Application for Community Health System IRB Review

IRB APPLICATION – Full Board Review

Investigators submitting an Application for IRB Review will be contacted via e-mail when the study application is received. Investigators who do not receive a notice within 72 hours should call the IRB Office at (559)499-6553 to ensure that the study was received.

The Full Board meets monthly, on the first Thursday of each month at 7:30 a.m. in the UCSF Fresno Center for Medical Education and Research, Room 111. The address is 155 N. Fresno Street, Fresno, CA 93701. Studies requiring Full Board review are assigned to the Board agenda only when all completed study documents are received. Please refer to Page 2 of this application packet to determine which documents are required.

All appropriate completed documents must be received in the IRB office no later than the 10 th of the month prior to the Full Board meeting. Investigators will be notified of a date and time when the study is assigned to the Board’s agenda. For greater-than-minimal-risk studies, Principal Investigators are required to present the study to the Full Board in person.

If you have any questions, please do not hesitate to contact the IRB Staff at the contacts listed below.

[email protected] Community Medical Centers Institutional Review Board (IRB) UCSF Fresno Bldg. 155 N. Fresno St., Suite 290 Fresno, CA 93701 559-499-6553 Office 559-499-6633 FAX

Version date 01Sep2016 Page 2 of 26

Page Application form 3-7 Requirements for Training in the Protection of Human Subjects 7 Area Director Agreement Form1 8 Consent Form Checklist 9-13 California Experimental Subjects Bill of Rights 14 Patient Authorization for Use & Disclosure of 15-16 Protected Health Information Request for Waiver of Subject Authorization2 17-18 Financial Disclosure/Conflict of Interest Form 19-20 for Principal Investigator3 Financial Disclosure/Conflict of Interest form 21-22 for Sub-Investigator/Study Staff3 Surrogate Self-Certification form4 23-24 Consent of the Subject to Continue to be in the Study4 25 New Study Registration Mnemonic Request form5 26

1Use if hospital resources/staff are required for the project 2Use if requesting a waiver of consent 3Use only if project is funded by other than departmental funding 4Required for projects for which patient/subject will be unable to provide consent for themselves at the time of enrollment (excludes pediatrics) 5Use if project requires hospital resources which should not be charged to patient or patient’s insurance

Application For Community Medical Centers Institutional Review Board Review

Protocol Number or Sponsor Identifier:

Study Title:

Study Sponsor:

C. TYPE OF FUNDING: Pharmaceutical Co. Foundation: Specify _____ State or Federal Government Not Funded Private CCFMG Internal Department Funding Other

State entity/institution which will receive study funds:

Type of Study (Check all that apply) [ ] FDA Approved Drug(s) [ ] Medical Records Review: [ ] Non-FDA Approved Drug(s) ____Retrospective [ ] FDA Approved Device ____Prospective [ ] Non-FDA Approved Device [ ] Computerized Database Review [ ] Biological Sample(s) [ ] Questionnaire ____DNA ____Blood [ ] Other ______Tissue (describe) List all sub-studies in which your site will participate:

Phase: [ ] Pilot [ ] I [ ] II [ ] III [ ] IV [ ] Expanded Access N/A [ ]

Subjects: Indicate whether the project will involve: Yes No Yes No Subjects Under the Age of 18: [ ] [ ] Biohazardous Agents: [ ] [ ] Pregnant Women: [ ] [ ] Recombinant DNA Molecules: [ ] [ ] Minority Subjects: [ ] [ ] Advertising for Subject Recruitment [ ] [ ] Surrogate Consent [ ] [ ] Radioisotopes: [ ] [ ]

Expected # of CMC Patients: [ ] Expected # of Total Patients at ALL enrolling sites: [ ]

Facility(ies) where study will be conducted: Community Regional Medical Center Community Living Center – Fresno Clovis Community Medical Center Community Subacute & Transitional Care Center Fresno Heart & Surgical Hospital California Cancer Center Community Behavioral Health Center

