Mount Carmel Institutional Review Board

Office of Research Affairs/IRB Office
Mount Carmel Corporate Services Center
6150 East Broad Street / Columbus, OH 43213
Phone: 614-546-4325 | Fax: 614-546-4328
Email:

APPLICATION FOR RESEARCH

INVOLVING HUMAN SUBJECTS

Administrative Information

Study Title:
Sponsor Protocol Number: / Version Date:
Proposed length of research study: / Start: / End:
Type of Review Requested:
Full Committee
Expedited
Note: If you wish to request exempt status for your study, submit the Exemption Request Form
Research Site(s):
Mount Carmel West Mount Carmel East Mount Carmel St. Ann’s
Mount Carmel New Albany Surgical Hospital Fairfield Medical Center Physician’s Office
Other, specify:
1.Principal Investigator Information
Name:
M.D. Ph.D. R.N. Other, specify:
Human Subject Protection Training Completed? Yes No
Address:
Telephone: / Fax: / E-mail:
2.Study Contact Information (if other than PI):
Name:
M.D. Ph.D. R.N. Other, specify:
Human Subject Protection Training Completed? Yes No
Address:
Telephone: / Fax: / E-mail:
3.Co-Investigator(s):
(1) Name:
Address:
Telephone: / Fax: / E-mail:
(2) Name:
Address:
Telephone: / Fax: / E-mail:
(3) Name:
Address:
Telephone: / Fax: / E-mail:
4.Additional Research Personnel not listed above
Note: Research personnel includes all individuals responsible for the design or conduct of the study who have access to confidential and identifying information, e.g., research nurses, study coordinators, students, and other support staff or persons assisting with the research
Name / Title / Role
Example: Jane Doe, RN / Coordinator / Data Collection
Attach additional page if necessary.
Have all research personnel listed above taken the Protecting Human Research Participants training at / Yes
No
 All research personnel must complete the training program prior to initiation of this research study and provide a copy of the completion certificate to the IRB Office.

Study Information

5.Study Details
Phase of Study: / N/A Phase 4
Phase 1 Post Market Study
Phase 2 Other, specify:
Phase 3
Study includes: / N/A Blood draw(s)
Questionnaire(s) Specimens to be obtained in the future;
Chart Review(s) specify:
Registry
Genes/DNA / N/A
Genetic research; specify:
Recombinant DNA
Other:
Radiological / N/A
Radioactive material is being used in this study. Specify:
Mount Carmel Radiation Safety Committee approval attached*
* If your study uses radioactive material, it must be approved by the Mount Carmel Radiation Safety Committee before it is reviewed by the IRB.
6.STUDY SUBJECTS:
Subject age range
Total number of participants stated in the protocol to be studied nationwide
Maximum number of participants that are planned to be consented by this PI
Does this study target one gender or specific social/ethnic group? / Yes; justification is provided in the protocol
No
If justification is not provided in the protocol, please explain:
Indicate all of the population types included in this study. / Check all categories of participants that will be involved in the research study, and answer the associated question(s):
N/A
Healthy volunteers
Pregnant women, fetuses, neonates or fetal materialAttach form:Pregnant Women,
Human Fetuses, Neonates or Fetal Material Addendum
Females of reproductive potential at the time of the research:
Check one of the following:
The research poses no added risk associated with pregnancy and/or lactation.
Precautions against pregnancy and/or lactation, and pregnancy tests are addressed
in the research protocol and consent document.
Adults with decisional impairment Attach form: Vulnerable Populations:Adults with
Decisional Impairment Addendum
Prisoners  Attach form: Vulnerable Populations: Prisoner Addendum
Students or employees of the investigator(s) and/or Mount Carmel
Institutionalized individuals (e.g. patients in state hospitals or nursing homes)
Other, specify:
7.Data Safety Monitoring ☐
Who will do the data and safety monitoring for this study? / Principal Investigator
Study sponsor
Does the study sponsor have a data safety monitoring board (DSMB) in place?
No
Yes
Other, explain:
Provide contact information for data safety monitor / Name:
Telephone #:
E-mail:
As part of the data safety monitoring the number of subjects screened/enrolled will be monitored / Yes
No / Patients who choose to withdraw will be monitored: / Yes
No
As part of the data safety monitoring primary and secondary endpoints will be monitored / Yes
No / Adverse events will be monitored using an accepted scale: / Yes
No
Frequency of data safety monitoring: / Every 12 months coinciding with the IRB renewal period
Every 6 months
Every 3 months
Other, specify:
Insert or attach any additional information regarding Data and Safety Monitoring for this protocol.
8.How will non-English speaking participants be consented?
Not Applicable at this time
Choose One: / A translated written informed consent document in a language understandable to the
participant. This should be an accurate translation of the full informed consent
document (consider having a translator present during the consenting process should
the participant have questions).
Orally, using a qualified translator to translate the English informed consent document
to the participant, and a translated short form in a language understandable to the
participant.
Note: It is acceptable to submit the English informed consent document and the English short form. If there is no current non-English speaking person identified for the study. Once identify, the translated informed consent document or the short form must be submitted to the IRB for expedited review and approval prior to consenting the participant.
9.Informed Consent
The study will use the following type(s) of informed consent, check all the apply: / N/A
Comprehensive written informed consent/authorization form
Short form informed consent
Other, explain:
This study’s consent procedure will require these waivers / N/A
Waiver of one or more elements of informed consent*
Waiver of documentation of informed consent*
Waiver of authorization for use/disclosure of protected health information**
*REQUEST FOR WAIVER, DOCUMENTATIONOF ELEMENTS OF INFORMED CONSENT must be completed if requesting a waiver of one or more elements of informed consent or the documentation of informed consent.
**A HIPAA Compliance Worksheet and Waiver of Authorization Request must be completed if requesting waiver of authorization to use/disclose PHI. Both of the aforementioned documents can be requested by email to
More than one consent form will be used for this study (not counting language translations). / Yes; list each consent title:
No
This study involves videotape or other electronic recording. / Yes, specify:
No
10.Participant Identification and Recruitment
How will prospective patients be identified and contacted (if applicable also describe how you have access to lists of potential participants?
Describe the steps for obtaining informed consent (e.g., by whom, his/her credentials, where, when, etc.)
Do you plan to solicit participants using advertisements? / No
Yes
 Choose all that apply:
Flyers Mass E-mail Solicitation Radio
Internet Newspaper Television
Letter Posters Telephone
Other, describe:
Include copies of all items checked with submission
Will protected health information (PHI) be accessed (used) in the course of screening/recruiting for this research study? / No
Yes
 If Yes, the following four conditions must be met:
  1. The use or disclosure of PHI is sought solely for the purpose of this research protocol.
  2. The PHI will not be removed from Mount Carmel.
  3. The PHI is necessary for the purpose of this research study.
  4. A completed HIPAA compliance form must be completed.

