The University of Toledo
Department for Human Research Protections
Biomedical Institutional Review Board
CCE Building – Room 0106
3025 Arlington Avenue, Toledo, Ohio 43614-2570
Phone: 419-383-6796 Fax: 419-383-3248
(FWA00010686)
INITIAL CONVENED REVIEW
INSTRUCTIONS & APPLICATION
For designation as a new research project involving more than minimal risk to
human subjects and requiring a full convened review by the Institutional Review Board.
INSTRUCTIONS:
The UT Institutional Review Board reviews research in accordance with the Food and Drug Administration
(FDA) regulations published at 21 CFR 50 and 56 and the Health and Human Service (HHS) regulations
published at 45 CFR 46, Subparts A, B, C, and D. In the review of research projects, the UT IRB must be
assured that:
1. Risks to subjects are minimized, a) by the use of procedures consistent with sound research design
which do not expose subjects to unnecessary risk, and b) when appropriate, by the use of procedures
already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to any benefits that might be expected from taking part in
a research study and to the importance of the knowledge that may result.
3. Selection of subjects is fair and equitable. For example, the UT IRB seeks to determine that no eligible
individuals are denied the opportunity to take part in any study, particularly those from which they may
benefit, based on arbitrary criteria such as sex, age, or social or economic status.
4. Participation is voluntary and informed consent is obtained from each prospective subject, or, where
appropriate, from the subject’s legally authorized representative in accordance with 45 CFR 46.116 and
21 CFR 50.116. Informed consent will be appropriately documented, in accordance with, and to the
extent required by 45 CFR 46.117 and 21 CFR 50.117.
5. Research interventions have been separately identified and assessed from those interventions that are
therapeutic.
6. When appropriate, the research plan provides for monitoring the data collected to protect the safety of
subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data.
8. When appropriate, there are additional safeguards in place to protect the rights and welfare of subjects
that are likely to be members of a vulnerable population.
Please complete the Initial Convened Review Checklist located on the Biomedical Forms page and
submit with this application
Biomed Initial Convened Application
Version date: 10/15/2010
Page 1 of 11
The University of Toledo
Department for Human Research Protections
Biomedical Institutional Review Board
CCE Building – Room 0106
3025 Arlington Avenue, Toledo, Ohio 43614-2570
Phone: 419-383-6796 Fax: 419-383-3248
(FWA00010686)
INITIAL CONVENED REVIEW APPLICATION
A. STUDY INFORMATION
Date:
IRB Number:
(Assigned by IRB office)
Study Title:
Company Protocol Number
and version date, if
applicable:
Principal Investigator or
Faculty Advisor:
Department:
SSN or
Rocket I.D.
Address or Mail Stop:
Pager:
Phone:
Email:
If not already on file with the IRB.
Fax:
Contact Person:
(If applicable)
Contact Person’s Phone:
Email:
Fax:
Pager:
B. STUDY PERSONNEL
Please list all personnel involved in the conduct of this study. Anyone who is “engaged in research” must be listed below.
This includes those personnel who, for research purposes, interact or intervene with subjects, have access to subjects’
identifiable private information or obtain the informed consent of subjects. This list may be different (usually longer)
than the key personnel list included in a federal grant.
All study personnel must complete the required training for the protection of human subjects via CITI Training.
Instructions for accessing CITI can be found at http://www.utoledo.edu/research/RC/HumanSubs/training.html
IRB review of the study will not begin without verifying completion of this requirement.
Only UT faculty, staff, students, or registered volunteers are considered “UT-affiliated” and thus covered by the UT IRB
review. All non-affiliated study personnel must have their participation reviewed by their institution’s IRB, or complete
an Individual Investigator Agreement with The University of Toledo.
Study Personnel’s
First/Last Name
UT
UT I.D. #
Role in Protocol
Affiliated
*John Smith
Biomed Initial Convened Application
Role in the
Consent Process
Explain
Only
Explain
& Obtain
Research Training
Completed?
