Human Subjects Research

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Human Subjects Research

• Valery M. Gordon, Ph.D., M.P.H.
• Extramural Human Subjects Research Policy Officer
• Office of Extramural Research, OD, NIH
• [phone]
• vg10w_at_nih.gov

6th Annual SBIR/STTR Conference, June 23, 2004
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Definition of a Human Subject

• a living individual
• about whom an investigator conducting research
  obtains
• (1) data through intervention or interaction
  with the individual, or
• (2) identifiable private information
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /45cfr46.htm46.102

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Definition of Research

• a systematic investigation
• research development,
• testing, and
• evaluation
• designed to
• develop or to contribute to generalizable
  knowledge
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /45cfr46.htm46.102

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Definition of Risk

• the probability of
• harm
• or
• discomfort
• Extracted from
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /45cfr46.htm46.102

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OHRP Responsibilities

• Office for Human Research Protections (OHRP) is
  in Office of the Assistant Secretary for Health,
  DHHS
• http//ohrp.osophs.dhhs.gov/index.html
• OHRP is responsible for
• Issuing Assurances to institutions engaged in
  federally-funded human research and registering
  IRBs which provide approval and oversight for
  human subjects research
• http//ohrp.osophs.dhhs.gov/irbasur.htm
• Developing and updating policy and guidance
  documents
• Education
• Compliance with HHS Human Subjects Protections
  Regulations
• http//ohrp.osophs.dhhs.gov/humansubjects/guidan
  ce/45cfr46.htm

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NIH Responsibilities

• NIH is committed to the highest ethical and
  scientific standards for Human Subjects research
• NIH assesses proposed research for protections
  against research risk
• Consistency with HHS Regulations
• Subpart A - Federal Policy for the Protection of
  Human Subjects
• Subpart B Additional Protections for Pregnant
  Women, Human Fetuses and Neonates
• Subpart C Additional Protections for Prisoners
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /prisoner.htm
• Subpart D Additional Protections for Children
• Compliance with NIH Policies and Guidance
• Data and Safety Monitoring Plans for Clinical
  Trials
• Required Education for Protection of Human
  Subjects in Research

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Application (PHS 398) Human
Subjects Research

• PI should enter YES in Item 4 on application
  facepage
• Exemptions designated in Item 4a often represent
  the opinion of the PI because
• OHRP Guidance states Exemptions should be
  independently determined
• http//ohrp.osophs.dhhs.gov/humansubjects/guidan
  ce/wirbproc.pdf
• Institutions often designate IRB to make
  determination and
• NIH does not require IRB approval until prior to
  award
• Required information must appear in the Research
  Plan in Section e. Human Subjects

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Human Subjects Section Non-exempt Research

• Non-exempt Human Subjects Research
• Risks
• Adequacy of protections against risks
• Data and Safety Monitoring for Clinical Trials
• Monitoring entity
• Adverse Event Reporting
• Potential benefits
• Importance of knowledge to be gained
• http//grants.nih.gov/grants/funding/phs398/phs398
  .html

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Human Subjects Section Exempt Research

• Exempt Human Subjects Research
• Exemption Category
• Justification for exempt status
• Population sample
• Number
• Age range
• Health status
• Sources of research materials or data

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Exemptions 1, 2

• Research in educational settings on educational
  strategies
• Surveys, interviews, observations of public
  behavior, if participants
• cannot be identified, either directly or
  indirectly OR
• may be identified, but would not be put at risk
  if information is disclosed
• E2 only applies to research with children for
  observations of public behavior when the
  investigators do not participate in the
  activities being observed
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /45cfr46.htm46.101

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Exemption 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."
• http//ohrp.osophs.dhhs.gov/humansubjects/guidanc
  e/45cfr46.htm46.101
• In order to be exempt from the requirement of IRB
  review and approval under exemption 4,
  researchers must propose the use of data or
  samples that are either
• - existing and publicly available
• OR
• - existing and unidentifiable

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Repositories and Databases

• Non-Research Repositories Databases
• IF samples or data collected for non-research
  purposes AND
• Samples or data submitted to the Repository
  without any links to identifiable private data or
  information THEN
• NOT HUMAN SUBJECTS RESEARCH

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Repositories and Databases

• Research Repositories Databases
• Samples or data collected for research purposes
• Sample or data collection is a research activity
• Repository Storage/Data Management is a research
  activity
• Use/Disclosure of Samples/Data is a research
  activity
• Each research activity is Human Subjects Research
• If archived samples/data are provided without
  links to individually identifiable information,
  then the research may meet the criteria for
  Exemption 4

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FAQS Human Subjects Research?

• Research with cadaver specimens?
• NO, Human Subjects research involves living
  individuals
• Research with tissue specimens?
• NO, if specimens obtained from non-research
  repository
• YES, if specimens obtained from research
  repository
• YES, if specimen collection is ongoing (even if
  samples were going to be discarded)
• Research with cell lines?
• NO, for commercially-available cell lines
• YES, if cell lines meet definition of human
  subject

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FAQs Human Subjects Research?

• Research involving Focus Groups
• NO, if research will involve consultants chosen
  for their expertise to improve research design
• NO, if research will involve individuals
  recruited to test a new product/survey instrument
  in order to identify problems (b-testing)
• YES, if research will involve small group
  representing target population and
  individually-identifiable information will be
  obtained, that could result in risks (pilot
  testing)

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Thank you!