Pre-screening vs screening: where consent draws the line

What is the difference between pre-screening and screening?

Pre-screening happens before a person signs a consent form. NIH's Office of Human Subjects Research Protections describes its purpose as finding out whether someone might qualify and is interested. Screening to determine further eligibility happens after consent, unless the IRB waives it.^⁠[1] UMBC's IRB adds that pre-screening may not include research procedures.^⁠[2]

Both stages are part of recruitment and need IRB oversight.^⁠[3] FDA says the IRB should receive a written outline of the screening procedure and how screening consent will be obtained.^⁠[4] ICH E6(R3) lists the "mechanism for pre-screening, where appropriate, and screening of participants" as protocol content.^⁠[16]

What can happen before consent?

Can staff review charts before consent?

For research under the Common Rule, 45 CFR 46.116(g) lets an IRB approve obtaining information to screen, recruit or determine eligibility without consent. That covers talking with the prospective subject and accessing records or stored identifiable biospecimens.^⁠[7] The 2017 final rule calls this an exception to consent, not a waiver, so the IRB no longer has to waive consent first.^⁠[8]

FDA's regulations have no provision worded like 46.116(g). Its 2023 informed consent guidance says reviewing records for eligibility, and recording limited information, is preparation for a clinical investigation and needs no consent under FDA rules. If the record lacks what is needed, consent may be required before collecting more.^⁠[6] Results of procedures done for routine care may be used for eligibility.^⁠[4]

HIPAA offers two common pathways. One is a review preparatory to research under 45 CFR 164.512(i)(1)(ii): the researcher represents that the review is only to prepare a protocol or for a similar purpose, that no PHI will leave the covered entity, and that the PHI is necessary. The other is a waiver of authorization, in whole or in part, approved by an IRB or privacy board under 164.512(i)(1)(i).^⁠[9] The right one can depend on who does the review; the IRB and HIPAA outreach guide covers the choice.

What can a pre-screening call ask?

A scripted call or text about diagnoses, medications or willingness to travel is pre-screening, and the script goes to the IRB first. FDA treats recruitment advertising as the start of the consent process and expects the IRB to confirm that phone screening scripts protect prospective subjects and handle sensitive information properly.^⁠[5]

Collect as little as the decision needs: health history gathered by phone creates new protected health information.^⁠[3] NIH OHSRP's guidance is that identifiable data collected before consent cannot be kept if the person is ineligible.^⁠[1]

What requires consent?

Any clinical procedure performed only to determine research eligibility needs informed consent first, including withdrawal from medication.^⁠[4] The basis is 21 CFR 50.20: no one may be a subject in FDA-regulated research without legally effective informed consent, apart from narrow exceptions.^⁠[10] For drug studies under an IND, 21 CFR 312.62(b) requires each subject's case history to document that consent came before participation.^⁠[11]

• Blood draws, ECGs, imaging or biopsies ordered because the protocol requires them, not because clinical care does.
• Stopping, changing or starting a medication to meet an eligibility window.
• Collecting information the chart does not hold and the approved pre-screening questions do not cover. FDA says this may require consent.^⁠[6]

Consent for screening is not always the full study consent. For screening tests that are minimal risk and would not need written consent outside research, FDA lets the IRB decide that subjects need not sign a consent document.^⁠[4] Some sites use a separate screening consent. WCG, a central IRB, advises that it describe the tests, why they are needed and the study in brief.^⁠[12]

Who counts as a screen failure?

University of Miami IRB guidance defines a screen failure as someone who consented and then failed eligibility criteria on screening procedures done after consent.^⁠[3] Some sponsor protocols widen it to anyone who consents but is not randomized, as GSK protocol 213744 does.^⁠[13]

Under the consent-based definition, a person ruled out at pre-screening is not a screen failure. Counting them as one inflates the screen failure rate and hides where candidates are lost.

The two rates use different denominators: the Indian audit counted every patient on its screening logs, and the French study counted only consented patients.^⁠[14],[15] The audit's leading reasons were not meeting inclusion criteria (54.9%) and declining treatment (22.2%).^⁠[14] Compare rates only when denominators match, and check how many of your own inclusion failures the chart already showed. See how to reduce screen failure for tactics.

What should pre-screening and screening logs record?

ICH E6(R3) lists a completed participant screening log, plus records of the recruitment, pre-trial screening and consent process, as essential records.^⁠[16] FDA published E6(R3) as final guidance in September 2025.^⁠[17] FDA inspectors collect screening and enrollment logs and confirm the counts match the subjects screened and enrolled.^⁠[18]

A pre-screening log can hold counts rather than names. NIMH's template covers everyone who completed a phone or online screen, typically before consent, and records how many were eligible for a screening visit, how many were not, and why.^⁠[19] University of Miami guidance says keeping identifiable details on people ruled out needs a HIPAA authorization or an IRB waiver of authorization.^⁠[3] Without one, key each row to a pre-screen number, not a name.

• Candidate source: chart query, referral, advertisement or registry.
• Date identified and date first contacted.
• Pre-screen outcome: eligible for a screening visit, ineligible, not interested or unreachable.
• Reason for exclusion, tied to the protocol criterion it failed.
• Consent date, which opens the screening log entry.
• Screening outcome: randomized, screen failure with reason, or withdrawn.

How do you measure each stage?

Measure the stages separately. Pre-screen yield is candidates sent to a screening visit divided by candidates pre-screened. The screen failure rate is screen failures divided by people consented. Falling yield suggests the chart query is too broad. A rising screen failure rate suggests pre-screening is missing a criterion.

Who pays for pre-screening and screening?

Pre-screening is staff time, not a billable clinical service, so the study budget has to cover it.

Medicare's clinical trial policy, NCD 310.1, covers routine costs in qualifying trials. Routine costs include conventional care that would happen without the trial and treatment of complications. They exclude the investigational item, items provided solely for data collection and analysis that are not used in the patient's clinical management, and items the sponsor usually provides free.^⁠[20]

A Medicare coverage analysis applies that policy to the protocol and assigns each billable service a path: routine cost billed to insurance, or research-only paid by the sponsor. USC's Keck School of Medicine requires one for any trial with billable patient-care services, even if no Medicare beneficiaries are expected.^⁠[21] Under the data-collection exclusion, a test needed only for eligibility usually lands on the research-only side.

How do Bond's stages map to pre-screening and screening?

Bond Health works before consent and supports the consent step; the site keeps screening and obtains consent. Bond signs a business associate agreement, and the site's HIPAA pathway and IRB approvals still set what outreach may happen.^⁠[24]

Bond's dashboard reports patients matched, contacted, pre-screened, consented and randomized, the stage counts a pre-screening log needs, and keeps an audit trail.^⁠[24] Full EHR integration typically takes 48 hours, depending on the EHR and IT review.^⁠[24] Implementation and security explain how a deployment is set up.

What should I do this week?

• Write down which HIPAA pathway your site uses for chart pre-screening and who it covers.
• Check that coordinators ask only what each study's IRB-approved pre-screening script contains. No script yet? Start from the pre-screening call script.
• For each active study, compare a recent consent date with the first protocol-only procedure date.
• Split the logs: pre-screen exclusions on one, consented screen failures on the other, each with a protocol-criterion reason.
• Confirm each study's coverage analysis and budget say who pays for eligibility-only tests and screen failure visits.
• Review your most recent screen failures and mark the ones the chart could have predicted.