Maine Medical Center Institutional Review Board
Maine Medical Center Institutional Review Board
Application for Human Subject’s Research
81 Research Drive
Scarborough, ME 04074
IRB Application Checklist:
Please note, this list will help you through the application. Everything with a checkbox () is a required item (i.e. that section of your application must be complete). Applications for human subject research submitted without all of the required items will not be accepted for review. If you have questions regarding the applicability of any required elements to your research, or general questions regarding how to complete the forms, please call our office (885-8240).
Page 1
Protocol Title (Section 1)
Principal Investigator Information, including telephone, fax and e-mail information (Section 2)
Funding / Protocol Information, A
Funding / Protocol Information, choose and complete either B, C or D
Page 2
Conflict of Interest questions (Section “D”)
Location of the study, including all locations in which the study team will see subjects (Section 4)
Attending Privileges/Employee Status Information, including sponsor information if appropriate (Section 4)
Subject Information, A & B (Section 5)
Page 3
All Recruiting Information, including A, B, and C (Section 6)
Payment to Subject Information (yes or no) (Section 7)
Page 4
Compensation for injury information, even if your study is not sponsored (Section 8)
Type of research, A, B, C and D (Section 9)
Investigational Drugs and Devices Information, check “no” if applicable (Section 10)
IND/IDE number and information, if you answered “yes” (Section 10)
Page 5
Device Risk information, if you completed Section 10B on page 4
Sponsor of the IND/IDE , if you answered “yes” in Section 10
Please attach an informed consent document. Please see below for requests of waiver of informed consent, and/or further instructions.
Confidentiality Information (Section 12)
Privacy Practices (HIPAA) (Section 13)
Informed Consent Document
If you are requesting a waiver of the informed consent document, the request must be included in your research plan. We will only allow waiver of informed consent when you have submitted information which indicates that a) it is a minimal risk study; b) waiver will not adversely effect the rights of the subject AND c) there is no practical way the study could be complete without waiving the informed consent. For requests for waiver of informed consent, please submit a HIPAA Privacy Requirements form as well (pp. 14-15).
Page 6
Risk Assessment and Assent for Children, ‘N/A” must be checked if you do not intend to enroll children (Section 13)
Page 7
Please attach a research plan. Please see below for further instructions.
All Investigators, including Co- and Sub- Investigators must sign this page
Research Plan
All research plans must be written in lay terms, using our format, and be no more than 4 pages in length. We cannot accept summaries copied out of the protocol as research plans for industry sponsored projects as they are written for practitioners in the field, and our Board is multi-disciplinary.
Page 8
Please see below for more instructions regarding Peer Reviews
Project Title (this is identical to the Protocol Title on Page 1)
Principal Investigator (this is identical to the PI on Page 1)
Contact Name and telephone number
Page 9
Brief Summary of the meeting. This is a description of what points were discussed at the meeting.
Number of votes, must match the number of signatures
Signatures of all persons present at the peer review; must include someone not involved with the project, and all signatures dates must be the same
Department Chief Signature, or note that it has gone to the Department Chief for signature
Peer Review
The peer review form is to be completed at a CONVENED meeting, with 4 people present. One of the people present must not be involved in the project.
Page 10
Principal Investigator (this is identical to the PI on Page 1)
Project Title (this is identical to the Protocol Title on Page 1)
Sponsor, type “N/A” if your project is not sponsored
Sponsor Contact Information OR Fee Does Not apply information
Other Items
CV’s or Resumes
If we do not have a CV or resume on file, you must submit one for each investigator (co-and sub- included). If you have not submitted a new CV or resume in the past 12 months, please submit an updated version.
Internal Services Checklist(p. 11)
If your study involves any other departments within MMC (pharmacy, laboratory, cardiology, emergency, nursing units, etc.) you MUST have the responsible person in the department sign off that they are aware of and approve of the study. Please give the department reviewer ample time to think about the ramifications of your study in their area.
Study Classification & Website Information (pp. 12-13)
Please take a minute to complete the Study Classification form for your study. The purpose of this form is to track your study, and include it in the proper category when we report to hospital administration. If you want to include your study on our website, please complete the Website Information portion of this form. Please remember that you must notify the IRB when you stop recruiting subjects.
