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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

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DIVISION OF RESEARCH Institutional Review Board (IRB) – Human Subjects Research Training


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slide1

DIVISION OF RESEARCH

Institutional Review Board (IRB) – Human Subjects Research Training

Fall 2011

Johndan Johnson-Eilola

IRB Chair

Kimberly Klatt

Research Compliance Officer

objectives
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
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
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
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
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
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
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
        • 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
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
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
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
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
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 intentis 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
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
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
What are “Human Subjects”?

HUMAN SUBJECT (DHHS): 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 (e.g., school transcripts, health records).
what are human subjects1
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
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
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
Types of IRB Review

“Minimal risk” is that which is encountered in normal daily activities.

No research can be entirely free of risk.

  • Full committee review
    • Standard (default) review
  • Expedited review
    • For “minimal risk” research
  • Exemption from full review
    • Must meet specific criteria
  • Determinations
    • Does my project require IRB review?
    • Are you engaged in Human Subjects Research?
process for exemptions
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
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
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/human_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
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 review1
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
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
Types of Risk
  • Coercion
  • Physical
  • Psychological
  • Economic
  • Social
informed consent process
Informed Consent Process
  • 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
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
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
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
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
    • 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
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
Clarkson Forms Available

At: www.clarkson.edu/dor/compliance/human_subjects.html

  • IRB Proposal template
    • Proposal Guidelines
  • Exemption Request
  • Project Modification Request
  • Continuation Request
  • Continuation Request with Modification
  • Adverse Event Report
  • Investigational Device Exemption
  • Human Subjects Determination Request
additional resources
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 resources1
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
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
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
Human Subjects Protection Program (HSPP)
  • Human Subjects Protection Program Plan
  • IRB Procedures
  • Forms
  • Checklists
  • Worksheets
  • Investigator Manual
  • Additional Investigator Guidance Documents
  • Improved Web presence
human subjects protection program hspp1
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:

    • Revised IRB forms
    • Investigator Manual
    • Additional Investigator guidance documents
    • Improved web presence