Quick Links
Connect with Us
Need Help? Have a Question?

Identify and Enroll Eligible Participants

Identify and Enroll Eligible Participants

The key steps involved with identifying and enrolling eligible participants include the following:

Pre-screen Records to Identify Eligible Participants

Pre-screen Records to Identify Eligible Participants

If you are using Epic or ORCA to identify possible subjects to approach for research, you should have IRB approval of a Waiver of HIPAA Authorization (and if the University of Washington is the Institutional Review Board reviewing the project, a Waiver of Informed Consent as well).

If you access patient medical information for research purposes under an IRB-approved HIPAA waiver, you must record and submit records of the dates and purposes of these disclosures to UW Medicine Compliance via the UW Medicine Disclosure Accounting online database.

UW MEDICINE COMPLIANCE
(206) 543-3098 | comply@uw.edu
Accounting of Disclosures
Use & Disclosure of Protected Health Information for Research
Accounting of Disclosures of Protected Health Information

You may also find it helpful to talk with an ITHS biomedical informatics consultant about leveraging medical records to identify potential participants. Visit the ITHS biomedical informatics web page to learn more.

Recruitment and Informed Consent

Recruitment and Informed Consent

Recruitment is often an iterative process. It is a good idea to document the effectiveness of individual recruitment techniques in case they are not working. You can use this data to change course later if needed.

Some funding agencies and industry sponsors require that you submit a list of potential participants screened as part of the recruitment process, along with documentation of why ineligible individuals did not meet study criteria. They may provide you with a screening log to submit, or you may need to create your own.

Once you have confirmed that an individual is interested in learning more about the study, you can proceed to conduct informed consent discussion. You will need to obtain documentation of informed consent as required by the Institutional Review Board-approved consent procedures. There may be multiple consent and assent forms, along with translated consent forms, depending on the study population. It may be necessary to tailor your consent discussion for each population involved, and to arrange for interpretation services.

Provide copies of the signed consent and HIPAA forms to participants, but keep the originals in your files. Check your Institutional Review Board approval to see if you described how to file documents that contain participant identifiers, and follow the process as approved.

Screening to Confirm Eligibility

Screening to Confirm Eligibility

Once a participant has provided informed consent for your study, check their information against the eligibility criteria to ensure they continue to qualify to participate in the study. If still eligible, proceed with any protocol-required screening procedures.

Once you confirm the participant can continue in the study, you can assign them a study identification code.

If the University of Washington Clinical Research Budget & Billing support office was involved in finalizing your budget, notify them of subject enrollment. See budget steps in the “Set Up the Study” section for more details on budget set up.

If you are working with an industry sponsor, you may need to notify them of enrollment and discuss study invoicing needs with your department fiscal specialist.

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.