Protecting the Rights and Welfare of Human Research Participants

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Protecting the Rights and Welfare of Human
Research Participants
NDSU Institutional Review Board Teri Grosz,
Director
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Who is a research participant?What
protections are we talking about?
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Why protect participants?

• Right thing to do
• Preserves integrity of research project
• Fosters public support of research
• For the public good
• Federal law, state law, NDSU policy

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Human subjects research

• If a project/activity involves both
• human subjects/participants
• and
• research
• gtgtgtthese policies apply to the activity

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Human subject Research participant

• -An individual, about whom, a researcher gathers,
  collects, or obtains data or information for the
  purposes of contributing to generalizable
  knowledge

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Some examples

• Gathering or collecting data by
• Surveys, interview, focus group, testing
• Sensory evaluation, clinical tests
• Use of academic, or other private records
• Human biological specimens
• Observation of people
• Use of existing data, documents, records or
  specimens

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Research

• Systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable
  knowledge
• An intent to draw conclusions beyond the specific
  instances being studied, inform policy, or
  generalize findings
• Usually a broad dissemination of the results is
  planned (ie, publication, presentation,
  dissertation, etc.)

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If a project will be done solely for

• Course assignment
• Evaluation of a program (no intent to disseminate
  or generalize)
• Quality improvement
• gtgtgtis not research (per this policy), BUT

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Dual-use Projects

• Even if research is a secondary goal, these
  policies apply to the project
• IRB review is required before the
  activity/project starts

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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How to protect participants?Multiple roles

• Institutiongtgt Ensure a functional program,
  educate research community, provide sufficient
  resources, maintain federal assurances
• Researchergtgt Design study to minimize risks,
  conduct study per approved protocol
• IRB gtgt Review proposed research, monitor ongoing
  research, address complaints, report
  noncompliance
• Sponsorgtgt Verify IRB review of funded research
• OHRP/FDAgtgtOversee IRBs and institutions

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Equitable recruitment

• Equal share of burdens and benefits
• Belmont principle of justice
• In the past, some high-risk research projects
  singled out only vulnerable, dis-enfranchised
  groups

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Vulnerable populations(vulnerable to coersion or
undue inducement)

• Children
• Prisoners
• Pregnant women, fetus, neonates
• Cognitively impaired
• Economically disadvantaged
• Educationally disadvantaged

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Research involving children

• In ND, under 18 yrs of age
• Requires parent/guardian permission, and
  child/youth assent (7 yrs )
• Parental permission should not override a childs
  objections
• Some college students may be under 18 yrs of age
  parent/guardian permission required

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Research involving prisoners

• Now very restricted after reports of abuse of
  prisoners in dermatological research
• Prison is a limited choice environment
• May only be involved with research that studies
  the prison environment or criminal behavior

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Other vulnerable groups

• Pregnant women, fetus, neonates
• Cognitively impaired
• Economically disadvantaged
• Educationally disadvantaged

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Complete understanding of the research

• Full information of purpose, procedures, etc.
• Appropriate reading level, language, format
• All elements of informed consent
• Sometimes a legal representative

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What should participants be told?

• Project involves research
• Purposes of the research
• Procedures to be followed, identifying any
  experimental
• Participation is voluntary
• Any alternatives available
• Description of risks, benefits
• Description of confidentiality procedures
• Contact for questions, concerns

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Informed Consent various formats

• Oral presentation
• Handout
• On-screen view
• Form that requires a signature

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Sometimes consent may be waived

• Regulations allow for limited use
• Waiver of signature requirement
• Waiver of some or all elements of IC
• Must meet specific conditions and receive
  approval by IRB

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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A free choice

• Non-coercive invitation
• Sufficient time to consider their decision
• Choice will not affect other benefits
• Cannot be made to waive their rights, or release
  institution from liability
• Dual relationships can be a problem

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Respect for privacy

• Type of information being requested, sensitive
  nature, etc. Setting of research procedures
  public or private
• Private information (medical, academic, etc.)
  HIPAA, FERPA

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Respect for confidentiality of their information

