Screening Potential Research Subjects

November - December 2019 Issue

Author(s):

• Fanny K. Ennever, PhD
  Research Compliance Officer, Boston Medical Center

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• Introduction
• Consent and Authorization
• Requirements Based on Screening Process
• Protection of Subjects
• Conclusion
• Appendix: INSPIR Sections

Introduction

Screening is the process of collecting information to determine whether a potential subject meets a study’s inclusion and exclusion criteria. The requirements for consent and HIPAA authorization for screening activities differ depending on what information is collected and how it is collected.

Consent and Authorization

In the context of screening, the IRB uses the term “consent” to mean the agreement of the potential subject to provide information. The IRB can waive the requirement for obtaining consent for screening if there is no direct contact with the potential subjects, as discussed in greater detail below. If contact with the potential subjects will occur, the IRB will require use of either Full Consent or a Brief Screening Agreement, depending on the nature of the information obtained. Full Consent uses a consent form that includes all of the consent elements required under the Common Rule, and the IRB may or may not require the subject to sign the form. A Brief Screening Agreement contains a subset of the required elements and the IRB does not require that the agreement be signed.

The requirements for obtaining authorization are based on regulations under the Health Insurance Portability and Accountability Act (HIPAA). Authorization means providing permission for the study team to obtain and use Protected Health Information (PHI) as defined by HIPAA. Again, if there is no direct contact with the potential subjects, the IRB can waive the requirement for HIPAA authorization. If there is contact with potential subjects, the IRB will require authorization. There is no HIPAA equivalent of the Brief Screening Agreement; all authorization elements must be included. The IRB usually requires that the authorization be signed, but can waive the signature if the screening cannot be practicably carried out if a signature is required (e.g., phone screening). It should be noted that the IRB does not use the “prep to research” exclusion from obtaining authorization because PHI used and disclosed under the “prep to research” provision cannot be released outside the covered entity. There is unavoidable ambiguity regarding who is and who is not part of the BMC covered entity, and there are potential penalties for inappropriate release of PHI outside of the covered entity.  Also, if screening involves obtaining information about a potential subject’s HIV testing status, this information can only be made available to members of the BMC workforce prior to the potential subject providing written consent.

In addition to the regulatory requirements, the IRB has an ethical obligation to evaluate the way in which potential subjects are recruited, particularly when the process involves a member of the study team making the initial contact (as opposed to, for example, an ad or brochure providing a number or website for the potential subject to initiate the contact). In general, the IRB expects that first contact with the potential subject be made by someone with whom they have a treatment relationship. The potential subject must be clearly told why they are being approached, how the person contacting them knew that they might be eligible for the study, and that their decision not to answer the screening questions will not affect their treatment in any way. In addition, if recruitment material is to be mailed to potential subjects, the study team must ensure that nothing will be mailed to patients who are on a DO NOT MAIL list. The first question in the Recruitment Procedures/Materials section of INSPIR (see Appendix) must provide sufficient information so that these issues may be evaluated by the IRB.

Requirements Based on Screening Process

The Table below lists the various ways in which information necessary to determine eligibility can be obtained, what is needed in terms of consent and HIPAA, and the sections in INSPIR that need to be completed.

Process for Screening	Consent	HIPAA Authorization	INSPIR Sections (see appendix for question numbers)
Medical Record Review only	Not required	Waiver required	Recruitment – under Screening (15.5), answer No to both questions HIPAA – answer Yes to 17.1 and describe identification of eligible subjects
Phone call without recording any PHI	Brief Screening Agreement	None required	Recruitment – under Screening (15.5), answer No to first question, Yes to second question Screening Procedures – answer all questions; describe secure storage of data in 16.2; describe use of Brief Screening Agreement in 16.3 HIPAA – answer Yes to 17.1 and describe identification of phone call recipients
Phone call with recording of PHI	Screening Questions Full Consent with HIPAA	Partial waiver of HIPAA (no signature)	Recruitment – under Screening (15.5), answer No to first question, Yes to second question Screening Procedures – answer all questions; describe use of Screening Questions Full Consent in 16.3 HIPAA – answer Yes to 17.1 and describe identification of phone call recipients; describe need for obtaining PHI without a signature in 17.9
In person without recording any PHI and without any clinical screening procedures	Brief Screening Agreement	None required	Recruitment – under Screening (15.5), answer No to first question, Yes to second question Screening Procedures – answer all questions; describe secure storage of data in 16.2; describe use of Brief Screening Agreement in 16.3 HIPAA – answer Yes to 17.1 and describe identification of eligible subjects
In person with recording of PHI but without any clinical screening procedures	Screening Questions Full Consent with HIPAA	Obtaining signed HIPAA authorization	Recruitment – under Screening (15.5), answer No to first question, Yes to second question Screening Procedures – answer all questions; describe use of Screening Questions Full Consent in 16.3 HIPAA – answer Yes to 17.1 and describe identification of eligible subjects
In person with clinical screening procedures	Full Consent (use regular consent form template)	Authorization will be in Full Consent if PHI is obtained	Recruitment – under Screening (15.5), answer Yes to both questions Screening Procedures – answer all questions; describe use of Full Consent in third question HIPAA – answer Yes to 17.1 and describe identification of eligible subjects

Protection of Subjects

Screening activities are almost never greater than minimal risk, because screening rarely provides a sufficient benefit to the person being screened to justify any appreciable risk. Screening information, like all study data, must be stored securely, to minimize the risk of having the subjects’ sensitive information revealed outside of the research process. The data security plan must be described in the INSPIR application.

Conclusion

Screening is an integral part of the study design.  It is the investigators’ responsibility to ensure that subjects provide appropriate consent and authorization prior to any screening activities in accordance with the regulations and IRB policies. Even subjects who screened out of a study may have been put at risk due to the research use of information about them. The IRB must ensure that adequate protections are in place to protect these subjects, as well as subjects who ultimately participate in all study interventions.

Appendix: INSPIR Sections

(*Note that the section numbers will differ depending on the type of application)

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