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).

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

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)

All Recruiting Information, including A, B, and C (Section 6) Payment to Subject Information (yes or no) (Section 7)

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)

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).

A Page 6 Risk Assessment and Assent for Children, ‘N/A” must be checked if you do not intend to enroll children (Section 13)

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.

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

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.

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.

B 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.

C OFFICE USE IRB # ______Dated Received ______MAINE MEDICAL CENTER IRB APPLICATION FOR HUMAN RESEARCH SUBJECTS Page 1 1. 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? Yes No (please list the company, even if you are not receiving monetary support for the protocol) 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

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D. 1. Do any of the investigators have significant equity interest in the Yes No sponsor of the study or the tested/studied product (significant equity = >$50,000 in stock)?

2. Do any of the investigators have proprietary interest in the tested Yes No product (proprietary interest includes patent, trademark, copyright or licensing agreement)?

3. Have any of the investigators received significant payments from Yes No 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)?

4. LOCATION OF RESEARCH A. Where will the study take place?

B. Will the PI be conducting and/or supervising study related activity at Yes No any sites not under the jurisdiction of this IRB/Privacy Board? 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-Patients Males 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.

6. RECRUITMENT

A. How many subjects does your site anticipate recruiting?

B. How will subjects be identified?

By chart / database review Course participants (see below) 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 No If yes, indicate total amount*, (dollar or equivalent):

Form of Payment: *Payment includes all types of reimbursement such as fares, parking fees, etc.

Will payment be prorated? Yes No

Explain how this will be done, and if not, why ?

8. COSTS TO SUBJECTS A. Compensation for injury

Who 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, Yes No inventories, or questionnaires? If yes, provide a copy of the proposed tests/questionnairs. B. Does the project involve administration of ionizing radiation to Yes No subjects for other than clinical purposes? (e.g. X-Rays, CTs, etc). If yes, contact the Radiation Safety Office (871-4332) C. Does the project involve gene therapy (administration of recombinant Yes No vectors) to human subjects for other than clinical purposes? If yes, contact the ORA office (871-8183) for further information. 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 Yes No DRUGS/DEVICES? 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

This 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 document

A. 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

12. CONFIDENTIALITY

A. What measures will be taken to ensure that only authorized individuals can access study data at your site? (locked drawers, computer passwords, etc)

Please refer to the “Confidentiality” section of the Informed Consent Template for who should have access to study data

13. PRIVACY PRACTICES (HIPAA)

A. Do you need to record identified subject information (e.g. from a medical record or Yes No admitting log), prior to a subject signing an IRB approved informed consent for this study? (e.g. for recruitment, pre-screening, studies with a waived informed consent)? (If YES, please complete the HIPAA form at the end of this document) Please check the comprehensive list of what is considered “identified” information at the end of this document. If what you want to record is on the list, please complete the HIPAA form. If you intend to use a “Limited Data Set” please complete the HIPAA form.

B. Your informed consent document must include HIPAA Authorization language (either as an addendum or incorporated into the body of the consent. If your sponsor has provided HIPAA Authorization language, please include that language in your consent. If you are not using a sponsor template, please be sure to include the HIPAA Authorization language starting on p.3 of our template.

14. RISK ASSESSMENT AND ASSENT FOR CHILDREN N/A

A. Check the category (1, 2, or 3) below which best represents the degree of risk and benefit to which the children in this study will be subject. Attach a copy of the assent form

1. No more than minimal risk. “Minimal risk” means the anticipated risks are no greater than those ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests.

2. Greater than minimal risk with the prospect of direct benefit to subjects. If you check this category, please answer questions 2a and 2b. *2a. Is the risk justified by the benefit? Yes No *2b. Is the benefit to risk ratio at least as favorable as that Yes No presented by alternative approaches? *Answers to 2a and 2b must be affirmative

3. Greater than minimal risk with no prospect of direct benefit to individuals, but likely to yield generalizable knowledge about the subject’s condition. If you check this category, please answer questions 3a, 3b, and 3c. *3a. Is the risk a minor increase over minimal risk? Yes No *3b. Does the procedure present experiences to subjects that are Yes No reasonable commensurate with those inherent in their actual or expected situations? *3c. Is the knowledge to be gained of vital importance for the Yes Yes understanding or amelioration of the condition? *Answers to 3a, 3b and 3c must be affirmative

B. Please indicate whether the children you plan to study generally are capable of providing assent, taking into account the ages, maturity, and psychological state of the children involved. Please specify why none, all, or some subjects are capable of providing assent. None are capable All are capable Some are capable

