Selection and Recruitment of Subjects in Research- PRO139   

procedure
 

Investigator Responsibilities

• Includes the following information for the target population in FOR200 IRB application eForm 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 FOR200 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, e-mail);
  • 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; and
  • Describes in FOR200the informed consent process including:
    • How consent is obtained and by whom;
    • Justification that potential participants are given an adequate period of time between introduction of the study(and any associated informed consent materials) and soliciting a decision; and
    • Any project-specific information sheets.
• Includes in FOR200 at 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; and
  • Information on any complaints related to the research (e.g., receipt of payment for participation).
• Submits modifications to the recruitment/selection procedures described in FOR200 for review and approval prior to initiation of the changes (e.g., advertisements, changes in eligibility requirements, increase enrollment)

OIRB Responsibilities

Reviewing Staff:

• For each submission, reviews the application and consent documents for the following information:
  • Description of subject recruitment including any recruitment materials, screening and enrollment procedures;
  • Description of the selection criteria of subjects and explanation for inclusion or exclusion of specific participant populations;
  • 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

• Reviews the proposed research and approves if:
  • 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, e-mails) 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.
• An Experienced Reviewer refers any research that the reviewer cannot approve or secure modifications for approval to the convened IRB for review.