IRB and Educational ResearchPresentation Transcript
Tracy L. Dietz, Ph.D. Chair, UCF IRB
When is IRB Approval Required?
According to the OHRP:
If the activity:
Involves any element that is “research”
Includes humans subjects:
identifiable data about humans,
identifiable cell lines,
data from humans
According to UCF Policy:
Only the IRB can determine if study is exempt
Investigators or others may not make this determination
What is Research?
45 CFR 46.112 defines research as:
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
What is a Human Subject?
45 CFR 46.112 defines a human subject as:
a living individual about whom an investigator (whether professional or student) conducting research obtains
Data through intervention or interaction with the individual, or
Identifiable private information
Thus, this includes actually interacting or intervening to obtain data but it also means identifiable cell lines and identifiable data taken from records (which are not public records)
What is Identifiable?
Social Security Numbers
Also, if the information that is obtained is specific enough with the different “variables” to allow someone to determine identity, then it is identifiable (such as in a very small population size).
What is a Public Record?
Public records are those data sources that are available to anyone from a public source (such as on the internet, from associations, from licensing agencies, etc).
What is not a public record?
Items that are part of a sealed report or record
MANY, MANY others. Just because they are existing does not mean they are public
What About Institutional Level Data?
Studies involving aggregate level data do not require IRB approval.
Numbers of people treated in any given month
Doctor to patient ratio
Policies that govern decisions at the clinic, etc.
How are studies classified
Full Board – greater than minimal risk or needing group decision as to risk, ethics, or other problem areas.
Expedited – according to specific federal regulation list and minimal risk only. See list.
Exempt – according to specific federal regulation list and minimal risk only – usually this is research involving databases, secondary data use, or existing (already collected and/or stored) data, documents, records, pathological specimens or diagnostic specimens. See list.
Federally designated vulnerable populations
For more information http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm
Fetuses and Human in vitro fertilization
The Cognitively impaired
Traumatized and comatose patients
Terminally ill patients
Elderly/aged ONLY when there is cognitive impairment or institutionalization
Socially and economically disadvantaged
Students, employees, and normal volunteers WHEN there are procedures that may create feelings of coercion, etc.
Several regulatory standards provide foundation and ethical codes. Much of it medically-focused.
The International Compilation of Human Subject Research Protections lists laws, regulations, and guidelines governing human subjects research world-wide http://www.hhs.gov/ohrp/international/HSPCompilation.pdf
Strategies for Protecting Human Subjects in Global Project
See summary report http://www.rti.org/pubs/protecting_research_subjects.pdf
Consent from gatekeepers or community leaders
Avoid undue inducement and avoid social harm (or perception of it)
Consider solicitation of community input
Signed consent not mandatory (consider literacy)
Strategies for Protecting Human Subjects in Global Project (cont)
Communities can be unaware of their rights
Communities can be distrustful of researchers
Issues of concern:
Confidentiality and privacy protection
Access to medicines and vaccines
Involvement of children in clinical research
Use of stem cells
Research with biological weapons
Things to consider in International Research
Risks of Research can be different in an international setting
What is considered private may be different
Age of majority may be different
May be gender differences
Cultural expectations about what is appropriate to do/ask
The Health Insurance Portability and Accountability Act of 1996, also known as the Privacy Rule
Established a set of national standards for the protection of certain health information.
Requires that an IRB or a Privacy Office review research involving identifiable health information.
Protected Health Information (PHI): What it is. What it isn’t.
UCF HIPAA components
Communication Sciences & Disorders and Health Services
What are the PHI identifiers?
Social Security number
Medical record number
Health plan beneficiary number
VIN, serial number, license plate number
Device identifiers and serial numbers
Full face/comparable images
Any other unique code
HIPAA Authorization & Waiver of Authorization
Waiver of HIPAA Authorization (example: retroactive chart review for data collection)
To qualify for a Waiver of Authorization
Research use of PHI does not represent more than a minimal risk to privacy
Research could not be done without the requested PHI
It would not be practical to obtain signed authorizations from research subjects (if you are talking to them, it is practical)
Specific elements of PHI are not more than the minimum necessary to accomplish study goals.
Biosafety Committee Review
Research involving hazards require biosafety and/or radiation committee approval.
Microbiological/viral agents, pathogens, toxins and other selected agents
Human cell or tissue samples
Physical agents such as ultraviolet light, lasers (class 3b
FDA regulation occurs with all medical devices http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf
What is a medical device?
IRB is to make determination of significant versus non-significant risk