Institutional Review Board at Tallahassee Memorial HealthCare, Inc. Form 4
Application for New Study Approval of Research Involving Human Subjects
THIS FORM MUST BE TYPEDHAND WRITTEN FORMS WILL NOT BE ACCEPTED.
IRB #: / Study Title:
Name of Principal Investigator:
(If a TMH only study, put PI name here OR if a Multi-center Study, put sponsor PI name here & TMH PI name as the Intramural PI.)
Email:
Evidence of Human Research Protections Education/Experience Attached: Yes No / (This could be a university, commercial sponsor, etc.)
Address:
Phone:
Fax:
Name of Intramural Principal Investigator at TMH:
Email:
Evidence of Human Research Protections Education/Experience Attached: Yes No / Address:
Phone:
Fax:
Research Coordinator: / Phone #: Email: Fax:
Detail current funding sources, awards, grants (if applicable):
List other IRBs having jurisdiction over study:
For projects that receive or have submitted application for federal funding, submit one complete copy of the grant/continuation application/NIH Progress Report applicable to this study.
Where will the study be conducted? (List all locations under IRB at TMH review.)
List the names of key personnel on this protocol. Attach the requested documentation.
Obtaining Informed Consent / Name
(Complete this Section for New Studies Only) / Evidence of Human Research Protections Education/Experience Attached / Conflict of Interest Attached / Resume/CV Attached
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
1) STUDY POPULATION
a) Study population will include recruiting: Males Females Children (<18 years) Minorities
(If the study is not gender/ethnic/racial/age group specific, the protocol must include justification for excluding women and/or minorities or specific age groups.)
b) Age range of subjects:
c) Study will include the following vulnerable populations (see Vulnerable populations Section 4.3.2): N/A skip to d)
Students Institutionalized Persons Educationally/economically disadvantaged
TMH Colleagues Children (<18 years) Fetuses
Pregnant women Children who are wards of the state Decisionally impaired persons
Abortuses Prisoners** Other: Specify
** In addition to individuals involuntarily confined or detained in penal institutions, the term “prisoner” includes those detained in other facilities as alternatives to criminal prosecution or incarceration in penal institutions, i.e., drug treatment facilities, etc. NOTE: if a research subject is incarcerated or detained in an alternative facility after enrolling in a study, the PI must notify the IRB immediately.
The protocol must include rationale for recruiting any vulnerable populations and details regarding the additional protections in the protocol.
If vulnerable populations are included, what additional protections are included to protect their safety?
d) Expected number of subjects at this site:
i) For multi-centered studies, expected total number of subjects:
e) Method for justification for total number of subjects: Power Analysis Other:
Invocation of the term "pilot study" does not exempt the investigators from justifying their choice of sample size.
2) RECRUITMENT METHODS
a) Where are you recruiting subjects? Chart reviews
Chart reviews TMH Colleagues Other
Your Patient Population Explain how you are related to the population:
If chart review will be utilized, you may need to request a Waiver of HIPAA Authorization. See Chart Review Guidance and IRB Form 4c.
b) What methods will you use to recruit subjects? (Check All That Apply)
Word of Mouth Letters Direct Contact
Internet Print Ads Subject Referral
Radio/TV Poster Other:
All recruitment of advertising materials including letters to patients or colleagues must be approved by the IRB prior to use. Prior to submission to the IRB, please click on Advertising for complete guidance on advertising preparation. Attach copy(ies) of advertising to this form.
c) Will any third party, i.e., someone who does not normally have access to patient/student/colleague/private information information, be involved in the recruitment process? Yes No
d) Does data from prior studies strongly support the existence of significant differences of clinical or public health importance in intervention effect upon gender and/or racial/ethnic subgroups? Yes No
i) If YES, is the study designed to evaluation the intervention effect among these subgroups? Yes No
If data from prior studies neither supports nor negates significant differences of clinical or public health importance in intervention effect between subgroups, the study is required to include sufficient and appropriate entry sex/gender and/or racial/ethnic subgroups so that valid analysis of the intervention in the subgroups can be performed.
