Mother Frances Hospital Tyler
Institutional Review Board
irb@tmfhc.org / (903) 606-2472
Initial Review
Principal Investigator:
Protocol Sponsor:
Protocol Title:
Name of person completing this form:
Date:
Handwritten, copied or scanned versions of this form are not accepted. To prevent errors and
delays due to legibility problems, submit the original to irb@tmfhc.org . All questions must be
answered. Indicate NA for questions that are not applicable.
Research staff
All research staff must complete the online human subject research training for Biomedical
Research or Social and Behavioral Research offered through the Collaborative Institutional
Training Initiative at the University of Miami (CITI). www.citiprogram.org. Training is to be
renewed every two years thereafter.
Principal Investigator:
Address:
Phone:
Email:
Complete for all co-investigators, research coordinators and others who have substantive
interaction with subjects (recruiting, obtaining consent, evaluating response). Copy and paste
table for each individual as needed. Each person listed must complete and sign a Conflict of
Interest statement.
Name:
Role:
Address:
Phone:
Email:
Research description
1. Abstract (maximum 250 words): Summarize the research objectives and procedures.
Emphasize what will happen to the subjects. Use language a non-scientist can understand.
2. Research procedures include (select all that apply):
Audiotaping / videotaping
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Interviews
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Biopsy
Clinical tests
Collection of clinical specimens
Drugs or biologics*
Electrocardiogram (ECG)
Electroencephalogram (EEG)
Gene therapy
Genetic analysis
Health record review – prospective
Health record review – retrospective
Internet*
* Complete Initial Review Supplement with same title
3. Clinical trial (select one):
This is not a clinical trial
Phase I
Phase I / II
Phase II
Ionizing radiation exposure
Medical devices*
Questionnaires / surveys
Specimen removal during surgery
Stored data for future use*
Surgical procedure
Tissue banking
Use of pre-existing tissues
X-ray
Other (describe)
Phase II / III
Phase III
Phase IV
4. Data collection: Describe data to be collected, data sources and data collection procedures.
Attach copies of all data collection tools (questionnaires, surveys, interview questions, etc). If
the data collection tool is a draft, it must be clearly labeled as such and a final version must
be submitted before data collection begins. If the research involves interviews that could
evolve as the research progresses, include a list of discussion topics and any “starter”
questions for each topic that can reasonably be expected to be covered.
5. Subject participation: Describe subject involvement, including total time involved and
frequency of participation.
6. Equipment: List all machines, equipment and/or instruments used (specific to this research)
and describe their use.
7. Adequacy of resources to protect subjects:
Yes
No
Principal and co-investigators have sufficient time to conduct and complete
the research
Adequate qualified staff are available for this research (including experience,
training and familiarity with the protocol)
Describe other resources needed for the protection of subjects in the conduct of this research
(e.g., communication needs, translation services).
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Explain how the Investigator has access to a population that will allow recruitment of the
required number of subjects.
Research setting
If any research procedures will be conducted internationally, complete Initial Review
Supplement – International Research.
1. Where will research procedures be conducted? (e.g., hospital, clinic, school, home, etc.).
2. Trinity Mother Frances site(s) where research procedures will be conducted (select all that
apply). Specify department and/or location for each site indicated.
Louis & Peaches Owen Heart Hospital:
Mother Frances Hospital Jacksonville:
Mother Frances Hospital Tyler:
Mother Frances Hospital Winnsboro:
Trinity Clinic:
Other:
3. If research procedures will be conducted at non-Trinity Mother Frances sites, list the site(s)
and include a copy of the Cooperative Agreement.
Not applicable.
Site(s):
Subject population
1. Vulnerable subjects will include (select all that apply and describe additional safeguards to
protect the rights and welfare of these subjects):
Adults who cannot consent for themselves
Children*
Children* who are wards of the state
Cognitively impaired*
Economically disadvantaged
Educationally disadvantaged
Employees / staff directly supervised by the Principal Investigator or subinvestigator
Employees / staff of the research site or research sponsor
Institutionalized
Limited or non-readers
Mentally disabled
Non-English speaking
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Nursing home residents recruited in the nursing home
Pregnant women, fetuses or neonates*
Prisoners*
Students of any member of the research team
Students to be recruited in their educational setting
Others vulnerable to coercion (specify)
None of the above
* Complete Initial Review Supplement with same title
2. Indicate the number of subjects per category, if known. The total goal enrollment for this site
should be provided if known.
