Navigating the IRB for Education Research. Objectives Define research and human subjects research. Show the "gray area" between research and practice.

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What is QI? -and can it be published?

Navigating the IRB for Education Research

ObjectivesDefine research and human subjects research.Show the "gray area" between research and practice.Describe the distinction between a medical education initiative and a medical education research initiative.Explain the human subjects protection research regulations.List and explain the types of IRB submissions that would be appropriate for medical education research and how to go about the process.2Define Research and Quality Improvement. Describe and utilize criteria to evaluate whether a QI project is research. Discuss examples of QI projects that do not meet the definition of research and compare with examples of QI projects that meet the definition of research. List best practices for Quality Improvement reporting (SQUIRE Guidelines).2I want to publish (present, etc.). so I have to submit to the IRB. Right?Why does it matter?For research that involves human subjects, regulations require that an ethics committee (IRB) must review and approve prior to starting.Risks/benefitsInformed consent Voluntary participationAssures that research is conducted according to ethical principles outlined in the Belmont ReportRespect for personsBeneficenceJusticeDHHS Protection of Human Subjects regulations 45 CFR 46

What happens if we dont get it right?Possible harm to the patient/subject.Breach of ethical obligations to the patient/subject.Formal evaluation by OHRP and/or FDA.Determination letters /Warning letters and resulting corrective actions, enforcement actions (including debarment).OHRP holds institution responsible for conduct of its agents; FDA holds sponsor, investigator and IRB responsible.State licensing board findings/actions.Erosion of public trust in the research enterprise.55International Committee of Medical Journal Editors (ICMJE) and Protection of Research ParticipantsWhen reporting research involving human data, authors should indicate whether the procedures followed have been assessed by the responsible review committee (institutional and national), or if no formal ethics committee is available, were in accordance with theHelsinki Declaration as revised in 2013..Approval by a responsible review committee does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html Examples of Indications of IRB Review in MedEd Journal ArticlesEnhancing motivation with the virtual supervisory role: a randomized trial (Wingo et al BMC Medical Education 2015, 15:76)The study was deemed minimal risk and exempt after Mayo Clinic IRB review. Prior to study initiation, informed consent was obtained. As part of the consent process, participants were informed that the study would compare two module formats to see if one format promotes more effective learning than the other.

The first OSCE; does students experience of performing in public affect their results? (Chan, et al. BMC Medical Education 2015, 15:59)Pre-admission statements made at the time of application (UCAS personal statements) were available in individual student files. Following ethics committee approval (Project SMBRER232), these statements were coded by a researcher (MC) who was not a student or graduate of this university. This was a specific requirement of the ethics committee.InnovationsNovel treatments/proceduresOff-label treatments/departures from SOCNon-validated practicesEducational initiativesQI/QA projectsCase report vs. n of 1When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. Belmont Report, 1979Gray AreaClinical PracticeClinical Research8When a clinician departs in a significant way from standard or accepted practice, the innovation does not in and of itself constitute research. However, radically new procedures of this description should be made the object of formal research at an early stage in order to determine whether they are safe and effective.

For clinical practice, must still stay between the boundaries of reasonable care and skill; there remains a duty for informed consent. This is especially important for any departure from standard practice

To consider:- Is the change in therapy to benefit the individual? - Are you veering from an accepted and successful standard? Why? Is there evidence to support what you are doing? Whatever you are doing that is new/novel may NOT be better than the accepted standard. So informed consent is necessary as a part of good medical practice.

The fact that a procedure is experimental in the sense of new, untested or different does not automatically place it in the category of research.

Innovative therapies that are not research: do not aim to produce generalizable knowledge but are aimed primarily at providing new forms of clinical care that have a reasonable chance of success for individual patients with few or no acceptable medical alternatives. Example: FDA acknowledges that expanded access is not research but is meant to diagnose, monitor, or treat a patients disease or condition, not to generate scientific data

Remember the downside of innovation (give examples)Just because someone is sick and will try anything doesnt make it right. Fen-PhenChild treated with stem cells later developed brain tumorsDrug eluting stents: trials showed that patients who had received drug-eluting stents had reduced reclogging rates after 9 months compared with those who had received bare metal stents and risks were similar; approved in 03 and 04. Used in about 80% of patients who received coronary stents, however, although these stents had been tested and approved for use in otherwise healthy patients with small, newly diagnosed heart blockages, about 60% of their real-world use was off label, specifically in patients with large blockages or additional health problems. Reports to AEs led to further FDA scrutiny an advisory panel concluding that off-label use is assoc. with an increased risk of thrombosis, death, or MI compared with on-label use and additional studies needed. New research suggests that some off label uses safe and effective but much uncertainty remains. (Cleveland Clinic Journal of Medicine vol 75, supplement 6, Nov 2008)

Non-validated practicesThere is concern that innovative therapies are bring applied in an unsupervised way, as part of practice. It is our recommendation that significant innovations in therapy should be incorporated into a research project in order to establish their safety and efficacy while retaining the therapeutic objectives.