University Surgical Associates University Orthopedics Associates 7415 N. Cedar Ave., Suite 102 2210 E. Illinois Ave., Suite 401 University Cardiology Associates University Dermatology Associates 2210 E. Illinois St., Suite 508 2335 E. Kashian Lane, Suite 410 University Central Medical Specialty Center University Gastroenterology & Hepatology 2828 Fresno St., Suite 203 Associates 7015 N. Chestnut Ave., Suite 101 University Oncology Associates University Neurology Associates 2335 E. Kashian Lane, Suite 301 2335 E. Kashian Lane, Suite 301 University Neurosurgery Associates University Women’s Specialty Center 2335 E. Kashian Lane, Suite 301 2210 E. Illinois Ave., Suite 301 Fresno Plastic Surgery University Psychiatry Associates 1855 E. Alluvial Ave., Suite 101 2027 Divisadero St. University North Medical Specialty Center University Rheumatology Associates 6311 N. Fresno St., Suite 106 2335 E. Kashian Lane, Suite 301 Valley Vascular Surgery Associates 1247 E. Alluvial Ave., Suite 101

Are you requesting a waiver of consent? Yes [ ] No [ ] Are you requesting a waiver of documentation of signed consent? Yes [ ] No [ ]

Are you requesting a waiver of patient authorization for use and disclosure of protected health information? Yes [ ] No [ ]

If the recruitment plan includes a retrospective review of a database or medical records to search for prospective subjects, then a waiver of consent and patient authorization preparatory to research must be requested. Are you requesting a waiver of patient authorization for the use and disclosure of protected health information preparatory to research? Yes [ ] No [ ] If yes, describe why the waiver is necessary:

Describe ALL methods by which subjects will be recruited. Discuss whether any study advertisements are planned, or whether letters to referring physicians, sources will be used. Submit copies of this documentation.

If requesting inclusion of non-English speakers in the study, describe the plan to provide information to the subjects in a language understandable to them:

The FDA now requires prospective randomized clinical trials to be registered at www.clinicaltrials.gov

Which Trials Must be Registered? The trials that must be registered are called “applicable clinical trials.” These trials generally include: (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance. Please review the statutory definition of applicable clinical trial to identify if any of your trials

must be registered to comply with the law [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=110_cong_public_laws&docid=f:publ085.110.pdf] See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)). NIH encourages registration of ALL trials whether required under the law or not.

Many journals, including annals, are taking a more general approach to this and requiring registration of "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." You are strongly urged to register the study if it falls into one of the above categories. How to create a user account with www.clinicaltrials.gov UCSF Investigators must request a USER account from [email protected] with the subject line: REQUEST for CT.gov User Account. Include all of your contact information (using your UCSF email address) in the body of the email, and someone will contact you to provide the information that you need.

CMC Investigators should contact the IRB office for instruction on registration.

Has the study been registered at Yes [ ] No [ ] N/A [ ] www.clinicaltrials.gov? ClinicalTrials.gov Registration Number:

Data and Safety Monitoring Plan (DSMP): All interventional studies involving more than minimal risk must include a DSMP. A DSMP is a plan established to verify that each research study has a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data. The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC), or a Safety Monitor. Note: Most, but not all studies (i.e., non-interventional studies) undergoing full board review will require a DSMP. The Investigator is responsible for ensuring that there is an appropriate DSMP in place at the time of initial IRB approval and for ensuring that the safety-monitoring plan is implemented over the life of the protocol. Please describe the Data and Safety Monitoring Plan:

Will the investigator, sub-investigators, study staff or institution be Yes [ ] No [ ] financially reimbursed for subjects enrolled or data submitted? If yes, please submit a Research Financial Disclosure form for all investigators and study staff. If yes, state the amount of reimbursement per subject: To whom will the reimbursement be paid?

Will subjects be paid? Yes [ ] No [ ] If yes, state the amount:

Please describe method by which subjects will be paid and at what intervals (e.g. cash, gift card, debit card; check will be paid after each

study visit, at completion of study, etc.):

Will the study require assistance/participation by CMC hospital employees/staff? Yes [ ] No [ ] Examples include: Requests for data from Health Information Management, Non-Standard of Care blood draws by hospital Laboratory staff, Imaging studies required as part of the research, Preparation/Dispensing of drugs/medications by Pharmacy, Involvement of Nursing staff, Pulmonary function testing by Respiratory Care, etc. If yes, state area(s) and what the role of the hospital staff will be:

A copy of the Area Director Agreement to Participate in Research must be completed by the administrative Director (not Medical Director) of each hospital area which will be required for the conduct of the study. This form must be submitted with this application Area Director Agreement Form(s) attached? Yes [ ] Not Applicable [ ]

Research-required procedures/tests, etc. which will be performed by INVESTIGATORS/ STUDY STAFF:

Research-required procedures/tests, etc. which will be performed by HOSPITAL Staff: Procedure Name Charge Code (Required)

Has this study been reviewed by another IRB and been disapproved? Yes No If yes, a copy of the written statement from the previous IRB should be included with this study documentation.