• Secure data safeguarding procedures
• Limit collection of identifiable information, if
  possible
• Limit use of data to what subjects have agreed to
  (dont share unless allowed by subjects)
• Sometimes research goal is to publish identifiers
  or names (ie, oral history)

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Data safeguarding procedures

• Must minimize potential for a breach of
  confidentiality of data
• Use a coded or numbered list that is kept
  separate from raw data
• Limit access to raw data (physical, and
  electronic security procedures)
• Remove identifiers at earliest opportunity

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To protect subjects, consider

• How will the data be recorded?
• Names, links to coded identifiers
• Anonymous collection collection involves no
  names, codes, or other links, or other
  information that can ID a person
• How will the results be reported?
• Summary form only, no individual results or names
• Individual names and data reported

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participating at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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• Potential risks of harm
• Physical
• Psychological
• Sociological
• Economic
• Legal
• Could disclosure (inadvertent breach of
  confidentiality) of individual research data
  place subjects at risk of criminal or civil
  liability, or be damaging to their financial
  standing, employability, or reputation?

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Physical Risks

• Injury during exercise
• Skin reaction to topical ointment
• Allergic reaction to a food ingredient
• Adverse side effect to a drug dose

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Psychological Risks

• Topic of study may bring up previously
  un-addressed issues
• Negative perception of self
• Emotional suffering (anxiety, shame)
• Aberrations of thought or behavior
• Anger, guilt
• Distress, fear (upon learning of a diagnosis)

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Social Risks

• Negative effects on interactions or relationships
  with others
• Social stigmatization

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Economic Risks

• Imposition of financial costs
• Loss of health insurance
• Loss of employment

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Legal risks

• Illegal activities
• Under-age drinking
• Theft, abuse, assault, etc.

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Possible risks of harm

• Likelihood (probability)
• Severity (magnitude)
• gtgtStudy design should reduce the likelihood and
  reduce the magnitude of harms
• gtgtConsent document should fully disclose any
  potential risks of harm or discomfort

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Minimize risk of harms to subjects

• Study is well designed
• Drugs, devices, or other instruments/testing
  devices are FDA approved, or FDA has approved
  study use
• Researchers are qualified to conduct the study,
  and handle any immediate adverse event
• Participants will be provided with counseling
  referrals (if applicable)
• Collect data in an anonymous fashion (no
  information that could potentially identify a
  subject is collected at any time in the study)
• Have robust confidentiality procedures in place
  (especially for sensitive and identifiable data)

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• Maximize potential benefits of research
• Design study to yield useful and valid results
  that will contribute to generalizable knowledge
  in the field.
• Provide participants with feedback about analysis
  of their individual information (if possible).
• Provide participants with an increased knowledge
  of a particular topic, or an increased awareness
  of their traits, habits, or behaviors.
• Provide subjects with an understanding of
  research participation and how research is
  conducted.

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Research subjects have a right to

• equitable recruitment
• complete understanding of the research
• a free choice
• quit participation at any time
• respect for their privacy
• respect for confidentiality of their info
• be informed of all potential risks
• ask questions or voice concerns

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Ask questions, voice concerns

• Ask before or during participation
• Ask anytime after participation
• Researcher study-related, injury, AE
• IRB research subjects rights, concerns, etc.

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What are NDSUs requirements for conducting human
subjects research?

• Detailed in the IRB Guidelines based on federal
  regulations, FWA terms and NDSU policy.
• Obtain prospective review and approval of the
  project from the IRB.
• Conduct project according to approved protocol,
  following Belmont principles.
• Report to the IRB any adverse events, problems,
  or other events that place participants at risk
  of harm.
• Make changes to the protocol only with
  prospective review and approval of the IRB.
• Submit continuing review/completion reports to
  the IRB (if applicable) on an annual basis.

