IRB Issues for Bench and Desk Scientists

Transcription

1 IRB Issues for Bench and Desk Scientists Elizabeth L. Hohmann MD Chair and Physician Director, Partners IRBs, BWH and MGH Associate Professor of Medicine/ID Massachusetts General Hospital

2 Case example Researcher wants to obtain samples of pituitary tumor from the OR, from pts with Acromegaly Fresh sample must be used to grow new cell line. Neurosurgeon is on the study team. A waiver of consent is requested. Can this be done?

3 Answers This can be done with IRB approval. It CANNOT be done without IRB approval. Pathology has to complete its work first Does not qualify for waiver of consent surgeon can certainly ask. Tiny specimen issue, small cell issue The IRB is going to ask some questions. We have had some mistakes where samples have gone awry. Best to have an ICF in the chart here. CARE TEACHING RESEARCH

4 Today s Topics Jurisdiction and authority IRB Processes Expedited vs. Full review Minimal Risk Samples and Records Some mistakes to avoid Quality vs Research Privacy matters I m not going to show you how to work Insight!

5 IRB reviews Human Subjects Research Defined as, by federal law: systematic collection and dissemination of data from or about living human subjects This is a very broad definition!

6 Why do I need to bother? It s: Only my patients. Just a retrospective review. No industry funding. Only a questionnaire. It s just x-rays Only blood from our lab techs and students.

7 Because Federal Law says so! We receive federal funds. The hospitals commit to reviewing and conducting all research at the same standard, with IRB review, regardless of funding. (=F.W.A.) Federal law has PROBABLY changed on Jan 19, 2017!

8 IRB Jurisdiction We must review, unless we decline to: Work done by our people Work done on our property Work done with money granted to us by federal agencies or others These mean we are ENGAGED Any IRB Review does not cut it! Increasingly we are cede-ing review You cannot go shopping for an IRB. Our IRB is accredited.

9 IRB review is PROSPECTIVE not retrospective! Mistake # 1 Whining to the IRB when a journal editor asks for an IRB review statement and you don t have one! Ignorance of the law..

10 IRB Processes Expedited Review Meets criteria for minimal risk. Not your definition the government s. Done by a chairperson on behalf of the committee committee notified. MD, RN, and PhD doing this at offices. Full Committee Review More than minimal risk. Special pops. Panel of 25 peers considers complete proposal don t embarrass yourself.

11 IRB Actions Approval Requires modification - minor changes. Deferral - Need significantly more info and has to go back to the reviewing scientific chairperson or complete panel. Disapproval (a chair alone can t do this!) These IRB actions apply to all reviews Your approval clock starts ticking at the time you get a requires modification action

12 IRB panels MGH 3 panels BWH 4 panels DFCI 3 panels We ARE the IRB for: Faulkner, NSMC, McLean Spaulding and IHP (01/17) Shriner s Burns Partners in Health PCHI some Planned Parenthood of MA Ceded review for Cancer Tx Only cancer pts ASK FIRST!

13 Inter-institutional Agreements Boston friends Newton-Wellesley HSPH Harvard University HMS Mass Eye and Ear BIDMC Children s Hosp. Joslin Diabetes Cambridge Health BU CTSA = Harvard Catalyst Agreement Mistake #2: You CANNOT assume one IRB can cover all you need to ask the relevant IRBs! We cede review on low risk studies, or where small component at one Harvard site. Mistake #3: Asking us to make an IIA with Iowa State.

14 Cede Review to OTHER IRBs Maria Sundquist point person Phase 2-4 Industry sponsored multicenter studies. NIH has mandated (Sept 2017) OHRP has mandated - domestic Most expedited studies simpler and faster to do your own!!

