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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FederalWide Assurance (FWA00002439)

• The DHHS Office of Human Research Protections
  (OHRP) has approved NDSU to conduct research with
  human subjects.
• Terms of the FWA state how NDSU will protect the
  rights and welfare of those who volunteer for
  research projects.
• These procedures are detailed in the NDSU IRB
  Guidelines (www.ndsu.edu/irb ).

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• What is a human subject/participant?
• When does a human subject become involved in
  research?
• What ethical principles should be considered when
  conducting research involving human subjects?
• What are NDSUs requirements when conducting
  human subjects research?

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• Human subject/participant
• - a living individual about whom an
  investigator conducting research obtains either
  (1) data through intervention or interaction with
  the individual, or (2) private information (DHHS,
  45 CFR 46.102)
• - an individual who becomes a participant in
  research, either as a recipient of a test article
  or as a control. May be a healthy human or a
  patient. (FDA, 21 CFR 50.3)

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• Intervention includes both physical procedures
  by which data are gathered, and manipulations of
  the subject or their environment
• Interaction communication or interpersonal
  contact between investigator and subject
• Private information
• information about behavior that occurs in an
  environment in which one can reasonably expect no
  observation or recording is taking place
• information provided for another purpose that one
  would expect not to be made public (ie, medical
  or other private records)

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Research

• A systematic investigation, research development,
  testing or evaluation designed to develop or
  contribute to generalizable knowledge (DHHS, 45
  CFR 46.102)
• There is 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, etc.)

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• Research maybe conducted as part of a larger
  project with other objectives (ie, an educational
  initiative with assessment activities)
• Research may be conducted as part of a dual-use
  project (ie, employer assigned duty and MS/PhD
  thesis NDSU research and outside entity project)

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Are course assignments research?

• Sometimes a class assignment will involve
  collection of data from human subjects (surveys,
  interviews) in research-like activities.
• The same ethical principles should be used for
  conducting the activity, but NDSU IRB does not
  consider this project to be research if it will
  be used ONLY for fulfilling requirements of the
  course.
• This project would be research if either the
  instructor or the student ALSO intends to broadly
  disseminate the results (ie, in a publication,
  presentation, dissertation, etc.)

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• All projects that fit the definition of
• human subjects research must follow
• Federal regulations and NDSU policies
• to protect participants rights and
• welfare.
• These projects are not limited to clinical
  studies, or social and behavioral science fields.
• May be conducted in any department or unit across
  campus, and in many different fields.

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The rights and welfare of research participants
are protected by federal regulations and
institutional policies

• Code of Federal Regulations, Title 45 Public
  Welfare, Part 46 Protection of Human Subjects
• Code of Federal Regulations, Title 21 Food and
  Drugs, Part 50 Protection of Human Subjects
• NDSU IRB Guidelines http//www.ndsu.nodak.edu/irb/
  forms/irb_guidelines.pdf

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What ethical principles should be considered when
conducting research involving human participants?

• The Belmont Report, 1979
• http//www.hhs.gov/ohrp/humansubjects/guidance/bel
  mont.htm
• Respect for persons
• Beneficience
• Justice

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Respect for persons gtgtInformed Consent

• Research participation is a voluntary choice.
• Participation (or choosing not to participate)
  should not affect any other rights or benefits
  participants would be entitled to.
• Subjects must receive adequate and understandable
  information about the research.

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Recruitment of subjects should be done in an
environment free of any coersion (overt or subtle)

• Dual relationships/dual roles
• Instructor/student
• Employer/employee
• Physician/patient
• Compensation offer an alternative (ie, for extra
  credit) equal in time/effort to research
  participation

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Participants must be provided with the following
information in non-technical, lay language

• Invitation to participate in a research study
• Participation is voluntary, can quit anytime
• Purpose of research, who is conducting it, how
  long it will take
• Description of any potential risks/discomforts,
  benefits
• Alternatives to participation, if any (ie, other
  ways to earn extra credit, etc)
• Description of if/how the information they
  provide will be held confidential, how the data
  will be reported
• Contact information for researchers, and IRB
  office

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• Consent shall be sought in an environment that
  minimizes the possibility of coercion or undue
  influence.
• Research subjects cannot be made to waive their
  legal rights, or release the investigator,
  institution, or agency from liability for
  negligence.

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Beneficence gtgt

• An obligation to protect persons from harm
• Maximize research benefits and minimize any
  possible harms

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• Possible harms resulting from research
  participation
• Physical
• Psychological (raises unaddressed issues)
• Sociological (embarrassment, invasion of privacy)
• Economic (loss of job)
• Legal (admission of crimes)
• Loss of privacy

Subjects may be harmed if confidentiality of
identifiable research data is breached and
becomes known to others outside the research
project.
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(No Transcript)
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Psychological Harms

• 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 Harms

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

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Economic Harms

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

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Possible harms

• Likelihood (probability)
• Severity (magnitude)
• Low probability/trivial harm
• High probability/trivial harm
• Low probability/severe harm
• High probability/severe harm
• gtgtDesign study to reduce the likelihood and
  reduce the magnitude of harms

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Minimize risk of harms to subjects

