Identification of the Materials Submitted for Review

Expedited Review Form for Protocol Modifications / Response to Contingencies / Revised Informed Consent

/ IRB Project
Number:

IDENTIFICATION OF THE MATERIALS SUBMITTED FOR REVIEW (IC LISTS SEPARATE)

Your correspondence dated (received on) and attachments were reviewed by Dr. on.

The proposed changes qualify for expedited review according to 45CFR46.110 (b) 2) minorchanges in previously approved research during the period (of one year or less) for which approval is authorized. The proposed changes were .

Protocol [sponsor’s or investigator’s protocol number and identification of the change as amendment, revision or version number] dated [date of sponsors protocol change], was .

Protocol Detail revised dated was .

was .

Based on expedited review of your response, contingencies of have NOT been fully satisfied, and contingencies of have NOT been fully satisfied.

Based on expedited review you must address the following contingencies before final approval is granted: [If the contingencies were not fully satisfied attach the Contingencies Form]

FOR PROPOSALS WITH CONTINGENCIES

[New Projects]This research project cannot be initiated until the investigator addresses these contingencies and the response has been approved by the IRB. You must receive a letter of final approval from the IRB Office before you initiate the research project. If you do not receive such a letter, you should contact the IRB Office to obtain a copy before you initiate this research project.

[Continuing Projects] You may continue the research related activities [including study drug] in subjects previously entered in your research project however you may not enter (accrue or enroll) additional subjects until these contingencies are addressed by the investigator and the response has been approved by the IRB. You must receive a letter of final approval from the IRB Office before you continue enrollment in this research project. If you do not receive such a letter, you should contact the IRB Office to obtain a copy before you continue enrollment in this research project.

When responding to these contingencies include a cover letter that addresses each contingency point by point using the same number sequence identifier.

The revised protocol must have a revision date and the revised text must be identified.

The revised informed consent form document must have a revision date on every page. Two copies of the proposed revised informed consent must be submitted. One copy must have all deleted text identified with a strikethrough and all added text must be underlined. The second copy of the informed consent must be without revision marks and will be the IRB approved informed consent. An approved copy with the IRB stamp noting the expiration date will be returned for use in the study.

FOR PROJECTS GIVEN FINAL APPROVAL WITH NO CONTINGENCIES

The Following documents have received final IRB Approval:

1. Sponsor's Clinical Protocol # Version# Dated:

2. List All Approved Informed Consents

3. Investigator's Drug Brochure/Pkg Insert

4. Questionnaire

[New Projects] In approving this research the IRB determined that all of the following requirements (45CFR 46.111) were satisfied: (1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, only those risks and benefits that may result from the research are considered (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). (3) Selection of subjects is equitable (the purposes of the research and the setting in which the research will be conducted were take into account). (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45CFR 46.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by 45CFR 46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

[New Projects] As the Principal Investigator you are required to ensure that this research and the actions of all project personnel involved in conducting the study will conform with the research project and it’s modifications approved by the IRB; HHS regulations (45CFR46); FDA regulations (21CFR50,56); International Conference on Harmonization Good Clinical Practice Consolidated Guideline; IRB Policies and Procedures and applicable state laws. Failure to comply may result in suspension or termination of my research project, notification of appropriate governmental agencies by the IRB, and/or suspension of your freedom to present or publish results. Any proposed changes in the research project must be submitted, reviewed and approved by the IRB before the change can be implemented. The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects. In such a case, the IRB should be promptly informed of the change following its implementation for IRB review. You must inform the IRB immediately if you become aware of any violations of HHS regulations (45CFR46), FDA regulations (21CFR50,56), applicable state laws or IRB Policies and Procedures for the protection of human subjects. You are required to notify the IRB office in the event of any action by the sponsor, funding agency or FDA, including warnings, suspension or termination of your participation in this trial. You must maintain all required research records and recognize the IRB is authorized to inspect these records.

The investigator is reminded of the requirement to submit any annual grant progress reports, non-competing continuations or competing renewals to the IRB review and approval.

Approval of your study will expire at the end of the day (i.e. midnight) on. IRB approval is valid for a maximum period of one year with continuing review by the IRB required at least annually in order to maintain approval status. You may not enter subjects on the study before IRB approval or if IRB approval expires. In the latter case you must immediately contact the IRB to obtain permission to continue subjects on the trial. You must submit a progress report (Continuing Review Form) sufficiently (one to two months) prior to your study expiration date to permit IRB review before the expiration date.

You must inform the IRB of any unanticipated adverse event or injury no later than two (2) business days following the time it becomes known that a subject suffered an adverse event/injury. To report adverse events you must use the Internal Adverse Event Report form for internal events and the External Adverse Event Report form for external events. These forms and their instructions may be downloaded from the IRB WEB site at Furthermore you must inform the IRB immediately of any significant negative change in the risk/benefit relationship of the research as originally presented in the protocol and approved by the IRB.

PROJECTS WITH WRITTEN INFORMED CONSENT DOCUMENTS

Revised [Label of Informed Consent for studies with multiple informed consents] Informed Consent Document dated .

Revised [Label of Informed Consent for studies with multiple informed consents] Informed Consent Document / Script / Information Sheet dated .

______.

Informed consent must be obtained by the investigator or person authorized to obtain informed consent from all research subjects or their legally authorized representatives. You must ensure that all project personnel involved in the process of consent/assent are trained properly and are fully aware of their responsibilities relative to the obtainment of informed consent/assent according to the IRB guidelines and applicable federal regulations.

