OVERVIEW OF HUMAN SUBJECTS RESEARCH AT ARIZONA STATE UNIVERSITY

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OVERVIEW OF HUMAN SUBJECTS RESEARCH ATARIZONA
STATE UNIVERSITY
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Overview

• Definitions
• Historical Framework
• Federal Guidelines
• Human Subjects Research at ASU

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Institutional Review Board (IRB)

• Reviews all proposed research involving human
  subjects to ensure that subjects are treated
  ethically and that their rights and welfare are
  adequately protected
• Diverse membership
• At least 5 members
• Males and Females
• Scientists
• Non-scientists
• At least one unaffiliated member

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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 conducting research obtains
• data through intervention or interaction with
• the individual or identifiable private
  information

http//www.hhs.gov/ohrp/humansubjects/guidance/45c
fr46.htm
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History
Those who cannot remember the past are
condemned to repeat it ." - George Santayana
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Tuskegee Syphilis Study (1932-72)

• Initiated by the US Public Health Service
• Studied the natural history of syphilis by
  denying treatment to the poor black sharecroppers
  who were enrolled in the study
• Participants were told that they were being
  treated for bad blood
• Individuals were deceived by the officials that
  conducted the study
• In 1997, President Clinton apologized on behalf
  of the United States Government to living
  survivors of the study

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Nazi War Crimes World War II

• "Medical experiments" were performed on thousands
  of concentration camp prisoners
• Examples of tortures
• Forced killings
• Injecting people with gasoline
• Immersing people in ice water
• Forcing people to ingest poisons
• 23 physicians and administrators were indicted
  before the War Crimes Tribunal at Nuremberg

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Nuremberg Code (1947)

• Voluntary consent
• Anticipate scientific benefits
• Benefits must outweigh risks
• Perform animal experiments first
• Avoid suffering
• No intentional death or disability
• Do no harm
• Subjects can withdraw at any time
• Investigators must be qualified
• Research will stop if harm occurs

http//www.hhs.gov/ohrp/references/nurcode.htm
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Belmont Report (1979)

• The National Commission for the Protection of
  Human Subjects of Biomedical and Behavioral
  Research issues a report Ethical Principles and
  Guidelines for the Protection of Human Subjects
• Expanded upon Nuremberg Code
• Established 3 ethical principles for
• human subjects protection

http//www.hhs.gov/ohrp/humansubjects/guidance/bel
mont.htm
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Federal Regulations

• 45CFR46 (Common Rule)
• Federal Policy for the Protection of Human
  Subjects
• 21CFR50 (Protection of Human Subjects)
• Regulations about FDA-regulated clinical
  investigations
• 21CFR56 (Institutional Review Boards)
• Regulations about responsibility of IRBs that
  review FDA-regulated clinical investigations

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What are the differences?

• Common Rule is based on funding
• FDA regulations are based primarily on
• use of FDA regulated products drugs,
• devices, or biologics

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Office for Human Research Protections (OHRP)

• Regulates
• Federally-supported research
• Institutional Review Boards (IRB)
• All research if a university chooses to apply
  45CFR46 to research

http//www.hhs.gov/ohrp/
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OHRP
http//www.hhs.gov/ohrp/humansubjects/guidance/dec
isioncharts.htm
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ASU Human Subjects ReviewAll human subjects
research must be reviewed approved prior to
data collection

• Exempt Studies
• Expedited Review
• Full Board

REVIEW TIME DEPENDS UPON THE TYPE OF
STUDY! Generally the review takes 1-6 weeks from
receipt by the Research Compliance Office!
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Summary of Exempt Research

• 1)Research conducted in educational settings,
  involving normal
• educational practices
• (i) research on regular and special education
  instructional strategies, or (ii) research
• on effectiveness of or comparison among
  instructional techniques, curricula, or
• classroom management methods.
• 2) Research involving use of educational tests,
  survey procedures,
• interview procedures or observation of public
  behavior
• unless (i) information obtained is recorded in
  such a manner that human subjects can be
• identified, directly or through identifiers
  linked to subjects and (ii) 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.
• 3) Research involving the use of educational
  tests (cognitive,
• diagnostic, aptitude, achievement), survey
  procedures, interview
• procedures, or observation of public behavior
  that is not exempt
• if (i)human subjects are elected or appointed
  public officials or candidates for public
• office or (ii) federal statute(s) require(s)
  without exception that confidentiality of
  personally

