IRB

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IRB BASICS
Part II
Prepared for Regent University 12/19/07 Stan
Hoegerman
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Informed Consent

• The voluntary consent of the human subject is
  absolutely essential.
• Potential subjects should have the legal
  capacity to give consent.
• But, if they dont, a parent or guardian
  must give consent for the
• participation of children under the age of 18
  or of mentally
• incompetent persons. The investigator must also
  have the assent
• of the potential subject.
• Assent uninformed consent.
• Investigator says Id sure appreciate
  your help. What we will
• do is. Is that OK with you. You really dont
  have to do this. If
• you dont, I wont get angry or anything
  like that. And, if you dont
• like it, you can stop any time you want.
  OK?
• Kid says OK.

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2) They should be able to exercise free power
of choice without any intervention
involving force, fraud, deceit, duress,
overreaching, or other form of constraint
or coercion. Payment of large sums of
money to encourage participation in
projects with significant degrees of risk is not
permitted. Actual expenses plus a modest
honorarium is acceptable. Personal opinion
Its OK to say I need your help with.
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• They should have sufficient knowledge and
• comprehension of the subject matter to
  enable them
• to make an understanding and enlightened
  decision.
• Potential subjects should be well educated on
  the subject
• matter.
• 4) This latter element requires that all risks,
  inconveniences
• and hazards reasonably to be expected be
  made known
• to them.
• This has been expanded to require the
  inclusion of
• improbable side effects and the like.

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Deception On the face of it, deceiving
subjects is impossible if subjects must be fully
informed. But, if deception as to the purpose
of the study is essential to its validity, such
deception is allowable. Subjects must be
debriefed immediately upon the completion of
their participation. At that time, the true
purpose of the study, and the nature of the
deception, must be explained to them. Caution
There must not be any deception regarding
risks.

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Documenting Informed Consent The Consent Form

• Must include
• 1) Title identifying the document as a
  consent form.
• 2) Statement that this is a RESEARCH project.
• 3) Description of the research including all
  potential
• risks (The most closely scrutinized part of
  any proposal.
• including psychological), inconveniences
• and time requirement.
• 4) If appropriate, a statement of what services
  will or
• will not be available to subjects if
  participation leads
• to negative physical and/or psychological
  trauma.

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4) A statement of what services will or will not
be available to subjects if participation
leads to negative physical and/or
psychological trauma (if appropriate). 5)
Potential subjects right to decline
participation or cease participation prior
to the studys conclusion. 6) A statement that
the data will remain confidential (if that
is the case). 7) The name, title, phone number,
email address, and postal address of the
person who should be contacted (the IRB
chair unless theres a potential conflict
of interest) if the subject wishes to report a
problem or concern.

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• 8) A statement that all subjects may
  request a copy (or
• summary) of the results of the study.
• 9) A place for the subject to sign and date
  the document.
• 10) A place for a witness to sign and date the
  document.
• (The witness may be the investigator or an
  assistant.)
• NOTE The form should be completed in
  duplicate
• with the subject receiving a copy.

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Is written informed consent essential?

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Is written informed consent essential?

(Sadly,) the answer is Yes and no.
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Is written informed consent essential?

(Sadly,) the answer is Yes and no.
No if requiring it would be impossible.
Telephone surveys not hanging up implies
consent. No if requiring it would drastically
limit participation and/or result in a
non-random sample. Surveys likely to include
undocumented workers. Surveys of illiterate
populations. Surveys of populations which
would view written consent as absurd
or insulting (ethnographic studies).
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Is written informed consent essential?

(Sadly,) the answer is Yes and no.
Yes in all other circumstances.
CAUTION If written consent is not required,
1) that DOESNT mean that informed consent
isnt required!! 2) it MAY still be appropriate
to give subjects a written
statement with all the material
normally in a consent form.
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The Consent Form
and, for that matter, all
other communication
with subjects
must have an
appropriate reading level.
Investigators (especially students) tend to
jargonize all their communications, either
subconsciously or in an attempt to impress
subjects.
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• The three categories of human
• research proposals
• Exempt
• Expedited
• Full Committee
• How do you decide which is which?

