3.12 Ethical Access

Last Revised: 3/5/2025

1.0 Purpose

The purpose of this policy is to define ethical access and to describe the Organization’s requirements to protect the privacy of potential subjects in the context of recruitment for participation in research, or for identification of potential subjects for review of medical records.


2.0 Policy

It is the policy of the Organization that


3.0 Ethical Access for Recruitment of Subjects

For the purposes of this policy, the recruitment of subjects requires two distinct activities, each of which must respect the privacy of potential subjects: (1) obtainment of information about the potential subject which leads the investigator to believe or conclude that the person is eligible for the research, and (2) subsequent approach to the person to explain the research and obtain their consent to participate.


4.0 Ethical Access for Review of Medical Records


5.0 Investigator Responsibilities


6.0 IRB Responsibilities


DOCUMENT HISTORY:

 Written: 4/16/2018 (Approved: 4/16/2018) - original author not recorded

 Revised: 11/20/2018 - revision not documented

 Revised: 2/18/2019 - revision not documented

 Revised: 3/5/2025 - Specified criteria for waiver of ethical access (section 3.1.1.3); removed citations to pre-2018 Common Rule; formatting and stylistic changes.


Revision #12
Created 24 October 2019 21:33:34 by Autumn M Eberly
Updated 17 April 2025 15:57:28 by Robert A Lewis