15. RESEARCH SUMMARY Please attach a description of this study following these recommendations.

Please include 3 copies of the grant or drug/device protocol and investigator’s brochure. Since these are usually too voluminous to be copied to all the individual members, please provide a concise summary of the Research Plan. This should be written in language that can be understood by people without medical training, yet should provide enough detail to allow evaluation of its scientific merit, of potential risks to human subjects and of significance of the knowledge to be gained as a result of this study. Please follow this format:

A. Introduction State the problem and hypothesis B. Background Previous work that has been done by others or yourself C. Specific Aims and Significance List of the purposes of the study D. Materials and Methods Identify all risks/benefits to human subjects Identify what is research and what is standard care Described patient population Describe how subjects will be identified, including who will obtain informed consent, if applicable Describe the follow-up, if applicable E. Analytical Methods Describe how the data will be analyzed

By signing this form, I acknowledge and accept responsibility for the following:  This study will be conducted according to the attached protocol/research plan  No changes shall be made to the research project without the prior approval of the MMC IRB  I have completed the required on-line training course  I am responsible for obtaining written informed consent from all human research subjects prior to initiating any study related procedure or activity  I am responsible for obtaining written authorization from all human research subjects prior to using or disclosing PHI  I am responsible for submitting all documentation requested by the MMC IRB, including (but not limited to): progress reports, continuation of treatment reports, serious and unexpected adverse events, changes in risk  I am aware that this project may be audited through the Research Compliance Education and Audit process.  I have read, understand and agree to my roles and responsibilities as defined by this institution (copies of your roles and responsibilities documents may be obtained from the IRB office) Principal Investigator Date

Co/Sub-Investigator(s) Date

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 MAINE MEDICAL CENTER SCIENTIFIC PEER REVIEW OF RESEARCH PROTOCOLS INVOLVING HUMAN SUBJECTS Page 8

Project Title: (Please provide full title. The title will be used for all return correspondence).

Abbreviated project title:

Principal Investigator: Tel #: Fax:

Please identify a member of the review team (NOT an investigator involved in the study) who will be responsible for discussing this protocol with members of the IRB if necessary.

Name: Tel #: Fax:

Scientific Peer Review process should include the following:

 A convened group of professionals composed of at least four persons with expertise in the area of research addressed in the proposal.  Multiple disciplines or other experts should be included, as appropriate.  To the extent possible, should not include individuals that would have a conflict of interest as a result of their involvement in the study.

The IRB must determine that risks to subjects are minimized by assuring that projects involve procedures that are consistent with sound research design and do not unnecessarily expose subjects to risk in relation to benefit. In reviewing this proposal, please consider the following items:

1. Do the scientific questions addressed in this protocol have adequate merit to justify Yes No experimentation involving human subjects? 2. Have the potential risk(s) of this study been accurately and fully described? Yes No 3. Is the study design adequate to answer the questions being asked? Yes No 4. Are the prior animal or in vitro studies adequate to support human risk? Yes No 5. Is there a method to investigate this scientific problem without the use of human subjects? Yes No 6. Does the principal investigator and co-investigator(s) have adequate resources and Yes No experience to conduct the study? 7. Does the project involve the use of a placebo control? Yes No If so, is its use justified on the basis of current accepted medical practice? Yes No If so, have these issues been addressed by the investigator? Yes No 8. Does the project impact on other aspects of medical care, safety of patients or staff other or Yes No hospital departments? 8a. What departments? 8b. Have these issued been addressed by the investigator? Yes No 8c. Have other departments been informed as to the nature of the research and it’s Yes No possible impact on their practice?

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Please provide or attach a brief summary of the discussion of the study design including issues that you think could be raised by the IRB.

Describe any financial inducements for patients or volunteers to participate (either direct pay, free or reduced changes for treatment). Please provide the dollar amount per patient / subject.

Vote: Number in favor: Number opposed: Number abstentions: Reason for abstentions: Action: Approved Disapproved: Deferred:

SIGNATURES: Members with a conflict of interest should indicate by placing “C” before their names. In signing this report, individuals attest they were present at this meeting and agree that this report accurately reflects the discussion.

Signature: Signature: Print Name: Print Name: Department: Department: Date: Date:

Division Director Signature: Date:

Department Chief Signature: I acknowledge that I have reviewed this project and examined all funding and budgetary aspects with respect to potential ethical conflicts or inappropriate inducements of either the principal investigator or research subjects. I also assure that, if this research is conducted at Maine Medical Center, it will be conducted according to Good Clinical Practices.

