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Research@UIC > Protocol
Review >
IRB > Getting Started
 Getting Started
A
Guide for Investigators and Research Staff
Top Ten Tips
- Be precise in your language
- Pay attention to grammar and punctuation
- Avoid deadline days
- Obtain all of the necessary signatures
- Include a research protocol with your application
- Have someone independent of the research proof-read
your documents
- Ask OPRS for a pre-review
- Allow adequate time for IRB review
- Submit all appendices, recruitment and informed
consent documents
- Use the OPRS on-line resources
- Be precise in your language:
- You
are submitting an “Application” for IRB review, not
an “IRB” for IRB review.
- Each type of Application
(EXEMPT, EXPEDITED, CONVENED) has a separate instruction sheet that
should be read and referred to when completing the Application.
- Adults
(over age 18) provide “Consent.”
- Children
provide “Assent.”
- Parents provide “Parental
Permission” for
their children to participate in research and sometimes also “Consent” to
participate in research with their child (e.g., mother-daughter dyads). You
can submit a combination Parental Permission/Adult Consent document
by using “You and your child are being asked to …” throughout
the document.
- All informed consent documents should be written at
a level appropriate to the population being recruited.
- Use UNIQUELY
IDENTIFYING FOOTERS to identify your various documents. Do
not use the same footer for all documents (e.g., “Very Important
Study”, version 1, 6/1/2007, page 1 of 3). Instead, you
should use:
- Consent Document for Very Important Study, version 1, 6/1/2007,
page 1 of 3
- Assent Document for Very Important Study, version 1, 6/1/2007,
page 1 of 2
- Recruitment Flyer for Very Important Study, version 1, 6/1/2007
- Recruitment Script for Very Important Study, version 1, 6/1/2007.
page 1 of 6
- Pay attention to grammar and punctuation:
- The
IRB must determine that the investigator is qualified to conduct
the proposed research ethically and responsibly. If the Application
and consent documents are fraught with grammatical and typographical
errors it does not inspire confidence in the Principal Investigator and
may impact how the IRB reviews the proposal. Additionally, the errors
may adversely impact the subjects’ ability to comprehend the
consent documents.
- Avoid deadline days:
- There are no
deadline days for Applications submitted for EXEMPT or EXPEDITED
review. Applications
submitted for CONVENED review have deadline days that are listed
on the OPRS website.
- The sooner the Application is submitted, the
sooner it will be reviewed (i.e., first in, first served)
- You should
avoid deadline days, because many people submit Applications on deadline
days and the volume may impact timeliness.
- Obtain the necessary signatures:
- Signatures of the Principal Investigator (PI), Department Head and
(if applicable) Faculty Sponsor are required
- If the Department Head is the PI, Co-Investigator, or the Faculty
Sponsor, the Department Head’s direct supervisor (i.e., Dean,
etc.) should sign as the Department Head.
- If the Department Head is not accessible, OPRS allows his/her designee
to sign, but an explanation should be added to the Assurance page of
the Application.
- The Faculty Sponsor and Department Head do not have to sign any revised
Applications if modifications are requested by the IRB.
- Include a research protocol with your Application:
- Each Initial Review Application (EXEMPT, EXPEDITED, CONVENED) requires
submission of a research protocol in addition to the IRB Application
form. The protocol represents the primary documentation of the
proposal for the purpose of IRB review. The protocol should provide
a complete explanation of the research plan, and should be used as the
basis for completion of the other IRB submission documents. The
Application form is used to summarize the research protocol and to
provide specific information about the human subjects protection
issues related to the protocol. In general, a protocol should contain
as many of the following elements as are applicable to the type of
research.
- Title page including title, investigators, affiliations, sponsor,
and protocol version number and date.
- Study Hypothesis and Specific
Aims (purpose, objectives)
- Background and Significance
- Methods
- Research Design
- Eligibility Criteria
- Justification for inclusion of any special or vulnerable
populations
- Plans for subject selection, recruitment, and documentation
of informed
consent
- Description of Procedures
- Statistical Methods
- Planned statistical analysis
- Rationale for selection of subject
- Safety Monitoring and
Assessment (if relevant, include provisions for managing
adverse reactions)
- Data
management (when relevant, address measures of privacy protection,
coding, storage of information)
- For
multi-site protocols, an overall study management plan should
be provided.
