DIVISION OF RESEARCH
Institutional Review Board (IRB) – Human
Subjects Research Training
Fall 2011
Johndan Johnson-Eilola
IRB Chair
Kimberly Klatt
Research Compliance Officer
Objectives
• Overview function of the IRB
– Mandate
– Regulations
– Processes
• Contrast types of review
– Provide examples of research that is exempt,
minimal risk, and requires full review
• Outline IRB review process
• Introduction to the Clarkson’s enhanced Human
Subjects Protection Program (HSPP)
IRB Mandate
• To assure that appropriate steps are taken to protect the
rights and welfare of humans participating in research.
• The IRB functions according to the guidelines of the Office
of Human Research Protection (OHRP) and other federal
regulatory agencies.
• Applies to all activities related to human subjects research.
• Clarkson University’s Federalwide Assurance with DHHS
OHRP.
Who is on the IRB?
The IRB is a committee with representation from CU faculty
and the community.
• 5-7 voting members
• Meet on a regular basis (usually monthly)
• One person from each School
– Provides a range of knowledge & experience
• At least one non-scientist
– Whose focus is on subject welfare
• One non-Clarkson member
– To ensure lack of bias
• All receive training in IRB regulations
Who Sets the Rules?
• Office for Human Research Protection (OHRP) under
Department of Health and Human Services (DHHS)
www.hhs.gov/ohrp/
• Food and Drug Administration (FDA)
• New York State Department of Health
www.health.state.ny.us/nysdoh/provider/volunteer
• Research Sponsor Terms and Conditions
• Clarkson Policy
http://www.clarkson.edu/dor/compliance/human_subjects.html
Regulations
HHS Regulations:
• 45 CFR part 46 HHS Regulations for the Protection of Human Subjects (1974)
• 45 CFR parts 160 and 164 Health Insurance Portability and Accountability Act
(HIPAA) Regulations for Standards for Privacy of Individually Identifiable
Health Information
• 42 CFR part 50, Subpart F HHS Regulations for Responsibility of Applicants
for Promoting Objectivity in Research for Which PHS Funding Is Sought
The Common Rule:
• Issued in 1991 by 15 federal departments and agencies.
• Based on the HHS 45 CFR part 46 subpart A, and includes identical language
in the separate regulations of those departments and agencies.
FDA:
• 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
• 21 CFR part 56 FDA Regulations for Institutional Review Boards
Ethical Foundations
The Nuremberg Code (1947)
• Directives for Human Experimentation
• Informed consent, lack of coercion, properly formulated scientific experimentation,
and beneficence towards experiment participants
• http://ohsr.od.nih.gov/guidelines/nuremberg.html
Declaration of Helsinki (1964)
• Ethical Principles for Medical Research Involving Human Subjects
• http://ohsr.od.nih.gov/guidelines/helsinki.html
The Belmont Report (1978)
• Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Due in part to the Tuskegee Syphilis Experiment (1932-1972)
• Respect for persons, beneficence, and justice
• http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
International Standards
•
Standards vary by country
•
Contact IRB for guidance
Professional standards regarding ethics
Human Subjects Training
• Clarkson participates in the CITI (Collaborative
Institutional Training Initiative at www.citiprogram.org)
–
Web-based ethical training program in human subjects
research to over 830 participating institutions and facilities
around the world.
–
Provides individualized courses
•
•
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Biomedical Focus
Social and Behavioral Focus
Data or Specimen Only Research
Students Conducting Minimal Risk Research
Refresher Courses
– Training required for all individuals involved in human subjects
research protocols submitted for review (including
continuations, modifications, and proposals for exemption).
• Required every two years
To Whom do the Rules Apply?
• All research conducted at Clarkson
• All research by Clarkson faculty, staff,
assistants, students, or any other research
collaborator.
• Applies to everyone at Clarkson because
Clarkson receives federal funds
– Requirement of Federal-Wide Assurance (FWA)
– Applies to you even if your research is not
federally funded
Consequences
• Greater risk of harm to a subject
– The researcher is liable
– Public and scientific communities may lose
respect for Clarkson
– Potential research subjects may lose trust
in Clarkson and/or research
• If research is performed without proper
IRB approval (even without harm)
– Data may be destroyed or confiscated
– Journals may refuse to publish
– Clarkson may have all federal funds frozen
Does My Project Require IRB
Approval?
Determined by examining the proposed activities and
answering the questions below:
 Question 1: Is your project Research*?
 Question 2: Does your project involve Human
Subjects*?
• If “no” to any one of the questions, your project does not
constitute Humans Subjects Research.
• If the answer to both questions is “yes”, the project is
considered to be Human Subjects Research
* As defined by the regulations
What is “Research”?
RESEARCH (DHHS): A systematic
investigation designed to develop or
contribute to generalizable knowledge.
–Key components are:
• systematic investigation
• generalizable knowledge.
What is a “Systematic
Investigation”?
