Conducting Human Subjects Research at CSUEB

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Conducting Human Subjects Research at CSUEB

• A Roadmap

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Examples of Human Subjects Research at CSUEB

• History Taking oral histories of prominent
  individuals
• Psychology Determining student attitudes
  through questionnaires
• Teacher Education Evaluating new teaching
  techniques in K-12 classrooms
• Womens Studies Studying womens health issues
  through surveys and interviews

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More Examples

• Kinesiology Determine if video modeling can
  help improve volleyball serve
• Entrepreneurship Life histories of successful
  business leaders
• Sociology Attitudes of native employees of call
  center in India
• Criminal Justice Questionnaires used to
  determine traits of Good Samaritans

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Even More

• Computer Science Gender-based and
  ethnicity-based attitudes in the computing
  sciences
• Social Work Encouraging cancer-prevention
  behaviors in traditional societies
• Anthropology Urban reactions to rural accents
  in Japan
• Communicative Sciences Computer-based
  interventions for Alzheimer's sufferers

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Principles of Human Subjects Research

• Belmont Report 1979
• Respect for Persons
• Acknowledge autonomy
• Protect those with diminished autonomy
• Beneficence
• Do no harm
• Maximize benefits, minimize possible harm
• Justice

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When Things Go Wrong

• Tuskegee Syphilis Study 1930s to 1972
• 400 African-American men with syphilis and 200
  without.
• Underwent unnecessary procedures
• Despite many deaths, infected subjects were not
  treated once a cure was found (penicillin in the
  40s).

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Government Regulations

• 45 CFR 46 The Common Rule
• Applies to almost all federally funded research
  (FDA has own regulations)
• Procedures for protecting human subjects
• Establishment of Institutional Review Boards to
  enforce procedures

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Definitions

• Research Systematic investigation designed to
  develop or contribute to generalizable knowledge
• At CSUEB, research masters thesis or above,
  anything published
• Class projects not included unless published

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Definitions

• Human Subject a living individual about whom an
  investigator conducting research obtains
• Data obtained through intervention or interaction
  with the individual, or
• Identifiable private information

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What Is Not Human Subjects Research?

• Journalism
• Research using publicly available data
• Research in which the data obtained is not about
  a person
• Research on an individual who is no longer living
• No interaction or identity determination

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If It Is Human Subjects Research

• P.I. submits research protocol to the IRB
• IRB screens to determine if human subjects are
  involved
• IRB determines if research is exempt from review
  if so, approved
• If not, protocol is reviewed (expedited or full
  review)
• Modifications may be requested prior to granting
  approval
• Project is reviewed again at least once per year
  (continuation review)

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Exempt Research

• 1) Research conducted in established or commonly
  accepted educational settings, involving normal
  educational practices
• 2) Research involving the use of educational
  tests (cognitive, diagnostic, aptitude,
  achievement), survey procedures, interview
  procedures, or observation of public behavior,
  unless
• The subject may be identified and
• Disclosure may result in risk of criminal or
  civil liability or damage to the subjects
  standing or reputation

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More Exemptions

• 3) Research not exempt under 2), but in which
  public officials are the subjects
• 4) Collection of data which is publicly available
  or if subjects are not identifiable
• 5) Research to study public benefit programs
• 6) Taste and food quality evaluation

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Please remember

• The IRB determines if research is exempt from
  review, not the researcher. The decision is made
  based on the risks of possible harm to the
  subjects.
• Also, there are some exceptions to the exemptions
  (for children, prisoners, etc.)

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The Research Protocol

• A description of the research to be done
  including what will be done, where it will be
  done, and who will be performing the research
• A description of the subject population
• A description of the possible risks to the
  participant
• Emotional upset indicate availability of
  counseling
• Loss of privacy ensure confidentiality

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Ensuring Confidentiality

• Store records in locked cabinets
• Encrypt data files
• Use codes to connect participant identification
  to collected data
• Anonymous surveys
• Certificate of Confidentiality

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Research Protocol (continued)

• Inducements or Benefits State whether the
  subjects will be paid and what benefit the
  research may produce
• Right to Withdraw The participants must be able
  to withdraw from the study at any time without
  reprisal
• A Consent Form Used in obtaining informed
  consent
• Surveys, questionnaires, interview outlines, etc.

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Requirements for Informed Consent

• Be obtained from subject or representative
• Provide subject time for consideration and no
  undue coercion
• Be in understandable language
• Not include exculpatory language
• Be prospective (retroactive consent not permitted)

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Consent Form (legally required)

• Purpose of research, duration, what to expect
• Description of risks
• Description of benefits
• Description of alternate procedures (if treatment
  is involved)
• Description of how confidentiality will be
  maintained
• A statement of whether compensation for harm is
  available

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Consent Form (legally required

• Contact information researcher, Director of
  ORSP
• Statement that participant is free to withdraw at
  any time

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Exceptions to Informed Consent

• Portions may be waived if necessary to research
  and research is no more than minimal risk
• Written documentation of consent may be waived if
  privacy issues warrant or no way to conduct
  research otherwise (example telephone survey)

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Vulnerable Populations

• Research with children
• The assent of the child must be obtained using a
  form written at the childs level
• The consent of both parents must be obtained if
  possible (may be waived)
• Some exemptions do not apply

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Vulnerable Populations

• Non-English speakers
• Alzheimers sufferers
• Prisoners
• Pregnant women
• Decisionally impaired psychiatric issues, drug
  use, dementia, etc.
• Terminally ill

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Mid-course Changes

• If changes need to be made to procedures,
  surveys, subject population, etc. Researcher
  submits changes and Modification review is done
  by IRB

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Resources

• CSUEB IRB site
• www.csueastbay.edu/ORSP
• Office for Human Research Protections
• www.hhs.gov/ohrp
• IRB Forum
• www.irbforum.org
• Journal of Empirical Research on Human Research
  Ethics
• www.csueastbay.edu/JERHRE

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Questions or Comments?