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					                                                                                                Medical Education & Research
                                                                                                                 P O Box 26666
                                                                                                   Albuquerque, NM 87125-6666
                                                                                                                   www.phs.org

Dear Investigators and Coordinators:                                                                          July 16, 2010

Enclosed is Presbyterian Healthcare Services Institutional Review Board’s updated Investigator’s Packet. The packet includes
policies and tools used for the initial submission and continuing review of your protocol.

The PHS IRB reviews all IRB policies and documents on a bi-annual basis to assure that they remain current with FDA
regulations. This Board reviewed and /or revised all existing policies and developed several new “guideline” documents
included in this packet.

A few of the most important changes include:
    • Guidelines for completing the Summary of Research Protocol and IND Safety Report Summary
    • The Summary of Research Protocol (intent and nature of study)
    • New requirements regarding the Informed Consent Form, including the inclusion of a version number or date and a
        signature line for the person obtaining consent
    • Revised SAE definition and reporting requirements and forms
    • IRB review fee changes
    • Revised Expedited Review policy.

Any of these documents can be e-mailed to you, for ease of use. Please remember to use and list the date of the most current
version of the Summary of Research Protocol when you submit a protocol for approval. Reports, summaries, letters etc. may be
returned for correction if they do not have all of the required information or if the committee decides to table
approval/acceptance for additional information.

Your introductory request letter should contain the following items:
        Provide the title and a clear and accurate statement that the study is research protocol, along with an explanation
        regarding the purpose(s) of the research.
        Listing of the type and level of study for the proposal (i.e. Category II, investigational device study).
        List the most current version number/name and the date of the Summary of Research Protocol and any Informed
        Consent forms when you submit a protocol for approval.
        Listing of the Primary Investigator and any sub-investigators.
        If the PI and sub-investigators are not on the Medical Staff of Presbyterian Healthcare Services, then they must find a
        “sponsor” on the Medical Staff, preferably a physician willing to be a sub-investigator.
        A CV and Human Subject Research Testing certificate or the equivalent must be submitted.
        If requesting an Expedited or Exempt study, please state this in the letter.
        Any fee waiver requests must be made in the letter.
        The answers to page 8 of the application packet must accompany the request.
        A protocol and any Informed Consent forms / HIPAA forms must accompany the request.
        Any references or articles for the IRB Committee to use should be listed last.
        All documents in the request should be one side per copy page, in at least a size 10 font, and typewritten. Paper clips,
        binder clips, or blank separation pages may be used to hold the material together. No staples or permanent binding
        should be used.

If you have any questions regarding the revision requests, please do not hesitate to call me.

Sincerely,

Lisa McCade, Coordinator
Medical Education and Research
Presbyterian Healthcare Services
505-841-1436


                                                               -1-
                                                                   Check List for Submission


                  How will costs of treatment for injury be paid?
                  Who to contact to answer questions regarding this research study.
                  Contact PHS Risk Management and the IRB for information regarding rights of research subjects.
                  Inclusion of statement regarding right to refuse to participate and right to withdraw without penalty or loss of
                  rights.
                  Statement indicating that by signing the Informed Consent Form, the patient does not waive any legal rights to which
                  he/she is otherwise entitled.
                  Investigator’s completed Financial Disclosure form is enclosed.
                  Patient/Subject Received Copy of Informed Consent and Questions Have Been Answered.
                  Amendments or Additions to the Protocol.


                  Signature, date, page / version criteria:
                              Patient’s
                                   (and/or) Legal Representative
                                   Person Obtaining Consent
                                   Physician (Investigator)
                                   Witness
                                   Name of any medical translator
                                   Line on each page of Consent Form for Patient's Initials
                                   Version number and/or date (version/date must be changed with each revision)
                                   Pages all numbered (Page X of X)


V. ACTIONS TAKEN:
            A. Approval of:
                        Protocol
                        Investigator(s)
                        Informed Consent

