Specific Recruitment Issues

1.      The steps taken to identify potential subjects for enrollment must be clearly indicated in the Application Form.

2.      The principal investigator must take all precautions to protect the privacy and confidentiality of subject-identifying information. 

a.      All subjects should be assigned a study identifier.

b.      Data collection forms should not include subject identifiers.

c.      The list linking subjects to their data should be kept in a locked cabinet and only those study staff with data collection or analysis responsibilities should have access to the list.

3.      The IRB recognizes that each potential subject has the right to make the decision about involvement in a research study.  The attending/referring physician should not deny their patients access to a research study for which they may be eligible. 

4.      Investigators may recruit patients who meet eligibility criteria from Crozer’s patient population in one of the following instances:

a.      The investigator is a direct care provider for the potential subject.

b.      If the investigator is not a direct care provider for the subject, specific recruitment strategies must be followed to maintain patient confidentiality.

5.   For studies in which the investigator has no direct relationship with Crozer, a Crozer contact person must be identified, at the direction of the IRB.  The contact person will be responsible for the initial contact with the potential subject, either by letter, telephone or in person.   No identifying information may be given to an investigator prior to the potential subject approving release of personal information.  The subject should indicate a willingness to be contacted by the investigator through a release of name form that is signed by the subject.  In select circumstances, as determined by the IRB, a waiver of release of identifying information may be granted to the investigator once initial contact has been made by the contact person.

ELIGIBILITY BY DIAGNOSTIC STUDY

If specific laboratory or diagnostic test results indicate the subject may be eligible for a clinical research study:

1.      The Lab (or diagnostic department) obtains the results of tests.

2.      The Lab (or diagnostic department) sends the results to the ordering physician.  The Lab (or diagnostic department) also sends a prescriptive note to the investigator indicating (1) that there is a positive test result, (2) initials only of a patient and (3) the ordering physician’s name.

3.      The Investigator contacts the ordering physician/attending physician/affiliated resident regarding the study and requests the attending contact the patient for interest in the study participation.

4.      The ordering physician contacts patient regarding test results, the availability of the clinical research study and possibility of participation in the study.

5.      The patient’s response is relayed to the investigator regarding participation in the study.

6.      If patient is interested and agrees to be contacted by investigator, investigator may contact patient.

The laboratory ONLY provides to the investigator:

1. The existence of a positive test result
2. The INITIALS of patient and
3. Ordering physician or attending physician’s name

Lab MAY NOT give any other patient-identifying information to the investigator unless directed by the IRB.

The attending/ordering physician/affiliated resident must contact the patient and obtain verbal agreement of patient to be contacted by the investigator about participating in the clinical research study BEFORE providing patient contact information to the investigator.

The investigator may contact the patient only AFTER the attending/ordering physician has contacted the patient and the patient has agreed to be contacted by the investigator regarding participating in the clinical research study.

ELIGIBILITY BY DIAGNOSIS

If clinical condition enables patient eligibility in research study:

1.      The initial evaluating physician (i.e., Emergency Department physician, consultant, pathologist) notes that patient has the clinical condition appropriate for study.

2.      The evaluating physician contacts the investigator with the following information (1) medical condition, (2) the patient’s initials and (3) name of attending/primary physician.

3.      The investigator contacts the attending/primary physician/affiliated resident regarding the study and requests the attending contact the patient for interest in study participation.

4.      The attending/primary physician/affiliated resident contacts the patient regarding the study and the possibility of participation in the study.

5.      The attending/primary physician contacts investigator indicating whether the patient is interested in study and agrees to be contacted by the investigator.

6.      If the patient is interested, and agrees to be contacted by the investigator, the investigator contacts the patient.

Other than patient initials, the evaluating physician may not give patient-identifying information directly to the investigator unless directed by the IRB.

The attending/primary care physician/affiliated resident must contact the patient and obtain verbal agreement of the patient to be contacted by the investigator about participating in the clinical research study BEFORE providing patient contact information to the investigator.

The investigator may contact the patient only AFTER the attending/primary care physician has contacted the patient and the patient has agreed to be contacted by the investigator regarding participating in the clinical research study.

The attending/primary care physician may give the subject information about the study and the investigator’s contact number for the subject to make the initial contact if they are interested in participating.

Advertisements

The IRB shall review any direct advertising to be used in the recruitment of subjects prior to publication.  This includes, but is not limited to, printed advertisement, letters to subjects or care providers, web based advertising and radio or television broadcasts.  Once reviewed, the IRB will stamp the material with an IRB approval date stamp.

Direct advertising information must be submitted to the IRB Committee with the protocol.  The Committee shall have the authority to make recommendations for changes or modifications to the recruitment material.  In reviewing the recruitment material the IRB shall consider the following issues:

·         Information may not be presented in a way that is misleading to potential subjects.

·         The procedure for recruiting subjects may not be coercive.

·         The advertisement may not state or imply a certainty of favorable outcome or other benefits beyond what is described in the approved consent form and protocol.

·         No claim may be stated or implied that a drug, biologic, device or procedure is safe or effective for the purposes under investigation or that a test article is known to be equivalent or superior to any other drug, biologic or device.