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THE COMMITTEE ON HUMAN RESEARCH
APPLYING TO THE CHR
CATEGORIES OF MODIFICATIONS (Revised
February 2005, July 2006)
The principal investigator should evaluate whether a
modification is major, minor, or administrative, using
the definitions and tables of examples below. The determination depends
on whether risks to participants are increased
and the complexity of the changes. Major modifications require more
copies and more intensive review than minor or administrative modifications.
For
questions about what kind of modification you have, please call the
CHR office at 476-1814 and ask to be connected
with a specialist handling modification requests or
contact
us.
Additional information is available at General
Instructions: Modification Request.
Definitions
(examples follow below)
- Major Modifications to previously
approved research are changes in which
- Any increase in risk to participants is
more than minimal
(See definition of Minimal
Risk.)
or
- any additional activity or procedure would
not be eligible for
expedited review if submitted as part of new research
or
- the research itself involves more than minimal
risks and the changes significantly alter
the study design.
- Minor Modifications to previously
approved research are changes in which
- any increase in risk to participants is
no more than minimal
risk
and
- all additional activities or procedures
would be eligible for review using the expedited
procedures if submitted as part of new research
and
- either the research itself involves minimal
risks or the changes do not significantly alter the
study design.
- Administrative Modifications are Minor
Modifications that do not affect study participants (subjects)
in any way.
Important Note: If reasonable reviewers may
differ on what category applies (e.g., on whether a change increases
risks so they are more than minimal) the application should be
submitted for the more stringent level of review.
Examples of types of modifications follow below: FOR STUDIES THAT INITIALLY REQUIRED FULL COMMITTEE
REVIEW
EXAMPLES
OF MAJOR MODIFICATIONS
for studies that initally require full committee review |
- Changing, adding, or deleting drugs, devices,
or other treatments being studied (significant alteration
of design of study) (however, substituting approved drugs,
devices, or other standard treatments that are being used
in standard ways may be a minor modification if risks clearly
are not increased)
- Adding or deleting major procedures or
diagnostic tests (e.g., adding bronchoscopy or spinal tap;
doubling duration of treatment; deleting adjuvant chemotherapy;
deleting diagnostic MRI or liver function test)
- Increasing major risks or discomforts
(e.g., risks from new procedures, deleted safety measures,
or newly discovered serious risks; risks that are serious
by themselves do not become minor even if subjects already
have a terminal disease)
- Changing study design (e.g., eliminating
1 arm of a multi-arm study or going from placebo-controlled
to open-label; call CHR office to discuss whether a new application
is more appropriate than a modification)
- Adding serious privacy risks (e.g., asking
participants about abusive behavior or current illegal activities)
- Adding vulnerable populations (e.g.,
minors, prisoners, patients unable to consent)
- Re-starting study after a hold for safety
concerns
- If sponsor or cooperative group specifically
requires full committee review
- Changing Principal Investigator in some
circumstances. See Changing
or Adding Investigators or Other Personnel.
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Requirements:
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Type of Review:
- Reviewed by full committee
- Approval letter sent when approved
- New expiration date is usually given
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EXAMPLES
OF MINOR MODIFICATIONS
(except for Administrative Modifications) for studies that initially required
full committee review |
- Changing minor procedures (e.g., adding
small-volume blood draws, ultrasounds, visits with noninvasive
procedures)
- Reducing risks
- Adding minor risks (e.g., risks of small
blood draws)
- Changing wording in CHR consent form,
application, or other documents
- Revising questionnaires (modification
is major if the new questions are more likely than the old
ones to evoke responses that would reasonably place subjects
at risk of criminal or civil liability or be damaging to
the subjects' financial standing, employability, insurability,
reputation, or be stigmatizing if the answers became known
outside of the study context)
- Adding or changing advertisements or
notices
- Changing or deviating from entry criteria
if the change creates no serious risks to participants
- Changing the Co-Principal Investigator
or other Key Personnel in some circumstances. See Changing
or Adding Investigators or Other Personnel.
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Requirements:
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Type of Review:
- Reviewed by a subcommittee (using “expedited” review
procedures)
- Approval letter sent when approved
- New expiration date is not given
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EXAMPLES
OF ADMINISTRATIVE MODIFICATIONS
for studies that initially required full committee review |
- Changing procedures that do not affect
participants (e.g., method of shipping samples)
- Fixing typographical, grammatical, or
spelling errors
- Changing personnel (but PI and Co-PI
stay the same) if no participant-contact documents are affected.
