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)}


Revision #25
Created 24 October 2019 21:38:47 by Autumn M Eberly
Updated 21 March 2025 13:41:16 by Robert A Lewis