Micheal A Kuhn MD Vice Chair Loma Linda University Institutional Review Board What type of research needs IRB review Anything and everything that involves human subjects Navigating the IRB process ID: 526596
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HOW TO PREPARE FOR IRB SUBMISSION
Micheal A. Kuhn, MD
Vice Chair, Loma Linda University
Institutional Review BoardSlide2
What type of
research needs
IRB review?
Anything and everything
that involves human subjectsSlide3
Navigating the IRB process
Application process
IRB submission and review
Revision
Initial approval
On going monitoringYearly renewal
http://researchaffairs.llu.edu/
Start HereSlide4
Research Affairs Forms and Documents
Click on IRB link or scroll down
Four printed pages of options
Include:
Applications
Full boardExpeditedRetrospectiveHumanitarian use device applicationChecklistsConsentsHow to prepare
Experimental Bill of RightsAbstract/protocol outlinesRadiation Safety applicationsRecruitment formsEmergency use of investigational deviceHIPAA forms
Waivers/assentsConflict of interest formsSlide5
I. GUIDE TO ASSEMBLY OF APPLICATION PACKET
Convened (Full Board) Review: Submit original and three
hardcopies in the order described below:
1.Smith_LymphomaStudy_application.pdf2.Smith_LymphomaStudy _abstract.pdf
3.Smith_LymphomaStudy _billofrights_icd_hipaa.pdf4.
Smith_LymphomaStudy _protocol.pdf5.Smith_LymphomaStudy _IB.pdf (if applicable)6.Smith_LymphomaStudy _flyer.pdf7.Smith_LymphomaStudy _questionnaire1.pdf8.Smith_LymphomaStudy _ctc_feasibility.pdf9.Smith_LymphomaStudy _device_worksheet.pdf (if applicable)
10.Smith_LymphomaStudy _ind_decision.pdf11.Smith_LymphomaStudy _clinicaltrialreg.pdf12.Smith_LymphomaStudy _bri.pdfApplicant ChecklistSlide6
Additional Requirements
Resource utilization
Services outside
instituion
Services inside institutionClinical Trials Center
Patient billing & reimbursementDevice studiesResearch conflict of interestContract with external sponsor/institutionIRB feeClinical trial registrationSlide7
Are you dizzy yet????Slide8
Or rethinking your career?Slide9
It is not as daunting as it seems
Most is straight forward
Follow the instructions
Important areas
Protocol
ConsentSupport personnel
Multi-center trialsSlide10
General Considerations
Understanding of medical knowledge/jargon will be varied
The IRB is made up of physicians, nurses, ancillary personnel and lay people
Keep protocols simple and easy to understand
Know what you are submitting
As the PI, you have the final review before submitting. REVIEW EVERYTHINGDo not rely on others to do it for youSlide11
General Considerations
As a rule, your consenting population will have little medical education.
Keep explanation simple
Using hospital resources for research needs to be cleared by individual entities
eg. Nursing, OR, cath
lab, etc.The Clinical Trials Center is an invaluable resource for assisting in multi-center trialsSlide12
ApplicationSlide13Slide14Slide15Slide16Slide17
Informed ConsentSlide18
Quick Tips
Know your audience
Lay people
Different socioeconomic backgrounds
Varying level of educationPotential language barriersKeep language in consent to a 6
th grade levelMinimize abbreviationsSlide19
1. Why are we doing this study?
The first thing in the consent should be the study purpose
Be clear, concise and to the pointSlide20
2. How will you be involved?
Section where the protocol is written
Keep concise and explain in lay person’s terms
Explain in clear terms the type of study
Especially important in randomized controlled studiesMake clear that placebo group is a
possibilityBe mindful of canned language especially in corporate sponsored studiesSlide21
3. What are the reasonably foreseeable risks or discomforts?
Explain the degree of risk
Use lay terminology
e.g.
vomiting for emesis, bruising for
ecchymosisDescribe in terms of varying riskMost common to rarestMildest to most severeTable format very useful in organizing riskvery common in drug studies
Do not explain standard of care risksSlide22
Do not rely on manufacturer terminologySlide23
4. Will there be any benefit to me or others?
Explain direct benefit to patient
Important in studies with high risk groups
Can impact approval if no benefit/higher risk
Benefit to society in generalSlide24
Other parts
What are your rights as a subject?
Will you be informed of significant new findings?
What other choices do you have?
How will information be kept confidential?What costs are involved?
Will you paid to participate in the study?Will study staff receive payment?Who do you call if you are injured as a result of the study?Slide25
Who do you call if you have questions?
Who is handling the
study?
Who can be reached
24/7?Appropriate phone numbers/pagersSlide26
Guarantees of Patient Protection
You are required by law to protect patient information
Need to supply secure form of data storage
Need to supply secure form of data transmission
Need to inform patient of what patient information will be published
Provide HIPAA form to patient and in application for reviewSlide27
Failure to comply can cause serious problemsSlide28
Genetic information
The practice of storing DNA information very common in industry
Can be limited to the specific study or planned for use in future study
DNA storage must be disclosed in the consent
Best done in a separate section with its own signature lineSlide29
Recruitment/Reimbursement
All brochures, flyers and other recruitment information must be provided to the IRB for review
Reimbursement for visits is reasonable if financially appropriate
You must avoid coercing patient
with financial rewardSlide30
Reimbursement
Reasonable forms of reimbursement:
Small cash payment
Gift cards
FoodGasSlide31
Other items
California Bill of Rights
Assents for underage subjects
HIPAA authorization form
Consent in second language
Consult website for the IRB submission checklist Slide32
So what happens if you get the application filled out correctly, have a well written consent, and provide all the appropriate information?Slide33Slide34
Controversies at the IRB
Travis Losey, MD
Chair, Loma Linda University IRBSlide35
What is the IRB?