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• 4) Research involving the collection or study of
  existing data, documents,
• records, pathological specimens, or diagnostic
  specimens,
• if these sources are publicly available or if the
  information is recorded by the
• investigator in such a manner that subjects
  cannot be identified, directly or through
• identifiers linked to the subjects.
• 5) Research and demonstration projects which are
  conducted by or
• subject to the approval of department or agency
  heads, and which are
• designed to study, evaluate, or otherwise
  examine
• Public benefit or service programs (ii)
  procedures for obtaining benefits or services
• under those programs (iii) possible changes in
  or alternatives to those programs or
• procedures or (iv) possible changes in methods
  or levels of payment for benefits or
• services under those programs.
• 6) Taste and food quality evaluation and consumer
  acceptance studies
• if wholesome foods without additives are consumed
  or (ii) if a food is consumed that
• contains a food ingredient at or below the level
  and for a use found to be safe, or
• agricultural chemical or environmental
  contaminant at or below level found to be safe,
  by
• the FDA or approved by the EPA or the Food Safety
  and Inspection Service of the USDA.

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Exempt Research at ASU

• Application for Exempt Research
• Identify exemption and provide rationale
• Include methodology, survey forms, etc.
• Submit 1 copy of the application to the Research
  Compliance Office
• Studies that fall under an exempt category must
  be submitted for review!

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ASU IRB Application Process(Full Board and
Expedited Studies)

• Human Subjects application and supplemental
  materials
• Social Behavioral Application
• Bioscience Application
• Researchers submit 1 copy of application and
  supplemental materials to the Research Compliance
  Office when the application is complete

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Expedited Review Categories

• 1) Clinical studies of drugs and medical devices
  only when certain conditions are met
• 2) Collection of blood samples by finger stick,
  heel stick, ear stick, or venipuncture when
  certain conditions are met
• 3) Prospective collection of biological specimens
  for research purposes by noninvasive means.
• 4) Collection of data through noninvasive
  procedures (not involving general anesthesia or
  sedation) routinely employed in clinical
  practice, excluding procedures involving x-rays
  or microwaves.
• 5) Research involving materials (data, documents,
  records, or specimens) that have been collected,
  or will be collected solely for nonresearch
  purposes (such as medical treatment or
  diagnosis).

http//www.hhs.gov/ohrp/humansubjects/guidance/45c
fr46.htm46.110
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• 6) Collection of data from voice, video, digital,
  or image recordings made for research purposes.
• 7) Research on individual or group
  characteristics or behavior or research employing
  survey, interview, oral history, focus group,
  program evaluation, human factors evaluation, or
  quality assurance methodologies.
• 8) Continuing review of research previously
  approved by the convened IRB as follows
• (a) where (i) the research is permanently closed
  to the enrollment of new subjects (ii) all
  subjects have completed all research-related
  interventions and (iii) the research remains
  active on for long-term follow-up of subjects
• (b) where no subjects have been enrolled and no
  additional risks have been identified or
• (c) where the remaining research activities are
  limited to data analysis.
• 9) Continuing review of research, not conducted
  under an IND application or IDE where categories
  2 through 8 do not apply but the IRB has
  determined and documented at a convened meeting
  that the research involves no greater than
  minimal risk and no additional risks have been
  identified.

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Principal Investigator

• Faculty or full-time staff member who assumes the
  following responsibilities
• Submission of all required forms to the
  appropriate review committee
• Conduct of the research
• Compliance with IRB decisions
• Submitting proposed changes to previously
  approved research

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Making changes to a protocol
Changes to exempt studies do not need
review unless the change makes the study
non-exempt.

• Submit ANY proposed changes for review and
• approval before implementing the changes. Use a
• Modification Form.
• Examples of such changes include
• Alteration of study design, methodology, or
  recruitment
• Changes to any instruments
• Changes to informed consent documents
• Addition/deletion of investigators
• Alteration of project title
• Addition of research sites

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Study Approval

• Non-exempt studies may be approved for up to 1
  year
• Study is complete when data analysis and data
  collection are complete

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What happens if research lasts longer than 1 year?

• Submit a Continuing Review Form if the project is
  to last longer than the approval period, which is
  typically one year
• Submit report 2 months prior to approval
  expiration

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What if happens when I am done with research?

• Submit a Close out Report to the Research
  Compliance Office when data analysis and data
  collection are complete
• Submit report 1 month after approval expiration

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Conclusions

• Treat human subjects ethically
• Be aware of Federal, State, and Institutional
  regulations and guidelines
• Ask questions