Research Involving Human Subjects

1
Research Involving Human Subjects

• All research involving the participation of human
  subjects must be submitted for review by the IRB
  (Institutional Review Board for the Protection of
  Human Subjects)

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DHHS Definition

• 45 CFR 46.102(d)
• Research means a systematic investigation,
  including research development, testing and
  evaluation, designed to develop or contribute to
  generalizable knowledge.

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DHHS Definition

• 45 CFR 46.102(f)
• Human subject means a living individual about
  whom an investigator (whether professional or
  student) conducting research obtains
• (1) Data through intervention or interaction
  with the individual, or (2) Identifiable private
  information.

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Review Categories

• Exempt
• Expedited Review
• Full board Review
• Depends on the Risk Level

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What is minimal risk?

• Minimal risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological examinations or tests.

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Review Categories

• May be Exempt
• Projects that present no more than minimal risk
  to the participants and do not compromise the
  privacy of the participants or confidentiality of
  the data
• Fits 1 of 6 categories
• Reviewed and approved by IRB Chair
• Common in Educational Research- No identifiers

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Review Categories

• May be Expedited
• Projects that present no more than minimal risk
  to the participants, and for minor changes in
  approved research
• Has to fit 1 of 7 categories
• Reviewed and approved by 2 IRB Committee Members
• Common in Educational Research for data
  collection methods that use audio/visual data
  collection- Retain identifiers

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Review Categories

• Full Board Review
• Projects involving more than minimal risk
• Full Committee meets once per month (Applications
  must be received at least 10 days before the next
  meeting date)
• Researcher presents the research proposal
• Committee members ask the researcher questions
  regarding the research and participation of human
  subjects
• Vote is taken (in the absence of the researcher)
  and recommendations are made

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Review Categories

• Continuing Review
• Annually for Expedited or Full Board approved
  applications.
• Email notifications sent two month prior to
  approval expiration date.
• Must complete the Continuing Review Form and
  attach a copy of the consent form.
• Same type of review as the original application
  with some exceptions.

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Criteria for IRB Approval of Research

• Risks to subjects are minimized
• sound research design which do not unnecessarily
  expose subjects to risk,
• using procedures already being performed on the
  subjects for diagnostic or treatment purposes.
• Risks to subjects are reasonable in relation to
  anticipated benefits, and the importance of the
  knowledge that may result.
• Selection of subjects is equitable.

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Criteria for IRB Approval of Research

• Informed consent is sought and documented.
• Plans for monitoring the data collected to ensure
  the safety of subjects.
• adequate provisions to protect the privacy of
  subjects and to maintain the confidentiality of
  data.
• additional safeguards to protect vulnerable
  population (children, prisoners, pregnant women,
  mentally disabled persons, or economically or
  educationally disadvantaged persons).

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Analyzing Risks and Benefits

• To judge the application the IRB needs full
  information about
• the selection and recruitment of subjects,
• research design,
• scientific rationale,
• conflicts of interest.

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Informed Consent

• Participants must understand the nature of the
  research.
• Participants must be able to knowledgeably and
  voluntarily decide whether or not to participate.
• Participants must understand the risks and
  benefits of participation.
• The IRB must determine that informed consent will
  be properly obtained.

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Elements of Informed Consent

• Eight Basic Elements
• Research, Purpose, Procedures (experimental),
  Expected duration
• Risks and discomfort
• Benefit
• Alternatives procedures (Treatments)
• Confidentiality of records
• Medical treatment in case of research related
  injury
• Contact Info Research Qs, Rights Qs, Injury Qs
• Participation is Voluntary

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Elements of Informed Consent

• Additional elements, as appropriate
• Unforeseeable Risk (embryo or fetus)
• Participation may be terminated by researcher
• Additional cost to subjects
• Consequences of early withdrawal by subjects
• Significant new findings that may affect wiliness
  to continue participation
• Approximate number of participants

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Elements of Informed Consent

• Voluntary
• Consent if voluntary, free of coercive elements
• Right to refuse or withdraw with no penalty
• Unjustifiable pressures occur when persons in
  authority urge a course of action for a subject
• Coercion is likely whenever possible sanctions
  are involved (implied or actual)
• Undue influence occurs through an offer of an
  excessive, unwarranted, inappropriate or improper
  reward
• Consent process may not involve the use of
  exculpatory language

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Elements of Informed Consent

• Comprehension
• Organized
• Ample time for consideration
• Opportunities for questions
• Lay language appropriate for subject

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Important Components of Protection

• Minimizing Risk
• Maintaining Confidentiality
• Maintaining and Destroying Records
• Maintained for at least 3 years after the
  completion of the study and then destroyed in a
  manner that will protect the identity of human
  subjects.
• Reporting Adverse Events Related to Research

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Approved Research

• Research must be conducted as approved by the
  IRB.
• Any changes to original application must also be
  approved before implementation.
• Report changes to IRB through e-mail message to
  Judette Haddad.
• IRB approval is valid for a maximum of one year
  a Continuing Review Form must be submitted to
  extend the research beyond one year.

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How to Apply

• Submit and application at http//www.oakland.edu/r
  esearch
• All sections of the form must be completed
• An endorsed hard copy of the signature page must
  be forwarded to the Research Office, 530 Wilson
  Hall.
• All research must be conducted or sponsored by an
  Oakland faculty member.

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What Happens?

• For research falling within the categories of
  exempt or expedited review, maybe reviewed and
  approved within 2-3 weeks.
• For research review by the full committee, you
  will be sent a written invitation to attend the
  committee meeting at which it will be discussed.
• Investigator will provide explanations and
  rationale for all procedures, discuss the risks
  and benefits, and information about informed
  consent procedures.
• If approved by the majority of IRB members
  attending the meeting, you will be notified in
  writing within a few days.

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Faculty Responsibilities

• All investigators conducting research involving
  human subjects need to be familiar with Oakland
  University IRB Guidelines http//www.oakland.edu/?
  id9074sid177
• Faculty training is available periodically
  throughout the year
• Take the tutorial at http//www.oakland.edu/?id90
  87sid177
• Faculty must inform students with whom they are
  working to read OU Guidelines
• Faculty must approve student application before
  it is submitted to the IRB
• All research must be exempted or approved before
  it can be conducted
• Research must be conducted as described in the
  approved or exempted application
• Research applications must be submitted through
  the Research Application Manager (RAM 2.0)

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Where Do I Find Information?

• Most information on guidelines, procedures, and
  submitting research applications can be found at
  http//www2.oakland.edu/research
• Contact Judette Haddad (Compliance Coordinator)
  at haddad_at_oakland.edu or 370-4898
• Contact Mary Stein (Chair, IRB) at
  stein_at_oakland.edu or 370-3086

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Tips Before you Apply

• Get a login and password for the RAM 2.0
• Be familiar with the questions that are asked on
  the application
• Write the major components of the application
  (Abstract, Protocol, Consent Form(s),
  Instruments)
• Use the suggested language on the checklist
  within the consent form
• Attach other items given to subjects such as
  survey questionnaire or advertisements
• Allow ample time for the review process to take
  place