Principal Investigator (PI) Note: For studies conducted by UCSF faculty, students, and staff, the Principal Investigator must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. Postdoctoral fellows may serve as PI in limited circumstances. PI name PI email address Sub-Investigator(s) IMPORTANT:  All investigators outside the CMC and UCSF Fresno institutions must have a CMC physician or staff member listed as a co-investigator

Please list all staff (e.g., data Study Staff Member Role of Study Staff Member managers, study coordinators, volunteers) who will be assisting with the study and state their role in the study.

NOTE: All persons listed above must complete mandatory training in the protection of human subjects in research. UCSF physicians & research staff: www.citiprogram.org For FAQs, please refer to: http://www.research.ucsf.edu/chr/Train/CITI_FAQ.asp Non-UCSF physicians, investigators, research staff: http://phrp.nihtraining.com/users/login.php or http://ethics.jaeb.org

P.I. Status Form NOTE: UCSF Fresno investigators who are not paid more than 50% by UCSF must complete a P.I. Status Form per UCSF requirements. The form is found at: http://www.research.ucsf.edu/cg/forms/pistatus.doc and should be forwarded to the UCSF Fresno Dean’s Office. For questions, or assistance with this form, please contact the UCSF Fresno Contracts and Grants Office at 559-499-6414.

If you have questions, do not hesitate to contact the IRB Office at the contact listed below. Office Address: Community Medical Centers Institutional Review Board (IRB) UCSF Fresno Bldg. 155 N. Fresno St., Suite 290, Fresno, CA 93701 559-499-6553 Office; 559-499-6633 FAX

BY SIGNING THIS FORM I AM AGREEING TO ABIDE BY ALL APPLICABLE FEDERAL, STATE AND LOCAL REGULATIONS, INCLUDING, BUT NOT LIMITED TO, HIPAA, OHRP, FDA, UCSF AND CMC REGULATIONS, LAWS, POLICIES, PROCEDURES AND GOOD CLINICAL PRACTICE. IN ADDITION, I ACCEPT RESPONSIBILITY FOR OVERSIGHT OF ALL STUDY STAFF AND SUB-INVESTIGATORS AND WILL CONDUCT THE STUDY AS OUTLINED IN THE STUDY PROPOSAL.

______Signature of Principal Investigator Date

Area Director Agreement to Participate in Research

Research studies often require the participation of one or more hospital departments or service areas. In order to ensure that areas have sufficient staff and resources to support research activities, all investigators will obtain the agreement from each area Director to participate.

A copy of this form must be completed by the Director of each area which will be necessary for the conduct of the study. Required areas include, but are not limited to Medical Records, Laboratory, Pharmacy, Radiology, Inpatient/outpatient nursing units, Nutrition Services, Pathology Registration & Billing services and others.

A copy of the study protocol, along with an explanation of services needed (see below) shall be submitted to each Director for review, along with specific study requirements for their area. Directors are requested to complete the review in a timely fashion and return the signed form to the Investigator/Study Coordinator. The form must then be submitted to the IRB Office as part of the application. IRB applications will not be considered complete until the signed form(s) is/are received.

Study Title:

Principal Investigator Study Coordinator Contact Information

Hospital/Practice Site/Facility Area(s) Required for Conduct of the Study:

Name of Director/Contact Person Contact Information

Information/services being requested of Director (please be very specific):

I have reviewed the study protocol and study requirements for the participation of my department in the research study.

I agree to the participation of my staff and department in the research study.

I do not agree to the participation of my staff and department in the research study.

I have the following concerns regarding the research:

Signature of Director: Date:

CONSENT FORM CHECKLIST

The following items are mandatory for all consent forms, unless otherwise stated. Those forms lacking any items will be returned to the investigator for corrections. Studies will not be considered for review by the IRB until all items are addressed.  The consent form must be written in SIMPLE, LAY LANGUAGE, AT AN 8TH GRADE READING LEVEL.  Per California state law all information given to subjects must be in 12 point font or higher. Purpose of the study Full explanation of procedures to be followed Description of how many people will take part in the study Description of how long subject will be in the study Description of benefits to be expected Description of potential risks/discomforts Description of alternative services Assurance of subject’s right to refuse to participate, without loss of benefits to which the subject is otherwise entitled Assurance of subject’s right to stop study, without loss of benefits to which the subject is otherwise entitled Addresses the patient’s right to privacy Confidentiality statement (must include the Community Medical Centers IRB’s right to inspect documents) Industry-Sponsored Studies: If the study is industry-sponsored and data may be reviewed by the sponsor, it’s authorized agents, the Food and Drug Administration, the National Institutes of Health, or the Office for Human Research Protection, they must be explicitly named in the consent form's discussion of confidentiality. Will my medical information be kept private? We will do our best to make sure that the personal information in your medical record is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

