IRB Issues for Medical IRB Issues for Medical Education ResearchEducation Research

Elizabeth L. Hohmann MDElizabeth L. Hohmann MD

Physician Director Physician Director

Partners IRBs. Partners IRBs.

Research, but not human subjects Research, but not human subjects research?research?

Publically available de-identified data sets. Publically available de-identified data sets. External consulting on anonymous datasets. External consulting on anonymous datasets. Data or samples obtained with NO LINKS to Data or samples obtained with NO LINKS to human subjects, collected independently for human subjects, collected independently for some other reason. some other reason. – 10 PTT’s from hematology with ALL numbers 10 PTT’s from hematology with ALL numbers

stripped; no way to get any info on subjects. stripped; no way to get any info on subjects. – Board performance data provided with no linksBoard performance data provided with no links– PFT data provided with no links to individual humansPFT data provided with no links to individual humans– MD orders before and after a formulary change madeMD orders before and after a formulary change made– These were collected for some other purpose, there is These were collected for some other purpose, there is

no research-specific interaction with a subject.no research-specific interaction with a subject.

Is it human subjects research?Is it human subjects research?

Systematic collection of dataSystematic collection of dataAbout identifiable human subjectsAbout identifiable human subjectsFrequently externally funded with specific Frequently externally funded with specific research goals or aims. research goals or aims. To generate generalizable knowledgeTo generate generalizable knowledge– Publication Publication – Presentation outside institutionPresentation outside institution– Changing practice WIDELY. Changing practice WIDELY.

SPIN and USE MATTERS! SPIN and USE MATTERS!

Is it Quality Improvement?Is it Quality Improvement?Looking at things known to work.Looking at things known to work.Striving to meet known national standards Striving to meet known national standards or guidelines, typically. or guidelines, typically. Generally for INTERNAL use, often ongoingGenerally for INTERNAL use, often ongoingGenerally part of hospital programs, Generally part of hospital programs, sanctioned by, and required as part of one’s sanctioned by, and required as part of one’s employment – therefore not optional.employment – therefore not optional.MAY involve review of records or identifiable MAY involve review of records or identifiable individuals including patients. individuals including patients. Generally not externally funded. Generally not externally funded.

Humans Subject Research, but Humans Subject Research, but exempt from IRB reviewexempt from IRB review

There is There is an interactionan interaction with an identifiable with an identifiable human, or identifiable human data but:human, or identifiable human data but:– You You don’t record any identifiersdon’t record any identifiers..– Assesses a govt. program like MedicaidAssesses a govt. program like Medicaid– It’s a totally anonymous or completely non -It’s a totally anonymous or completely non -

sensitive survey if identifiable. sensitive survey if identifiable. – Involves taste/food qualityInvolves taste/food quality– It’s a standard educational assessment IN an It’s a standard educational assessment IN an

educational setting/program (NOT pts.)educational setting/program (NOT pts.)NOT new unproven educational programs. NOT new unproven educational programs.

What is peer review? What is peer review?

Narrowly focused, specific activities. Narrowly focused, specific activities.

Generally sanctioned by hospital and Generally sanctioned by hospital and Office of General Counsel. Office of General Counsel.

Shielded from some disclosures.Shielded from some disclosures.

IRB process/Internal Audit is NOT a peer IRB process/Internal Audit is NOT a peer review process (we tried). review process (we tried).

Just calling it that does not cut it! Just calling it that does not cut it!

Who decides?Who decides?

Quality - you can – see IRB website. Quality - you can – see IRB website.

Not HSR – you can, but you better not Not HSR – you can, but you better not make mistakes!make mistakes!

Peer review – requires legal to agree.Peer review – requires legal to agree.

Human subjects research that is exempt Human subjects research that is exempt from IRB review – only the IRB decides:from IRB review – only the IRB decides:– Federal Regulations/GuidanceFederal Regulations/Guidance– Institutional POLICY. Institutional POLICY.

AdviceAdvice

Bottom linesBottom lines– Funded as a research project – GET IRB Funded as a research project – GET IRB

APPROVAL.APPROVAL.– Err on the side of cautionErr on the side of caution– Ask if you’re uncertainAsk if you’re uncertain– Define your hope/expectation in a cover letterDefine your hope/expectation in a cover letter– A formal submission is best – exemption letterA formal submission is best – exemption letter– If you markedly change the project, you If you markedly change the project, you must return to us for another opinion.must return to us for another opinion.

**IF HMS ONLY as subjects, esp if someone at **IF HMS ONLY as subjects, esp if someone at HMS/Deans – prefer to send to HMS IRB. HMS/Deans – prefer to send to HMS IRB.

Can you publish Quality?Can you publish Quality?

Yes, you can. Yes, you can.

You should call it publication of a data You should call it publication of a data from a quality initiative. from a quality initiative.

You should not state it was IRB approved You should not state it was IRB approved unless it was! unless it was!

Rarely we are asked to formally state for Rarely we are asked to formally state for editors – don’t encourage that!editors – don’t encourage that!

Some Hot Button IssuesSome Hot Button Issues

Assessments of competence that affect Assessments of competence that affect employability.employability.

Illegal behaviors – drug/alcohol use, fatigue, Illegal behaviors – drug/alcohol use, fatigue, or near misses.or near misses.

Peer access to data – resident projects?Peer access to data – resident projects?

Remedial placements, schedule - ?validatedRemedial placements, schedule - ?validated

Inappropriate electronic data transmission?Inappropriate electronic data transmission?

Obviating voluntary ACTIVE participation.Obviating voluntary ACTIVE participation.

Deception or inadequate disclosure. Deception or inadequate disclosure. – What would annoy, if found out post hoc?What would annoy, if found out post hoc?

What is “sensitive?”Anything involving drug or alcohol use. Anything involving illegal behaviors.Virtually anything involving psychiatry.HIV testing –special state laws; geneticsMost things involving employability or performance evals (esp if outside usual norms for the job).Reporting others’ performance – esp if negativeVideo, audio, other recording, esp where not anticipated. For many of these might consider C of C.