• Researchers are qualified to conduct the study,
  and handle any immediate adverse event
• 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 data)
• Participants will be provided with counseling
  referrals (if applicable)

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Maintain confidentiality of sensitive 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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• 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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Justice gtgt Fair distribution of research burdens
and benefits

• In the past, some high-risk research projects
  singled out only vulnerable, dis-enfranchised
  groups
• Current regulations require extra protections
  when vulnerable groups are involved in research

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Vulnerable populations

• Children
• Prisoners
• Pregnant women
• Terminally ill, mentally incapacitated,
  elderly/aged, economically or educationally
  disadvantaged persons

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Research involving children

• In ND, under 18 yrs of age
• Requires parental consent, youth assent
• A childs objections should override parental
  consent
• Includes some college freshman
• If a college-aged group, some studies choose to
  limit participation to those 18 and older

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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
• Prisoner anyone involuntarily confined or
  detained in a penal institution
• May only be involved with research that studies
  the prison environment or criminal behavior

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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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NDSU IRB Members, 2004-2005

• Bob Sylvester, Chair, College of Pharmacy
• Joe Mike Jones, Vice Chair, College of Business
• Jim Council, College of Science Math
• Joel Hektner, College of Human Development
  Education
• Leanna Bouffard, 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
• V. B. Rao, College of Engineering
• Don Matthees, MD, Innovis Hospital
• Pastor Julie Tweit, Boulger Funeral Home

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How to obtain IRB approval of your project

• Prepare a protocol to submit to the IRB (Forms
  page)
• Project will be reviewed according to IRB
  Guidelines
• You will be notified of approval of the project,
  or requested to provide additional information,
  and/or revisions
• You may begin collecting data

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IRB Protocol includes

• Protocol form (example on website)
• 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)

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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 categories
• Expedited review some risk of harm is
  possible, 9 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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Obtain prospective IRB approval for any changes
made to the approved protocol

• Additional investigators
• Additional study procedures
• A change in the participant group
• A change in recruitment procedures
• Additional information collected from subjects
• Other changes

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Continuing Review Requirements

• Applies to only expedited and full-board projects
• IRB must review at least once/year
• of participants enrolled/completed/to be
  recruited
• Adverse events, problems, withdrawals
• Significant new findings, summary of results

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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 a study
• Unanticipated event involving risks to subjects
  or others
• Serious or continuing noncompliance with the
  federal regulations and/or IRB directives

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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

• Normal educational practice, normal educational
  setting
• Parental consent, child assent, if minors
  involved

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Research involving the use of educational tests,
surveys, interviews, focus groups, oral histories

• Identifiers ? Anonymous?
• Collection of sensitive information?
• Recruitment procedures
• Compensation offered?
• Alternatives?
• Maintaining confidentiality

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Observation of public behavior

• Interaction with participants ?
• Collection of identifiers ?
• Nature of the data collected
• May qualify for a waiver of informed consent

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Research involving medical records, academic
records, other documents, or datasets

• Publicly available information?
• Pre-existing vs. future records ?
• Already being collected for another purpose
• Legitimate access ? Other regulations may also
  apply (HIPAA, FERPA)
• May be a concern with invasion of privacy
• Identifiers or de-identified ?
• May qualify for a waiver of informed consent

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Research involving human biological tissues,
specimens

• Commercially available?
• Pre-existing, or future collections?
• Collected for research, or other purposes?
• Identifiers included? Medical info included?
• Training in Bloodborne Pathogens, IBC protocol

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• Taste and food quality evaluations, consumer
  acceptance studies

• Wholesome foods, no additives
• Safe levels of ag chemicals, contaminants

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Exercise studies, muscular strength
testing, flexibility testing

• Subject inclusion/exclusion criteria
• Address how to deal with potential injuries,
  health problems related to the study medical
  treatment, payment plan
• Inform IRB of injuries, adverse events, etc.,

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Collection of data from voice, video, digital,
or image recordings

• Identifiers collected?
• Sensitive information? Confidentiality?
• Disposition of audio/video tapes length of
  storage, access, destroyed once information has
  been obtained?

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Collection of data using non-invasive procedures
routinely used in clinical practice

• Subject selection, recruitment
• If a medical device is used, has FDA approval
• Identifiers, confidentiality measures

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Research on individual or group characteristics
or behavior (ie, perception, cognition, language,
communication, cultural beliefs, social behavior)

• Subject selection, recruitment procedures
• Collection of identifiers vs. anonymous
• Nature of the data collected
• Confidentiality provisions
• Compensation?

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Clinical studies of drugs, medical devices,food
additives, cosmetics, electronic products also
require approval by the FDA
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A medical device, per FDA, is

• Any health care product intended for use in
  diagnosis, cure, treatment or prevention of
  disease in man or animals
• Some examples surgical lasers, wheelchairs,
  sutures, pacemakers, vascular grafts, intraocular
  lenses, orthopedic pins
• Also includes diagnostic aids such as reagents
  and test kits for in vitro diagnosis (IVD) of
  disease and other medical conditions

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The Protection of Human Research Participants is
a Shared Responsibility

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

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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/irb