11.Data Collection, Storage of Data/Specimens and/or Issues of Confidentiality
Describe the tools that will be utilized in the collection and storage of research information including data (hard copies and electronic databases, specimens, audio/videotapes, ect.). Indicate who will have access to the research information and describe the final disposition of research information when the study is concluded (e.g. will information be destroyed or will PI maintain the information)
Describe how the confidentiality of participants will be assured. Include a description of any issues specific to the study that might increase the risk of breach of confidentiality. Describe how codes will be generated if codes are used to protect identities and who will have access to the codes.
12.Conflict of Interest
Conflict of Interest Annual Financial Disclosure Form(s)are attached for the Principal Investigator and all research personnel
Conflict of Interest Annual Financial Disclosure form can be found at

or requested by email to IRB @mchs.com / Yes
No
 If NO, explain:

Investigator’s Responsibilities Checklist

The following are the minimum responsibilities of Principal Investigators as stated in the formal agreement between Mount Carmel Health System and the Office Human Research Protection (the “Assurance”).
  • I, the Principal Investigator, acknowledge and accept my responsibility for protecting the rights and
welfare of human research subjects and for complying with all applicable provisions of the Assurance.
  • If I intend to involve human research subjects in my research, I will be responsible for obtaining IRB review and approval prior to the initiation of that research.

  • I am responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement or the study is determined by the IRB to be exempt.

  • All signed consent documents will be retained in a manner approved by the IRB.

  • Unless otherwise authorized by the IRB, I am responsible for obtaining and documenting informed consent in accord with applicable federal regulations at 45 CFR §46.116 and 45 CFR §46.117.

  • I shall be responsible for promptly reporting proposed changes in previously approved human subject research activities to the IRB. My proposed changes may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to my subjects.

  • I will report to the IRB any unexpected and serious events or other unanticipated problems involving risks to subjects or others within 10 calendar days of my first discovering it.

  • I will submit a progress report at least four weeks prior to the date at which the IRB has determined continuing review is
required. If the progress report is not received by the due date, I understand that it cannot be guaranteed that my study
will be reviewed before the expiration of the IRB approval date. If my study is not reviewed prior to the expiration date,
all enrollment is suspended and I may not continue with the study for previously enrolled subjects except as approved
by the IRB.
  • I will ensure that all research patients are properly registered for services at all Mount Carmel facilities following all Mount Carmel policies and procedures.

  • I have completed and will require my research team to complete an educational program on the protection of human
subject research participants.

PI’s Signature

Date
Print Name
Signature / I attest that the information contained herein is a true and accurate representation of my proposed study. I attest that I have not been disbarred, suspended or restricted by any federal or state agency from conducting this research study. I will abide by the requirements of Mount Carmel and the IRB as per the above investigator’s responsibilities checklist, federal and Ohio state laws and regulations, and the agreement with the sponsor in the conduct of this research study’s protocol.

The Office of Research Affairs/IRB Office staff will thoroughly review your submission. You will be contacted prior to IRB review if there are questions or clarifications required.

IRB Application for Approval of Research Involving Human Subjects

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