The IRB office has stamped the approved informed consent form(s) for use in this research project. It should be photocopied, as appropriate, onto the correct letterhead for the hospital or institute. You may not use this informed consent form document to consent new subjects after its expiration date. A photocopy of this IRB approved informed consent form document(s) bearing this stamp must be used for consenting and/or reconsenting the study subjects. The study subject must sign and date the informed consent document. The person obtaining informed consent must also sign the study consent form at the time consent is obtained. One copy of the informed consent should be given to the study subject, one copy placed in the medical record, and the investigator should retain one copy.

As a result of this new information you are required to re-consent all study subjects (including subjects who had previously signed an informed consent) with this updated informed consent document containing the new information.

The assent of a minor subject and the permission/consent of one / both parent(s) must be obtained.

FOR PROJECTS WITH A WAIVER OF WRITTEN INFORMED CONSENT

The request for a Waiver Of Written Informed Consent has been approved as the protocol detail adequately documents that:

The only record linking the subject and the research would be the consent document, and a principal risk would be the potential harm resulting from a breach of confidentiality (the subjects would be placed at risk by documents linking them with an illegal or stigmatizing characteristic or behavior). Each subject must be asked whether the subject will permit documentation linking the subject with the research, and the subject’s wishes will govern.

The research present no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context.

Submit the script of the verbal informed consent. [Note only for studies qualifying for a waiver of written informed consent according to 45CFR46.1179(c)] NOTE TO IRB: Hipaa documents may still be required (i.e., medical release authorization or addendum).

Submit a written statement regarding the research to be provided to the subjects. [Note only for studies qualifying for a waiver of informed consent according to 45CFR46.116(d)] NOTE TO IRB: Hipaa documents may still be required (i.e., medical release authorization or addendum).

Insufficient information is provided to justify the request for a WAIVER OF WRITTEN INFORMED CONSENT consistent with 45CFR46.117(c).

The protocol detail fails to adequately document that: (a) The only record linking the subject and the research would be the consent document, and a principal risk would be the potential harm resulting from a breach of confidentiality (the subjects would be placed at risk by documents linking them with an illegal or stigmatizing characteristic or behavior). In such a case each subject must be asked whether the subject will permit documentation linking the subject with the research, and the subject's wishes will govern. or (b) The research present no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context. Submit a revised protocol detail that adequately addresses and documents these points.

You must utilize the script for obtaining informed consent dated which has been approved by the IRB and a progress note documenting that informed consent had been obtain must be made in the medical record.

You must utilize the information sheet dated approved by the IRB for obtaining informed consent. A copy of the sheet must be given to the study subject and a progress note documenting that informed consent had been obtain must be made in the medical record.

FOR PROJECTS WITH A WAIVER OF INFORMED CONSENT

The request for a Waiver Of Informed Consent is approved as the protocol detail adequately documents that: (a) the research involves no more than minimal risk to the subjects; (b) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (c) the research could not practicably be carried out without the waiver or alteration; and (d) the subjects will be provided with additional pertinent information after participation.

The request for a WAIVER OF INFORMED CONSENT consistent with 45CFR46.116(d) is not approved as the protocol detail fails to adequately document: (a) the research involves no more than minimal risk to the subjects; (b) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (c) the research could not practicably be carried out without the waiver or alteration; and (d) the subjects will be provided with additional pertinent information after participation (where appropriate). Submit a revised protocol detail that adequately addresses these points.

COMMON INFORMED CONSENT STIPULATIONS

Revise the Informed Consent document to be consistent with the template language in the IRB Informed Consent Template available on the IRB web site. Please obtain this template from the WEB at and revise the informed consent accordingly.

Version date the informed consent revisions. Each page of the informed consent should have a version date and should be paginated.

45CFR46.116 requires the information that is given to the subject or the representative to be in language understandable to the subject or the representative. Your informed consent must be rewritten using lay language that can be understood by the subjects. See the Informed Consent Guide for assistance or contact Diana Shycoff, the IRB Chair or Vice-Chairs.

The informed consent should be written using Flesch-Kincaid reading ease score at an eighth grade level or less. Contact the IRB Office for further information.

The informed consent lacks one or more of the elements required under 45CFR46.116(a) and (b). Either revise the informed consent to include all elements or provide sufficient information to justify a waiver of informed consent consistent with 45CFR46.117(d).

LANGUAGE TO INCLUDE IN THE LETTER TO PI’S REGARDING SURROGATE CONSENT REQUIREMENTS

Federal law requires that an investigator obtain informed consent from the human subject or the subject's legally authorized representative, prior to conducting a research study. For medical experiments relating to the cognitive impairment, lack of capacity, or serious or life threatening diseases and conditions, California law authorizes certain individuals to provide surrogate informed consent on behalf of the subject if the subject is unable to consent on his or her own behalf. Those individuals are, in the following descending order of priority:

(1) The person's agent pursuant to an advance health care directive.

(2) The conservator or guardian of the person having the authority to make health care decisions for the person.

(3) The spouse of the person.

(4) An individual as defined in Section 297 of the Family Code (i.e., domestic partners as defined under state law).

(5) An adult son or daughter of the person.

(6) A custodial parent of the person.

(7) Any adult brother or sister of the person.

(8) Any adult grandchild of the person.

(9) An available adult relative with the closest degree of kinship to the person.

When there are two or more available persons who may give surrogate informed consent and who are in the same order of priority, if any of those persons objects to having the subject participate in the medical experiment, consent shall not be considered as having been given. Also, consent of a person who is in lower priority cannot supersede the refusal to consent by a person who is a higher priority surrogate.

The IRB has determined that the surrogate consent requirements stated above as required under California law, apply to your study. Accordingly, please obtain surrogate informed consent in the manner described above. You must follow the specific provisions in the amended section 24178 of the Health and Safety Code (Assembly Bill 2328) as to who can sign the informed consent. The full text of the California state law can be found at: