IRB Application InstructionsPage 1

MHS Office of Research Administration

Instructions for Completion of the IRB Application for Human Subjects

PART 1 - ADMINISTRATIVE

A:STUDY INFORMATION

  1. Indicate the title of the project.
  2. Indicate the protocol number for industry-sponsored studies.

B:PRINCIPAL INVESTIGATOR (PI)

1-2. Indicate the name, phone and email address.

3.Indicate thePI’s medical specialty(ies).

4.Indicate whether the PI is on the medical staff or employed by a MemorialCare institution.

The Principal Investigator must be a member of the professional staff for a MemorialCare Institution (i.e., LBMMC / MCHLB, SMMC-LH, SMMC-SC, OCMMC or CHLB). Postdoctorate fellows, residents or other allied health professionals may serve as a co-principal investigator or sub-investigator.

C.REGULATORY CONTACT

1-2. Indicate the name, phone and email of the individual who will be the primary contact with whom the Office of Research Administration staff work with regarding the initial application and any ongoing administrative issues (i.e., annual reports, amendments, deviation reports, etc) regarding the project.

3.Indicate the address for all regulatory correspondence.

D.CLINICAL RESEARCH COORDINATOR (CRC)

1-2. Indicate the name, phone and email of the individual who will be the Clinical Research Coordinator.

Note: If the CRC is not a MemorialCare employee, indicate the name of the company he/she represents.

E.STUDY PERSONNEL

1.Indicate the names of all sub-investigators who will be participating in this trial.

2.Indicate the name and role of other study personnel involved in the study (i.e., clinical research coordinators, biostatisticians, consultants, etc.).

F.IRB OF RECORD (if other than MHS IRB)

If the MHS Institutional Review Board will not be the IRB of record, indicate which organization will be assuming this role (i.e. Central IRB or other IRB with which MemorialCare has an active agreement. Please note that this can only be for IRBs which have an agreement with MemorialCare.

G.STUDY SITE(s) AND PROPOSED NUMBER OF SUBJECTS

  1. Indicate if the study is seeking to enroll subjects that are considered inpatient, outpatient or private office.
  2. Indicate the number of proposed subjects from each MHS Institution necessary to answer the study objectives. Also,indicate the proposed number of groupwide subject to necessary to answer the study objectives (if applicable).

H:STUDY DESCRIPTION

  1. Attach the complete study protocol.
  2. Indicate if the study involves an investigational drug, biologic or dietary supplement.

2a:If the answer to #2 is an Investigational Drug, provide documentation from the sponsor or the FDA verifying the IND number.

2b:If the answer to #2 is a Dietary Supplement, provide a copy of the investigator’s drug brochure, package inserts and/or other background information.

  1. Indicate if the purpose of the study is to determine the safety or effectiveness of an investigational device.

If the answer to #3 is yes, provide one of the following: (1) FDA letter granting an IDE for the proposed use; (2) Letter from the sponsor stating that the study is a non-significant risk device study and the basis for determination, or (3) Documentation explaining why the investigation is exempt from the IDE requirements under 21 CFR 812.2(c) (such as the PMA approval letter/number or 510(k) clearance letter/number or otherwise exempt.

  1. Indicate if the study involves any form of gene transfer. If yes, address items a and b regarding an Institutional Biosafety Committee review.
  2. Indicate if the services of the Research/Pharmacy Lab Support Center will be needed.

I.SUBJECT INFORMATION

  1. Indicate the age ranges of the potential subject population.
  2. Indicate if the research will involve a vulnerable population. If so, indicate which type and summarize the additional safeguards that will be implemented for the subject population.
  3. Indicate if the potential subject population being approached will be unable to read, speak or understand English. If yes, indicate what percentage of the proposed subject population.

NOTE:Federal guidelines and MHS Policy dictate that it is inappropriate to deny entry into a research study based solely on the language the patient speaks. An exception applies if no one on the research team speaks the language in question and interpreter services are unavailable. If it is reasonable to assume that patients speaking a particular non-English language will be eligible for this study and interpreter services are available, then a translated consent form and interpreter must be provided for these patients. Please clarify if interpreter services will be unavailableor revise to indicate how Spanish or other non-English speaking patients will be included.

