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of two general outcomes are possible following review: |
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(a) The investigators
can begin the study without submitting additional information
to the CHR, or |
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The investigators
may not begin the study until additional information is provided.
Based on the discussion during the review process, one of the
following five categories of approval is applied to each application: |
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| Study
Can Begin and Approval Letter is Issued |
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1. Straight Approval
or Approval with Comment: |
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Granted when the Committee
has no questions about the application. |
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The members may, however, make
comments about this approval or recommendations for future
submissions. Such comments will be included in the approval
letter itself. |
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2. Conditional
Approval: |
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Granted when the Committee
approves an application with conditions and the members recommend,
but do not require, a response to those conditions. Such conditions
usually involve changes in the consent form; however, the members
are willing to allow the study to be conducted even if no changes
are made. Conditional approval can also be given, for example,
if an investigator is asked to submit a finalized version of
a questionnaire or letters of support from campus departments
cooperating in the research. Conditional approval may not be
given if federal requirements are not met. Conditions will
be explained in the approval letter. Once the investigator
responds to the conditions, a letter is sent out that indicates
the conditions have been removed; however, no new approval
letter is generated. |
| Study
Cannot Begin Until Committee's Concerns or Required Changes
are Communicated in Writing, the Investigators Respond to
The Concerns or Requested Changes, and the Response is Approved: |
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1. Contingent
Approval: |
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The Committee approves the
study in principle. |
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However, the members require
a written response from the investigator regarding particular
items of concern. The members may ask the investigator to:
(a) clarify a point, (b) provide further information, (c)
make revisions in, for example, the protocol, recruitment,
and/or
consent form. |
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Click here for 'Important
Suggestions for Responding to Your CHR Contingent Approval
Letter' |
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The investigator's response
is normally reviewed by the Chairman alone, although the Chair
has the option of sending the response to the Full Committee
or a Subcommittee. It has been tradition and practice not to
raise additional issues at the time of response unless, in
rare cases, federal requirements have not been met or an important
matter of human subject protection was overlooked. |
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No approval number is given
until the questions and/or concerns of the Committee have been
satisfactorily addressed and approved by the Chair. |
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2. Return for
Additional Information: |
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Committee is not prepared to
approve the study without additional information and review. |
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Requested when serious concerns
are raised about the risk/benefit ratio or other issues of
human subject protection and the members agree that additional
information, justification, or changes are needed before approval
can be reconsidered. The Committee members have explicitly
asked that the study be returned to them for additional review. |
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The investigator must respond
to this request in writing and this response is then reviewed
by either the Full Committee or the Subcommittee, depending
on the decision of the members or Chair. Usually, the revised
protocol is granted contingent, conditional, or straight approval
at the time of the second review. However, the study may be
returned again if the members request it. |
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3. Denial of Approval: |
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Committee disapproves the study
in principle. |
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Decided, though very rarely,
after a study has been returned for additional information,
at least once, and the members' concerns for the protection
of the subjects have not been satisfactorily addressed. |
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The investigator must be invited
to present his/her justifications to the members before a project
can be denied approval as the CHR action to disapprove may
not be reversed, except by the CHR itself. |
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