Yes
No
*Principal Investigator
Version date: 10/15/2010
Page 2 of 11
*Jane Doe
*Coordinator
*Ann Jones
*Co-Investigator
*Example of required information, please delete examples when filling in table.
C. STUDY FUNDING
Unfunded
Amount: $
Funded
Intramural
Per subject
*Extramural
Total
If Intramural, please provide UT Institutional Account number:
If *Extramural, please provide the following information for IRB billing purposes:
Agency ID No./Protocol #:
Agency/Company Name:
Agency/Company Address:
Agency/Company Contact:
Agency/Company Contact Phone:
Contact E-Mail:
Extramural Funding Status:
Pending
Funded
Contract Status:
Pending
Finalized
Planned
Grant or Company Protocol Title: (If different than study title)
*GRANT PROPOSAL - If the research protocol is currently supported by a grant proposal, OR if support for the
research protocol has been requested under a grant proposal, attach the research proposal/protocol that was sent to the
agency, committee or sponsor.
ALL UT Faculty/Staff listed as study personnel must submit a Disclosure of Potential Conflict-of-Interest Form
for Unsponsored Human Research UNLESS a Conflict of Interest Form for Sponsored Research has been
submitted to the RSP office as part of the contract process. Please see section J. to explain potential Conflict-ofInterests.
Biomed Initial Convened Application
Version date: 10/15/2010
Page 3 of 11
D. PERFORMANCE SITE(S)
List all performance sites for this study. Attach permission letters (on site’s official letterhead) and/or current IRB
approval memos for off-campus sites if applicable. Check box if site is “engaged in research.” A site becomes
"engaged" in human subjects research when its employees or agents: (i) intervene or interact with living individuals for
research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR
46.102(d),(f)]. (Do not list non-UT sites in industry-sponsored or cooperative group multi-center studies.)
Performance site
Name
Engaged in research
Address
Yes
No
E. PROPOSED RESEARCH DESCRIPTION
E-1. METHODS AND PROCEDURES
This section must be written in terms that can be understood by the non-scientific members of the IRB.
Descriptions that are too technical cannot be reviewed. Do not just “cut and paste” from the protocol and do not write
only “see attached.”
1. Describe the background and significance of the study.
2. What are the objectives of the study?
3. Describe the study design and all procedures (sequentially) to which human subjects will be subjected.
Include plans for how the data will be analyzed. Clearly distinguish between procedures that are performed
as standard care for the subject and those that are being done because the subject has volunteered to be in
the study.
For instance, a clinical research protocol may involve interventions that are strictly experimental, or it may involve
some aspect of research (e.g., randomization among standard treatments for collection and analysis of routine
clinical data for research purposes). It is important for this section to distinguish between interventions that are
experimental and/or carried out for research purposes (protocol-induced) versus those procedures that are
considered standard therapy.
Literature Search:
A comprehensive literature search must be performed not only to find other published work in the field of study, but
also to identify potential risks of the proposed intervention (e.g., adverse effects, complications, drug interactions,
toxicity, approved indications and routes of administration, contraindications) The IRB strongly recommends you
consult with an experienced medical librarian.
List the method(s), sources, databases, years searched, date search was conducted, who conducted the search, and key
words that were consulted for your literature search.
Methods:
Biomed Initial Convened Application
Version Date: 01/04/2010
Page 4 of 11
Sources:
Databases:
Years covered by the search:
Date of Search:
Person conducting the search:
Keywords:
Please summarize the relevant findings from your literature search:
You must also submit a COMPLETE PROTOCOL or GRANT PROPOSAL in addition to this application
form. Complete the protocol checklist at the front of this application to ensure that all elements of the protocol have
been submitted. See “Elements of a Research Protocol” on the RSP Web page for guidance in developing a protocol.
E-2. INTERVENTION INFORMATION –
1. Check all interventions that apply and complete the Section indicated by the associated number.
Drug/Biological #2
Device/Procedure #3
Biological Specimens #4
Genetic Testing #5
Tissue Bank #6
Radiation Use #7
Medical Record #8
Survey, Questionnaire #9
2. Drug or Biological Information:
Please use E-2 Drug Information Attachment and respond to all of the questions listed.