  1. Indicate if subjects will be financially reimbursed for participation in the study. If yes, indicate the nature of compensation (cash, check or gift card), the schedule of payments (at each visit, quarterly, etc.), and the total each subject would expect to receive for their participation.

J.INFORMED CONSENT

  1. Indicate if a signed consent document will be obtained.
  2. Indicate if a translated document will be used for non-English speaking subjects.

Note: Translated consent documents must be accompanied by an attestation statement from the certified translation specialist attesting to accuracy of translation from the IRB approved consent document.

  1. Indicate the plan for initially presenting the consent document; and ongoing communications with a non-English speaking subject.
  2. Indicate if a waiver for the documentation consent is being requested.
  3. Indicate if a waiver of consent is requested and provide reason.
  4. Short Form.

For more information, please see MHS Policy #304.

  1. Use of Surrogate may be considered by the IRB if requested.. For more information, please see MHS Policy #303 and particularly note the differences between a surrogate for research and for medical care.
  2. Indicate if a legal guaradian or person with a durable power of attorney is anticipated to provide consent.

For more information, see MHS Policy #303

K.RECRUITMENT

  1. Indicate how potentials subjects will be identified and/or recruited.
  2. If recruitment materials are being used, indicate what type.
  3. Indicate if written or verbal materials are being used to screenfor subjects.

L.HIPAA AUTHORIZATION

  1. Indicate if, and what type of, direct patient identifiers will be used during the study.
  2. Indicate if, and what type of, indirect patient identifiers will be used during the study.
  3. Indicate if a Waiver of Authorization for the Use and Disclosure of Protected Health Information is being submitted.

M.INVESTIGATORINFORMATION

  1. Indicate if there is a conflict of interest of the study is being funded from and external source. If yes, indicate the type of financial interest in question.
  2. Indicate if the PI, sub-investigator(s) or research team will be receiving or providing a recruitment bonus. If yes, please complete the Recruitment Bonus Disclosure Form at the end of the IRB application.
  3. Indicate if the PI will be paid to conduct the study and the type of arrangement, i.e., one-time payment or a per-subject payment.
  4. Indicate if the PI has received an FDA warning that has not previously been made known to the MHS Institutional Review Board.
  5. Indicate if the PI has ever been suspended or terminated by an IRB.
  6. Indicate if the PI has been involved in acts that have caused he/she to be disbarred or disqualified; could be considered for disbarment from bio-medical research; been disciplined or is currently the subject of such a proceeding.
  7. Indicate if the sub-investigator(s) or research staff has been convicted of a felony crime; been disciplined or is currently the subject of such a proceeding.

CHECKLIST

Attach a complete protocol with the application.

The Feasibility Application (Strategic, Scientific and Financial) and Estimated Research Costs (excel document) are required for all new research projects. Approvals from select institutional officials are part of this form.

The review of this Feasibility Applicationwill be concurrent with the review of the IRB Application. Note: Completion of all elements of BOTHapplications will be required before a project can proceed to review by either a designated member or a fully convened meeting of the MHS Institutional Review Board.

If an independent Scientific Review has already been conducted, then submit a copy of that review or acknowledgment by the industry sponsor.

Per MHS Policy #105, all investigators and study personnel who will have direct access to subjects are required to provide a certificate of competency of training in human subjects research. If this was not already obtained via a university program or the Collaborative Institutional Training Initiative (CITI), then it may be obtained by completing the NIH tutorial at the following link and submitting the completed certificate to the ORA.

PART 2– ABSTRACT / PROJECT SUMMARY

  • The abstract should be written using as non-technical language as is feasible (such as would be found in a newspaper for the general public) for use by non-scientists who are members of the IRB. A full scientific description of the study should be provided in the research protocol.
  • Each of the 4 listed abstract components must be completed in concise form and the entire abstract should be no longer than a 2 pages.
  • No attachments, tables, figuresor references are allowed.

PART 3–RECRUITMENT BONUS DISCLOSURE FORM

This form must be included if Item M-2 indicated ‘Yes’ - conflict of interest witho one or more of the individuals involved in conducting the study (i.e., PI, sub-investigator(s) or research team).