Case Study vs. N of 1 research study, in which there is systematic manipulation of an intervention to produce generalizable results.

8Gray AreaSignificant innovations should be incorporated into a research project to establish safety & efficacy.IntentExtentLittle/less knownMore evidence to support goalsIndividual therapyGeneralizablePRACTICERESEARCHUnit/program/dept. specific (i.e. QI/QA)- Is the intent to generate internal improvements to a program or service.IRB is not constituted to oversee medical interventions, even though they may be high risk. If an innovative therapy is re-defined as research in order to ensure both oversight and the broadest benefits from utilizing the intervention, and if it follows the standards demanded by scientific research such as protocol development, review by peers, etc, then an IRB would be appropriate. Otherwise, another committee or mechanism should deal with the issues that arise from potentially risky innovative therapies. Casebook on Ethical Issues in International Health Research p. 40. 9What is Research?Process of systematic inquiry or study to build knowledge in a discipline (i.e. generalizable).

Results foundation on which practice decisions and behaviors are laid.Evidence-based practice

The purpose of research is to develop an empirical body of knowledge for a discipline or profession.

Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors

Validates and refines existing knowledge and develops new knowledge. Burns and Grove, 2003

10Overview of ResearchActivities designed to test an hypothesis, permit conclusions to be drawn, and contribute to generalizable knowledge.Usually described in a formal protocol with an objective and set of procedures. (systematic)Treatment choices made per protocol, not necess. in the best interest of the patient/subject. ex: random assignment (systematic)Purpose is to gain knowledge, not necessarily to benefit the individual. (generalizable)Elements under study may not be of direct benefit to the subject.11Results foundation on which practice decisions and behaviors are laid.Evidence-based practice

Primary intent of research is KNOWLEDGE PRODUCTION.

The purpose of research is to develop an empirical body of knowledge for a discipline or profession.

Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors

Validates and refines existing knowledge and develops new knowledge. Burns and Grove, 2003

11Quality ImprovementSystematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings. Quality improvement is an intrinsic part of good clinical care, in which data from clinicians own settings guide them in improving their practices.

Lynn, et. Al. Ann Intern Med. 2007;146:666-673Is my medical education activity QI (only) or research?QI of Med Ed program. Or Research?INTENTIs your activity designed to identify successful and unsuccessful initiatives and improve the local program only? Or, in addition to the above do you hope to provide support to change medical education beyond BMC? Are you designing this to understand what makes new educational activities better than current. Thus intending at onset to generalize?

EXTENTIs your education initiative based on existing evidence from other programs?Or, are you implementing something that is it particularly novel/untried?The distinction can be difficult... Efforts to contribute to generalizable knowledge in order to help future populations are often driven by curiosity as well as an initial need to solve an immediate problem.Johansson et al, Academic Medicine, vol 86, # 7, July 2011More likely to be research..Testing of new education practices that go beyond current knowledge informed by science and experienceRandomization of learners into different intervention groups to enhance confidence in differences that might be obscured by nonrandom selectionDeliberately delayed feedback of data to those monitoring the implementation of changes, especially if done to avoid biasing the interpretation of data.Involvement in key project roles of researchers who have no ongoing commitment to improvement to the local learning environment.Funding or substantial participation by parties outside the learning setting helps direct the implementation and/or evaluation protocols of the educational activity, and specific outcome data are required.Johansson et al, Academic Medicine, vol 86, # 7, July 2011What requires IRB Review?1) Is it research?2) Are there human subjects?

17Is this about improving care on your unit17DefinitionsResearch (OHRP regs: 45 CFR 46.102 (d)) a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Clinical Investigation (FDA regs: 21 CFR 312.3 (b)) any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

1818DefinitionsWhat is "generalizable knowledge"?

An activity may be thought to develop or contribute togeneralizable knowledgeif the information collected is intended to be applied beyond a particular patient/setting/program.

Intent of the research is to add info to the field of study. Results applied beyond the subject population to other settings.

Intent to test or develop scientific hypotheses, draw conclusions to be shared beyond the populations or situations being studied.

US Dept. Justice: http://www.ojp.usdoj.gov/funding/decision_tree.htm BU CRC IRBGeneralizable knowledge means that the intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings. It doesnt matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.

Purpose or intent of the project is to test or to develop scientific hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied.

19More on generalizable knowledgeThe knowledge contributes to a theoretical framework of an established body of knowledge.The primary beneficiaries: other researchers, scholars and practitioners in the field of study.Publication, presentation or other distribution of the results is intended to inform the field of study.The results are expected to be generalized to a larger population beyond the site of data collection.The results are intended to be replicated in other settings.

Cal State Univ. San Marcos IRBGeneralizable Knowledge would include one or more of the following concepts:The knowledge contributes to a theoretical framework of an established body of knowledge.The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.Publication, presentation or other distribution of the results is intended to inform the field of study.The results are expected to be generalized to a larger population beyond the site of data collection.The results are intended to be replicated in other settings.Web based publication for professional purposes.

Purpose or intent of the project is to test or to d...

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