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• The three categories of human
• research proposals
• Exempt negligible risk
• Expedited minimal risk
• Full Committee moderate to high risk
• How do you decide which is which?

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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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• The three categories of human
• research proposals
• Exempt negligible risk
• Expedited minimal risk
• Full Committee moderate to high risk
• How do you decide which is which?

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Federal Criteria for Exemption from Review

• Research conducted in established or commonly
  accepted
• educational settings, involving normal
  educational practices,
• such as research on regular and special
  education instructional
• strategies, or research on the effectiveness
  of or the comparison
• among instructional techniques, curricula, or
  classroom
• management methods.
• 2a. Research involving the use of educational
  tests (cognitive,
• diagnostic, aptitude, achievement).. unless
  information
• obtained is recorded in such a manner that
  human subjects can
• be identified, directly or through
  identifiers linked to the subjects
• and any disclosure of the human subjects'
  responses outside the
• research could reasonably place the subjects
  at risk of criminal
• or civil liability or be damaging to the
  subjects' financial standing,
• employability, or reputation.

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2b. Research involving survey procedures,
interview procedures or observation of
public behavior, unless information
obtained is recorded in such a manner that human
subjects can be identified, directly or
through identifiers linked to the subjects
and any disclosure of the human subjects'
responses outside the research could
reasonably place the subjects at risk of criminal
or civil liability or be damaging to the
subjects' financial standing, employability,
or reputation. Translation If you ask
questions about illegal activity, drug usage or
any behavior considered socially unacceptable to
some, you cant have identifiers (usually, but
not necessarily, names) which could be used to
link particular subjects to their responses.
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2b. Research involving survey procedures,
interview procedures or observation of
public behavior, unless information
obtained is recorded in such a manner that human
subjects can be identified, directly or
through identifiers linked to the subjects
and any disclosure of the human subjects'
responses outside the research could
reasonably place the subjects at risk of criminal
or civil liability or be damaging to the
subjects' financial standing, employability,
or reputation. Translation If you ask
questions about illegal activity, drug usage or
any behavior considered socially unacceptable to
some, you cant have identifiers (usually, but
not necessarily, names) which could be used to
link particular subjects to their responses.

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Escape Hatch!
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Surveys -
but You

You Gonna
Gotta
Hate

Love Em EM
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While on the subject of surveys Proposals will
be submitted for approval without the attachment
of the survey itself. Pending or The
questionnaire will be similar to the one
previously used. will be frequent comments.
Dont let anyone get away with this! The actual
questions may effect whether or not the proposal
is exempt and/or poorly worded questions may
reveal fundamental weaknesses.
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There may be similar problems with interviews
Proposals will be submitted for approval
without any sort of a script.. While it would be
unrealistic to prohibit investigators some degree
of latitude, they should be restrained from
wandering too far from their stated line of
questioning. It may be appropriate to ask for a
list of will not go there topics.
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3. Research involving the use of educational
tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview
procedures, or observation of public behavior
that is not exempt under paragraph (b)(2) of
this section, if the human subjects are
elected or appointed public officials or
candidates for public office OR federal
statute(s) require(s) without exception that the
confidentiality of the personally
identifiable information will be maintained
throughout the research and thereafter.
Translation Public officials or candidates are
not guaranteed the protections against
disclosure of potentially damaging information
that other citizens enjoy.
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4. Research involving the collection or study of
existing data, documents, records,
pathological specimens, or diagnostic
specimens, if these sources are publicly
available or if the information is recorded
by the investigator in such a manner that
subjects cannot be identified, directly or
through identifiers linked to the subjects.
Note Abstracting hospital records would fall
into this category as long as identifiers
arent recorded.
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5. Certain classes of research conducted by
governmental agencies. 6. Taste tests if
the food either contains no additives or contains
additives at established safe levels.
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Federal Criteria for Expedited Review