15 Minimal Risk Defined in the federal regs specifically. Please do not use this term in the vernacular in your submissions. don t call skin biopsy or x-ray minimal risk. No risk also not recommended; maybe there is no physical risk. Why do you care? No full committee = much faster, very expert. Shoehorn it into Minimal Risk if possible

16 NOT minimal risk per regs Anything involving ionizing radiation even: CXR or extra view of knee when knee x-rayed. Anything involving sedation or more Any administration of an investigational d/d. Many off label uses of approved drugs MOST things involving randomization to one or another treatment plan Full panel: Copy, assign, distribute, meet, write, send.

17 Minimal risk Phase IV studies of approved drugs and devices Observational Approved use Devices without an IDE; i.e. marketed, or Blood draws from healthy people 550/8wk/2x per wk Other people: < 50 ml in 8 wk or 3cc/kg Samples: Urine, saliva, placenta, sputum, hair Data: noninvasive routine clinical exams Data collected for other reasons

18 More minimal risk Characteristics, perceptions, beliefs: e.g. questionnaires, focus groups. Voice, video, digital, image recordings. Moderate exercise (assess health of subjects). U/S, MRI on FDAapproved devices, Doppler, EKG, EEG, Echo, MEG, TMS, Acupuncture

19 What is exemption and why request exemption? Human subjects research but so low level that we exempt if from further review going forward. Does need initial review by us, but no ongoing continuing reviews! Please note that you cannot alter the project substantively! If you do, you are obligated to return to us for an additional determination. Amendments are now possible.

20 EXEMPT from IRB review, at discretion of the IRB. 45 CFR Six formal exemptions. Standard educational assessments or tests in educational settings (not pts). Anonymous surveys, or surveys where no risk to privacy, no sensitive information, i.e. Sex, drugs, abuse, psych, ID, employ/standing NO KIDS HERE Existing data/samples with NO LINK TO PT, publicly available data. (exemption #4) Public service benefits/programs * those under the Social Security Act Medicare. NEW EXEMPTIONS

21 Common expedited protocols: NPC! Excess Human Materials/Health info Health Info only = Medical Records Secondary Use of Research Samples Tissue or Data repository (some may have pt contact = OK) Quality Improv mt vs. Research long story See our website under guidance!

22 Waiver of consent? If no pt contact, is a waiver of pt consent appropriate? Maybe. Specimens Op consent, BRIEFLY Records - HIPAA form, BRIEFLY These clinical documents discuss our uses of these for non-care activities of an AMC, i.e. teaching and research, but these stmts don t meet legal criteria for Informed Consent in the research context! If you re interacting with a pt generally you need to get their consent

23 EIGHT Criteria for Waiver- HIPAA and 45 CFR 46 IRB must find AND document that: No more than minimal risk to subject Won t affect rights/welfare Could not practically be carried out without a waiver Notification afterwards when relevant or when the IRB requires. No more than min. risk to PRIVACY Plan to protect from disclosure/misuse Plan to destroy ID at earliest opportunity Investigator provides written assurance of no reuse/disclosures Mistake #5: you re doing something and pt is in front of you.

24 Might verbal consent work? Sometimes called implied consent Written documentation of consent, i.e. a signature, is waived, but consent IS given. People still provide informed consent. IRB can require statement or letter Examples: One time blood draw/no record review Simple questionnaires Urine sample Trivial clinical intervention (BP)

25 Info sheet/cover letter What? Why? Who? How long? Payment? Privacy? Questions? KISS Big font Write for a 9 th grade reader No complex sentence structures or medical terminology! One page!

26 What are medical records? Hospital paper records. Your clinic s charts/research records. All EPIC data. Your personal clinical database Just my OWN patients. Pathology records. X-rays themselves and other test results. MRI or other computerized image data. Single case reporting vs case series see policy at website.

27 Sample and data labeling Do not use names, birthdates or SSNs. Use a code number. We prefer you not incorp. initials. A code number is an IDENTIFIER. Scrub identifiers from materials whenever no longer needed. Locked files and locked offices. Standard password protections.

