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Completing the Subject Identification and Recruitment Section

March 2012

What is the purpose of the Subject Identification and Recruitment section?

The Subject Identification and Recruitment section of the initial review application asks study teams to provide information about what methods will be used to identify subjects, how subjects will be recruited, and the overall recruitment plan.

When does the Subject Identification and Recruitment section display?

The Subject Identification and Recruitment section is the eighth section of the initial review application and will automatically display for most application types.

What information about subject identification and recruitment should study teams provide?

Subject recruitment can involve a variety of methods, such as approaching potential subjects at clinic visits, contacting a targeted set of potential subjects through email, letters, and telephone, or advertising to a general public via flyers, websites, newspaper, television, and radio. Answers in the subject identification and recruitment section should provide the IRB with a picture of:

  • How the potential subject population will be identified (e.g., through billing or medical records, DoIT or purchased email lists, already established recruitment databases, interactions during a clinic visit)
  • What information will be provided to potential subjects about the study
  • The method(s) used to disseminate information about a study to potential subjects, including where information will be distributed and how frequently it will be provided
  • Any differences in recruitment methods by potential subject group (e.g., differences in recruitment methods between a patient population versus a control group)
  • Who on the study team will be involved in recruitment and which aspect of recruitment they will be involved in

Below is guidance regarding what information should be provided in the IRB application for some of the most frequently used methods to identify and recruit potential subjects.

Billing records
  • Describe which records will be used, how the records will be reviewed to identify and contact potential subjects, who will provide the list of potential subjects to the study team, and and who will conduct the record review. 
  • A waiver of informed consent also will need to be requested if billing records will be used to identify potential subjects.
Email Solicitation
  • Describe the source of the email list, how many times an email will be sent to potential subjects, and, if applicable, the group(s) of subjects to which the email will be sent.
  • Upload a copy of the proposed email(s) where indicated in the IRB application.
  • See the HS-IRBs Document 18872 is unavailable at this time. for additional information.
Identification in clinical practice: investigator's own
  • Explain how potential subjects identified through the investigator's own clinical practice will be approached and who will approach potential subjects.
  • If potential subjects will be mailed a letter describing the study, also select the "mailed letter" option on the Subject Identification and Recruitment: General page.
  • If potential subjects will be called, also select the "phone" option on the Subject Identification and Recruitment: General page.
  • If you will review medical records to identify potential subjects, also select the "medical records" option on the Subject Identification and Recruitment: General page.
  • Please note that institutional policy requires that all patient subjects be initially informed about a study by someone they recognize as being involved in their care.  If this person is not on the study team, recruitment will need o be completed by someone who is.
Identification in clinical practice: other
  • Describe how potential subjects being seen in another clinical practice will receive information about the study and whether potential subjects will be directed to call the study team or be asked instead to provide permission to release their names and contact information to the study team. This method is often called a referral.
  • If potential subjects will be mailed a letter describing the study, also select the "mailed letter" option on the Subject Identification and Recruitment: General page.
  • If potential subjects will be called, also select the "phone" option on the Subject Identification and Recruitment: General page.
  • If you will review medical records to identify potential subjects, also select the "medical records" option on the Subject Identification and Recruitment: General page.
  • Please note that institutional policy requires that all patient subjects be initially informed about a study by someone they recognize as being involved in their care.  If this person is not on the study team, recruitment will need to be completed by someone who is.
Internet (e.g., web posting)
  • Describe whether any study-related recruitment materials will be posted on the internet, including Facebook and other social media sites.
  • Describe the range of sites that recruitment materials will be posted on. 
  • Upload a copy of the recruitment materials where indicated in the IRB application.
  • If potential subjects would be expected to provide information to the study team via a website, describe the information that will be collected and how that information will be protected.
Mailed letters
  • Explain how the study team will identify potential subjects to target with recruitment letters.
  • Clarify whether any information will accompany the letter (e.g., a consent form).
  • Indicate who will address the letter(s) as well as who will sign the letter(s).
  • If the correspondence is from someone who is not a member of the study team, provide a letter of support from the person who will be sending/signing the correspondence.
  • Upload a copy of the letter where indicated in the IRB application.
  • If potential subjects will be called after receiving the letter, also select the "phone" option on the Subject Identification and Recruitment: General page.
Medical records
  • Describe which records will be used, how the records will be reviewed to identify and recruit potential subjects, who will provide the list of potential subjects to the study team, and who will conduct the review.
  • If you will review medical records to identify potential subjects, a waiver of informed consent also will need to be requested.
Newsletters
  • Describe the source of the newsletter, how many times a newsletter will be sent to potential subjects and, if applicable, the group(s) of subjects to which the newsletter will be sent.
  • Provide a copy of the proposed newsletter wording for the IRB review to review.
Telephone
  • Explain how the study team will identify potential subjects to target with telephone calls or what potential subjects will be expected to call the study team.
  • Clarify whether the telephone call will be preceded by other contact by the study team (e.g., mailed letter, email).
  • Indicate who will make or receive the telephone calls.
  • Describe what will be discussed during the telephone calls and whether any screening to determine subject eligibility for study participation will occur. If screening will occur in addition to recruitment, information about the screening process also will need to be provided where indicated in the IRB application.
  • See Telephone Recruitment and Screening Guidance for additional information. 
  • If potential subjects will be called after receiving information via another method (e.g., mailed letter, email, newsletter, flyer), also select these options on the Subject Identification and Recruitment: General page.
Posters/Flyers
  • Describe where materials will be posted and how it will be ensured that permission to post materials is obtained.
  • State how subject will be expected to respond to the flyer to indicate their interest in the study.
  • Upload a copy of the materials that will be posted where indicated in the IRB application.
Radio
  • Indicate the expected radio markets/stations that will be targeted.
  • Upload a copy of the radio script where indicated in the IRB application.
Television
  • Indicate the expected television markets/stations that will be targeted.
  • Upload a copy of the script of the commercial where indicated in the IRB application.






Keywords:subject recruitment, identification, billing records, medical records, flyers, radio, television, phone, telephone, mailed letter, internet, web , recruitment materials   Doc ID:23342
Owner:Faye L.Group:Health Sciences IRBs
Created:2012-03-20 14:49 CDTUpdated:2016-12-20 17:06 CDT
Sites:Health Sciences IRBs
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