• Clinical studies of drugs and medical devices
  involving no more than minimal risk.
• 2) Collection of relatively low volume blood
  samples by finger stick, heel stick, ear stick,
  or venipuncture.
• 3) Collection of biological specimens (such as
  hair and nail
• clippings, deciduous teeth, permanent teeth
  which need to be
• extracted, saliva, placenta removed at
  delivery, etc.) for
• research purposes by noninvasive means.
• 4) Collection of data through noninvasive
  procedures (not involving
• general anesthesia or sedation) such as
  moderate exercise,
• muscular strength testing, body composition
  assessment, and
• flexibility testing where appropriate given
  the age, weight, and
• health of the individual.

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Federal Criteria for Expedited Review

• Clinical studies of drugs and medical devices
  involving no more than minimal risk.
• 2) Collection of relatively low volume blood
  samples by finger stick, heel stick, ear stick,
  or venipuncture.
• 3) Collection of biological specimens (such as
  hair and nail
• clippings, deciduous teeth, permanent teeth
  which need to be
• extracted, saliva, placenta removed at
  delivery, etc.) for
• research purposes by noninvasive means.
• 4) Collection of data through noninvasive
  procedures (not involving
• general anesthesia or sedation) such as
  moderate exercise,
• muscular strength testing, body composition
  assessment, and
• flexibility testing where appropriate given
  the age, weight, and
• health of the individual.

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5) Research involving materials (data, documents,
records, or specimens) that have been
collected, or will be collected solely for
nonresearch purposes (such as medical treatment
or diagnosis). NOTE Some research in this
category may be exempt from the HHS
regulations for the protection of human
subjects as indicated in 45 CFR 46.101(b)(4) This
listing refers only to research that is not
exempt. 45 CFR 46.101(b)(4) exempts such
research if the information is recorded by
the investigator in such a manner that
subjects cannot be identified, directly or
through identifiers linked to the subjects.
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6) Research on individual or group
characteristics or behavior (including, but
not limited to, research on perception,
cognition, motivation, identity, language,
communication, cultural beliefs or practices,
and social behavior) or research employing
survey, interview, oral history, focus group,
program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE
Some research in this category, covered by 45
CFR 46.101(b) (2) and (b)(3) may be exempt.
This listing refers only to research that is not
exempt.) 45 CFR 46.101(b) (2) exempts
some of these research categories if there
are no identifiers or disclosure of identity
would not be damaging to the subject. (b)(3)
exempts some of these research categories if
the subject is a public official or a
candidate for office.

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7) Collection of data from voice, video, digital,
or image recordings made for research
purposes. 8) Continuing review of research
previously approved by a convened IRB meeting
if (i) the research is permanently closed
to the enrollment of new subjects (ii) all
subjects have completed all research-related
interventions and (iii) the research
remains active only for long-term follow-up of
subjects or (b) where no subjects have been
enrolled and no additional risks have been
identified or (c) where the remaining
research activities are limited to data
analysis. 9) Continuing review of research. ,
where categories two through eight do not
apply but the IRB has determined and
documented at a convened meeting that the
research involves no greater than minimal
risk and no additional risks have been
identified.

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7) Collection of data from voice, video, digital,
or image recordings made for research
purposes. 8) Continuing review of research
previously approved by a convened IRB meeting
if (i) the research is permanently closed
to the enrollment of new subjects (ii) all
subjects have completed all research-related
interventions and (iii) the research
remains active only for long-term follow-up of
subjects or (b) where no subjects have been
enrolled and no additional risks have been
identified or (c) where the remaining
research activities are limited to data
analysis. 9) Continuing review of research. ,
where categories two through eight do not
apply but the IRB has determined and
documented at a convened meeting that the
research involves no greater than minimal
risk and no additional risks have been
identified.