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How to obtain IRB approval of your project

• Prepare a protocol
• Submit to the IRB for review
• Receive notification of approval (or revisions
  needed)
• Begin research procedures after approved

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IRB Protocol includes

• Protocol form (example on website)
• Other attachments
• Informed consent document (oral script, handout,
  cover letter, or signed)
• List of survey/interview questions (if
  applicable)
• Permission letter from cooperating group (if
  applicable)
• Recruitment ad (copy, or oral script, if
  applicable)
• Grant/contract agreement, if applicable

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Protocol review procedure varies with risk level
of the project

• Exempt categories of research little or no
  risk of possible harm to subjects, 6 permissible
  categories
• Expedited review some risk of harm is
  possible, 9 permissible categories
• Full Board review greater risk of harm,
  and/or involves a vulnerable participant group
• Protocol form provides guidance for what level of
  review is required for the research project.

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What criteria does the IRB use to approve
research?

• Risks to subjects are minimized
• Risks are reasonable in relation to benefits
• Selection of subjects is equitable
• Informed consent will be sought
• Informed consent will be documented
• Research will be monitored to ensure safety, as
  applicable
• Privacy will be protected, and confidentiality of
  data maintained, as applicable
• Additional safeguards are in place for subjects
  vulnerable to coercion or undue influence

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Later on, you may also need IRB approval for

• Changes to the protocol, like
• Additional investigators
• Additional study procedures
• A change in the participant group
• A change in recruitment procedures
• Additional information collected from subjects
• Continuation of the project beyond 1 year

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Reporting Requirements(Researcher gtgtgt IRB)

• Research-related injuries
• Adverse reactions or events
• Problems/complaints from participants
• Breach of confidentiality of sensitive data
• Other unanticipated problems involving risks to
  subjects or others

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Reporting requirements(IRB gtgtgtOHRP,
institutional officials, funding agency, other
entities)

• Suspension or termination of study approval
• Unanticipated event involving risks to subjects
  or others
• Serious or continuing noncompliance with federal
  regulations and/or IRB directives
• Conducting research (non-exempt) without IRB
  approval

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The Protection of Human Research Participants is
a Shared Responsibility

• Research Team principal investigator,
  co-investigator, key personnel
• IRB chair, members, staff
• Institution Institutional Official, leadership
• Sponsor agency, or company
• Federal agencies - OHRP, FDA

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NDSU IRB Members, 2007

• Bob Sylvester, Chair, College of Pharmacy
• Joe Mike Jones, Vice Chair, College of Business
• Wolfgang Teder-Salejarvi, College of Science
  Math
• Joel Hektner, College of Human Development
  Education
• Nicholas Bauroth, College of Arts, Humanities
  Social Sciences
• Julie Garden-Robinson, Extension Service, Food
  Nutrition
• Paul Ode, College of Agriculture
• Dennis Cooley, ethicist, College of Arts,
  Humanities Social Sci.
• Rhonda Magel, Dept. of Statistics, College of
  Science Math
• Magdy Abdelrahman, Dept. of Civil
  Eng/Construction
• Don Matthees, MD, Innovis Hospital
• Pastor Julie Tweit, Boulger Funeral Home
• Adam Tyma, Graduate student rep
• Daniel Eiler, Undergraduate student rep

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NDSU IRB website

• Basic information
• Current protocol forms
• Guidelines
• Meeting schedule
• Membership list
• Links to online training, federal OHRP site,
  other information
• www.ndsu.edu/research/irb

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Different Types of Research involving Human
Participants
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• Research on regular and special education
  instructional strategies, effectiveness of
  instructional techniques, curricula, or classroom
  management methods

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Research involving the use of educational tests,
surveys, interviews, focus groups, oral histories
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Observation of public behavior
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Research involving medical records, academic
records, other documents, or datasets
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Research involving human biological tissues,
specimens
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• Taste and food quality evaluations, consumer
  acceptance studies

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Exercise studies, muscular strength
testing, flexibility testing
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Collection of data from voice, video, digital,
or image recordings
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Collection of data using non-invasive procedures
routinely used in clinical practice
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Research on individual or group characteristics
or behavior (ie, perception, cognition, language,
communication, cultural beliefs, social behavior)
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Clinical studies of drugs, medical devices,food
additives, cosmetics, electronic products also
require approval by the FDA