Department Chief Signature Date:

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 Page 10 In March 1999, MMC instituted a policy authorizing a one time fee for the processing of commercially-funded research protocols through MMC’s Institutional Review Board. A fee of $2,000 is charged for full IRB review and $500 is charged for Expedited approvals. Projects lacking external funding are exempt from this fee, as are federal, state, local and institutional grants. Fee assistance will be sparingly authorized by the Institutional Official. (revised 10.01.2008)

The Principal Investigator/Research Coordinator should notify the sponsor of this policy during the external budget negotiation process.

Please complete this form and return it with your IRB application. Please contact Linda Reinholdtsen at 885-8183 for questions regarding how to complete this form.

For Contract or Grant assistance, please contact Susan Libby at [email protected] or (207-885-8184)

Principal Investigator Tel:

Study Coordinator Tel:

Protocol Title:

Protocol Number:

Site Number:

Have you negotiated the cost of the IRB processing fee in your Yes No N/A external budget?

Sponsor

Do you want the sponsor billed directly? Yes No

Billing contact -Name (Be Specific) Address Tel:

Fee does not apply: Emergency approval Compassionate use study Extension study CALGB, COG, RTOG Study Grant (NIH, AHA, ACS, MRC, etc.) Unfunded Other: ______

For Office Use:

IRB #: Action: Full Board ($2,000) Expedited ($500)

Account No. Billing information: Fee for IRB processing of Dr. Protocol Entitled: [as given above]

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 MAINE MEDICAL CENTER INTERNAL SERVICES CHECKLIST

If this project will involve any Department at Maine Medical Center that will be necessary to support your research study, you must obtain review and sign off from each Department before your application is submitted to the IRB. A separate form should be used for each Department (copy this form as many times as necessary).

Allow at least 2 weeks for internal services reviews.

Full Project Title:

Principal Investigator: Phone # Fax: Pager: Email Clinical Research Coordinator: Phone # Fax: Pager: Email Funding Source / Sponsor:

Contact Person: Phone #: Fax #:

Project Period:

Department:

Name of Authorized Reviewer: Signature Date Department: (Please Print)

(Title of Authorized Reviewer) Comments:

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 Page 12 STUDY CLASSIFICATION AND WEBSITE INFORMATION

One of the ways that the MMC IRB keeps track of your study is by classifying it in the IRB database. Please help us do this by telling us what kind of study this is, and under what major group it should be classified.

1) Please choose your “type” of study: Compassionate Case Controlled Classification Dose Intensification Treatment Evaluation Genetic Genetic Counseling Humanitarian Use Device Open Label Treatment Outcomes Parallel Group Design Pharmacogenomics Phase I Phase II Phase III Phase IV Prevention Quality Improvement Tissue Collection Observational Pilot Study Quality of Life Registry Survey Record Review

2) Categorization of your project: This list includes the major classes of research we have in our database currently. If you do not feel that your research fits into one of these categories, please choose “Other” and write in your own category. Main Category Secondary Category Bone Osteoporosis Other Acute Lymphocytic Leuk. Astrocytoma Acute Myeloid Leuk. Bone Brain Breast Cancer Chronic Lymphocytic Leuk. Colon Endometiral Head & Neck Hodgkin’s Disease Lung Adult Pediatric Lymphoma Myelomonocytic Leukemia Muscle Neuroblastoma Other Ovarian Pancreas Prostate Skin Angina Angioplasty Arrhythmia Cardiology Atherosclerosis Heart Failure Hypertension Myocardial Infarction Other Sudden Cardiac Death Diabetes Growth Other Endocrine Thyroid Crohn’s Disease Other Polyps Gastrointestinal Ulcer Genetic Cystic Fibrosis Other Hematology (not Anemia Bleeding Other cancer) Thrombosis AIDS Bacterial Hepatitis Infection Other Viral Intensive Care Lipid/Cholesterol Hypercholesterolemia Hyperlipidemia Other Metabolic Dialysis Other Renal Failure Nephrology Transplantation (continued on the next page) Page 13 Neurology Other Stroke Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 Orthopedic Other (please list): Pain Psychiatric Depression Other Psychosis Respiratory Asthma Other Smoking Surgery Vascular

Information on all actively recruiting clinical trials is available on the Maine Medical Center website. This information may be accessed by anyone looking at the Maine Medical Center website (including physicians, and patients). If a patient accesses the information, no contact names or numbers are provided, the patient is instructed to print the information, and present it to their primary care physician. No contact information will be provided unless requested.