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Federal Criteria for Review by a Convened
Meeting ( Full Committee Review) A majority of
members, including at least one non-scientist,
must be present. Typically, the proposal would
neither be exempt from review nor eligible for
expedited review. The committee may adopt more
stringent criteria.

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The Good News!

The vast majority of proposals will fall in the
Exempt category. A small minority will be
eligible for Expedited Review. Proposals
requiring a Convened Meeting will be few and far
between.
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The Bad News (which really isnt all that bad)!

Convened meetings will be rare. This hinders
the growth of both group cohesiveness and a
shared body of knowledge. Future leaders will be
slow to develop. There should be a minimum of
one convened meeting per semester. Routine
business should include the distribution of a
list of proposals considered during the previous
six months. The list should include, for each
proposal, the project title, the name(s) of the
PI(s), a one-sentence description, and the
disposition of the proposal including whether it
was Exempt, or received Expedited or Full
Committee Review.
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Miscellaneous Matters
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Special Populations
Cons
Kids
plus pregnant women and the mentally challenged
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Special Populations The Code contains
modified, stricter rules for dealing with such
populations. They are especially strict regarding
research on prisoners requiring, for example,
that an IRB must have a member with experience
working with this population if such proposals
are to be evaluated. Important exception
There are no special rules for research on
children if the research is strictly on
EDUCATIONAL subjects listed in the portions of
the code dealing with exempt and expedited review
matters.

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Modifications of rules in the Code An IRB may
not adopt rules that are less stringent than
those specified in the Code. However, an IRB
may adopt stricter rules. Committee Chairs may
bump up a proposal to Full Committee Review if
they are uneasy over the amount of risk to which
subjects may be exposed. Example Duke has a
rule that any research in which PIs will solicit
their own students as subjects must receive Full
Committee Review.

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Financial ( other) Compensation Subjects may
be compensated for their time and inconvenience,
including reimbursement for travel expenses.
The amount of compensation should not be so
large that it will induce subjects to expose
themselves to otherwise unacceptably high
risks. Children may be bribed compensated with a
small treat (e.g., a small bag of
chips). Compensation, and any conditions
attached to its receipt, should be described in
the consent form.

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Intra-Committee Reporting A form, similar or
identical to the following, should be used by
Expedited Review Committee reviewers when
reporting back to the Chairs of such ad hoc
committees. Note Some-such is needed because
/- 80 of proposals will need tweaking.

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Expedited Review Proposal Evaluation Report 1)
___ I have read the proposal entitled
XXX" submitted by XX Prof. XX 2a)
___ I vote to approve the proposal as submitted.
(OR) 2b) ___ I have the following
reservations and/or request the
following modifications 3a)
___ I authorize the Chair to negotiate over the
concerns raised above. (OR 3b
below) 4a) ___ I wish
to see the modified proposal prior to its
final
approval. (OR) 4b)
___ I do not need to see the final
modifications. 3b) ___ I consider the
proposal's shortcomings to be serious and
therefore call for an Expedited Review
Committee meeting.
(electronically signed) ________________________
(date)
________________________

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Periodic Review All approvals are for a
maximum of one year. Prior to the end of that
year, the PI should be contacted and asked if
the research has been completed. If not, the PI
must apply for an extension. As with the initial
approval, extensions are for a maximum of one
year.

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Disclaimer This presentation has been a summary
of the rules and regulations for the review of
human research by an IRB. As a summary, it is, by
its very nature, incomplete. For the full text of
the applicable regulations, see Title 45, Part
46 (Protection of Human Subjects) of the Code of
Federal Regulations (http//www.hhs.gov/ohrp/human
subjects/guidance/45cfr46.htm46.110)

I recommend that IRB members subscribe to the
IRB Forum http//www.irbforum.com/register.php
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MERRY CHRISTMAS
and all the best in the New Year