            B. Frequency of review (in months) ________________________________



Policies\IRB Checklist
2/88, 6/95, 10/99, 6/01; 7/10




                                                                          -2-
                                   GUIDELINES AND POLICIES FOR
                         SUBMITTING A PROTOCOL FOR REVIEW TO THE PHS IRB


Presbyterian Healthcare Services (PHS) Institutional Review Board (IRB)

The PHS IRB, the members and chairpersons, which are appointed by the elected president of the Medical Staff under the
Presbyterian Healthcare Services (PHS) Medical Staff Bylaws, serves as the (IRB) for PHS Albuquerque and its affiliated facilities.
Federal law requires the IRB to conduct initial and continuing review of all research using human subjects, or derivatives of human
subjects, which is developed by or carried out by faculty, staff, students, or others at PHS.

Subjects may be either healthy human volunteers or patients. The function of the IRB is to safeguard the rights and welfare of human
subjects, utilizing the procedures and regulations as set forth by the United States Department of Health and Human Services
(DHHS) and the Food and Drug Administration (FDA). The Presbyterian IRB meets regularly to review and vote on the
acceptability of research proposals and to conduct other related business as set forth in these guidelines. Meetings are held each
month at Presbyterian Hospital.

COMMITTEE MEMBERSHIP

The PHS IRB shall: (l) consist of at least thirteen (13) members of sufficiently diverse backgrounds (including racial, cultural and
sensitivity to community attitudes and issues) to promote respect for its advice and counsel in safeguarding the rights and welfare of
human subjects, (2) include persons who are able to ascertain the acceptability of research application in terms of institutional
commitments, applicable law, and professional standards, (3) include members of both sexes, (4) include at least two members whose
primary concern is in a nonscientific area, for example- lawyers, ethicists, members of clergy, (5) consist of members representing
more than one profession and more than one medical specialty, (6) include at least one member who is not affiliated or related to a
person who is affiliated with Presbyterian Healthcare Services. A member may not participate in the initial or continuing review of
any project in which the member has a conflict of interest, except to provide information requested by the IRB.

Alternate IRB members may be identified to substitute for primary members of the IRB. The alternate is appointed in the same
manner as primary member and only substitutes for a specific designated member, upon request, in their absence. Qualifications of
each alternate member should be comparable to the primary member to be replaced. Alternate members of the IRB may only
function as a part of the quorum when the primary member is absent, but may assume the same functions as primary members when
acting for the member. A quorum of the membership must be present to vote on research proposals. A quorum consists of a at least
two physicians and a total of five members of the IRB and includes at least one member whose primary concerns are in a
nonscientific area.


SUBMITTING A PROTOCOL FOR REVIEW BY THE IRB

All research proposals involving human subjects must be approved in writing by the PHS IRB before a study is initiated. The
following materials should be sent at least three weeks prior to a scheduled IRB meeting to Medical Education & Research,
Presbyterian Hospital; PO Box 26666, Albuquerque, New Mexico 87125-6666. These items must be maintained in the IRB file for at
least seven years:
    1.       Complete copy of the research protocol.
    2.       Informed Consent form (see Informed Consent Guidelines).
    3.       Completed Summary of the Research Protocol (include sufficient detail so that the committee can determine the risk to
             subjects and the benefit to be gained from research).
    4.       The CV/resumes of the principal investigator, each co-investigator or sub-investigator, and each research coordinator or
             research assistant.
    5.       The Investigator’s Brochure or Packaging Insert (for drug studies).
    6.       The IRB Fee (See Charges for IRB Review and Follow-up) must be paid before initiating a new study. Requests to
             waive the fees should be submitted in writing with the above materials.
    7.       A copy of each investigator’s and coordinator’s Human Subject Research Testing Certificate. If they do not have copies
             of this document they can go to the following site, take the test and print a copy of their certificate:
             http://phrp.nihtraining.com/users/login.php .
NOTE: New protocols received less than three weeks before an IRB Committee meeting may not be reviewed until the
      following month

                                                                 -3-
THE RESEARCH PROTOCOL
Each research proposal is unique and requires an individual protocol. In order to understand the risk, to which subjects may be
exposed, the protocol should contain:

