Screening for Research Studies
When researchers conduct a study, they must make sure that people who join are eligible. To do this, they usually use two steps: pre-screening and screening.
When researchers conduct a study, they must make sure that people who join are eligible. To do this, they usually use two steps: pre-screening and screening.
Key Points
- Both pre-screening and screening must be described in the study protocol.
- The IRB must review and approve these procedures and instruments that will be used before they begin.
- Researchers should collect only the minimum information needed to determine eligibility for the research study.
- Privacy and confidentiality must always be protected.
Pre-Screening
Pre-screening happens before a person signs a consent form. Its purpose is to see if someone might qualify and is interested in the study.
Pre-screening can be done by phone, in person, or online. It must not include research procedures.
What Is Allowed During Pre-Screening?
Only minimal and necessary information needed to see if the individual meets inclusion criteria can be collected such as:
- Age
- Sex (if relevant to the study)
- Confirmation of diagnosis of the condition being investigated, if applicable.
- Ability to travel to the study site
- Availability for study visits
Pre-Screening Activities Prior to Consent: Protocols Approved Under the Pre - 2018 Common Rule vs. 2018 Common Rule
Pre-2018 Common Rule
Pre-screening activities require either
- Informed consent from the individual as approved by the IRB (with or without a waiver of documentation of consent), or
- IRB approved waiver of informed consent.
2018 Common Rule
The IRB can approve research for which an investigator will obtain information or specimens for screening, recruiting, or determining the eligibility of prospective subjects without the informed consent if the investigator will:
- Obtain information through oral or written communication with the prospective subject/LAR or
- Obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Examples of allowed pre-screening activities before consent is obtained (under the 2018 Common Rule)
- Email, written, in-person, or telephone communication to obtain basic information as specified above
- Reviewing existing medical records
- Reviewing existing MRI, X-ray, or CT images
- Reviewing existing photographs or videos
- Reviewing existing pathology reports or specimens collected for diagnostic (not research) purposes
Examples of pre-screening activities that are not permitted
- Any research procedures
- Collection of any new biospecimens (like drawing blood)
- Full eligibility testing
- Collecting unnecessary private information
- Collection of health information beyond confirmation of condition being studied.
IRB Review of Pre-screening Activities
- Pre-screening activities must be described in the protocol.
- Screening tools must be reviewed by the IRB.
During pre-screening you should:
- Explain that the questions are being asked to see if the person qualifies.
- Record identifiable contact information only If pre-screening indicates that the person seems to be eligible and is interested.
- Destroy or remove identifying information if the person does not enroll.
Screening
Screening to determine further eligibility happens after consent is obtained (unless waived by the IRB).
Screening activities must be approved by the IRB and can be conducted two ways.
Protocol specific screening (Preferred)
- Screening is done under an individual protocol
- Includes only screening activities needed to confirm eligibility for that study.
General screening protocol (less ideal)
- Collects information that is used for determining eligibility for other studies.
- Individuals may have procedures done that are not necessary to determine eligibility for a given protocol.
- The protocol and consent form must explain that information may be shared with other investigators.
- Other studies must explain they are using information from the general screening protocol to determine eligibility
Examples of Screening Activities Described in Protocol and Consent
- Reviewing clinical or research records
- Physical exams
- Drawing blood or other biospecimens for lab tests needed to determine eligibility only
- Questionnaires
- Interviews
- Screening tools or scripts
- CT or MRI scans
- Confirmation of pathology
Screening Materials Must be Submitted for Prospective IRB Approval
Any formal questionnaires or interviews used as part of screening to determine eligibility should include the actual questions that will be asked.
- These materials should explain the purpose of the questions that will be asked.
- If applicable, inform the participant that some of the questions may be sensitive and may make them feel uncomfortable, and they do not have to answer any question they do not want to answer.
- A statement should be included to let the participant know if they qualify for the study or not or, alternatively, when they will be contacted with this information (e.g., after results of a blood test required for screening are available).
Key Differences Between Pre-Screening and Screening
Pre-Screening
Happens before consent
Minimal risk activities only
No new testing or biospecimen collection
Determines initial eligibility and interest
Limited information collected
Screening
Happens after consent
Includes research procedures needed to determine eligibility
May include tests and biospecimen collection needed to determine eligibility
Confirms full eligibility
More detailed information collected
Screen Failures
If someone is screened and found to be not eligible:
- Identifiable data collected before consent cannot be kept.
- Data collected after consent may be kept if this was explained in the consent form.
Summary
Pre-screening is a very limited step before consent to see if someone might qualify and is interested. It only allows minimal risk activities.
Screening happens after consent and includes specific research activities to confirm eligibility.