OTHER ITEMS THAT MAY BE REQUIREDFORSUBMISSION WITH THE

IRB APPLICATION

The State of California requiresall documents presented for patient review – such as consent and assent forms – be printed at a minimum font size of 12 points. The MHS IRB recommended font is Arial.

INFORMED CONSENT ANDRIGHTS OF HUMAN SUBJECTS IN MEDICAL RESEARCH

  • Information and instructions are provided throughout the template document.
  • There are numerous “standard statements” and their omission or modification is likely to needlessly delay the processing of the research application.
  • This document is to be completed in the second person (“you”), other than the final statement, which should be stated in the first person.
  • Please See MHS Policy 301 (Informed consent) for detailed information

PEDIATRIC ASSENT(required for subjects 7 to 17 years of age)

  • Information is provided in the template document.
  • This document is to be completed in the second person (“you”), other than the final statement, which should be stated in the first person.
  • See MHS Policy 302 (Consent and Assent Issues in Children) for detailed information.

The State of California requries HIPAA-related documents given to patients to be printed in 14 point font. As above, the MHS IRB-recommended font is Arial.

AUTHORIZATION FOR THE USE AND DISCLOSURE OFPROTECTED HEALTH INFORMATION

Federal regulations based on the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule went into effect on April 14, 2003. Therefore, all MHS research projects must account for the use of protected health information (PHI) for research purposes. There are several aspects to this requirement:

  • By including an authorization form as an addendum to the Informed Consent document

It is anticipated that an authorization form for the use and disclosure of PHI will be included with every project that includes a consent form

  • By requesting a waiver of authorization in situations where informed consent documentation is not required.

This applies to chart reviews and similar projects

  • By requesting permission to access PHI as part of activities preparatory to research

This includes such activities as reviewing logs or charts to assess project feasibility, or reviewing a small number of charts to help develop research hypotheses

Templates are available for each of these purposes. Instructions on completion are embedded into each form. In some cases, it may be necessary to submit both an authorization form and a waiver of authorization form (or a request for access preparatory to research). Examples include:

  • Where an investigator needs to obtain PHI from other 'non-investigator' clinicians to determine if a patient is eligible for a study prior to the patient giving informed consent/authorization. A waiver for this purpose, as well as an authorization to be signed during the consent process, will be needed.
  • Where a research nurse wishes to review patient logs or census records to determine which patients to approach about study participation. Since many patients will not subsequently be approached to give consent/authorization, permission for this preparatory activity must be separately given.

In the case of waivers or preparatory access, specific criteria must be met and the investigator must initial the form where indicated to attest to meeting these criteria.

OTHER SUPPORTING INFORMATION

OTHER SUPPORTINGINFORMATION

  • Flow sheet(s), data collection sheet(s), and questionnaire(s) surveys should be included if relevant.
  • Grid displays showing how subjects will be allocated to treatment groups and how they will be managed through various project contingencies are strongly encouraged.

CURRICULUM VITAE OF PRINCIPAL INVESTIGATOR OR SUB-INVESTIGATOR(s),

A recent curriculum vitae must be on file for each Principal Investigator or Sub-investigator. This should be included with the project application if the investigator is submitting a research application to the MHS Office of Research Administration for the first time or has not submitted an updated CV within the past year.

FOR MORE INFORMATION

ADMINISTRATION

Mel Marks, MD, Exec. Vice President, Research...... (562) 933-9701

REGULATORY/RESEARCH APPLICATION &

RESEARCH COSTS

Sharon Denham, Regulatory Compliance Coordinator...... (562) 933-5602

Teri Cilurso, Regulatory Compliance Coordinator...... (562) 933-5603

Vance Gardner, MD, Senior Reviewer...... (949) 683-5440

or

ACCOUNTING

Ronald Siu, Sr. Accountant for Research...... (562) 933-9574 or 933-5605

CONTRACTS & GRANTS ADMINISTRATION

Sally Lane, Director...... (562) 933-8005

CLINICAL TRIAL AGREEMENTS

Karen Weinstein, Esq...... (714) 377-3204

Senior Associate Counsel, MHS Legal

Information regarding application deadlines and meeting dates are available on the Research Administration intranet pageor can be obtained by calling (562) 933-5600.

Version: 08-10-2012