• The activity is designed, that is involves a predetermined
method to study some phenomenon to answer a question
and generate new knowledge. Research typically involves a
fixed protocol, goal, methodology, population and time
period. (i.e., the gathering and analysis of information)
• Planned and organized generation of data, whether or not
there is a plan for publication or dissemination.
• The intent is that the activity is undertaken to contribute to
generalizable knowledge, not to provide immediate and
continuous improvement and feedback in the local setting.
• May be quantitative or qualitative
What is “Generalizable
Information”?
• The intent to draw conclusions from the research which
will develop or contribute to a general body of knowledge.
• Is designed to draw general conclusions (i.e., knowledge
gained from a study may be applied to populations outside
of the specific study population), inform policy, or
generalize findings.
• Generally interpreted to include research findings or data
intended for public dissemination or presentation in any
form, including via the Internet, poster presentation, or
scholarly paper, etc… The definition also includes
research undertaken by students for the purpose of
independent research papers, theses, or dissertations.
Examples of Projects Not
Considered “Research”
• Teacher and student evaluations used solely by the institution
• Class-related data collection projects conducted solely for didactic
purposes where the results are not disseminated outside the
classroom
• Activities conducted for quality improvement/quality assurance
intended solely for internal use
• Data collection activities performed as a commercial service to
inform business decisions regarding a specific process or product
that will not be made public by the researchers or the sponsor
• Journalism or documentary work
What are “Human Subjects”?
HUMAN SUBJECT (DHHS): 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 (e.g., school
transcripts, health records).
What are “Human Subjects”?
Key components of the definition to consider when making a
Determination:
•
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.
•
Interaction: includes communication or interpersonal contact between
investigator and subject.
• Private information: includes information about behavior that occurs in
a context in which an individual can reasonably expect that no
observation or recording is taking place, and 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).
Examples of Projects Involving
“Human Subjects”
• Interviewing people
• Testing individuals
• Making observations of identifiable
individuals
• Looking at records
• Conducting a survey
• Involving human tissue or biological
specimens ( case-by-case basis).
What Needs IRB Full Review?
• All human subjects research
– Unless it is Exempt from IRB review
– Exemptions must be certified by the IRB
• Researchers are not authorized to decide if their
human subjects research requires IRB full review
– DOR or IRB should decide
• What does NOT require IRB review
– Classroom-only activities
– Quality assurance surveys
• If in doubt, ask early!
Types of IRB Review
• Full committee review
“Minimal risk” is that
– Standard (default) review
which is encountered
in normal daily
• Expedited review
activities.
– For “minimal risk” research
No research can be
entirely free of risk.
• Exemption from full review
– Must meet specific criteria
• Determinations
– Does my project require IRB review?
– Are you engaged in Human Subjects
Research?
Charts available at:
Human Subject
Regulations
Decision Charts
(2004)
Research involving
surveys or
interviews of
children is NOT
exempt
Process for Exemptions
• If Exempt from full review:
– Submit Exemption Request Form
– Exemption does not need to be renewed
unless the research changes in a way that
impacts involvement of human subjects
– Campus surveys require review by:
• Involving students - Vice President for University
Outreach and Student Affairs (Kathryn Johnson)
• Involving staff - Vice President for External Relations
(Kelly Chezum)
• Exemptions are ‘certified’ not approved
Exemptions: Special Cases
• Existing data
– Needs to be de-identified
• Existing tissue samples
– Must be collected prior to the exemption
request
• Educational research
– Normal educational practices
• Survey research not part of normal
educational practices (not for children)
• Case reports of data already collected
Process for Standard Review
• Read the Clarkson Policy (link on IRB website)
• Complete The CITI Human Subjects Research
Course (link on IRB website)
• Complete protocol form
– Available on IRB website
• http://www.clarkson.edu/dor/compliance/hum
an_subjects.html
– Instructions also available on website
– Have someone familiar with IRB process review
& give feedback
– You can contact IRB Chair/member for guidance
Writing the Protocol
• Utilize language when writing the protocol that
reflects an educated, but non-expert audience
• Proof-read carefully
– Sloppy writing indicates sloppy researcher
• Students’ advisors must review and have
student revise prior to submission
• Students Advisors must sign protocol
• Advisors are responsible for the quality of the
submission.
