Introduction to the Institutional Review Board (IRB): Minnesota State University, Mankato

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Introduction to the Institutional Review Board
(IRB)Minnesota State University, Mankato

• Patricia M. Hargrove, Ph.D.
• IRB Coordinator
• Anne Blackhurst, Ph.D.
• Dean/IRB Administrator

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IRB Framework

• 1974--National Research Act
• 1978--National Commission for Protection of Human
  Subjects
• Belmont Report
• 1991--Common Rules and FDA

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1978 The Belmont Report

• Principle 1 Respect for
  Persons
• Principle 2 Beneficence
• Principle 3 Justice

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Respect for Persons

• MAJOR COMPONENTS
• Right to autonomy and self-determination
• Protecting vulnerable subjects

5
Respect for Persons

• IRB REQUIREMENTS
• Avoid coercion or undue influence versus
  voluntary actions
• Provide informed consent.
• Maintain privacy and confidentiality.
• Insure the right to withdraw from participation
  without penalty.

6
Beneficence

• MAJOR COMPONENTS
• It is important to insure the well-being of
  research participants.
• There are trade-offs between individual and
  societal benefits to research.

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Beneficence

• IRB REQUIREMENTS
• The risks of research are justified by the
  potential benefits to subjects and/or society.
• The study is designed so that risks are
  minimized.
• Conflicts of interest are managed adequately.

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Justice

• MAJOR COMPONENTS
• Distribute the risks and potential benefits of
  research equally among those who may benefit from
  the research.

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Justice

• IRB REQUIREMENTS
• Vulnerable subjects are not targeted for
  convenience.
• People who are likely to benefit from research
  participation are not systematically excluded.

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Purpose of the Minnesota State Mankato IRB

• Safeguarding the rights and welfare of subjects
  in research and related activities.
• Assisting faculty and staff engaged in relevant
  research from unknowingly committing unethical
  acts.

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Steps in Applying to the IRB Paper Application

• The PI must be MSU faculty or staff.
• Go to the IRB webpage (http//grad.mnsu.edu/irb/)
  and review the IRB Proposal Guidelines and IRB
  Information.

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Steps in Applying to the IRB Paper Application

• Complete the application (IRB
• Proposal Guideline).
• 4. Submit the application.
• - Graduate Office
• - AH 103 (Speech Hearing
• Clinic)
• 5. Wait until you receive approval to begin data
  collection.

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Steps in Applying to the IRB Online Submission

• The PI must be MSU faculty or staff.
• Go to the IRB webpage (http//grad.mnsu.edu/irb/).
  
• 3. Click on Online Proposal Submission.

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Steps in Applying to the IRB Online Proposal

• Student be sure to click on Special Note for
  Students Submitting Online Proposal.
• be sure to get advisors (PIs) support.
• Complete the application (IRB Proposal
  Guideline).
• 6. Submit the application.
• 7. Wait until you receive approval to begin data
  collection.

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Steps in Applying to IRB Online Submission

• HINTS
• Make start date about a week out
• If student submits, he/she must notify advisor
  that he/she needs to
• Go online
• Access the proposal
• Submit and notify
• Provide permission

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IRB Levels

• IRB is concerned with 3 levels of research
• BUT
• Classroom activity, laboratory courses, or field
  assignments are normally not classified as
  research and typically are not reviewed by the
  IRB.
• These are considered to be exempt at MSU.

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Level I

• See Level I Review Checklist
• Children
• Standardized educational tests, surveys,
  interviews, observations of public behavior
• Cannot identify participants
• Disclosure does not put participant at risk
• Public officials
• Pre-existing data
• Wholesome food

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Level I

• Research involves less than minimal research.

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Level II

• Proposals which involve minimal or less risk and
  are not eligible for Level I review.
• Recordings of identifiable information with minor
  risks.
• See IRB Manual

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Level II

• Moderate exercise by healthy volunteers.
• Research on individual or group behavior or
  characteristics of individuals (e.g., as studies
  of perception, cognition, game theory, or test
  development.)

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Level II (some examples)

• Recording of data from subjects 18 years of age
  or older using non-invasive procedures routinely
  employed in clinical practice.
• Collection of blood samples in amounts not
  exceeding 450 milliliters in an eight-week period
  and no more often than two times per week.

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Level III

• Involves the most serious risks.

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Characteristics of a Consent Form

• Purpose provided.
• Procedures clearly described.
• Risks and discomforts disclosed.
• Potential benefits provided.
• In intervention research, describe alternative
  treatments.
• Confidentiality provisions detailed.

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Characteristics of a Consent Form (continued)

• Note that the research is voluntary.
• Assent form for minors or vulnerable adults
• Provide contact information for
• Student investigator (optional)
• Principal investigator
• IRB Administrator
• and explain why they are resources

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Hints

• Remember to include signature(s) in all paper
  versions.
• Number pages on paper versions.
• The PI has to be a faculty member or a staff
  member.
• Consent forms must be held by PI.

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CASE

• A researcher wants to investigate the social
  experiences of elementary school children from
  migrant families. To obtain consent to interview
  the children, she sends a consent form home to
  their parents.

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Case

• A researcher wants to investigate the career
  aspirations of inner city youth. She advertises
  her study by posting fliers in several community
  centers. The fliers state that participants will
  be given an iPod in exchange for their
  participation.

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Case

• A researcher wants to study the effects of a
  stress reduction technique. She contacts a local
  halfway house and requests permission to recruit
  residents to participate in her study.

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Case

• A graduate student in English wants to compare
  the composition skills of high school students
  who are English language learners with students
  for whom English is their first language. She
  contacts a local high school teacher and requests
  access to students writing assignments. The
  assignments will not include students names.

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Case

• A researcher wants to study the social networks
  that often form in assisted living facilities and
  long-term care facilities for older adults. She
  plans to obtain informed consent from the
  residents before conducting individual interviews
  and focus groups to explore the role of social
  networks in their lives.

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Case

• A researcher wants to investigate the
  effectiveness of an employee assistance program
  for chemically dependent employees. She contacts
  a local corporation and obtains permission to
  implement the program at their corporate
  headquarters. She plans to obtain informed
  consent to collect data on substance use and
  absenteeism from employees who voluntarily
  participate in the program.

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Case

• A researcher is interested in how teen girls make
  decisions about contraception and STD protection.
  She plans to recruit girls who seek
  contraception or pregnancy counseling at a local
  Planned Parenthood clinic and interview them
  about their sexual histories and sexual decision
  making.

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References

• Amdur, R. J., Bankert, E. A. (2007).
  Institutional Review Board Member handbook (2nd
  ed.) Sudbury, MA Jones and Bartlett.

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MSU Contact Information

• http//grad.mnsu.edu/irb/
• patricia.hargrove_at_mnsu.edu