3. Device/Procedure Information:
Please use E-2 Device/Procedure Information Attachment and respond to all of the questions listed.
4. Biological Specimens (includes blood, tissues, etc.)
Attach a separate sheet with the answers to these questions.
a. What kind of biological specimens will be removed for purposes of this research?
b. Will the biological specimen be removed for research purposes only or as part of the standard care of the subject?
c. By what method will biological specimens be removed?
d. What is the weight, size, or volume of the biological specimen?
e. How often will biological specimens be removed?
f. What is the likelihood that the research to be carried out on the biological specimens may lead to the development
of a commercial product that may bring financial benefit to the investigator and/or institution?
g. Will genetic information be obtained through studies on biological specimens, and will this information be shared
with the subject? IF YES, PLEASE COMPLETE #5 BELOW.
Biomed Initial Convened Application
Version Date: 01/04/2010
Page 5 of 11
5. Genetic Testing, Markers of Disease Susceptibility
Attach a separate sheet with the answers to these questions.
a.
b.
c.
d.
What is the specific purpose of the genetic analysis?
Will there be identifiers on the samples that link back to the subject?
How long will the samples be kept? Who will keep the samples?
Are there plans for the sponsor/investigator to keep the samples for use after the proposed research is complete? If
so, what is the intended use? IF YES, PLEASE COMPLETE SECTION 6
e. What genes or other markers will be investigated?
f. Will children or other vulnerable populations be included in the sample population?
g. Will subjects be informed of any test results? Are there provisions for genetic counseling?
h. Could there be potential consequences of the genetic information to insurability, employability, or social esteem of
the subject?
i.
Are there any potential implications to the subject’s family members?
6. Tissue Bank or Repository
Attach a separate sheet with the answers to these questions.
a.
b.
c.
d.
e.
To whom are the samples being sent? What is the name of the responsible party?
Provide a detailed description of all tissue/data that will accumulate in the repository.
Where is the physical location of the repository?
What security measures are in place to protect the repository?
Is there a separate repository/banking consent form?
7. Radiation Use
Attach a separate sheet with the answers to these questions.
External sources of radiation (x-rays, beta rays, gamma rays, etc.)
a. Will subjects be exposed to ionizing radiation from external sources (x-ray, beta-rays, etc.) solely for research
purposes?
b. If so, what type(s) of procedures will be done?
c. What are the fields of exposure, target organs, frequency and total duration of use?
Internal sources of radiation (radioisotopes)
a. What Isotope will be used?
b. Investigators License Number
c. What dose will be administered per subject and route of administration?
d. What is the frequency and total duration of use?
If you do not have a License, contact the Radiation Safety Office.
8. Medical Records Review
Attach a separate sheet with the answers to these questions.
a. Will you have ongoing contact with the subjects?
b. Will you be recording identifiers?
c. What is the timeframe of charts that you plan to review (for example, 2/1/1999 – 2/1/2001) A retrospective chart
review can only occur on charts that were in place BEFORE you received IRB approval.
Biomed Initial Convened Application
Version Date10/15/2010
Page 6 of 11
9. Surveys and Questionnaires
Attach a separate sheet with the answers to these questions. Please attach a copy of each instrument.
a. What type of instrument(s) will be used?
b. Describe the setting and mode of administering the instrument (e.g., by phone, one-on-one, group) and the
provisions for maintaining privacy and confidentiality (e.g. anonymous). Include duration, intervals of
administration, and overall length of participation.
E-3. RISK/BENEFIT ASSESSMENT
1. What is the investigator’s overall assessment of the risk classification of the study? (minimal, or more than
minimal risk)
According to DHHS/FDA Regulations, minimal risk means “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.” When the risk associated with a new
procedure or product are unknown, they cannot be classified as “minimal.”
2. Describe in detail any potential risks/discomforts associated with each intervention or research procedure.
Assess the probability and magnitude of such risks - minimal or more than minimal.
