Education Module
Enrollment, Recruitment & Retention of Study Subjects: Practical Advice Relevant for an Interventional Randomized Study

Introduction

There are many potential barriers to recruiting clinical research participants.  This module reviews some potential barriers and possible solutions.

Recruitment: Potential Barriers and Solutions

Case 1: Naive Client

It is important to develop a relationship with potential study subjects.  Continuity of the provide, support groups, and counselors can all be used for this purpose.  The provider should assist the client in identifying the issues most important to them.

Case 2: Enrolling Women

To enroll women in clinical research, determine measures to make visits easier to attend.  Assess family support and opposition for patient enrollment.  Family members may be opposed to patient enrollment.  It is important to encourage family members to attend visits and be involved in care if the patient agrees.  Always allow time for questions.

Case 3: Concern about Blood Draws

Always draw the least amount of blood possible within the study protocol.  Provide an explanation of tests to the study participant and let the patient know how much blood will be drawn (visual may be best).

Case 4: Fear of Side Effects

Discuss the most common side effects with study participants to alleviate any concerns.  Provide suggestions for reduction of side effects if they occur and provide contact information for problems that may arise between developments.  Contact study participants between appointments to ensure they are not experiencing side effects.

Case 5: Fear of Personal Disclosure

Discuss the importance of confidentiality with the patient and ensure that personal information will not be disclosed.

Case 6: Completing Protocol Questionnaires During Visits

Visits may be time-consuming due to long questionnaires or literacy issues.  Discuss the importance and contribution of questionnaires with all study participants. 

Case 7: Information Overload

Information should be provided to research participants in small, manageable amounts.  Provide simple, concise written material for study participants to review and take home.  Information should be reviewed often and as necessary with patients.

Types of Study Visits

Study protocols dictate what visits occur and when.  The schedule of events, kept in the study protocol, should be consulted to determine when patients must return for study visits. 

Screening Visits

After consent is signed, the protocol for required procedures should be followed.  Some required procedures may include drawing required labs, physical examination, obtaining medical history and current medications, and/or obtaining consent for release of medical records.

Eligibility

After screening, obtain an eligibility checklist.  If the participant meets all criteria, he/she should quality for the study.  After completing the eligibility checklist, the original should be filed in the research chart.  After the checklist is completed, another staff person should review, sign, and date the document.

Randomization

If appropriate, the checklist should be given to a data manager prior to a patient's appointment.  When the participant arrives for their study visit, the data manager can randomize the patient. 

Question and Answer

This question and answer section is designed to test your knowledge of audits in clinical research.  Answers are provided so that you can ensure you know the right answer.  No credit is given for completing these questions.

Question 1
Question: The following are potential barriers to the recruitment of study subjects: (1) concern about blood draws; (2) fear of side effects; and (3) fear of personal disclosure.
Answer: All of these are potential barriers to recruitment of study subjects.

Question 2
Question: True or False.  It is not important to file the eligibility checklist in the research chart?
Answer: False.  After completing the eligibility checklist, the original should be filed in the research chart.

Acknowledgements

This module was adapted from power point presentations originally given by Brown University faculty and staff as part of an ACTG-sponsored training.