Is this Research Human Research Exempt

1
Is this Research? Human Research? Exempt?

• Presented by
• Marisue Cody, PhD
• Deputy Director, PRIDE

2
Objectives

• Evaluate if the activity is research
• Evaluate if a study is human subjects research
• Evaluate if a study meets exempt criteria
• Evaluate if a study meets expedited criteria

3
Definitions

• Exempt Encarta Dictionary, to allow or entitle
  one to not do what others are obliged to do.
  The IRB Chair or designee must approve the exempt
  status.
• Expedited Encarta Dictionary, to deal with
  something swiftly and efficiently. In reference
  to research, it is a review process by the IRB
  Chair or designee for a study that involves human
  subjects.
• FYI The IRB needs to be informed of what items
  have been exempted and expedited.

4
Is it Research?
5
Research
a systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable
knowledge. (38 CFR 16.102d)
Widespread information
6
Case 1 Social Work Intern project

• She is reviewing 3 groups of outpatients
• Day treatment group,
• Never attended group,
• Used to attend group but dropped out.
• She is asking standard questions regarding their
  feelings and opinions about the group. She will
  collect demographic and treatment information but
  it will be collected without identifiers. Her
  primary goal is to report the results to the
  Chief of Mental Health.
• Can it be exempt, expedited, or neither?

7
When is it a QA Activity?

• QA activities that are designed solely for
  internal program evaluation purposes, with no
  external application or generalization, usually
  do not constitute human subject research and
  usually do not require IRB review.
• QA activities constitute human subject research
  and require IRB review, when they are designed or
  intended, at least in part, to develop or
  contribute to generalizable knowledge.

8
Are there Human Subjects?
9
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 (45 CFR 46.102f)

10
Human Subject defined by FDA regulations

• .means an individual who is or becomes a subject
  in research, either as a recipient of the test
  article or as a control. A subject may be either
  a healthy human or a patient. (21 CFR 50.3(g),
  21 CFR 56.102(e) A human subject includes an
  individual on whose specimen a medical device is
  used. 21 CFR 812.3(p)

11
Case 2

• An investigator proposes to do a study of genetic
  markers of colon cancer. He will purchase cells
  from a company that archives tissue for these
  purposes. The cells will have no identifiers.

12
Is it Research with Human Subjects?
13
Guidance from AAHRPP
14
(No Transcript)
15
(No Transcript)
16
Guidance from OHRP

• The Human Subject Regulations Decision Charts
  dated September 24, 2004, are at the following
  website to assist in determining if an activity
  is research involving human subjects under the
  requirements of 45 CFR part 46.
• http//www.hhs.gov/ohrp/humansubjects/guidance/dec
  isioncharts.htm

17
Is it Exempt?
18
Exempt

• Unless otherwise required by Department or Agency
  heads, research activities in which the only
  involvement of human subjects will be in one or
  more of the following categories are exempt from
  this policy
• Exemptions b(1-6) 45 CFR 46.101(b)
• Exemption categories 1-5 are not applicable to
  research governed by FDA regulations (21 CFR
  50.20)

19
Categories of Exempt Research

• Research conducted in established educational
  settings, involving normal educational practices
• Research involving the use of educational tests,
  survey procedures, interview procedures, or
  observation of public behavior
• Same as 2, but covers elected officials
• Research involving use of existing data
• Research and demonstration projects by approval
  of agency heads
• Taste and food quality

20
Exempt if it is ONLY

• Research in one or more exempt categories, for
  example, an anonymous survey of adults.

• AND NOT research in any covered research
  category, for example, collecting private
  identifiable data from future records.

21
Is It a Covered Activity?
22
What are the Covered Research Categories?

• Identifiable private information?
• Vulnerable populations?
• Subjects vulnerable to coercion or undue
  influence?
• Treatments or procedures?
• Incomplete Information?
• These types of activities would not qualify for
  exemption.

23
Case 3

• The IRB chairperson receives a protocol
  requesting exemption from IRB review under 45 CFR
  46.101(b) 4 (refer to chart 2 5). The protocol
  includes the use of adipose tissue being taken
  from patients during liposuction. The samples are
  being collected at another site, and the local
  investigator wants to obtain them for use in a
  study at the VA. When the VA investigator
  receives the samples they will be de-identified.
  The patients at the site collecting the samples
  were not consented for this use.
• What should the Chair do?

24
Points to consider

• Does this study use existing specimens?
  Existing means existing before the research is
  proposed to the IRB to determine whether the
  research is exempt.
• Should the subjects be or have they been
  consented (from another studyuse your data for
  future studies)?
• Are they asking for a waiver of consent?
• FDA may not recognize exemptions from a specimen
  collection that has not been authorized by an
  IRB.

25
IRB determinations for exemptions

• IRB Chair or an IRB member designated by the
  Chair (some sites may elect full committee
  review)
• Exemption documented in the IRB records
  (including category)
• Decision communicated in writing to investigator
• RD Committee reviews requests for exemption
  prior to initiation (VHA Handbook 1200.5)
• Subject to RD Committee annual review (VHA
  Handbook 1200.5)

26
What research activities are eligible for
expedited review?

• No more than Minimal Risk.
• Must fit one or more of the categories on the
  Expedited Review Categories List Authority 45
  CFR 46.110 and 21 CFR 56.110
• Minor changes in previously approved research
  during the period for which the approval is
  authorized

27
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 tests. (45 CFR 46.102(i))

28
Expedited Categories

• Clinical studies of drugs and medical devices
  only under specific conditions
• Collection of blood samples
• Biological specimens obtained by non-invasive
  means
• Collection of data through non-invasive
  procedures
• Materials collected solely for non-research
  purposes
• Collection of data from voice, video, etc.
• Research employing surveys, etc. (OMB Issue)
• Continuing review under specific conditions

29
Case 4

• This study proposes to collect data on 5,000 VA
  patients with ICU admissions from 2003-2004 to
  compare statistical models of risk adjustment and
  mortality prediction. There is no direct patient
  contact and scrambled patient identifiers are
  used to link data from various sources (Austin,
  Pharmacy Benefits Management, CPRS).

30
Case 5

• An investigator proposes a medical record review
  of 200 charts. No identifiers will be recorded.
  The data will be collected during the upcoming
  year as new patients join the Endocrinology
  clinic. Does the study qualify for exemption
  under 45 CFR 16.101(b)(4)?

31
Another Good Reference

• Guidance on Research Involving Coded Private
  Information or Biological Specimens
• http//www.hhs.gov/ohrp/humansubjects/guidance/cde
  biol.pdf

32
IRB Determinations

• IRB Chair or one or more experienced reviewers
  designated by the Chair from among members of the
  IRB
• Notification of IRB members PI
• Minutes and/or protocol file must reflect
  eligibility category
• Subject to continuing review based on IRB
  approval date
• Requires RD Approval (currently, there is no
  option for expedited/exempt review from the RD
  Committee)

33
QUESTIONS