Screening potential participants is essential to the successful recruitment to a research study. This is the process by which the research team determines whether an individual may be an appropriate candidate for the study.
If the research study requires the screening of protected health information (PHI) prior to making initial contact with the potential participant, a Partial Waiver of HIPAA Authorization is required at the time of IRB initial submission. The Partial Waiver allows the research team to identify, and if appropriate, contact potential participants regarding the possibility of participating in the research study. Full HIPAA Waivers can be requested, but there are very strict guidelines as to the type of research studies that qualify for this request. These are typically retrospective, de-identified chart review studies.
Access to PHI for a study must be requested and approved by the HIPAA Privacy Officer. For studies that have received a partial or full Waiver of HIPAA Authorization, the research team will then need to request access to the actual databases or electronic medical records. To request access to these systems, visitehelpDesk. Once the account modification form is submitted, the request is forwarded to the OSU Health System Privacy Office. This office will verify that the research individual has the authorization to access the databases or medical records. Additionally, the office may verify the location of the stored data and the completion of CITI and HIPAA training.
Most research studies require the participant to sign the HIPAA Authorization form at the time of signing the informed consent. It is important to note that the consent must be signed prior to the initiation of any research specific testing/procedure or completion of study specific questionnaires that may qualify as participation in the research study. In other words, informed consent must be obtained before anything is done to a potential participant that is not deemed standard of care for the patient diagnosis and only done for the purposes of determining patient eligibility for enrollment in the research study.
The Privacy Rule allows activities “prepatory to research”. The rule allows research teams to identify the feasibility of conducting a specific research study. This is merely an exploratory process and does not allow the collection of PHI or allow the research teams to actively identify and recruit individuals for a study.
- ORRP HIPAA and Human Subjects http://orrp.osu.edu/irb/hipaa/index.cfm
- OSUMC Joint Notice of Privacy Practices http://medicalcenter.osu.edu/pdfs/privacy/HIPAA_HealthSys.pdf
- OSUMC Summary Notice and Acknowledgement http://medicalcenter.osu.edu/pdfs/privacy/AcknowledgementForm2008.pdf
Participants enrolled in a research study should represent the selected patient population identified for analysis. Each research protocol should include defined inclusion and exclusion criteria to allow clear identification of appropriate study participants. The study team should be well acquainted with the details and requirements of eligibility for their research study. Eligibility criteria must be strictly followed to ensure that ineligible participants are not enrolled and exposed to unnecessary risk and so that the final data points can be analyzed without compounding variables. All information provided by the potential participant and source documents must be reviewed to identify all important elements that may or may not make the patient eligible for the research study.
Enrolling ineligible subjects is considered to be a compliance violation of the currently approved IRB protocol (investigational plan), GCP guidance, federal regulations, and the Statement of the Investigator (FDA Form 1572). If specific eligibility criteria are negatively impacting recruitment and enrollment of participants, it is recommended that the study team evaluate the possibility of amending the protocol to allow for more flexible eligibility criteria. Accepting waivers for eligibility from sponsors for anything other than eliminating the apparent and immediate hazard to research participants is also considered to be a compliance violation.
- ICH E6 Good Clinical Practice http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf
- FDA : 21 CFR 312.70 General Responsibilities of Investigators http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
- ORRP: Noncompliance http://orrp.osu.edu/irb/osupolicies/documents/Noncompliance.pdf
Initial Screening of Medical Patients
For interventional research studies such as drug and device trials, the treating medical team often will briefly screen patients for potential participation on research studies. They will then enlist the assistance of the research team to consent the subjects and obtain HIPAA Waiver of Authority. This will allow the research team to review the subject’s medical records in detail and assist in determining eligibility. Once consent is obtained, specific research tests or procedures for determining eligibility for the study can then be conducted. It is important to inform a potential participant that although they consented to the research study, eligibility must be checked and verified prior to enrollment on the study. There is still a possibility that potential subjects may not ultimately be eligible and thus cannot participate in the research study.
It is helpful to have at least two members of the research team review and confirm eligibility of the participant to reduce the chances of accidentally enrolling an ineligible participant.
- ORRP:Recruiting Methods, Recruitment Material and Particpant Compensation http://orrp.osu.edu/irb/osupolicies/documents/RecruitingMethods.pdf
A screening log is a helpful tool that the research team can utilize to track why individuals are not eligible for a research study. It allows for easy identification of the specific criteria that may be negatively impacting participant enrollment. Many sponsors require a site to maintain a screening log. It is important to note that unless an individual signs the consent and HIPAA Waiver of Authorization, the potential participant information must be de-identified.