Interacting with the IRB

1
Interacting with the IRB

• APS Workshop on Human Research Protections
• Karen Hegtvedt, Ph.D.
• Emory University

2
What does interaction involve?

• Pre-submission questions
• Review of submitted protocol
• what is the study about?
• who is involved?
• what are data collection/handling methods?
• Decisions
• More reviews
• Governed by 45 CFR 46

3
What is the study about?

• Substantive research question
• Lay description
• Translation from the theoretical to the
  empirical

4
Who does the study involve?

• Participants
• characteristics (e.g., age, mental capacity,
  legal status, pregnancy status)
• captures principle of justice
• Researchers
• PI level
• staff
• Contractors

5
What are the data collection and handling
methods?

• Data collection methods
• sets up expectations for respect beneficence
• informed consent
• risk/benefits
• types
• navigating requirements for multiple methods
• Data handling
• sets up expectations for confidentiality

6
What data collection materials should be
included?

• Informed consent documents/process
• Recruitment materials
• Instruments

7
What does an IRB expect of an application?

• Clarity in statement of problem methods
• Consistency in content of all documents
• Completeness of all materials

8
What are types of IRB review?

• Based on
• participant characteristics
• risk/benefit analysis
• methods
• IRB decision (NOT researcher decision)
• Three types of review
• exempt (committee chair reviews)
• expedited (committee chair reviews)
• full board

9
What do IRBs consider in determining type of
review?

• Is It minimal risk?
• 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
• What is the level of physical, psychological, or
  social harm or stress?
• What is the risk of loss of confidentiality?
• Is there deception or intervention?
• Can participants be identified, even indirectly?

10
What can be exempt by IRBs?

• Falls into one of the following categories
• Surveys, interviews, observations of public
  behavior, provided
• participants cannot be identified by their
  answers, AND the responses could not harm a
  subject's financial interests, employability or
  reputation
• Evaluation of educational practices tests
• Existing data, without identifiers
• Subjects are public or elected officials

11
What gets expedited review?

• Minimal risks
• No deception
• Written informed consent
• Possible risk of loss of confidentiality, but the
  research design minimizes this risk
• Collection of voice, video, image recording for
  research purposes
• (Biological specimens, non-invasive clinical
  procedures)

12
What gets full board review?

• Special categories of subjects
• children or diminished capacity
• prisoners
• pregnant women
• More than minimal risk
• physical harm or stress
• loss of confidentiality

13
More on full board...

• Deception
• Changes to informed consent (unless exempt)
• alteration of elements
• waiver
• non-written informed consent

14
How well does protocol protect human research
participants?

• Clear understanding of what researcher is doing
• Clarity of proposed communication with
  participant
• Demonstration by researcher of an understanding
  of ethical issues
• Anticipation of problems/other risks
• Balance of risks/benefits

15
What happens after review?

• Approval
• Pending approval
• request changes, usually minor
• Deferral
• request major changes
• requires re-review
• Denial

16
What happens after initial review?

• Researcher submits for review modifications
  (if any)
• Yearly (at least) continuation reviews

17
What is the bottom line for interaction?

• When in doubt, ask questions seek help
• Remember clarity, consistency, completeness
• On-going process
• IRB enforces regulations, but strives for high
  standards of ethical research
• Researchers and the IRB advance common goals