MSU HRPP Manual Section 6-4-E
Informed Consent Exception for Screening, Recruiting, or Determining Eligibility
“Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:
(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.” 45 CFR 46.116(g)(2018 Requirements)
For studies subject to the Revised Common Rule (2018 Requirements), the Institutional Review Board (IRB) may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative if the IRB determines that the regulatory criteria for the exception are met. The relevant criteria must be met for the IRB to approve an exception. This exception eliminates the requirement for the IRB to waive informed consent for these activities.
In approving this exception to informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective subjects, the IRB will be reviewing and approving the entire research proposal. Therefore, all of the IRB approval criteria at 45 CFR 46.111 will need to be satisfied, including that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46.111(a)(7)). Thus, as part of its review and approval of the research, the IRB must determine that there are adequate privacy and confidentiality safeguards for information or biospecimens obtained by investigators for these activities.
If prospective subjects are identified through these activities, then all other relevant requirements of this rule must be met if they are subsequently recruited to participate in the research.
This exception does not apply to studies subject to the Pre-2018 Common Rule Requirements and/or studies regulated by the U.S. Food and Drug Administration (FDA). See FDA Guidance “Screening Tests Prior to Study Enrollment - Information Sheet” and “Recruiting Study Subjects - Information Sheet” for FDA guidance on screening and recruiting activities.
Review and Documentation
Review and approval of this exception follows the procedures as required by the level of review. See HRPP Manual 8-2 “Expedited Review Procedure” and/or 8-3 “Full Board Review Procedure” for policies and procedures on review and documentation required to approve the exception.
Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements)” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.
This policy and procedure supersedes those previously drafted.
Approved By: Senior Vice President for Research and Innovation, 1-18-2019.
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