Process for Standard
Review
• Compile into a single document
–All appendices and attachments must
be included in the proposal document
• Submit at least 1 week before
scheduled IRB meeting
–Can submit earlier for preview to
identify and correct major problems
• At least 1 full week earlier
Review Criteria
•
•
•
•
Research is scientifically sound
Risks are minimized and reasonable
Subject selection is fair
Safeguards for vulnerable populations
– Children, instructors’ students, staff…
– Protect against coercion
• Informed consent process adequate
• Privacy & confidentiality maintained
Types of Risk
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Coercion
Physical
Psychological
Economic
Social
Informed Consent Process
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IC is an ongoing process
Need to answer subjects’ questions
Use IC template form
IC must be understandable
– 8th grade reading level standard
– Utilize tool available in Word
• Subjects get to keep a copy
IRB Decisions
• Accept proposal without changes
• Request clarifications or changes
– Approval conditional upon addressing IRB
concerns
• Reject
– Problems insurmountable or would require
such significant changes that a new proposal
needs to be submitted
• Response letter sent within 5 working days
– You are responsible to follow-up with the IRB
if you do not receive a response
After Approval
• Project assigned an approval number
• Need to submit the signed cover sheet
– Signed by PI and Dept Chair/advisor
• This is a ‘contract’ stating the PI’s
responsibilities
PI Responsibilities
• All individuals interfacing with subjects or
data should be adequately trained
– Necessary research procedures
– Human subjects research training
• Data kept secure & confidential
• Report Adverse Events or Unanticipated
Problems
• Submit Project Modifications
• Continuation Request annually
• Allow for IRB audits if requested
IRB Audits
• How are projects selected?
–
–
–
–
Several projects are audited each year
Randomly selected projects
If any concerns have been raised
High risk projects
• Audit process
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Review proposal
Observe data collection process
Interview researchers (including students)
Interview subjects
• Submit a report to the PI and IRB
– May request changes or monitoring
Grant Proposal Submission
• NIH, NSF, and other sponsors require additional
information pertaining to human subjects
– Does your proposal involve human subjects
research?
– Does it require IRB approval?
– Does it qualify for exemption?
– If so, what exemption are you claiming?
• Often requires consultation with the IRB
• Inquire early
• May require an exemption determination prior to
submission
Clarkson Forms Available
At: www.clarkson.edu/dor/compliance/human_subjects.html
• IRB Proposal template
– Proposal Guidelines
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Exemption Request
Project Modification Request
Continuation Request
Continuation Request with Modification
Adverse Event Report
Investigational Device Exemption
Human Subjects Determination Request
Additional Resources
Biological Materials & Data
• Coded Private Information or Biological Specimens: Issues
to Consider in the Research Use of Stored Data or
Tissues, Operation of Biological Repositories: OPRR
Memoranda (1996, 1997)
• Coded Private Information or Biological Specimens: OHRP
Guidance on Research (2008) [PDF - 37.5K]
• Coded Private Information or Biological Specimens,
Research Use (Video)
• Research Involving Private Information or Biological
Specimens (flowchart) (PDF - 27 KB)
• Office of Human Subjects Research (at NIH)
– http://ohsr.od.nih.gov/
Additional Resources
• Office of Human Subjects Research (at NIH)
– http://ohsr.od.nih.gov/
•
OHRP FAQs
– http://www.hhs.gov/ohrp/policy/faq/index.html
•
Financial Conflict of Interest: HHS Guidance (2004) [PDF]
•
Reviewing and Reporting Unanticipated Problems Involving Risks to
Subjects or Others and Adverse Events: OHRP Guidance (2007) [PDF 180KB]
•
Reviewing and Reporting Unanticipated Problems Involving Risks to
Subjects or Others and Adverse Events (Video)
•
Engagement of Institutions in Human Subjects Research: OHRP
Guidance (2008)
Professional Organizations
• The American Psychological Association, section 8 of:
– http://www.apa.org/ethics/code2002.html
• American Physical Therapy Assoc. Integrity in Research:
– www.apta.org (search for Integrity in Research)
• NIH HIPAA regulations for research involving patients:
– http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp
• Research Involving Human Biological Materials:
– http://bioethics.georgetown.edu/nbac/hbm_exec.pdf
• American Anthropological Association:
– http://www.aaanet.org/stmts/irb.htm
• The Association of Internet Researchers:
– www.aoir.org/reports/ethics.pdf
• The American Educational Research Association:
– http://www.aera.net/AboutAERA/Default.aspx?menu_id=90&id
=669
• The Academy of Management code of ethics:
– http://www.aomonline.org/aom.asp?ID=268&page_ID=240
Contacts
• IRB web site:
– http://www.clarkson.edu/dor/compliance/
• Dr. Johnson-Eilola, IRB Chair (for policy and
guidelines)
– jjohnson@clarkson.edu
• Kimberly Klatt, Research Compliance Officer (for
policy, guideline, & grant proposal questions)
– kklatt@clarkson.edu
• Becky Thatcher, IRB Administrative Assistant
– rthatche@clarkson.edu
Human Subjects
Protection Program (HSPP)
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Human Subjects Protection Program Plan
IRB Procedures
Forms
Checklists
Worksheets
Investigator Manual
Additional Investigator Guidance Documents
Improved Web presence
Human Subjects
Protection Program (HSPP)
Phase I:
 Streamlined IRB Procedures
• Checklists
• Worksheets
Phase II:
 Human Subjects Protection Program Plan
• Revision of current policy
 Creation of Human Subjects Research Focus Group
• Assist and provide feedback on Phase III implementation
Phase III:
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Revised IRB forms
Investigator Manual
Additional Investigator guidance documents
Improved web presence