division of research institutional review board (irb) – human subjects research training

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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 - PowerPoint PPT Presentation


  • DIVISION OF RESEARCHInstitutional Review Board (IRB) Human Subjects Research Training

    Fall 2011

    Johndan Johnson-EilolaIRB Chair

    Kimberly KlattResearch Compliance Officer

    Clarkson IRB Training

  • ObjectivesOverview function of the IRBMandateRegulationsProcessesContrast types of reviewProvide examples of research that is exempt, minimal risk, and requires full reviewOutline IRB review processIntroduction to the Clarksons enhanced Human Subjects Protection Program (HSPP)

    Clarkson IRB Training

  • IRB MandateTo 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 Universitys Federalwide Assurance with DHHS OHRP.

    Clarkson IRB Training

  • Who is on the IRB?The IRB is a committee with representation from CU faculty and the community.

    5-7 voting membersMeet on a regular basis (usually monthly)One person from each SchoolProvides a range of knowledge & experienceAt least one non-scientistWhose focus is on subject welfareOne non-Clarkson memberTo ensure lack of biasAll receive training in IRB regulations

    Clarkson IRB Training

  • 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 Healthwww.health.state.ny.us/nysdoh/provider/volunteer

    Research Sponsor Terms and Conditions

    Clarkson Policy http://www.clarkson.edu/dor/compliance/human_subjects.html

    Clarkson IRB Training

  • RegulationsHHS 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

    Clarkson IRB Training

  • Ethical FoundationsThe Nuremberg Code (1947)Directives for Human Experimentation Informed consent, lack of coercion, properly formulated scientific experimentation, and beneficence towards experiment participantshttp://ohsr.od.nih.gov/guidelines/nuremberg.htmlDeclaration of Helsinki (1964)Ethical Principles for Medical Research Involving Human Subjectshttp://ohsr.od.nih.gov/guidelines/helsinki.htmlThe Belmont Report (1978)Ethical Principles and Guidelines for the Protection of Human Subjects of ResearchDue in part to the Tuskegee Syphilis Experiment (1932-1972)Respect for persons, beneficence, and justicehttp://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlInternational StandardsStandards vary by countryContact IRB for guidanceProfessional standards regarding ethics

    Clarkson IRB Training

  • Human Subjects TrainingClarkson 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 coursesBiomedical FocusSocial and Behavioral FocusData or Specimen Only ResearchStudents Conducting Minimal Risk ResearchRefresher 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

    Clarkson IRB Training

  • To Whom do the Rules Apply?All research conducted at ClarksonAll 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

    Clarkson IRB Training

  • ConsequencesGreater risk of harm to a subjectThe researcher is liablePublic and scientific communities may lose respect for ClarksonPotential research subjects may lose trust in Clarkson and/or researchIf research is performed without proper IRB approval (even without harm)Data may be destroyed or confiscatedJournals may refuse to publishClarkson may have all federal funds frozen

    Clarkson IRB Training

  • 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

    Clarkson IRB Training

  • What is Research?RESEARCH (DHHS): A systematic investigation designed to develop or contribute to generalizable knowledge.

    Key components are:systematic investigation generalizable knowledge.

    Clarkson IRB Training

  • 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

    Clarkson IRB Training

  • 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.

    Clarkson IRB Training

  • Examples of Projects Not Considered ResearchTeacher 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 sponsorJournalism or documentary work

    Clarkson IRB Training

  • 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).

    Clarkson IRB Training

  • What are Human Subjects?Key components of the definition to consider when making aDetermination:

    Intervention: includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subjects 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).

    Clarkson IRB Training

  • Examples of Projects Involving Human SubjectsInterviewing peopleTesting individuals Making observations of identifiable individualsLooking at recordsConducting a surveyInvolving human tissue or biological specimens ( case-by-case basis).

    Clarkson IRB Training

  • What Needs IRB Full Review?All human subjects researchUnless it is Exempt from IRB reviewExemptions must be certified by the IRBResearchers are not authorized to decide if their human subjects research requires IRB full reviewDOR or IRB should decideWhat does NOT require IRB reviewClassroom-only activities Quality assurance surveysIf in doubt, ask early!

    Clarkson IRB Training

  • Types of IRB ReviewFull committee reviewStandard (default) reviewExpedited reviewFor minimal risk researchExemption from full reviewMust meet specific criteria DeterminationsDoes my project require IRB review?Are you engaged in Human Subjects Research?Minimal risk is that which is encountered in normal daily activities. No research can be entirely fre


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