Transcript Human Subjects Research

HUMAN SUBJECTS RESEARCH
Dustin Yocum, MA
Institutional Review Board
University of Illinois
OBJECTIVES
 Discuss what an Institutional Review Board (IRB) does
 Find out why the IRB exists
 Discuss the regulations and classifications
 Discuss the application process
 Discuss the elements of infor med consent
 Field questions
WHAT DOES THE IRB DO?
 Independent Review and Oversight Committee
 Board of experts in conducting research
 Uphold federal, state, and local regulations
 Review research applications for ethical standards
 Purpose of the IRB is to facilitate safe and ethical research with
human subjects conducted by UIUC students, faculty, and staff
WHY DOES THE IRB EXIST?
Examples of research with serious ethical issues
Tuskeegee Syphilis Study
Human Radiation Exeperiments
Milgram Study
Willowbrook State School Hepatitis Study
FEDERAL REGULATIONS
45 CFR 46 – Common Rule - Regulations for
the Protection of Human Subjects of
Biomedical and Behavioral Research
Basic regulations established in 1974
Adopted by 16 federal agencies as the Common
Rule in 1991
Proposed changes in the regulations being
reviewed
BELMONT PRINCIPLES
 Respect for Persons
 Individual autonomy, above the value of the research, to society or to any
individual person
 Protection of individuals with reduced autonomy
 Beneficence
 Do not harm, regardless of benefits
 Maximize benefits and minimize the risk of doing harm
 Risk–benefit analysis should justify all risks
 Justice
 Equitable subject selection and distribution of research benefits and burdens
WHAT POSSIBLE HARM?
Physical harm
Emotional distress, Psychological Trauma
Invasion of Privacy, Loss of Confidentiality
involving:
 Embarrassment, Loss of Social Status
 Risk to Reputation, Employment, Financial Standing,
Insurability
 Criminal or Civil Liability
INVESTIGATOR RESPONSIBILITIES
 The investigator is ultimately responsible for protecting the
subject.
 The use of human volunteers in research is a privilege, not a
right.
 Society’s trust in the research process deter mines funding,
support, regulation
WHAT IS HUMAN SUBJECTS RESEARCH?
Research – A systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge.
Human Subject - 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?
Intervention
 Includes both physical procedures by which data are gathered
(for example, venipuncture) and manipulations of the subject
or the subject’s environment that are performed for research
purposes (45 CFR 46.102(f)).
Interaction
 Includes communication or interpersonal contact between
investigator and subject (45 CFR 46.102(f)).
WHAT IS HUMAN SUBJECTS RESEARCH?
 Private Information
 Information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is
taking place
 Information which has been provided for specific purposes by an
individual and which the individual can reasonably expect will not
be made public (for example, a medical record)
 Private information must be individually identifiable (i.e., the
identity of the subject is or may readily be ascertained by the
investigator or associated with the information) in order for
obtaining the information to constitute research involving human
subjects.