Unknown.
Male
Female
Total
Adults
Children
Total
3. Provide the rationale for use of special groups or subjects whose ability to provide voluntary
informed consent may be in question.
Not applicable.
Rationale:
4. Indicate which groups or categories of subjects are excluded from this research and provide
the rationale for the exclusion.
Not applicable.
Rationale:
5. Explain how the subject selection process is fair and equitable. Include eligibility criteria,
vulnerability, the recruitment process, avoidance of exploitation and minimizing coercion.
Subject recruitment
1. Describe how subjects will be recruited.
Attach all subject recruitment material (e.g., fliers, posters, pamphlets, advertisements or
scripts for on air advertisements or telephone calls). All subject recruitment material must be
approved by the IRB prior to use.
2. Recruitment methods include (select and describe all that apply):
Advertising company. Name and service provided:
Database search. Types and locations:
Electronic record search. Files maintained by:
Paper record search. Location of files:
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Physician referral. Note HIPAA regulations prohibit physician to physician referral.
Patients must first be informed of a trial and agree to be contacted before any
physician referral can be initiated.
Printed materials. Method of distribution:
Web posting. Website address:
Other. Specify:
3. Compensation. If ‘none’, proceed to next section.
None.
Conditions:
Type:
Schedule and amount:
Substantiate compensation does not constitute (or appear to constitute) undue pressure or
influence on the subject to volunteer, or to continue to participate:
Substantiate compensation does not constitute (or appear to constitute) coercion on the
subject to volunteer, or to continue to participate:
Verify compensation terms and amounts are specified in the informed consent:
If monetary compensation, complete the following:
Total payment amount:
Substantiate payment is appropriate, reasonable and commensurate with the expected subject
contributions:
Risks
1. Overall risk classification (select one):
Minimal. “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.”
Greater than minimal.
2. If minimal risk, justify why that classification is appropriate, and proceed to next section.
3. If greater than minimal risk:
Describe all the risks (including non-physical risks) in detail and assess their seriousness:
Precautions taken to minimize risks:
Other alternatives and accepted procedures considered and why they will not be used:
4. Describe how the research will be monitored to ensure subject safety in the “Data and Safety
Management” section.
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Benefits
1. Assess the potential benefits to science and/or society which may accrue as a result of this
research.
2. Explain any benefits which may accrue to the individual subjects in this research.
3. If the study is greater than minimal risk, explain how the risks are reasonable in relation to
the benefits.
Informed consent
Unless waived by the IRB, informed consent is necessary for all research involving human
subjects and must be documented in some manner. The investigator may determine the best
method to serve the interest of the subject population, but the IRB reserves the right to require
alternative or more stringent means of securing consent.
1. Obtaining consent (select one):
Informed consent will be obtained from all subjects and documented with a signed,
written consent form. Proceed to next question.
Informed consent will be obtained from subjects, but no signed consent form will be
used. This includes oral consent and implied consent (e.g., completing a survey).
Complete Initial Review Supplement – Consent Waiver and proceed to next question.
Fully informed consent will not be obtained from all subjects. This includes
deception, withholding information, etc. Complete Initial Review Supplement –
Consent Waiver and proceed to next section.
This research involves children. Complete Initial Review Supplement – Children and
proceed to next section.
This research involves cognitively impaired subjects. Complete Initial Review
Supplement – Cognitively Impaired and proceed to next section.
2. Informed consent. Refer to 21 CFR 50.25 for basic elements of informed consent.
a. Describe how the required information will be presented to subjects (consent form,
orally, information sheet, etc.). Attach a copy of what will be presented.
b. Indicate the location of the consent process (select all that apply):
In a private room
In a waiting room
In an open ward
In a group setting
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In a group setting with follow up in a private room
In emergency situations (describe the process):
Online (describe the process):
In public (describe the process):
Over the phone (describe the process):
Other (specify locations and describe the process):
c. Who will obtain consent? Describe their experience in obtaining consent.
d. How will you be sure there is sufficient opportunity for the subject or the subjects’
authorized representatives to consider whether to consent? Select all that apply.
