Research Involving Human Subjects

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Research Involving Human Subjects

• Institutional Review Board
• (IRB)
• Judette Haddad, PhD, CIP

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History and Ethical principles

• Nuremberg Code 1947
• Declaration of Helsinki 1964
• National Research Act 1974
• Belmont Report 1979
• Respect for person- Informed consent
• Beneficence- Favorable benefit-risk ratio
• Justice- Selection of subjects
• Public Heath Services Act 1985

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Human Subject Protection Regulations

• DHHS Regulations
• 45 CFR part 46- Subparts A, B, C, D, E
• FDA Regulations
• 21 CFR part 50, Protection of Human Subjects
• 21 CFR part 56, Institutional Review Boards
• 21 CFR part 312, Investigational New Drug
  Application
• 21 CFR part 812, Investigational Device
  Exemptions

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OU Federal Wide Assurance

• 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 (cntd)

• 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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DHHS Definition (cntd)

• Private Information
• Information about behavior that occurs in a
  setting in which the individual can reasonably
  expect that no observation or recording is taking
  place
• information that has been provided for specific
  purposes, other than research, where the
  individual can reasonably expect that it will not
  be made public (e.g., a medical record.) 45 CFR
  46.102(f).
• Protected Health Identifiers (PHI)

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DHHS Definition (cntd)

• Coded Private Information or Biological Specimens
• DHHS Office of Human Research Protection (OHRP)
  policy considers private information or specimens
  to be individually identifiable when they can be
  linked to specific individuals either directly or
  indirectly through coding systems.
• DHHS OHRP guidance states that only a
  knowledgeable person or entity is authorized to
  determine if coded specimen or data constitute
  research. An investigator cannot make that
  determination.

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Institutional Review Board

• IRB is a review committee established to help
  protect the rights and welfare of human research
  subjects.
• Authority of the IRB
• Approve, disapprove, or modify research
• Conduct continuing reviews
• Observe and verify changes
• Suspend or terminate approval
• Observe the consent process and research
  procedures

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Review Categories

• Exempt
• Expedited Review
• Full board Review
• Depends on the Risk Level (physical,
  psychological, social and economic risk)

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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 (cntd)

• 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 by IRB Chair or a designated member
• Common in Educational Research- No identifiers

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Review Categories (cntd)

• 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 1 or 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 (cntd)

• 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 are invited to present the research
• 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 (cntd)

• 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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Review by Institution

• Research that has been approved by an IRB may be
  subject to further appropriate review and
  approval or disapproval by officials of the
  institution.
• However, institutional officials may not approve
  the research if it has not been approved by an
  IRB.

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Criteria for IRB Approval of Research

• 1. 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.
• 2. Risks to subjects are reasonable in relation
  to anticipated benefits, and the importance of
  the knowledge that may result.
• 3. Selection of subjects is equitable.

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Criteria for IRB Approval of Research (cntd)

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

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IRB Requirements

• IRB must review
• Qualification of the PI and collaborators
• Full description about conflicts of interest
• A complete description of the proposed research
• Provisions for the adequate protection of rights
  and welfare of subjects
• Compliance with pertinent federal and state
  laws/regulations and institutional policies

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HIPAA Requirements

• Health Insurance Portability and Accountability
  Act
• Mandated standards for storage and transmission
  of healthcare information
• HHS- The Privacy Rule Security Rule
• The research must be HIPAA compliant
• HIPAA language requirement in consent form
• PHI- Protected Health Information- 18 identifiers
• Authorization, Limited Data Set (16 ids) and Data
  Use Agreement
• De-identified Health Information- No restrictions

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Informed Consent Process

• It is a process and not just a form.
• It includes
• Recruitment materials
• Verbal instructions (in person or via video, DVD)
• Written materials
• Q A session(s)
• Documentation of consent by signature

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Informed Consent Process (cntd)

• 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 (cntd)

• 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 (cntd)

• 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 (cntd)

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

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Waiver or Alteration of Consent

• The IRB may approve a waiver or alteration of the
  consent process provided
• The research involves no more than minimal risk
  to the subjects
• The waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• The research could not practicably be carried out
  without the waiver or alteration and
• Whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation.

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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
  Dr. Haddad haddad_at_oakland.edu
• 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 an application at http//www.oakland.edu/re
  search
• 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.
• Non-tenured track professors and staff members
  may obtain a Special Permission to sponsor
  research.

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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
• Complete CITI Training.
• Faculty training is available periodically
  throughout the year.
• Faculty must inform students with whom they are
  working to read OU Guidelines and complete CITI
  training.

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Faculty Responsibilities (cntd)

• 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 Dr. Judette Haddad (Compliance Officer)
  at haddad_at_oakland.edu or 370-4898.
• Contact Dr. Chris Stiller (IRB Chair) at
  cstiller_at_oakland.edu or 370-4047.

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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.

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CITI Training

• Collaborative Institutional Training Initiative
• https//www.citiprogram.org
• Register- Choose OU as Participating Institution
• Four Routes
• Undergraduate Student
• Graduate Students
• Faculty and Staff
• IRB Members
• Mandatory Starting January 2011

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CITI Course in Basic Human Subject Research

• Undergraduate Students
• 1. Oakland University
• 2. Research Misconduct 1-1215
• 3. Students in Research SBR

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CITI Course in Basic Human Subject Research- OU
Maters Final Projects or Theses, and Doctoral
Dissertations

• Oakland University
• Belmont Report and CITI Course Introduction
• Defining Research with Human Subjects SBR
• Assessing Risk in Social and Behavioral Sciences
  SBR
• Informed Consent SBR
• Privacy and Confidentiality SBR
• Records-Based Research
• Internet Research SBR
• Research and HIPAA Privacy Protections
• Research Misconduct 1-1215
• Data Acquisition, Management, Sharing and
  Ownership 1-1308
• Conflicts of Interest and Commitment 1-1622
• If Applicable
• Research with Children SBR
• Research with Prisoners SBR
• Vulnerable Subjects - Research Involving Pregnant
  Women and Fetuses in Utero

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CITI Course in Basic Human Subject Research-OU
Faculty Modules

• Oakland University
• Belmont Report and CITI Course Introduction
• Defining Research with Human Subjects SBR
• Assessing Risk in Social and Behavioral Sciences
  SBR
• Privacy and Confidentiality SBR
• HIPAA and Human Subjects Research
• Data Acquisition, Management, Sharing, and
  Ownership
• Informed Consent SBR
• Conflicts of Interest in Research Involving Human
  Subjects
• Records-Based Research
• Internet Research SBR
• If Applicable
• Research with Children SBR
• Research with Prisoners
• Vulnerable Subjects Research Involving Pregnant
  Women and Fetuses in Utero

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Questions?

• haddad_at_oakland.edu