HIPAA Privacy Requirements
All health care entities must obtain patients’ permission before using their private health information (PHI) for certain purposes other than treatment, payment, and routine operations. Therefore, you need to obtain permission before using their PHI for most clinical research. Please see the MMC Informed Consent Template for an example of the required language in an authorization to use or disclose PHI (starting on page 3 of the template). Under HIPAA, your site must retain the authorization for at least six years after the subject has signed it. Waiver of authorization may be requested if your research meets the required criteria for waiver. Also, waiver of authorization may be requested for certain pre-screening and recruitment practices (Complete pp. 14-15 to request a waiver).
Other Information
If you intend to use advertising, questionnaires, letters to subjects, or information sheets in your project, copies of those must be submitted to the IRB for review and approval prior to use.
Required Education
Investigators, research coordinators, and any other individuals in contact with subjects and/or human research subject data need to complete the CITI course through the University of Miami before approval of their project is granted. Investigators/staff conducting research on drugs or devices (investigational or non-investigational), or any non-behavioral/non-social research must complete all of the Biomedical Research modules (1-12). Investigators/staff conducting social or behavioral research must complete all of the Social / Behavioral Research modules (1-11). Please see the directions for details, or contact our office at 885-8240 for a copy of the directions or further assistance.
B
OFFICE USE
IRB # ______
Dated Received ______
MAINE MEDICAL CENTER
IRB APPLICATION FOR HUMAN RESEARCH SUBJECTS / Page 11. / STUDY TITLE (Match the title provided by the sponsor or the title of your grant)
Abbreviated Title or Acronym:
2. / SITE AND RESEARCH STAFF:
A. / Principal Investigator: / (Attach Current CV)
Department: / Phone:
Address: / Fax:
Address: / Pager:
Address: / E-mail:
B. / Research Coordinator: / None
Department: / Phone:
Address: / Fax:
Address: / Pager:
Address: / E-mail:
C. / List Co-Investigators (Attach Current CV) or None
D. / List Sub-Investigators (Attach Current CV) or None
3. /
FUNDING / PROTOCOL INFORMATION
A. / Who wrote the protocol or plan for this study? (please choose only one)Funder/Sponsor (Listed in 3C) / Principal Investigator (listed in 2A) / Cooperative Group PI
Other
B. / Is this protocol being supported by a federal (or non-federal) funding agency (e.g. / Yes / No
NIH, AHA, etc)? If yes, please provide a copy of the entire Grant (research plan) for review
What funding agency is supporting your protocol:
Grant Title:
C. / Is this protocol being sponsored by an Industry (Pharmaceutical or Device) Sponsor? (please list the company, even if you are not receiving monetary support for the protocol) / Yes / No
Name of Industry Sponsor:
Contact Person & Title:
Address: / Phone:
Address: / Fax:
D. / If this protocol is not being funded by either a funding agency, or an industry sponsor, please indicate where the funding for the conduct of this protocol is being obtained (if any):
Medical Research Committee / Non-Funded /
Departmental Funding
/Cooperative Group
MAINE MEDICAL CENTER
IRB APPLICATION FOR HUMAN RESEARCH SUBJECTS / Page 2D. / 1. Do any of the investigators have significant equity interest in the sponsor of the study or the tested/studied product (significant equity = >$50,000 in stock)? / Yes / No
2. Do any of the investigators have proprietary interest in the tested product (proprietary interest includes patent, trademark, copyright or licensing agreement)? / Yes / No
3. Have any of the investigators received significant payments from the sponsor, exclusive of those payments for the conduct of the study, this includes payments given as grants for ongoing research, retainers, and honoraria (significant payment = >$25,000)? / Yes / No
4. /
LOCATION OF RESEARCH
A. / Where will the study take place?B. / Will the PI be conducting and/or supervising study related activity at any sites not under the jurisdiction of this IRB/Privacy Board? / Yes / No
If yes, please provide name and address for each location AND documentation of approval to conduct research at these sites.
Note: MMC IRB approval of your protocol does not include permission to perform any protocol-related activities at these sites. Additional IRB approval may be required from these sites.
C. / Will this study require hospital admission? / Yes / No
If yes, you must notify the Admitting Department after IRB approval.
D. / Do you have attending privileges at Maine Medical Center? / Yes / No
E. / Are you an employee of Maine Medical Center? / Yes / No
If no to both questions (D. & E.), you must have an MMC sponsor.