 [List relevant organizations, e.g. study sponsor]

 The University of California

 The National Cancer Institute (NCI) and other government agencies, e.g., the Food and Drug Administration (FDA), involved in keeping research safe for people. [Note: The FDA must be named here in all studies using drugs, devices, or biologics regulated by the FDA]. Statement that research is voluntary Statement as to whether the subject will be financially compensated for enrollment to the study. Statement as to whether the investigator and/or institution will be financially compensated for each subject enrolled to the study. A statement of the amount of compensation is not required.

Disclosure statement of any financial or non-financial conflict of interest on the part of the investigator or sub-investigators. Statement of whom to call if subject has questions – “For information about your disease and research-related injury, or about this study you may contact (Investigator Name) at (Phone #). For information about your rights as a research subject, you may contact the Chair of Community Medical Centers Institutional Review Board at (559)499-6553.” Also, the following statement must be included verbatim: “ClinicalTrials.gov is a website that provides information about clinical trials. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” Risks of randomization: You will be assigned to a treatment program by chance, and the treatment you receive may prove to be less effective or to have more side effects than the other study treatment(s) or other available treatments. Risks of blood drawing: Drawing blood may cause temporary discomfort from the needle stick, bruising, and infection. Risk of placebo: If you are in the group that receives placebo, your condition will go without the active (study) treatment for [XX weeks].  Radiation risks: [Include one of the three paragraphs below if your study involves radiation. The paragraph you include will depend on the total effective dose from all treatments used, regardless of whether they are standard of care or experimental. Studies in which patients will receive different total effective doses should either use the maximum possible dose that a patient could receive or use multiple consent forms. IN NO INSTANCE SHOULD A PATIENT RECEIVE MORE RADIATION THAN THE MAXIMUM STATED ON THE CONSENT FORM.]

Total Effective Dose of <3 mSv This research study involves exposure to radiation from [type of procedure]. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation that you will receive as a result of participating in this study will be less than the yearly natural background radiation in the US (3 mSv). The use of radiation involves minimal risk and is required to obtain the desired research information. If you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study.

Effective Dose of 3 to 50 mSv This research study involves exposure to radiation from [type of procedure]. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation that you will receive as a result of participating in this study will be a maximum of approximately [insert amount] mSv, which is equivalent to [insert amount] the yearly natural background of radiation in the US (3 mSv). The use of radiation may involve a low risk of cancer and is required to obtain the desired research information. If you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study.

Effective Dose of >50 mSv

This research study involves exposure to radiation as part of the protocol. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation that you will receive as a result of participating in this study will be a maximum of approximately [insert amount] mSv, which is equivalent to [insert amount] the yearly natural background of radiation in the US (3 mSv). The use of radiation in this research study involves a low risk of cancer. However, the UCSF Radiation Safety Committee has reviewed the use of radiation in this research study and has designated this use as acceptable to obtain the benefits provided by the results of the study. If you are pregnant or breast feeding, you SHOULD NOT participate in this study. If you have any questions regarding the use of radiation or the risks involved, please consult the physician conducting the study.

Risk of CT scan: CT scans involve the risks of radiation (see above). In addition, if contrast material (iodine dye) is used, there is a slight risk of developing an allergic reaction, from mild (itching, rash) to severe (difficulty breathing, shock, or rarely, death). The contrast material may also cause kidney problems, especially if you are dehydrated or have poor kidney function. The study doctors will ask you about any allergies or related conditions before the procedure. If you have any of these problems, you may not be allowed to have a CT scan [/continue in the study].

Having a CT scan may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia when placed inside the CT scanner, or by lying in one position for a long time. If contrast material is used, you may feel discomfort when it is injected [/given by XXX]. You may feel warm and flushed and get a metallic taste in your mouth. Rarely, the contrast material may cause nausea, vomiting or a headache. [List other risks as appropriate to the method by which contrast agent is administered]. [If sedation may be used, discuss risks of sedation here]. Risks of MRI: Because the MRI machine acts like a large magnet, it could move iron-containing objects in the MRI room during your examination, which could in the process possibly harm you. Precautions have been taken to prevent such an event from happening; loose metal objects, like pocket knives or key chains, are not allowed in the MRI room. If you have a piece of metal in your body, such as a fragment in your eye, aneurysm clips, ear implants, spinal nerve stimulators, or a pacemaker, you will not be allowed into the MRI room and cannot have an MRI.

