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?
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)
This type of recruitment is strongly discouraged by our IRB.
What is cold calling?
This is where you can find all policies set forth by the institution.
What is PolicyStat?
Our IRB does not allow this population to be recruited via MyChart.
Who are children / minors?
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?
This waiver can be considered if a study involves only remote recruitment, survey, and chart review procedures.
What is an alteration of HIPAA Waiver?
All advertisement recruitment materials must include this word.
What is "Research" ?
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?
This approval is required when new study uses ionizing radiation for research purposes outside of standard of care.
Who is Radiation Safety?
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?
These projects are designed to evaluate outcomes and determine appropriate institutional clinical, practical or administrative practices.
What is Quality Improvement (QI)?
This should not be listed as a talking point in the phone script.
What is compensation?
This department is contacted when a protocol is storing data on an un-approved method of data storage.
Who is Research IT?
This hospital cannot be added as a research location if the study is examining birth control methods, preventing contraception, etc.
What is Saint Johns?
Per the Federal Regulations children, pregnant women and prisoners are considered to be this type of study population.
What is a vulnerable population?
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)?
This is the character limit on the MyChart recruitment description.
What is 1000 characters?
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?
This template cannot be used for a new AI study.
What is the chart review protocol template?
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?
This is needed when a study is administering a non-FDA approved drug for treatment only.
What is an IND?
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?
This electronic system is our preferred storage method for research data.
What is REDCap?
What is a suicide risk mitigation plan?