3) SAFETY MONITORING See guidance on Data Safety Monitoring Boards (Glossary).
a) Is there a Data Safety Monitoring Board (DSMB) in place? Yes No
i) If NO, project should provide a justification.
4) INFORMED CONSENT
Detail the process of Informed Consent including the following: (See guidance on Informed Consent Process (Section 9)
a) a)
b) Where will informed consent be obtained? Physician’s/Researcher’s Office Clinic
Bixler Emergency Center Other
c) Will the subject sign a consent form prior to the initiation of any research procedures? Yes No
d) Will consent be documented by signature on a written consent form? Yes No
e) Are you requesting a waiver of informed consent, documentation of informed consent or elements of informed
consent? Yes No
i) If YES, complete IRB Form 4b. See guidance on Elements of Informed Consent (Section 9)
f) Will informed consent be documented in the medical record? Yes No
i) If NO, justify:
g) Who will document in the medical record the explanation of the consent process and that informed consent was
obtained?
h) Will the subjects be paid or given other incentives to participate? Yes No
i) If YES, give the total amount and prorated scheduling:
i) Do you anticipate that any of the subjects will be decisionally impaired due to the following? Yes No
Sedation Dementia Emotional Distress
Mental Illness Coma/Unconsciousness Learning Disability/Mental Retardation
Other
See guidance on subjects who are decisionally impaired.
5) RESEARCH TYPE
Check all the items involved in this study and complete the corresponding sections. Use additional pages if necessary. ______
Section A – Behavioral Interventions Section E – Withdrawal or Withholding of Therapeutic Procedures
Section B – (1) Invasive Section F – Collection of Biological Specimens
Section B – (2) Non-invasive Procedures Section G – Minors or Decisionally Impaired Subjects
Section C – Drugs/Placebos/Biologics/Other Section H – Threat, Embarrassment, Deception, Sensitive Information
Section D – Medical Devices Section I – Observational or Other
______
Section A Behavioral Interventions N/Aa) Name and describe interventions in detail; include reasons for their use:
b) Describe in detail any risks associated with the use of these interventions and the precautions that will be taken to minimize these risks. NOTE: Not all risks are immediate, physical or exclusive to the individual subject.
Section B (1) invasive Procedures N/Aa) Name and describe the procedures in detail; include reasons for their use:
b) Will the procedure be conducted at a TMH facility? Yes No
i) If no, is the facility licensed to do this procedure? No Yes – Attach a copy of the current
facility license.
c) What are the sponsor’s requirements for the investigator(s)/key personnel to participate in the study?
d) Do the investigator(s)/key personnel currently have this credentialing/privileging/certification at TMH to participate in the study? Yes No
e) At the facility where the study will take place? Yes No
f) List the names of all investigators who are credentialed/privileged/certified to perform these procedures:
g) Describe in detail any risks associated with the use of these procedures and the precautions that will be taken to minimize these risks. NOTE: Not all risks are immediate, physical or exclusive to the individual subject.
Section B (2) Non-invaisive Procedures N/Aa) Name and describe the procedures in detail; include reasons for their use:
b) Will the procedure be conducted at a TMH facility? Yes No
c) If no, is the facility licensed to do this procedure? Yes No
(Attach a copy of the current facility license)┘ .
d) What are the sponsor’s requirements for the investigator(s)/key personnel to participate in the study?
e) Do the investigator(s)/key personnel currently have this credentialing/privileging/certification at TMH to participate in the study? Yes No
f) At the facility where the study will take place? Yes No
g) List the names of all investigators who are credentialed/privileged/certified to perform these procedures, if applicable:
h) Describe in detail any risks associated with the use of these procedures and the precautions that will be taken to minimize these risks. NOTE: Not all risks are immediate, physical or exclusive to the individual subject.
Section C Drugs/Placebos/Biologics/Other Agents N/Aa) Name of drug(s) and if applicable trade name and/or placebos, biologics, radioisotopes, or other agents:
b) Suppliers(s):
c) Amount and concentration to be used:
d) Method(s) of administration:
e) Are any of these agents investigational new drugs? ( i.e., not used in a manner not consistent with its labeling, not on the market, not FDA approved) Yes No
i) If YES, has a formal filing with the FDA been made? Yes No
(1) If yes, attach a copy of the IND filing with the FDA and their response, when available.