Subjects will be allowed to take home the unsigned consent form for consideration
Subjects will be allowed a waiting period of at least (indicate hours or days) to
consider their decision
Other (specify)
e. How will you be sure subject or the subjects’ authorized representatives understand the
information presented?
f. If English is not the subjects’ native language, how will translation be provided?
3. Documenting consent. Provide copies of all written consent forms. Signed, written consent
forms are required unless waived by the IRB.
a. Indicate all the ways the subjects’ informed consent will be documented:
Signed, written consent
Telephone consent
Verbal consent
Videotaped consent
Other (specify)
b. If non-English speaking subjects will be included, describe how translation of consent
forms will be provided. All translated consent forms must be submitted to the IRB along
with back translations.
Not applicable. Non-English speaking subject will not be included.
Description:
c. If subjects cannot read the consent form, due to literacy or language problems, how will
consent be documented?
Not applicable. Subjects with literacy or language problems will not be included.
Description:
Privacy and confidentiality
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1. Explain how privacy interests of subjects will be protected. How will investigators contact
subjects and/or access private information from or about subjects during and after their
involvement in the research (e.g. time, place, etc. of research procedures) and the subjects’
expectations of privacy in the situation.
2. Data collection:
Yes
No
Data collected may be sensitive (e.g. mental health). If yes, provide
rationale for why this data is needed.
Disclosure of data may have adverse consequences for subjects or damage
their financial standing, employability, insurability or reputation.
A Certificate of Confidentiality will be obtained.
Data that identifies individual subjects will be published or disclosed to
third parties (other the project personnel). If yes, describe the data to be
published or disclosed. Ensure this information is included in the informed
consent.
3. Specific safeguards used to protect confidentiality of data (select all that apply):
Access to data is limited to only authorized individuals
Access to electronic data requires unique identification of authorized users
Access to electronic data requires password protection
Anti-virus controls are present on devices that store electronic data
Audio and/or video recordings are transcribed and then destroyed to eliminate
audible identification of subjects
Automatic backups protect electronic data against loss or theft
Data stored on computers is password protected
Electronic data has appropriate and restricted security safeguards
Encryption is used for any data stored on portable devices (laptop, personal digital
assistants, removable hard drives, etc)
Identifiers are removed prior to data storage
Paper copies are kept in a restricted room
Paper copies are locked in a file cabinet
Research personnel will be required to sign statements agreeing to protect the
confidentiality of data
Study codes are used instead of identifying information. The separate document
linking the study code to the subject is secured in a separate location
Other:
Data and safety management (complete for all research involving more than minimal risk)
1. If data will be reviewed by an independent Data Safety Monitoring Board, indicate the page
and/or section in the research protocol this is described.
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2. Who will monitor research progress and subject reactions, and how?
Data Safety Monitoring Board
Other (describe):
3. The plan for reporting adverse events and unanticipated problems involving risk to subjects
or others is:
Data Safety Monitoring Board
Other (describe):
4. The plan to assure compliance with reporting of adverse events and/or unanticipated
problems involving risks to participants or others is:
5. The plan to assure data accuracy and protocol compliance is:
Checklist
Indicate all documents included with this submission. Submit original (not scanned or copied)
forms, except for documents requesting signatures. All documents requesting signatures must be
completed, printed, signed and scanned.
Conflict of Interest. A separate, signed document is required for all investigators
and research staff
Curriculum vitae for all investigators
Data collection tools (questionnaires, surveys, interview questions, etc)
Informed consent
Initial Review Supplement – Children
Initial Review Supplement – Cognitively Impaired
Initial Review Supplement – Consent Waiver
Initial Review Supplement – Drugs or Biologics
Initial Review Supplement – International Research
Initial Review Supplement – Internet
Initial Review Supplement – Medical Devices
Initial Review Supplement – Pregnant Women, Fetuses or Neonates
Initial Review Supplement – Prisoners
Initial Review Supplement – Signature Page. (Required)
Initial Review Supplement – Stored Data for Future Use
Instruction for use manual (for medical device study)
Investigator’s drug brochure (for drugs / biologics study)
Protocol
Professional license (copy) for Principal Investigator
Subject recruitment material
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