28 Definitions and preferred terminology Directly identifiable- names, MRNs, DOB s on the tube Indirectly identifiable = CODED code number, elsewhere linked to name and a specific human Not identifiable = No one anywhere can link it to a subject. (= truly anonymized)

29 Ambiguous terms Anonymous bad, as does not clarify to whom it is anonymous maybe not everybody! De-identified per HIPAA? Or more? All HIPAA identifiers removed but can still be coded and indirectly identifiable. Please use terms on preceeding slide for clarity

30 1 minute HIPAA refresher 18 HIPAA identifiers SSN, DOB, Address, zip code, VIN, Internet address, etc. If you remove all 18 and has a code number, it can be shared with others without invoking HIPAA LDS dates and zip codes DUA If you send HIPAA data elements outside without authorization tracking needed. All ICF s have HIPAA disclosure section in them! You re HIPAA compliant! HIPAA de-identified and coded is.. still subject to IRB regs!

31 Sending samples/data off site? An intellectual collaboration is required; no tissue/data for dollars Materials transfer agreement is needed if to commercial/for profit entity (MTA); LOA for academic. Samples should NEVER be identifiable to collaborators off site; coded is OK. C of I issues must be considered.

32 Other expedited protocols: Patient contact! Blood draws, other sample collection Physical exams/observation Non-invasive imaging without ionizing radiation, e.g. MRI, fmri Questionnaires, surveys, registries Usually have a written consent form NB Insight or e-irb differentiates these at outset; You are interacting with a subject.

33 Research Databases -1 Database part of existing, consented interventional protocol - NO separate approval. Database to manage a retrospective medical records project - NO separate approval. Database which is a bigger research tool for multiple people - needs separate approval as database protocol, e.g. MGH IBD Database Special pathway for this too in Insight!

34 Databases - 2 Purpose. Procedures. Data collected (submit forms, fields, questionnaires). Confidentiality precautions (coding, access, password protection etc). Consent vs. no consent: either is possible No marketing from databases. No Trojan Horses! Database may be large enough to spawn multiple new projects/queries - Lump these. Update at CR as to studies completed/planned.

35 Databases - 3 Databases for recruiting: A. OK to keep an Interest List for mailings at least for now without specific IRB approval. B. More complex databases with health information used to assess suitability of subjects for research based upon medical data should be IRB approved Should get consent of subject for B.

36 Electronic data Stolen data on laptops/drives The Red Line Incident and more. DO NOT have identifiable info on mobile computers or drives Coded ONLY! NO SSN s! REALLY! NONE. No dates, none of the 18 HIPAA ID s No key to code files on your computer. Remember erased may be still recoverable unless device encrypted! All laptops must be encrypted a safe harbor under new HiTECH rules just do it already!

37 Quality vs Research See the policy and checklist at the website. Complete the checklist and keep it in your research files. If you can t decide, submit to the IRB and we will.

38 A word on Conflict of Interest Institutional, and Harvard policies. The IRB assists the institutions. If you re going to maybe make a million dollars, subjects should know that before they take part. Harvard de minimis limit is now 25K per year, per company.

39 IRB Forms NOT a plot to torture you personally! We need to have this info to find and document specific things. Complete them! No blank sections. Repeat yourself if needed. Make them internally consistent!

40 Updates to Regulations Limited IRB Review Continuing review not needed! Focus on privacy/confidentiality Limits your uses too! Single IRB for multicenter US 3 yrs Changes to consent forms more requirements Less continuing review (?) Minor loosening of prisoner research

41 More help? Your IRB protocol administrator. Their supervisor. IRB section of the Navigator website IRB Chairs especially: Megan Morash RN for clinical specimens, genetics, tissues, tissue banks, repositories Melinda Abelman for medical records/data

42 If you enjoyed this. Come to the next one: What does the IRB really want? = full panel review studies more than minimal risk Feb 9 th 2 pm same place.