Research Participants
Regulatory Considerations
Recruitment
There's a Policy for That!
Institution Specific
200

Persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction which the research will be conducted.

What are children / minors?

200

An investigator must follow this timeframe for storing consent forms, IRB correspondence, and research records.

What is a minimum of three years after study completion? (UH IRB Policy)

200

This type of recruitment is strongly discouraged by our IRB.

What is cold calling?

200

This is where you can find all policies set forth by the institution.

What is PolicyStat?

200

Our IRB does not allow this population to be recruited via MyChart.

Who are children / minors?

400

An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

What is a Legally Authorized Representative?

400

This waiver can be considered if a study involves only remote recruitment, survey, and chart review procedures. 

What is an alteration of HIPAA Waiver?

400

All advertisement recruitment materials must include this word.

What is "Research" ?

400

This policy is sent to study team that wants to enroll over 500 subjects and share data outside of the institution. 

What is IS-22?

400

This approval is required when new study uses ionizing radiation for research purposes outside of standard of care.

Who is Radiation Safety?

600

People who are involuntarily being held in a jail, prison, juvenile justice center, treatment or other facility or who have been detained while awaiting arraignment, trial, or sentencing.

What are prisoners?

600

These projects are designed to evaluate outcomes and determine appropriate institutional clinical, practical or administrative practices.

What is Quality Improvement (QI)?

600

This should not be listed as a talking point in the phone script.

What is compensation?

600

This department is contacted when a protocol is storing data on an un-approved method of data storage.

Who is Research IT?

600

This hospital cannot be added as a research location if the study is examining birth control methods, preventing contraception, etc.

What is Saint Johns?

800

Per the Federal Regulations children, pregnant women and prisoners are considered to be this type of study population.

What is a vulnerable population?

800

This is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.

What is a Humanitarian Use Device (HUD)?

800

This is the character limit on the MyChart recruitment description.

What is 1000 characters?

800

An ancillary review should be sent to Pediatrics if minors are involved in the study and the primary department does not include these.

What is pediatrics or psychiatry?

800

This template cannot be used for a new AI study.

What is the chart review protocol template?

1000

When persons under the direct supervision of the Principal Investigator are the ones participating in the research, this type of influence should be evaluated by the IRB.

What is coercion or undue influence?

1000

This is needed when a study is administering a non-FDA approved drug for treatment only.

What is an IND?

1000

When pre-screening questions to determine eligibility are a necessary component of phone recruitment, these items must be directly relate to what part of the Protocol?

What is the inclusion or exclusion criteria?

1000

This electronic system is our preferred storage method for research data.

What is REDCap?

1000
This must be added to a study if it includes formal depression screening.

What is a suicide risk mitigation plan?

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