Having an MRI may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia and by the loud banging noise during the study. Temporary hearing loss has been reported from this loud noise. This is why you will be asked to wear ear plugs. At times during the test, you may be asked to not swallow for a while, which can be uncomfortable.

[If appropriate, also discuss the risks of contrast agents and/or sedation here].

Because the risks to a fetus from MRI are unknown, pregnant women cannot participate in this study. Reproductive risks: You should not become pregnant or father a baby while on this study because the drug(s) in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important to understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. [Include a statement about possible sterility when appropriate. For example, "Some of the drugs used in the study may make you unable to have children in the future." If appropriate, include a statement in the section on procedures that

Version date 01Sep2016 Page 12 of 26 pregnancy testing will be required.] HIV testing risks: Being tested for HIV may cause anxiety regardless of the test results. A positive test indicates that you have been infected with the HIV virus, but no one knows for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about your positive test results, you may have trouble obtaining insurance or employment. If your test is negative, there is still the possibility that you could be infected with the HIV virus and test positive at some time in the future. Also, it is always possible that the test results could be wrong. Statement of Research Related Injury  For CMC Studies: “In the event of a research related injury, medical care will be available. However the cost of care will by charged to you or your insurance company. By signing this consent form, you will not be waiving any of the legal rights to which you would otherwise be entitled. You may also contact the Community Medical Centers IRB office at (559) 499-6553 for further information.”  For studies conducted by UCSF Fresno Physicians/Staff: The following statement must be used in its entirety, and may not be modified “Treatment and Compensation for Injury: If you are injured as a result of being in this study, the University of California will provide necessary medical treatment. The costs of the treatment may be billed to you or your insurer just like any other medical costs, or covered by the University of California or the study sponsor [sponsor name], depending on a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Community Medical Centers IRB office at (559) 499-6553.” A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject Subject printed name, CMC Medical Record number, date/time signature lines Investigator printed name, date/time signature lines Witness printed name, date/time signature lines Person obtaining informed consent printed name, date/time signature lines Footer with “subject’s initials_____” Page numbers in header or footer

CMC’s Interpreter Statement:

In the event that an interpreter is needed:

I have accurately and completely read the foregoing document to: (patient or legal representative's name) in the patient’s (or legal representatives) primary language. (identify language used)

He/She understands all terminology/conditions, acknowledges his/her agreement by signing the document in my presence.

______Signature of Interpreter Date/Time

______Printed name of Interpreter

California Experimental Subject’s Bill of Rights (attached) for research studies involving “medical experimentation”. NOTE: This document must be discussed and signed by the subject PRIOR TO discussion of the consent. If a Non-English Bill of Rights is needed, please contact the IRB Office at 559-499-6553. Financial Responsibility Statement which discusses costs related to the subject’s participation in the study. i.e. “Participation in this study may lead to additional costs”. Then describe those study- related costs and whether the subject or third party will be billed for the costs. Please also list whether any drugs/devices/ tests will be provided free of charge. The following statement is recommended: “You or your third party payors must provide payment for the study drugs, (list study drugs) (OR “The following study drugs/devices/tests will be provided to you by _____ at no charge) and other payments for hospital, clinical and other medical costs related to this study”. Note: List the individual drugs/devices/tests using bullet point format. “Before you take part in this study, you should call your health insurer to find out if the cost of these tests and/or procedures will be paid for by the plan. Some health insurers will not pay for these costs. You will have to pay for any costs not covered by your health insurer.” For Studies involving investigational drugs, and other standard treatments, as appropriate: “Many side effects go away shortly after the drugs are stopped, but in some cases, side effects may be serious, long lasting, life threatening or result in death.” HIPAA - It is the policy of Community Medical Centers to obtain patient authorization, a Waiver of Authorization, or a Researcher Attestation prior to using or disclosing Protected Health Information (“PHI”) for Research purposes. If you will be collecting protected health information, please use the appropriate form in 14-point font, found in this application packet.

CALIFORNIA EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

California law requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to:

1. Be informed of the nature and purpose of the experiment. 2. Be given an explanation of the procedure to be followed in the medical experiment and any drug or device to be utilized. 3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment. 4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable. 5. Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits. 6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise. 7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved. 8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice. 9. Be given a copy of the signed and dated written consent form. 10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.