- Relevant Literature
Please refer to Section 6 of the "E6 Good Clinical Practice Consolidated
Guidance" found at http://www.fda.gov/cder/guidance/959fnl.pdf and “The
IRB Information Sheets-A self-Evaluation Checklist for IRBs” found
at http://www.fda.gov/oc/ohrt/irbs/irbchecklist.html for
additional FDA guidance regarding elements of clinical trial protocols.
- If
your research is federally funded, you must submit the entire research
grant or the relevant portions of the grant subcontract (i.e.,
cover page, portions of the grant that pertain to research conducted
at UIC, and signature page).
- UIC policy requires that the research protocol be a separate document
from the research grant, grant sub-contract, or contract proposal
(scope of work). This policy is consistent with Federal
guidance from OHRP Guidance on Written IRB Procedures (January
15, 2007).
- If submitting your thesis or dissertation research, a copy of your
proposal may be used as the research protocol as long as it reflects
the research as it is currently being conducted.
- Have someone independent of the research
proof-read your documents:
- Applications frequently contain technical jargon that is clear to the
PI, but confusing to others.
- Review the protocol, Application, recruitment materials and consent
documents for consistency in regards to number of subjects, procedures,
payment of subjects, etc.
- Do the timelines make sense? Is there a logical path for subject recruitment,
consent, participation, compensation and follow-up?
- The Application is an opportunity to educate the IRB. Do
not assume that the IRB knows as much as the PI about the research.
- Ask OPRS for a pre-review:
- OPRS cannot design the research, but the staff can provide guidance
on the best way to present information regarding your research to the
IRB and how best to complete the Application forms.
- Investigators who are new to UIC or who are commencing research in
a new area are encouraged to seek a pre-review of their research to facilitate
IRB review
- Although a pre-review will delay IRB submission by 1-2 weeks, it
will typically reduce the overall review time by identifying and
helping to correct or resolve problems that may delay IRB approval.
- Before making an appointment for a pre-review, complete your research
protocol, the Application form, recruitment materials and informed
consent documents. Once draft versions of the above have been completed,
they can be emailed to OPRS staff to review or you can request an
in-person consultation by calling the OPRS office at 312-996-1711.
- Allow adequate time for IRB review:
- Claims of Exemption: approximately 1 week
- Expedited Initial Review: approximately 2 weeks
- Convened Initial Review: approximately 3 weeks
- If you have not heard from OPRS within the above timeframe contact
OPRS by phone: 312-996-1711 or email: uicirb@uic.edu
- Do not assume the IRB review will result in an approval of the research
the first time the IRB reviews the research.
- If you are submitting a Continuing Review application, submit it
approximately 45 days prior to the expiration date, but not earlier. Do
not rely on OPRS to remind you about the expiration date. The expiration
date can be found in your approval letter and is stamped on your
consent documents (if applicable).
- Submit all appendices, recruitment and informed
consent documents:
- Include copies of all flyers, scripts, recruitment letters, email announcements,
brochures, etc.
- Submit all questionnaires, survey instruments, interview guides, discussion
guides or data collection instruments that will be used.
- Submit separate Appendices A and E and the investigational drug
brochure (IB) or approved product information for each drug or biologic
(approved as well as investigational agents) administered or prescribed
solely due to the subject’s participation in the research.
- Include Appendix D for studies that involve tissue banking, DNA
and databases.
- Include Appendix F, Department Review, if submitting for convened
IRB review.
- Include Appendix H for research involving protected health information
(PHI).
- Attach a copy of the data collection instrument to the IRB application
if the research involves the collection and recording of information
from the medical record (e.g., retrospective chart review) .
- Include copies of all consents, assents, parental permissions,
and HIPAA authorizations .
- Submit each document separately so OPRS staff can stamp each document
with an approval/expiration date and return it to you after IRB approval. Allow
adequate space on each document for the approval stamp.
- If you are requesting Waivers please explain, in the Application, why
the waiver(s) is/are necessary.
- Once you have been assigned a protocol number by OPRS refer to that
number when communicating with OPRS.
- Use the OPRS on-line resources:
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