Guidance for Principal Investigators and Research Team Members

The IRB recommends the following guidelines:

Proactive measures:

• Describe all recruitment methods used as part of the proposed study in the recruitment and consent sections (VII.D.) of the HawkIRB application.  Attach any associated recruitment materials (e.g. recruitment letter, phone script, etc.) in the attachments section of the HawkIRB application.   
• Investigators should not propose cold-calling potential subjects as a recruitment method in the HawkIRB application unless:
  • the potential subjects have previously agreed to be listed on a research registry for future research studies
  • the potential subjects are currently participating in a study conducted by the same investigator; or
  • they are frequently seen by or are well known to the investigator
• Potential research subjects should be introduced to the study either:
  • by an individual who, by virtue of his/her position, would normally have access to the potential subject’s confidential information (e.g., the personal physician of the potential subject or a member of the clinic or practice staff); or
  • by an introductory letter or other informational material sent or given directly to potential subjects prior to a telephone call
• If the potential research subject shows an interest in study participation, s/he should be asked to
  • contact the investigators directly; or
  • allow the individual who initiated contact to share the person’s interest in study participation with the research team so that the researchers can contact the potential subject and provide more information about the study

Corrective measures:

• If the Principal Investigator (PI) determines a non-IRB approved recruitment method was used as part of their study, he/she should:
  • submit a noncompliance Reportable Event Form (REF) in HawkIRB
  • submit the REF within 10 working days of the incident or the PI becoming aware of the incident; and  
  • include a corrective action plan in the REF to explain how the PI will avoid this (or this activity) noncompliance from occurring in the future

Code of Federal Regulations Citations and Guidance

VHA 1200.05 Requirements for the Protections of Human Subjects in Research

University of Iowa IRB Policy Citations and Guidance

None

University of Iowa Operations Manual and Guidance

None

University of Iowa IRB ICD Template Wording

None