For questions about patient rights, contact the Chairman of the Institutional Review Board at Community Medical Centers at (559) 499-6553.

I have carefully read the information contained above and I understand fully my rights as a potential subject in a medical experiment involving people as subjects.

Signature (Subject) Printed Name Date Time

Signature (Legally Authorized Representative) Printed Name Date Time

If signed by other than patient, indicate relationship

______Witness Signature Printed Name Date Time

Studies which will gather protected health information from subjects must include an Authorization for Use of Protected Health Information for Research Purposes (the HIPAA form).

Please fill in the italicized information as appropriate to the study, and attach to the consent form:

USE AND DISCLOSURE OF YOUR PROTECTED HEALTH INFORMATION

Protected Health Information is any personal health information through which you can be identified. A decision to participate in this research means that you agree to the use of your health information for the purposes explained in this consent form. By signing this form, you are authorizing the use and disclosure of your health information collected in connection with your participation in this research study. Your information will only be used in accordance with the provisions of this consent form and applicable law.

Your health information related to this study, including, [List any and all medical information collected from or about the subject in connection with this study, for example: blood and other tissue samples and related records, physical examinations, histories, x-rays, MRIs, etc. {If records from outside the time span of the study are pulled into the study, indicate span of time from which the records are pulled.}] may be used or disclosed in connection with this research study. Study records that identify you will be kept confidential as required by law. Except when required by law, you will not be identified by name, SS#, address, phone#, or any other direct personal identifier in study records disclosed outside of the Community Medical Centers (CMC). For records disclosed outside of CMC, you will be assigned a unique code number. The key to the code will be kept in a locked file in the office of the Principal Investigator, Dr. ______.

Representatives of the following groups are authorized to use and/or disclose your health information in connection with this research study: The principal investigator, ____(name)__ The Community Medical Centers Institutional Review Board [Please list every other class of persons or organization affiliated with CMC {for example: the research team, the study coordinators, etc.} who might need to use and/or disclose the subject’s information in connection with this study.]

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study: The Office of Human Research Protections Department Of Health and Human Services [Please list every other class of persons or organization not affiliated with CMC {for example: collaborators at other institutions, outside data analysts, the Data Safety Monitoring Board, the NIH, the FDA, etc.} to whom the subject’s information might be disclosed.]

Use the following if appropriate to the study:  Representatives from regulatory agencies in other countries may join in the review of your research records, including research related medical reports and information, in conjunction

with the above sponsor and/or the FDA.

 Your information may be re-disclosed if the recipients described above are not required by law to protect the privacy of the information.

EXPIRATION DATE OR EVENT FOR THE RETENTION OF RECORDS

The study results will be retained in your research record (for at least six years or until after the study is completed, whichever is longer) (or for the period of 25 years) – CHOOSE ONE. At that time either the research information not already in your medical record will be destroyed or information identifying you will be removed from such study results at Community Medical Centers. Any research information in your medical record will be kept indefinitely.

VOLUNTARY PARTICIPATION

Your participation is voluntary and you may choose not to participate in this research study or withdraw your consent or authorization for the use and disclosure of your health information at any time. Your choice will not at any time affect the commitment of your health care providers to administer care and there will be no penalty or loss of benefits to which you are otherwise entitled. If you decide to end your participation in the study, please notify the researcher(s) in writing.

If you have questions or concerns regarding your privacy and the use of your personal health information, please contact the Privacy Officer, at 559-459-2742.

Signature (patient) Printed Name Date Time

Signature (parent/legal guardian/conservator) Printed Name Date Time

If signed by other than patient, indicate relationship

Witness Signature Printed Name Date Time

REQUEST FOR IRB WAIVER OF PATIENT AUTHORIZATION

Research Project Title:

Principal Investigator:

1. The use or disclosure of Protected Health Information (PHI) involves no more than a minimal risk to the privacy of individuals. Explain why. Include a detailed list of the PHI to be collected and a list of the source(s) of the PHI.

2. Describe the plan to protect identifiers and indicate where PHI will be stored and who will have access (researchers must list all of the entities that might have access to the study’s PHI such as IRB, CMC representatives, sponsors, FDA, data safety monitoring boards and any others given authority by law).

3. All identifiers collected during the study will be destroyed at the earliest opportunity consistent with the conduct of research, which is: (explain below).

