Ethics of Subject Recruitment~Bryon H. Adinoff, M.D., E. Sherwood Brown, M.D., Ph.D., and David R. Karp, M.D., Ph.D.

Objectives:

At the end of this session, participants should be able to:

1. Identify subject populations typically considered “vulnerable” and why.

2. Describe precautions to assure fair, informed, and noncoercive recruitment in a variety of vulnerable subjects.

3. Describe some boundary conditions where telephone screening is adequate and others which demand an in-person screening evaluation, as well as indications for proxy screening.

4. Describe special precautions for recruiting the mentally ill, prisoners, minors, and individuals involved in criminal misconduct.

Cases for Discussion:

Case 18:  You are the PI for a clinical trial of a new drug, X, for osteoarthritis.  You conducting a double-blinded comparison of the new drug against a standard therapy.  A patient referred from a colleague calls in and says “I understand you are offering free treatment with X. How do I sign up?”  What do you say to the individual, and how do you say it?

Case 19:  You are funded to conduct a study that involves enrolling active injection drug users.  You are going to pay them for their time with Target gift cards.  You want to only interview persons who inject drugs.  You do not want duplicate interviews; however, you need to do the study anonymously since the data to be collected includes information on illegal behaviors.  So you do not want to ask for photo identification.  What screening and enrollment processes can you put in place to enable this population to participate in your study?     (Case 19 courtesy Anne Freeman)

Variations:

Case 19a:  This study involves recruiting HIV positive individuals who do not practice “safe sex” procedures.  You are interested in comparing viral loads and clinical outcome with individuals who practice safe sex against matched controls who do not practice safe sex.  What screening and enrollment processes can you put in place to enable this population to participate in your study?    What issues are involved in studying individuals who pose public risk?  How should you address them?

Case 19b:  What about the case of 19a, but the study population is prisoners?

Case 19c:  What about the case of 19a, but the study populations are adolescents?

Case 20:  You are conducting an open-label study in outpatients with intractable chronic pain with a new, atypical analgesic that is not yet on the market.  The inclusion criteria for your study require the patient to have failed four standard-of-care treatment regimens, which are objectively defined in terms of variables like medication dosage and treatment duration.  As a consequence, you expect to have a number, perhaps all, of your subjects to be in desperate pain at the time of referral.  How will you access this population?  How will you screen the potential subjects? How will you assess for freedom of consent?  Is the trial ethically permissible under these conditions and study design?

Selected Reading: 

Miller, Franklin G. Recruiting Research Participants., The Oxford Textbook of Clinical Research Ethics. 2008:397-403.