Consent Form (ICF).


2.0 Policy

It is the policy of the Organization that:


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


4.0 IRB and/or ORA Responsibilities


DOCUMENT HISTORY:

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

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

 Revised 12/11/2024 – added (and clarified) types of procedures which might not require written consent outside the research setting (section 3.1.2); added requirement that application describe an appropriate alternative mechanism for documenting that informed consent was obtained under 45 CFR 46.117(c)(1)(iii) (section 3.1.3); minor stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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 policy 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 for Non-English Speaking Subjects


4.0. Specific Protections and Requirements for Visually Impaired or Blind Subjects


5.0. Specific Protections and Requirements for Hearing Impaired or Deaf Subjects


6.0. Specific Protections and Requirements for Illiterate or Low Literacy Subjects


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.

A. For research conducted solely within the Organization acceptable translation by a “qualified” translator includes, in order of preference:

  1. Translation provider by a translator certified by The American Translators Association (https://www.atanet.org/)
  2. Translation provided by a translator certified by any other non-profit organization, or Federal, State or Municipal government agency
  3. Translation provided by a professional translation service that will certify the accuracy of the translation
  4. Translation by a person deemed “competent to translate” and accompanied by a certification statement that the document translation is complete and accurate (see https://www.atanet.org/client-assistance/what-is-a-certified-translation/). A person deemed “competent to translate” includes (a) foreign language instructors employed by an accredited university or college; or (b) graduate students in foreign language currently in training at an accredited university or college; or (c) a bilingual person able to write in two languages with equal fluency (including members of the research team). For research involving greater than minimal risk (per 45 CFR 46.102(j)), translation by someone other than a certified translator (categories 1 and 2) or a professional service (category 3) must be accompanied by a back-translation by a different person or group, preferably of categories 1, 2 or 3. B. For Multi-institution research where the Organization is a participating site, translation must be accompanied by documentation that the translation was performed by a “qualified” individual, as defined above.

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.

Qualified interpreters include, in order of preference:

  1. A person holding certification by the National Board of Certification for Medical Interpreters, the Certification Commission for Healthcare Interpreters, or any similar credentialling body, or certified by any other non-profit organization, or Federal, State or Municipal government agency.
  2. A person employed by, or contracted by, the Organization to provide interpretation services in a clinical context. This includes commercial interpretation services (such as CyraCom).
  3. UNMC, Nebraska Medicine, CH&MC, BMC, UNO or study site staff who are fluent in both English and the language of the subject.
  4. Study personnel who are fluent in both English and the language of the subject.
  5. Other persons, including (a) foreign language instructors employed by an accredited university or college; or (b) graduate students in foreign language currently in training at an accredited university or college; or (c) a bilingual person; specifically, a person using or able to speak in two languages with equal fluency.

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)

 Revised: 3/7/2023 – deleted requirement for signature of interpreter when obtaining informed consent using a translated ICF (section 3.1.1.4); revised Addendum A to explicitly state use of a profession translation service is acceptable {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 2/7/2024 – add use of Short form to section 4.4.1. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised - 11/12/2024 – allowed for recording or employee number of interpreter (rather than name) (section 3.1.6); revised numbering {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}