|
WIRB® Forms
and Information
WIRB® SUBMISSIONS: All submissions to WIRB® should
be dropped off at the Office of Human Subject Protection (OHSP) in
Room 1-7009 at the Medical Center. In addition to all study documents,
the University of Rochester's Application for Industry-Sponsored
Research Review and the WIRB® Initial Review Submission Form are required for
review.
Forms
Institutional Guidance
and Additional Information
- University’s Compensation for Injury Policy: A copy of
the subject injury language from the contract is no longer required
as a part of your submission documentation. An agreement between
ORPA (Office of Research and Project Administration) and the OHSP
(Office for Human Subject Protection) provides for standard
Compensation for Injury (subject injury) language in the
clinical trial agreement and in the informed consent document.
(See Below…)
Note: The new standard compensation for injury language
is for all new studies submitted after December 18, 2003.
In order to be consistent with previously approved contract
language, we will not incorporate this language for amended or
re-approved studies.
If you are injured by the drugs or devices that
are being studied, or by required study procedures, the [sponsor]
will reimburse your reasonable and necessary medical expenses, through
the University. However, the [sponsor] will not pay medical expenses
that are covered by your medical or hospital insurance. In addition,
the [sponsor] will not pay for expenses that result from the University's
negligence, misconduct or failure to follow the study protocol.
The [sponsor] does not plan to provide any other compensation to
you.
The University of Rochester Medical Center will
provide medical care for any emergency medical problem that you
may experience as a direct result of your participation in this
research. You will not have to pay for this emergency care, but
the University may seek reimbursement for this care from your health
insurance carrier or the study sponsor. Decisions regarding care
and compensation for any other research related injury will be made
on a case-by-case basis.
- Source of Funding: University of Rochester informed consent
documents for new studies will now include a Source of Funding
section. This section will contain the following statement: The
University of Rochester is receiving payment from [sponsor’s name]
to conduct this study.
- Submission of Departmental Letterhead: WIRB® has requested
the inclusion of 5 sheets of original departmental letterhead with
each new study submission. This is an effort to ensure that current
letterhead is used for consent forms.
- Consent Form Submission: WIRB® prefers that you submit
sponsor consent forms in one of the following ways: (1) Submit a
hard copy of the sponsor consent with your hand-written changes
clearly visible or (2) submit the sponsor consent on disk with your
changes highlighted in red-lined format. WIRB® often already
has an approved sponsor consent template. If your submitted changes
are simply standard UR items, the consent may qualify for
expedited review.
Change of Principal
Investigator
- The amendment process for a change in study responsibility from
one investigator to another usually requires the following information
to be submitted to WIRB®.
From the Relinquishing Principal Investigator:
- A letter stating that there will be a change in study responsibility.
The new principal investigator should be named.
From the Study Sponsor:
- A letter or fax from the sponsor indicating acknowledgment and
approval of this change in responsibility.
From the new Principal Investigator:
- A completed WIRB® Research Review Submission Form
- A letter accepting responsibility for the study
- A revised FDA Form 1572 [Statement of Investigator] (if applicable)
- A copy of the new investigator’s Curriculum Vitae
- A copy of the new investigator’s current medical license
|
RSRB Home