If risks are minimal, please describe in a narrative form in the space below.
If risks are more than minimal, please enter the potential risks or discomforts and rank them using the descriptions
provided under the Seriousness and Likelihood column title.
Potential Risks/Discomforts
Seriousness
Likelihood of Complications
Low, Moderate, High
Common > 15%, Occasional 5-15%, Uncommon 1-5%, Rare <1%
3. What procedures will be utilized to prevent/minimize any potential risks or discomforts (including loss of
confidentiality, physical, psychological, social, economic, and legal risks)?
4. Describe the potential direct benefits the subjects may receive as a result of their participation.
5. Describe the potential benefits to society that may be expected from this research. Societal benefits generally
refer to the advancement of the scientific knowledge and/or possible benefit to future patients/subjects.
6. Explain how the benefits of the research outweigh the potential risks and how these risks are justified.
7. What therapeutic alternatives, if applicable, are reasonably available in the non-research and/or research
context that may be beneficial to the potential subject? (This section should include a reasonably detailed
description of therapeutic alternatives that could be used to treat a patient should they elect not to participate in the
protocol.)
Biomed Initial Convened Application
Version Date10/15/2010
Page 7 of 11
F. HUMAN RESEARCH SUBJECTS
Subject Population:
Maximum number to be enrolled at this institution:
If multi-site, total number of subjects for entire project:
What is the gender of the subjects?
Male
Female
Both
What is the age range of the subjects
1. To what health/disease category will the human subjects belong? (Example – healthy adult, children with
asthma, etc.)
2. What will be the total duration of involvement of each subject in the study? (Include follow-up period.)
3. Is the research limited to any particular age, gender, ethnic, or racial group? (If an equitable recruitment from
among all populations is not anticipated, please provide justification. If research is not limited to any particular group,
be sure to check the appropriate boxes in #4 if any of the listed vulnerable populations may possibly be included in the
study population.)
4. Will members any of the following vulnerable populations be included as study subjects?
Minors
Prisoners
Mentally Incapacitated
Minorities
Elderly
Cognitively Impaired
Fetuses
Terminally ill
Severe Psychological
Disorders
Pregnant women
Non-English speaking
UT students or staff
5. What safeguards will be used to protect vulnerable populations involved with the proposed research?
6. Outline the criteria for selection and exclusion of subjects.
7. Will subjects receive compensation for their participation, monetary or otherwise? Yes
If yes, specify.
No
8. What financial obligations will subjects incur as a result of participating in the research study. Identify
expenses such as travel costs, drugs, devices, lab tests, etc. Be as specific as possible. (Itemize the procedures not
covered by research funds and approximate their cumulative cost.)
G. RECRUITMENT PROCEDURES
1. What method(s) will be used to identify and recruit prospective subjects? Specify the source of potential
subjects.
Biomed Initial Convened Application
Version Date10/15/2010
Page 8 of 11
2. On the list that follows, please check all types of recruitment material that will be utilized in the study.
Attach copies of this material to the application.
Advertisements
Brochures
Flyers/posters
Newsletters
Radio
Other (Describe)
Internet
Contact letters to patients or physician
None
3. Will you access stored medical records, data, or specimens for research use? If yes, specify the source.
H-1. INFORMED CONSENT
1. How and where will the informed consent be obtained? (e.g., in the clinic, PI’s private office, subject’s home,
etc.)
2. When will the potential subjects or their legally authorized representatives initially be approached for
consent and by whom?
3. Will there be an opportunity for potential subject to take the consent form home to consider the options and
to discuss participation with family members. If not, explain why.
4. If subjects are minors or mentally disabled, describe how and by whom permission will be granted?
5. How and by whom will it be determined that the subjects or their legally authorized representatives
understand the research project and their rights as participants?
6. Where will the record of consent be stored? Please note: If the subject is a patient of UTMC, a copy must be
kept in their permanent medical record.)
7. List all study personnel who are obtaining the informed consent.
I. CONFIDENTIALITY
Data include not only paper documents, but also blood samples, tissues, etc.