4. Please describe the procedure used to destroy all the data collected during the study (electronically, paper, audio/video, photography, other). OR

5. Alternatively, the identifiers collected during the study will not be destroyed because: (explain below).

6. Reasons the research could not practicably be conducted without the waiver.

 * PHI: individually identifiable health information transmitted or maintained in any form (electronic, on paper, or through oral communication) that relates to the past, present or future physical or mental health or conditions of an individual.

7. The research could not practicably be conducted without access to and use of the protected health information because (explain below).

8. The HIPAA regulation requires reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure or request. Please note that researchers are also accountable for any PHI released under a waiver. Explain why PHI obtained for this study is/are the minimum information needed to meet the research objectives.

The information listed in the waiver application is accurate and all research staff will comply with the HIPAA regulations and the waiver criteria. All research staff will complete CMC’s privacy competency training prior to study initiation.

I assure that the information I, or my study staff, obtain as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those listed on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entity I will seek approval by the IRB.

Principal Investigator’s Signature Date

DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS (TO BE COMPLETED BY PRINCIPAL INVESTIGATOR)

Name: Title:

Dept/Organization:

Study Title:

Study Sponsor(s):

I am participating as the Principal Investigator in the above named clinical trial.

Indicate by marking Yes or No if any of the financial interests listed below apply to you, your spouse or dependent children. If yes, please describe the conflict, along with a description of steps taken to minimize the potential bias of clinical study results by any of the disclosed arrangements or interests.

Y [ ] N [ ] 1. Any financial arrangement entered into between the sponsor of the covered study and the clinical investigator involved in the conduct of the covered study, whereby the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study. If yes, please describe:

Y [ ] N [ ] 2. Any payments made by the sponsor of the covered study, to investigators, such as funds to conduct the study, grants to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria

If yes, please describe the type of payments, to whom the funds will be paid, and the amount:

If yes, please attach study budget

Y [ ] N [ ] 3. Any payments made by the sponsor of the covered study, to departments or institutions, such as funds to conduct the study, grants to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria

If yes, please describe the type of payments, to whom the funds will be paid, and state amount:

Y [ ] N [ ] 4. Will you, your department or institution accept recruitment bonuses or incentives for this trial? If yes, please describe:

. Y [ ] N [ ] 5. Any proprietary interest in the product tested in the covered study held by the investigator/study staff. If yes, please describe:

Y [ ] N [ ] 6. Any significant equity interest as defined in 21 CFR 54.2(b)*, held by the investigator/ study staff in the sponsor of the covered study. If yes, please describe:

Y [ ] N [ ] 7. Any significant equity interest in investigator’s study-related business. If yes, please describe:

Y [ ] N [ ] 8. Any non-financial conflict of interest. If yes, please describe:

In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information provided on this form is, to the best of my knowledge and belief, true, correct, and complete. Furthermore, if my financial interests and arrangements, or those of my spouse and dependent children, change from the information provided above during the course of the study or within one year after the last patient has completed the study as specified in the protocol, I will notify the Institutional Review Board promptly.

Signature of Principal Investigator Date

DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS (To be completed by each sub-investigator and study staff member)

Name: Title:

Dept/Organization:

Study Title:

Study Sponsor(s):

I am participating as: sub-investigator [ ]study staff [ ] in the above named clinical trial.

Indicate by marking Yes or No if any of the financial interests listed below apply to you, your spouse or dependent children. If yes, please describe the conflict, along with a description of steps taken to minimize the potential bias of clinical study results by any of the disclosed arrangements or interests.

Y [ ] N [ ] Any financial arrangement entered into between the sponsor of the covered study and the clinical investigator involved in the conduct of the covered study, whereby the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study. If yes, please describe:

Y [ ] N [ ] Any significant payments of other sorts made from the sponsor of the covered study such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria If yes, please describe:

Y [ ] N [ ] Will you, your department or institution accept recruitment bonuses or incentives for this trial? If yes, please describe:

Y [ ] N [ ] Any proprietary interest in the product tested in the covered study held by the investigator/study staff. If yes, please describe:

Y [ ] N [ ] Any significant equity interest as defined in 21 CFR 54.2(b), held by the investigator/ study staff in the sponsor of the covered study. If yes, please describe:

Y [ ] N [ ] Any significant equity interest in investigator’s or employer’s business If yes, please describe:

Y [ ] N [ ] Any non-financial conflict of interest If yes, please describe:

In accordance with 21 CFR Parts 54.1 to 54.6, 1 declare that the information provided on this form is, to the best of my knowledge and belief, true, correct, and complete. Furthermore, if my financial interests and arrangements, or those of my spouse and dependent children, change from the information provided above during the course of the study or within one year after the last patient has completed the study as specified in the protocol, I will notify the Institutional Review Board promptly.

