Library Document Details

Procedure for Selection and Recruitment of Subjects in Research - IRB PRO139

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for the selection and recruitment of subjects in research.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO139
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Selection and Recruitment of Subjects in Research

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Includes the following information for the target population in FOR200 Human Subjects Protocol (HSP) at the time of initial review:
    • The number of participants to be enrolled;
    • Participants' age range;
    • Participants' health status; and
    • Any requirements for specific gender, race, or ethnicity for inclusion.
  • Describes in the HSP the process to be used to recruit participants including:
    • The location and setting (e.g., classroom, schools, businesses, other institutions);
    • The methods and materials (e.g., advertisements, flyers, letters, scripts, videos, email);
    • Any compensation for participants, the type, amount and the payment schedule;
    • How participants are screened for eligibility (e.g., databases, employees, medical records reviews, referrals from other physicians or participants);
    • How participants are enrolled;
    • Criteria for inclusion and factors that may exclude potential participants;
    • Whether vulnerable populations are targeted and any need for added protections by completing the Special Populations checklist, as required;
    • Describes in the HSP the informed consent process including:
      • How consent is obtained and by whom;
      • The time period between informing and soliciting a decision or basis for a waiver of the 24-hour period before soliciting a decision;
      • Any project-specific information sheets.
  • Includes in FOR225 Investigator's Progress Report for continuing review:
    • Number of participants enrolled;
    • Information on age, gender and race/ethnicity of participants screened and enrolled;
    • Information on any problems encountered in obtaining informed consent;
    • Information on withdrawals and the reasons for withdrawal from research;
    • Information on any complaints related to the research (e.g., receipt of payment for participation).
  • Submits modifications to the recruitment/selection procedures described in the HSP for review and approval prior to initiation of the changes (e.g., advertisements, changes in eligibility requirements, increase enrollment).

OIRB Responsibilities

The Senior Staff:

  • Reviews the HSP and consent documents at the time of initial and continuing review or review of modifications to determine if the following have been included, if appropriate:
    • Description of subject recruitment including any recruitment materials, screening and enrollment procedures;
    • Description of the selection criteria of subjects and explanation for inclusion or omission of subjects;
    • Use of any additional safeguards to prevent undue influence or coercion in the selection/enrollment process;
    • Proposed changes in the inclusion/exclusion criteria;
    • Any compensation to participants and the schedule for payment;
    • Any incentives to the investigator or research personnel for enrollment of participants; and
    • Any payments by investigators to others for enrollment.
  • Examines all advertisements for appropriate content.

IRB Responsibilities

The IRB, or experienced IRB reviewer for expedited review, at the time of initial and continuing review or review of modifications:

  • Reviews the proposed research and approves only if IRB finds:
    • Selection of subjects is equitable based on the purposes of the research, the setting in which the research will be conducted, and the adequacy of additional safeguards to protect vulnerable populations from undue influence or coercion;
    • All recruitment materials (e.g., advertisements, flyers, letters, scripts, videos, emails) contain appropriate wording (see POL039 UAB Policy on Subject Selection and Recruitment for Research);
    • Recruitment processes, including advertisements, minimize the possibility of any undue influence or coercion; and
    • Time is sufficient between informing the participant and soliciting a decision to participate.
  • The experienced expedited reviewer refers any research that the reviewer cannot approve or secure modifications for approval to the convened IRB for review.

Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director