1. What are the methods used to ensure confidentiality of participation and data obtained?
2. How will data be collected and recorded?
3. Where will data be stored during the study and how will it be secured?
4. Who will have access to the data and/or to the codes?
Biomed Initial Convened Application
Version Date10/15/2010
Page 9 of 11
5. If data with identifiers will be released, specify the person(s) or agency to whom this information will be
released?
6. What will happen to the data when the research is complete?
PLEASE NOTE: For purposes of IRB requirements, principal investigators must maintain study records for three (3)
years following the expiration of IRB approval. Although it is beyond the scope of the DHRP to provide advice on authority
outside of the DHRP, investigators should consider the following when determining applicable retention periods:
(1)
State of Ohio rules and regulations,
(2)
HIPAA Privacy Rule,
(3)
Institutional Requirements,
(4)
Sponsor Requirements, e.g. Clinical Trial Agreement,
(5)
FDA Regulations,
(6)
ICH GCP Guidance (Applies to FDA Regulated Research), and
(7)
Other laws, regulations or guidance applicable to the research.
J. CONFLICT OF INTEREST
Is there any real or apparent conflict of interest on the part of any study personnel ?
(e.g., stock or stock options, interest in technology, consultant to sponsor)? Yes
No
If yes, please explain
ALL UT Faculty/Staff listed as study personnel must submit a Disclosure of Potential Conflict-of-Interest Form
for Unsponsored Human Research UNLESS a Conflict of Interest Form for Sponsored Research has been
submitted to the RSP office as part of the contract process.
Biomed Initial Convened Application
Version Date10/15/2010
Page 10 of 11
K. ASSURANCES
Principal Investigator's Assurance Statement:
 I certify that the information provided in this application is complete and accurate.
 I understand that as Principal Investigator, I have the ultimate responsibility for the protection of the rights and
welfare of human subjects, and the strict adherence to any study-specific requirements required by the IRB.
 I agree to comply with all IRB and Institutional policies and procedures, as well as with all applicable Federal, State,
and local laws and regulations regarding the protection of human subjects in research and the conduct of clinical
research.
 I also agree to the following:
1. to accept responsibility for the scientific and ethical conduct of this research study,
2. to obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent form, study sites or study personnel, recruitment procedures,
3. to immediately report to the IRB any serious adverse reactions and/or unanticipated effects on subjects which may
occur as a result of this study,
4. to train study personnel in the proper conduct of human subjects research,
5. to assure that the personnel approved to explain and obtain consent have read the protocol, understand the study,
and are fully knowledgeable of ALL details of the protocol and are able to answer ALL questions from research
subjects such as risks and alternative treatments and therapies.
6. to obtain IRB approval through the Continuing Review process until data analysis is complete,
7. to complete the Final Report Forms required by the UT IRB,
8. to adhere to the standards of Good Clinical Practice (GCP)*, developed by the International Conference on
Harmonization (ICH).
______________________________________________
Signature of Principal Investigator
_______________
Date
______________________________________________
Printed name of Principal Investigator
For information regarding Good Clinical Practices (GCPs), please access the following link:
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
Departmental Chair/Dean Assurance Statement:
My signature certifies that:
1. I have reviewed this application, and I believe that the benefits of the proposed research outweigh the risks to the
study subjects.
2. The Principal Investigator has appropriate training, experience, and expertise to conduct this study.
3. The Principal Investigator has adequate staff and facilities to conduct the project.
4. If I become aware of any factors which have the potential to adversely affect the risk/benefit ratio for study subjects,
or any issues that may reflect noncompliance with UT policies, or FDA and OHRP regulations regarding research
with human subjects, I will immediately report these to the UT IRB.
______________________________________________
Signature of Chair/Dean*
_______________
Date
______________________________________________
Printed name of Chair/Dean
_______________
* Note: If the Principal Investigator is the Chair of a Department, the appropriate Dean’s signature is required.
Biomed Initial Convened Application
Version Date10/15/2010
Page 11 of 11