Signature of Sub-Investigator/Study Staff member Date

Signature of Principal Investigator Date

SURROGATE SELF-CERTIFICATION FORM

Self-Certification of Surrogate Decision Makers for Potential Subject’s Participation in Research

Section 1: I am willing to serve as a surrogate decision maker for: ______(Potential Subject)

to participate in ______(Title of research project)

research conducted by: ______(Principal Investigator)

Section 2: Check the category that best describes For the categories listed your relationship above yours, provide the to the potential name(s) of others who are subject: best described in those categories: Category of Potential Surrogate: 1. An agent under an advance health care directive. [ ] 2. Conservator or guardian of the person having authority to make health care decisions. [ ] 3. Spouse of the potential subject [ ] 4. A registered domestic partner. [ ] 5. Adult son or daughter of the potential subject [ ] 6. Custodial parent of the potential subject [ ] 7. Adult brother or sister of the potential subject [ ] 8. Adult grandchild of the potential subject [ ] 9. An available adult relative with the closest degree of kinship. [ ]

Section 3: The following section information must be completed only for surrogate consent to participate in research in non-emergency settings: (Check the statement which best describes the basis of your knowledge of the potential subject) ______I live with the potential subject and have done so for ______years. ______I have discussed participation in research with the potential subject and believe that I can carry out his/her preferences. ______Other (please describe): ______

Section 4: Potential Surrogate’s Contact Information: Name: ______Phone: ( )______Address: ______

______Signature of Potential Surrogate Printed Name Date Time

______Signature of Witness Printed Name Date Time

CONSENT OF THE SUBJECT TO CONTINUE TO BE IN THE STUDY

Continuing Consent

Your legal representative gave his/her consent for you to be in this research study. This is because you were not able to make your own decision due to your illness. Your condition has now improved. You are being asked to decide whether to continue to be in this study. Your decision is voluntary. This means the decision is up to you. You have read the information in this form or someone has explained to you what study procedures will be continuing. Your questions have been answered to your liking. You believe you understand all of the information about this study. Please check appropriate lines

To continue in this study.

______I agree _____I do not agree

______Signature of Subject Date Time

Printed name of Subject

______Signature of Person Obtaining Consent Date Time

______Printed Name/Title of Person Obtaining Consent

PLEASE REVIEW THE INSTRUCTIONS ON WHOM TO SEND THE REQUEST TO LISTED AT THE BOTTOM OF THIS FORM. For any questions, please contact the IRB Office at [email protected] or 559-499-6553 Study Registration Mnemonic Request form

Full name of Research Project: Mnemonic Requested: (please choose a mnemonic between 4-8 characters, beginning with the letter “R” which you would like to have assigned to your project – Choose something that will readily identify your study, for example “RSNAKBTE” for a study which would involve rattlesnake bites)

Physician overseeing project:

Study Coordinator name(s): Contact phone # & e-mail for each:

Research-required procedures/CPT codes Charge Codes for each procedure listed at left: which are not to be charged to the patient (i.e. arterial blood gas – 90630906…) or insurer, and which will be performed If unsure, please contact your study manager, or by CMC. Please list all specific hospital staff contact person procedures, including screening  procedures, using a bulleted format: 

Hospital department(s) involved in study: Facility(ies) where testing may done: (i.e., lab, radiology, pathology, etc.) [ ] CRMC [ ] SIERRA OUTPT. [ ] CLOVIS [ ] FHSH [ ] OTHER (specify __ )

Please e-mail this request form to [email protected] You will be given a HEAT TICKET number. When the study mnemonic is completed, you will be notified that the HEAT TICKET is completed. You must cc the following people to your request:  [email protected]  Deborah Garcia ([email protected])  IRB Office ([email protected]) Please request the mnemonic in advance to allow sufficient time for the Customer Support analysts to complete the request. IN ORDER TO ENSURE COMPLIANCE WITH RESEARCH STUDY BILLING, FINAL IRB APPROVAL WILL NOT BE GRANTED UNTIL THE STUDY MNEMONIC IS ACTIVATED IN THE SYSTEM. To request the status of a HEAT TICKET, please contact Customer Support at 459-6560.

Version date 01Sep2016