Please provide the name of that person:
5. /
SUBJECT INFORMATION
A. / Subjects will be: / Inpatients / Outpatients / Non-PatientsMales / Females
Will subjects who do not understand English be enrolled? / Yes / No
If yes, describe your resources to communicate with these subjects:*
*Add an additional sheet if needed
B. / Potentially Vulnerable Populations: None
Children / Prisoners / Fetuses / fetal material
Pregnant Women / Students / Other (describe)
If you are recruiting children, please complete Section 14 regarding risk and assent and attach a copy of the assent form.
MAINE MEDICAL CENTER
IRB APPLICATION FOR HUMAN RESEARCH SUBJECTS / Page 36. /
RECRUITMENT
A. / How many subjects does your site anticipate recruiting?B. / How will subjects be identified?
By chart / database review
(see below) / Course participants
From the Investigator’s own patients / Circumstance (i.e., hospital admission, homeless)
Referrals / Living conditions (street, nursing home)
Describe any other sources / Direct advertising (complete Section 6F)
C. / How will subjects be recruited for participation?
At a scheduled visit by the investigator
Letter / Phone / Other (describe)
By chart / database review
Who is the custodian of these records?
Initial contact must be made by the custodian of the records. Attach any letters or information that will be sent to the subjects.
Describe how the custodian is going to contact the subject(s)
D. / Who will be approaching potential subjects for informed consent?
E. / How much time will subjects have to make a decision about study participation?
F. / Direct subject advertising None
Media for subject recruitment includes:*
Radio / Television / Letter to patients
Newspaper / Bulletin board / flyer / Letters to providers
Internet / Other
*Please attach a copy of the ad
7. /PAYMENT TO SUBJECTS
Will subjects be paid for participation? / Yes / NoIf yes, indicate total amount*, (dollar or equivalent):
Form of Payment:
*Payment includes all types of reimbursement such as fares, parking fees, etc.
MAINE MEDICAL CENTERIRB APPLICATION FOR HUMAN RESEARCH SUBJECTS / Page 4
Will payment be prorated? / Yes / No
Explain how this will be done, and if not, why ?
8. /
COSTS TO SUBJECTS
A. / Compensation for injuryWho is responsible for costs incurred by the subject due to injury?
Sponsor
Insurance will be billed first, then the Sponsor will cover any outstanding costs
Other (please explain)
Will subjects or their insurers be required to pay for any study related procedures or products? If yes, explain: / Yes / No
9. /
TYPE OF RESEARCH
A. / Does the project involve the administration of personality tests, inventories, or questionnaires? If yes, provide a copy of the proposed tests/questionnairs. / Yes / NoB. / Does the project involve administration of ionizing radiation to subjects for other than clinical purposes? (e.g. X-Rays, CTs, etc).
If yes, contact the Radiation Safety Office (871-4332) / Yes / No
C. / Does the project involve gene therapy (administration of recombinant vectors) to human subjects for other than clinical purposes? If yes, contact the ORA office (871-8183) for further information. / Yes / No
D. / Does this protocol involve any invasive procedures? / Yes / No
Surgical Procedure(s)
Blood Collection (total per subject)
Other
10. /
DOES THIS PROJECT INVOLVE INVESTIGATIONAL DRUGS/DEVICES?
/ /Yes
/ /No
If yes, complete this section
A. / This study involves a drug or biologic: IND #, if applicable:This study is: / Phase 1 / Phase 2 / Phase 3 / Phase 4 / Treatment
B. / This study involves a device: IDE #, if applicable:
This device is / Investigational / Marketed
Humanitarian exemption device
MAINE MEDICAL CENTER
IRB APPLICATION FOR HUMAN RESEARCH SUBJECTS / Page 5This device is / Significant Risk Device / Non-Significant Risk Device*
*Sponsor must include justification on Non-Significant Risk per 21 CFR 812.66
C. / Who is the Sponsor of the IND/IDE?
Submit three complete copies of the Protocol and Investigator’s Brochure
11. /INFORMED CONSENT
Please complete the following section regarding your informed consent documentA. / Informed consent must be obtained from the subject prior to enrollment and/or treatment. Each subject or their legal representative must sign a consent document. If a patient is unable to consent for themselves, how will pertinent information be provided to the subject(s) at a later date? Attach your debriefing plan.
Attach your informed consent document(s) for IRB review.
If you are developing your informed consent document(s) without a Sponsor consent document, please use the Maine Medical Center template*. If there is a Sponsor consent document, prepare your informed consent document(s) by editing the Sponsor prepared forms to include all of the information contained in the major heading of the MMC informed consent template.
*See consent document template