1) Would you like information on this clinical trial posted on the website? Yes No Please note: Observational, Pilot Study, Quality of Life, Registry, Survey and Record Reviews will not be available for access on the website, unless requested

2) Purpose & Criteria: Please try to summarize using “lay” terms, as patients will have access to this information. If you wish to include contact information, please write it into the “Criteria” section. If the protocol provides more information than will fit into these spaces, please summarize the important points of the purpose, objective and criteria, use additional pages as needed.

PURPOSE:

CRITERIA:

Please read and sign the following if you agree to have information posted on the website. INVESTIGATOR’S STATEMENT: By signing this form, I agree to accept responsibility for the content of the information posted on the MMC website, I will provide to the MMC IRB written notification of any changes that need to be made to the posted information, and I will notify the MMC IRB when recruitment has stopped so that the information may be removed from the website.

______Principal Investigator Date

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 Page 14 HIPAA – PRIVACY REQUIREMENTS

In order to comply with the federal regulations, the IRB/Privacy Board must determine what category of activity you are proposing. Please consider the following list carefully, and indicate (by checking yes) which activity you wish to conduct.

A. Are you requesting a Review Preparatory to Research approval for your screening or recruitment activities? YES NO A Review Preparatory to Research may be obtained if all of the following are true: 1) The information to be recorded will be obtained from Maine Medical Center 2) The person recording the identifiable information is a Maine Medical Center employee 3) The information will not be shared outside of Maine Medical Center 4) This review and recording of the information is strictly for this protocol/IRB application If all of the above are true, please initial here (principal investigator only) ______, and complete 1, 4, & 5 below

B. Are you requesting a Waiver of Authorization For Screening or Recruitment purposes? YES NO You need a Waiver of Authorization for Screening or Recruitment purposes if any of the following are true: 1) The information to be recorded for screening/recruitment will be obtained from MMC, and the person recording it is not a MMC employee 2) The sponsor is requesting screening logs which contain any one of the items on the list of identified information (last page of this document) 3) The information to be recorded for screening/recruitment is from another institution/office, the person recording the information is not an employee of that institution/office, AND the other institution/office is willing to accept a MMC IRB/Privacy Board waiver 4) The information to be recorded and shared outside of MMC is part of a limited data set. (see the last page of this document for a list of what is allowed). If any of the above are true, please complete 1-6, below

C. Are you requesting a Waiver of Informed Consent? YES NO If you are requesting for a waiver of informed consent, you will also need to request a waiver of authorization Please complete 1-6, below.

------1. Describe the data necessary for this request:

2. Describe the plan to protect the data from improper use and disclosure:

3. Describe the plan to destroy the identifiers at the earliest opportunity, unless there is a health or research justification for retaining the identifiers:

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4. Is this data being collected for disclosure (release) outside Maine Medical Center? YES NO

a) If yes, explain to whom:

b) Regulations require the ability to track names of patients when PHI is disclosed without consent. Please also provide tracking process description:

5. Please provide a statement including why the research could not practicably be conducted without the waiver of authorization or review preparatory to research approval and without access to this data:

PI initials ______provides written assurance that the PHI will not be reused or disclosed to any other entity, except as required by law.

6. Data Use Agreement : Limited Data Set or Use of Protection Health Information (PHI):

By signing below the researcher(s) agree: a. to the use of the data or PHI to the specified purpose as described above b. to limit who can use or receive the data to the research team directly involved in this project c. not to re-identify the data or contact the individuals to whom the data belongs

[ ] Yes, I agree to the above.

Principal Investigator Signature: ______Date: ______

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008 “ IDENTIFIABLE” INFORMATION (FROM THE HIPAA REGULATIONS

• Names • Geographic subdivisions smaller than a state • Zip codes • Dates (birth, admission, discharge, death) • Age, if over 89 • Telephone numbers • Fax numbers • E-mail addresses • Social security numbers • Medical record numbers • Health plan beneficiary numbers • Account numbers • Certificate and license numbers • Vehicle identification and serial numbers • License plate numbers • Device identifiers and serial numbers • URLs • Internet Protocol address numbers • Biometric identifiers (finger and voice prints) • Full face photos and comparable images • Any other unique identifiers • LIMITED DATA SET The limited data set permits the retention of some identifying items not found in the "de-identified" list.

Not Allowed Allowed Names Admission Dates Street Addresses Discharge Dates Telephone and Fax Numbers Service Dates e-Mail Addresses Death Date Certificate or License Numbers Age (including 90 or over) Vehicle ID and Serial Numbers Social Security Number URLs and IP Addresses Five Digit Zip Codes Full Face Photos and Comparable Images

Sanctioned by the IRB on 08/27/02 Revised 10/01/2008