Slide36Slide37
Research Ethics
In 1932 the "Tuskegee
Study of
Untreated
Syphilis in the Negro Male” was initiated.Initial plan was for a 6 month study.Enrolled 600 black men – 399 with syphilis, 201 who did not have the disease. The
study was conducted without patients' informed consent. Researchers told the men they were being treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insuranceSlide38
Research Ethics
In 1945 PCN was shown to be the
treatment of choice for syphilis,
however for study purposes subjects were not told their
true diagnosis and were not provided treatment.CDC and local chapter of AMA supported the study. 127 medical students rotated through the study. In 1972 (40 years after initiation) news articles about the study appear and it is terminated. Slide39
Research Ethics
Three basic ethical principles:
Respect for persons
Beneficence (maximize benefit & minimize harm)
Justice Slide40
What standards does the IRB use?
Slide41
What are the common questions asked at IRB meetings?
Is the study ethical (
respect for persons, beneficence, and
justice)?
Are subjects appropriately informed of the nature of the study as well as its risks and benefits?
Are appropriate federal regulations addressed (i.e. IND)? Are institutional policies followed (billing, collaboration with support services)?Slide42
What are the common questions asked at IRB meetings?
Slide43
What is the IRB not focused on
The IRB is not an editorial service.
The IRB is not a scientific journal club.
The IRB is not the Office of Legal Counsel.Slide44
Controversy: QI project or research?
An investigator proposes five evidence-based procedures recommended by the CDC as having the greatest effect on the rate of catheter-related bloodstream infection and the lowest barriers to implementation (hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with
chlorhexidine
, avoiding the femoral site and removing unnecessary catheters).
All hospitalized patients will receive all interventions.Slide45
Controversy: QI project or research?
These interventions reduced the rate of catheter associated bloodstream infections by 66%.
This study was published in the New England Journal of Medicine and cited in >2500 publications. Slide46
Controversy: QI project or research?
A complaint was filed with OHRP due to the fact that this federally funded project was conducted without IRB review or subject consent.
JHU contended that it did not qualify as research and was a QI project.
OHRP rejected this contention and demanded a corrective action plan from Johns Hopkins University.Slide47
Does the project involve the collection of data through intervention, interaction with an individual or the use of identifiable private information?
YES
NO
Is the project planned in advance, and does it use data collection and analysis to answer a question?
Are any of the following present
?
•
The project includes randomization to enhance confidence in differences that might be obscured by nonrandom selection
•
The project tests issues that are beyond current science and experience, such as new treatments
•
The project involves
investigators who
have no ongoing commitment to improvement of the local care situation
•
Feedback from implementing changes is delayed or altered as part of the project
•
Project receives
funding
from
an outside
organization with a commercial interest in the results
ON
YES
Is the project expected to yield information that expands the knowledge base of a scientific discipline or other scholarly field of study?
ON
YES
This project meets criteria for human subjects research and requires IRB review.
This is not human subjects research and IRB review is not
needed.
NO
The project may be human subjects research. Advise contacting Research Protection Programs for a formal determination.
YESSlide48
Controversy: Ethics in studies performed by corporations
Slide49
Controversy: Risk for studies involving “standard of care”
Slide50
Controversy: Risk for studies involving “standard of care”
Slide51
Controversy: Risk for studies involving “standard of care”
Draft Guidance:
For subjects randomized between different “standards of care”,
the
reasonably foreseeable risks
of each of the potential treatments should be disclosed to potential subjects and considered in assigning the risk of the study.The risks of the research do
not include the risks that are created by the medical condition for which the person is being treated, or the risks associated with treatment that they would receive for that condition outside of the research.Thus, if an observational study compares two standards of care that are chosen by individuals with a given medical condition in consultation with their clinical care providers, and the research plan does not assign subjects to any specific standard of care, then the risks of the standards of care are
not risks of research.Slide52
Controversy: Risk for studies involving “standard of care”
What are the risks for subjects in the study?
A:
Minimal risk
. As all treatments are “standard of care” the only risk is loss of confidentiality.
B: Greater than minimal risk. In addition to A, there is a risk of seizures of 25-50% with all treatments.C:
Greater than minimal risk. the risks of each of the study medications should be disclosed to potential subjects as different subjects might be concerned about different side effects.D: All of the aboveSlide53
Practical Advice
What to do when things go wrong.Slide54
Slide55
Tips for IRB submissionsSlide56
Tips for IRB submissions
Protocols
should be clearly written, direct and internally consistent. The scientific rational should be included in the protocol, references should be cited for reviewers who have additional questions but critical findings from these references should be included in the protocol. Risks should be clearly and directly addressed.
Informed consent documents
should avoid medical jargon, completely and honestly discuss risks of the study and explain how treatments in the study differ from standard care. A person who does not have a medical background should be able to understand the study after reading the consent. Slide57
Tips for IRB submissions
Protocol deviations
:
Should be requested in advance if possible as a one time change request.
Serious Protocol
Violations:Should be clearly acknowledged with a thoughtful plan to prevent recurrence. Minor Protocol ViolationsShould be recorded in a excel spreadsheet which should be attached the annual renewal request. Slide58
Emergency Research
In emergent situations, access to investigational drugs or devices may be required. Contact:
IRB chair
( Dr Travis Losey) or Vice Chair (Dr Michael Kuhn or Dr Andrea Rey) for ethics approval.
Research Coordinator
(though department, Lila Dalton or Amy Casey at CTC can help to identify).If institutional signature is needed, Dr Anthony Zuccarelli or Dr Michael Kirby.Slide59