(2) Date submitted to the FDA: IND #: Sponsor:
ii) If NO, is this drug FDA approved for the use indicated in this submission? Yes No
f) FDA approved drugs used for non-approved indications may required an IND (Investigational New Drug application) to the FDA. When the principal intent of the investigational use of a test article is to develop information about a products safety or efficacy, submission of an IND or IDE may be required. An IND is not required if all six of the following are met:
i) It is not intended to be reported to the FDA in support of a new indication of use or to support any other significant
change in labeling for the drug;
ii) It is not intended to support a significant change in advertising for the drug;
iii) It does not involve a route of administration or dosage level, use in a subject population, or other factor that
significantly increases the risk or decreases the acceptability of the risks associated with the use of the drug
product;
iv) It is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively];
v) It is conducted in compliance with the promotion and sale of drugs [21 CFR 312.7] and;
vi) It does not intend to invoke 21 CFR 50.24 (Exception from Informed Consent Requirement for Emergency Research).
If you feel you do not need to apply for an IND based on the six criteria above explain:
g) Describe in detail any risks associated with the use of these drugs/placebos and the precautions that will be taken to minimize these risks:
h) Where will the study drug be stored?
i) Who will receive the study drug?
j) Who will maintain the study drug tracking log?
k) Who will label the study drug?
l) Who will dispense the study drug?
m) Will open label drug be used?
n) Will the study drug be randomized?
o) Where will the randomization take place?
p) Where will the instructions regarding the manner to randomize the study drug be sent?
q) Who will implement the instructions to randomize the study drug?
r) How will the study drug use, side effects, mixing methods, special administration procedures and special requirements such a necessary follow-up lab work be explained to the users?
Section D Medical Devices N/Aa) Name and description of the medical device(s) including the name of the manufacturer:
b) Is this an investigational device? Yes No
c) Is this an investigational use of an approved device? Yes No
i) If YES, what is the sponsor’s classification of the device?
Significant Risk (SR) Non-significant Risk (NSR)
d) Has the device been submitted to the FDA for review? Yes No
(If Pending, submit FDA documents when received.) Pending
i) IF YES or Pending, date filed for:
(1) Premarket Notification (510K) Provide # Class I Class II
(2) Investigational Device Exemption (IDE) Provide # SR NSR
(3) Humanitarian Device Exemption (HDE) Provide #
e) Describe in detail any risks associated with the use of the medical device(s) and the precautions that will be taken to minimize these risks.
f) Is this a post-market registry? Yes No
Section E Withdrawal or Withholding of Therapeutic Procedures N/Aa) Describe the therapeutic procedure(s) that will be withdrawn or withheld from subjects and the reason for withdrawing or withholding the therapeutic treatment(s):
b) Describe the effects/risks that withdrawing/withholding the treatment(s) will have on the subjects and the precautions that will be taken to minimize these risks:
Section F Collection of Biological Specimens N/Aa) Do you plan to use blood, tissue or other specimens as part of this research study? Yes No
b) Is the collection of biological specimens required for participation? Yes No
c) Are you using retrospectively collected samples? (meaning specimens that are already in existence at the time of the proposed research) Yes No
d) Will you be collecting samples prospectively? Yes No
e) Describe specimen collection procedures and any risks involved:
f) Will specimens be banked for future use? Yes No
g) Will specimens be obtained from procedures being performed for non-research purposes? Yes No
If YES, would these samples otherwise be discarded? Yes No
h) Are samples anonymous (impossible to link to an individual)? Yes No
i) Does your research involve genetic testing? Yes No
j) Do you plan to share specimens with other investigators? Yes No
If YES, will the specimens have identifiers? Yes No
k) Is there a potential for commercial use of these samples? Yes No
l) What are the sponsor’s requirements for the investigator(s)/key personnel to participate in the study to collect specimens? (i.e., licenses/certifications/equipment/education, etc.)