Brief Introduction to Review of Human Subjects Research in the Health Sciences Presentation to...
-
Upload
grant-mccoy -
Category
Documents
-
view
213 -
download
0
Transcript of Brief Introduction to Review of Human Subjects Research in the Health Sciences Presentation to...
Brief Introduction to Review ofHuman Subjects Research in the
Health SciencesPresentation to Primary Care Faculty Development
Program
Nichelle Cobb, PhD
Director, Health Sciences IRBs
November 2010
Definition of Human Subjects Research: A Refresher
Definition of human subjects research
Research is defined by the Common Rule as, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A human subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What is human subjects research?
Covers a wide variety of activities, including studies of:Human testing of drugs, devices, or
products developed through research Data from surveys, interviews, and
observation Employment information or records of
earnings Medical records Bodily materials, such as cells, blood,
urine, tissues, organs, hair, nail clippings, or DNA, when these are linked to specific individuals
QA, QI, & Program Evaluation
Difficult to determine sometimes whether a project constitutes research rather than QI/QA or program evaluation
May be research if:There is an intent to publish Procedures involve randomizationStandard of care is altered
Case Studies/Case Reports
Case reports involving three (3) or fewer patients generally do not require review by a UW-Madison IRB because they are not viewed as meeting the definition of research under the Common Rule
HIPAA Privacy Rule may apply
What an IRB Assesses
Writing Your Application to Address These Issues
What Does the IRB Evaluate?
IRBs review research to help ensure: it is as safe as possible for people to take part in the
study if there are serious risks, they are as low as possible
and the right kind of monitoring is in place to prevent adverse effects or identify adverse outcomes as soon as possible
that the subject population is the appropriate population to answer the study question
the study design is acceptable so that the question posed can be answered by the research the right number of people will be enrolled (not too many
or too few) so that as few people are exposed to risk as possible
the information given to potential research participants is sufficient to allow them to make an informed choice about whether they want to take part in the research study
Put Another Way (What the Common Rule Says) Risks to subjects are minimized Risks to subjects are reasonable in relation to anticipated benefits, if any, to
subjects, and the importance of the knowledge that may reasonably be expected to result
Selection of subjects is equitable Informed consent will be sought from each prospective subject or the subject's
legally authorized representative (includes ensuring consent forms contain required elements of consent) – consent can be waived by IRB in some cases
Informed consent will be appropriately documented – documentation of informed consent can be waived by IRB in some cases
The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects
Submitting to an IRB
Which IRB?
There are four campus IRBs Health Sciences IRB
Primarily reviews clinical trials/research protocols involving medical interventions
Minimal Risk IRB Primarily review medical records research,
research database and tissue banking projects, survey and interview research, and exemption applications
Social & Behavioral Sciences IRB Reviews social, behavioral, and non-medical
health research Education IRB
Concentrates on K-12 education research
Electronic IRB submission
Implementation of ARROW, a system for electronic submission and tracking of IRB protocols, for all researchers as of November 17, 2010
Animal and biosafety committees expected to adopt this system as well
Initial roll out began in 2010
Which Application Type?
Initial Review Application: Full reviewAny study that presents more than
minimal riskMinimal risk research that is not
exempt or not a medical records reviewSome questionnaires, interviews, and
survey studies (e.g., involving children, asking sensitive questions that are linked to identifiers)
Which Application Type?
Initial Review Application: Non-Exempt Medical Records Review For studies of medical records or
images (e.g., those that retain identifiers)
• May include some contact with patients for outcome information
Which Application Type?
Initial Review Application: ExemptionMust be minimal riskSome survey and interview studiesSome evaluations of educational
activities, curriculaUse of existing data (e.g., medical
records), specimens that are unidentifiable (e.g., residual tissue)
Exempt Research
IRBs, not researchers, make the determination as to whether a research protocol is exempt
Common examples of exempt researchQuestionnaires, surveys, interviews that are
anonymous or not sensitiveChart review studies and no identifiers are
recorded Evaluations of educational techniques,
curricula when the intent is to publish
Not Human Subjects Research
IRB Office reviews to determine whether it meets the federal definition of “research” and/or of “human subject” Once determination made no further interaction with IRB for
project needed unless project begins to meet definition of research and/or includes human subjects
Examples of not research Program evaluation, quality assurance activities
Examples of not involving human subjects Use of coded data when researchers do not have access to
the key to the code and entity holding code will not release link to researchers
Research on decedents
A Note on Identifiability
An identifier includes any information that could be used to link research data with an individual subject. E.g., initials, address, zip code, phone number, gender, age,
birth date, occupation, employer, racial or ethnic group, type of biopsy performed, date sample taken, diagnosis, primary care physician, referring physician, and genealogy.
Some of the identifiers listed above become less problematic if the sample size is large enough so that the potential identifiers could describe several individuals and thus cannot be linked to only one person.
Data coded by numbers or letters that may be linked to identifiers are not anonymous or unidentifiable.
IRB Review Process
Health Sciences IRBs Submission Process May 28, 2009
To the IRB for triage
OR
APPROVAL
APPROVAL
IRB ReviewAPPROVAL
Pre-Review by IRB Staff
Communication with Research
Team
No institutional scientific review needed
Modifications requested
Communication with Research
Team
Submission of New Protocol by Research Team
Institute of Clinical &
Translational Research (ICTR) Scientific Review
Communication with Research
Team
Cancer Center Scientific Review
Communication with Research
Team
OR
Overview of Submission and Review Process for Full Board Review (I)
Electronic copy of application sent to the IRB Office first
IRB Office will send to scientific review committee if needed
If no scientific review required, the application will be forwarded to an IRB reviewer
If scientific review required, IRB review does not proceed until the scientific review committee agrees the study can be forwarded to the IRB for review
Overview of Submission and Review Process for Full Board Review (II)
If no scientific review needed or the scientific review committee approves, a staff reviewer will work with the study team to address any missing information, revisions needed to ensure the study complies with campus and federal policies and IRB review conventions
2 cycles of feedback are given by the staff reviewer
Once the pre-review is complete, paper copies are then requested and the study is scheduled for review by the full IRB
Pre-Review Concentrates On…
Completeness, accuracy of applicationCompliance with
institutional policy (e.g., PI qualifications, training requirements, COI issues)
State Lawfederal regulations
Common RuleFDA regulations, if applicableVA regulations, if applicable
other institutional precedentsSpotting major issues that will be a challenge
at the formal review stage
How to Contact the IRB
There are many ways to get information and help from the IRB….
View the WEBSITE at www.medicine.wisc.edu/irb - contains policies, guidance, forms, news/updates
CALL the HS-IRBs Office at 263-2362 - we have nice, smart staff on call daily who can help you
EMAIL us at [email protected] – general questions answered promptly
Make an APPOINTMENT for a consultationQuestions about ARROW – email
[email protected] or call 262-0041 Join our LIST-SERV – sign up to receive regular
updates and newsletters from the IRB
Questions?(General or Project Specific)