LEVELS OF REVIEW
 Not Human Subjects Research
 Exempt
 45 CFR 46.101(b)
 45 CFR 46.401(b) Children
 Expedited (New and Continuing Cases)
 45 CFR 46.110
 No more than minimal risk and/or minor changes
 Full IRB (New and Continuing Cases)
NOT HUMAN SUBJECTS RESEARCH
In order to be considered human subjects
research the activity must:
be systematically designed to contribute to
generalizable knowledge
obtain information about living individuals
involve intervention or interaction
be individually identifiable
involve private information
EXEMPT RESEARCH
 Activity must classify as human subjects research
 Submitted on Exempt application
 Reviewed by staff member only
 Minimal risk
 3 year approval period
 Federal regulation do not apply (University regulations apply)
EXEMPT CATEGORY 1
 Exempts research conducted in established or
commonly accepted educational settings,
involving normal educational practices, such as:
 (a) research on regular and special education instructional
strategies, or
 (b) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
EXEMPT CATEGORY 2
 Exempts research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior, unless
 (a) information obtained is recorded in such a manner that
human subjects can be identified, directly or through
identifiers linked to the subjects; and
 (b) any disclosure of the human subjects’ responses outside
the research could reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subjects’
financial standing, employability, or reputation
EXCEPTIONS TO THE RULE
 Category 1
 Research on physical education that involves exercise if the activity is altered
in a significant way for the purposes of the research
 Category 2
 Research involving surveys that may cause the subject to experience severe
emotional distress or discomfort
 Research involving psychologically invasive surveys
 Regarding Children: Research involving surveys, interviews, or observations
of public behavior when the investigator is a participant in the activities
being observed
 All Categories
 If the study is greater than minimal risk
 Prisoners
 Research involving deception
EXPEDITED RESEARCH
 Activity does not fall into one of the 6 exempt categories
 Submitted on IRB-1 application
 Review by staff and exper t IRB member
 Minimal Risk
 1 year approval period (continuing reviews)
 Federal regulations apply
FULL BOARD RESEARCH
 When a study is considered more than minimal risk
 Deter mined during review of IRB -1 applications
 Reviewed by staff and full IRB committee
 1 year approval period
 Approval period could be less if Board wants to review again
 Board decides if study must stay Full Board after initial approval
 Federal regulations apply
WHAT IS THE APPLICATION PROCESS?
Is it human subjects research?
IRB-1 or Exempt?
WHAT DO I SUBMIT?
Complete application (including signatures)
Research Team Attachment
Recruiting materials
Data collection measures
Consent forms
Additional forms(device/equipment, waivers, etc.)
Funding proposal
Approvals from outside institutions
WHAT IS THE PROCESS AFTER I SUBMIT?
Application is submitted to [email protected]
Application is logged into system and assigned to a
reviewer
Pre-Review is conducted
Correspondence and revisions
Once revisions are complete with IRB staff:
If exempt, study can be approved in IRB office
If expedited/full board, study will be sent to an
expert reviewer.
 Stipulations
 Approval
CITI REQUIREMENTS
 All researchers must have completed the following CITI
online training requirements before approval will be given:
 Belmont Report - SBR
 History and Ethical Principles - SBR
 Defining Research with Human Subjects - SBR
 Assessing Risk in Social Behavioral Sciences - SBR
 Informed Consent - SBR
 Privacy and Confidentiality – SBR
 Online CITI training is good for 3 years
WHAT IF I NEED TO MAKE A CHANGE
AFTER APPROVAL?
Amendment Process
Complete the Research Amendment Form
Make revisions to all applicable parts of application
Make sure new documents are signed by RPI
Send revised/additional documents to staff reviewer
ELEMENTS OF INFORMED CONSENT
Purpose
Procedures
Risks and Benefits
Voluntariness
Confidentiality
Contact Information
Signature Statement
INFORMED CONSENT OVERVIEW
Signed (written) Informed Consent
Waiver of Informed Consent
Alteration of Informed Consent
Waiver of Documentation
INFORMED CONSENT OVERVIEW
Informed consent is an ongoing process rather
than just given/obtained at a moment of time.
No exculpatory language, 8th grade reading
level, correct grammar/typos
Give participants opportunities to ask
questions
Ensure participants understand what they have
consented to do
Ensure participants understand that they can
discontinue at any time
QUESTIONS?
ADDITIONAL RESOURCES
Campus IRB Web site: www.irb.illinois.edu
UIUC IRB Training Module:
http://www.irb.uiuc.edu/edu/module1.asp
Belmont Report:
http://www.irb.uiuc.edu/ethics/belmont.asp
Office for Human Research Protections (OHRP):
http://ohrp.osophs.dhhs.gov/
U.S. Food and Drug Administration (FDA):
http://www.fda.gov/cdrh/index.html
CONTACT INFORMATION
Main IRB Office
Suite 203, MC–419
528 East Green Street
Champaign, IL 61820
Phone: 217-333-2670
Fax: 217-333-0405
Email: [email protected]
Online: www.irb.illinois.edu