See Changing
or Adding Investigators or Other Personnel.
- Not changing procedures that
affect participants
- Not changing risks
- Not changing information on
the CHR application form or protocol beyond fixing typographical,
grammatical, formatting, or spelling errors
- Not changing CHR consent form
beyond fixing typographical, grammatical, formatting, or
spelling errors
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Requirements:
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Type of Review:
- Noted and filed
- No approval letter sent
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FOR STUDIES THAT INITIALLY
REQUIRED EXPEDITED REVIEW
| EXAMPLES OF
MAJOR MODIFICATIONS for studies that initially required expedited
review - WITH CHANGE THAT NOW REQUIRES FULL COMMITTEE REVIEW |
- Any change that:
- Examples of changes that do not fit
expedited review categories:
- Adding invasive procedures other
than small-volume blood draws
- Adding use of experimental drugs
or devices
- Adding serious privacy risks
(e.g., asking participants about abusive behavior
or current illegal activities)
- Revising questionnaires if the
new questions are more likely than the old ones to
evoke responses that would reasonably place subjects
at risk of criminal or civil liability or be damaging
to the subjects' financial standing, employability,
insurability, reputation, or be stigmatizing if the
answers became known outside of the study context
- Changing retrospective record
review of standard care to randomized test of two
standard regimens
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Requirements:
Study
is no longer eligible for expedited review.
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Type of Review:
- Reviewed by full committee
- Approval letter sent when approved
- New expiration date is usually given
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| EXAMPLES OF
MINOR MODIFICATIONS (except for Administrative Modifications)
for studies that initially required expedited review (MAY INCLUDE SIGNIFICANT CHANGES IF STILL ELIGIBLE FOR EXPEDITED REVIEW) |
- Changing major procedures or activities
without adding more-than-minimal risks (e.g., adding participant
contact to a record-review study, adding a new round of
participant contact and interviews, changing from review
of past patients’ records to review of current patients’ records)
- Changing study design without adding
more-than-minimal risks (but changes in study purpose or
changes in basic study design are usually best submitted
as new studies, in order to avoid complexity, confusion,
and delayed approval)
- Changing method of contacting participants
(e.g., from talking to PI’s patients to sending letters
to patients ID’d through medical records)
- Changing, adding, or deleting approved drugs,
devices, or other standard treatments that are being used
in standard ways
- Adding vulnerable populations (e.g.,
minors, patients unable to consent) as long as risks
remain minimal and other criteria for expedited review
are still met. Adding prisoners is almost always a major
modification requiring full committee review
- Changing wording in CHR consent form,
application, or other documents
- Changing or adding questionnaires or
other study instruments (but the study should be submitted
for full committee review if the new questions are more
likely than the old ones to evoke responses that would
reasonably place subjects at risk of criminal or civil
liability or be damaging to the subjects' financial standing,
employability, insurability, reputation, or be stigmatizing
if the answers became known outside of the study context)
- Adding or changing advertisements or
notices
- Changing or deviating from entry criteria
if the change itself creates no more than minimal risks
to participants
- Changing Principal Investigator, Co-PI,
or other Key Personnel in some circumstances. See Changing
or Adding Investigators or Other Personnel.
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Requirements:
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Type of Review:
- Reviewed by a subcommittee (using “expedited” review
procedures)
- Approval letter sent when approved
- New expiration date is not given
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| EXAMPLES OF
ADMINISTRATIVE MODIFICATIONS for studies that initially required expedited
review |
- Changing procedures that do not affect
participants (e.g., method of shipping samples)
- Fixing typographical, grammatical,
or spelling errors
- Changing personnel (but PI and Co-PI
stay the same) if no participant-contact documents are
affected See Changing
or Adding Investigators or Other Personnel
- Not changing procedures that
affect participants
- Not changing risks
- Not changing CHR consent form
beyond fixing typographical, grammatical, formatting, or
spelling errors
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Requirements:
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Type of Review:
- Noted and filed
- No approval letter sent
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Important Note: If a CHR
member reviewing a "minor" or “administrative” modification
request feels that it is too substantive to receive this type
of review, the application will be referred for a higher level
of review.
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