        1. Statement of the study's objectives and purpose.
        2. Study sponsor's name and address.
        3. Patient selection and exclusion criteria with the estimated number of patients to be studied.
        4. A description of the study design, including any controls and a description of methods to minimized bias on the
           subject’s part, investigators and analysts.
        5. For drug studies, include the method for determining the doses to be administered, the planned maximum dosage,
           and the duration of individual patient exposure to the drug. For device studies, include the method for determining
           the treatment parameters, including administration and duration of individual patient exposure to the medical
           device.
        6. A description of the observations and measurements to be made to fulfill the study's objectives.
        7. A description of clinical procedures, laboratory tests, or other measures to be taken to monitor the test or control
           article's effects in human subjects and to minimize risk.

        Note:    The Principal Investigator must be prepared to present the research protocol to the IRB for initial approval if
                 requested to do so.


CURRICULUM VITA (CV) / RESUMES
The CVs/resumes of the principal investigator and all co or sub-investigators must be submitted with the research
proposal for review by the IRB. CVs should reflect the qualifications of the investigator(s) to conduct the proposed
research. CVs/Resumes of research assistants or coordinators must also be submitted for IRB review. This is required for
access to Presbyterian Healthcare Services facilities.


IRB REVIEW OF RESEARCH
All research proposals involving human subjects are sent to all members of the IRB for review one week prior to the meeting date.
Each committee member receives pertinent parts of the protocol, the informed consent and a prepared Summary of Research
Protocol and the complete protocol, and a copy of the letter of request to review the study are available to Committee Members at the
meeting. A copy of the Investigator’s Brochure is also reviewed by an IRB member prior to the meeting at which the study is
reviewed.


INVESTIGATIONAL NEW DRUGS (IND)
Projects involving the use of investigational new drugs must be approved by at least two committee members (within the
membership quorum) licensed to administer drugs.




                                                                -4-
CHANGES REQUESTED BY THE IRB
The total research study must be in compliance with all IRB standards prior to implementation. If approval is given pending
changes, these changes must be submitted to the IRB. Specific changes may be reviewed by the Chairman of the IRB or his/her
designate and approval given in writing. When major or complex changes are required, they must be reviewed and approved by
the committee prior to implementation. Please see attached Policy MSA.PHS-E.217: Format Requirements for Submission of
Protocol Amendments to the PHS IRB.


EMERGENCY APPROVAL OF RESEARCH PROTOCOL
Emergency use of a test article is permitted, for ONE time only, however the physician must notify the chair-person of the IRB
or in his/her absence, the Chief of Staff, or the Medical Director of Presbyterian Healthcare Services prior to using it. Any
subsequent use of the test article at PHS is subject to IRB review and approval at a convened meeting. In order to be exempt
from the requirements for prospective IRB reviews, a life threatening or severely debilitating condition must exist. The IRB is
notified of the emergency use of an investigational article at the next fully convened meeting. Physicians who anticipate that
there is any chance that they will have cause to use the test article more than once are encouraged to obtain IRB approval for
the study.


CONTINUING REVIEW OF APPROVED RESEARCH PROJECTS (REAPPROVAL)
All studies approved by the IRB will be reviewed at least annually, and at more frequent intervals if requested by the board.
The IRB will determine how often a study must be reapproved at the time of initial approval, and with each reapproval.
Progress report must accompany requests for continuation and must provide the following information:
   1. The number of subjects/patients initiated into the research project;
   2. a brief review of local activity since the last progress report including adverse events, protocol/informed
       consent amendments/revisions, and other significant developments (include a brief review of each adverse
       event that you have reported since your last progress report);
   3. results of research thus far, if known;
   4. a current assessment of risks and benefits based on study results;
   5. any new information that has come to light since the last Presbyterian Institutional Review Board review –
       including any added incentives to increase or speed up patient enrollment;
   6. current version date of Informed Consent Form being utilized (if applicable);
   7. an accounting of Informed Consent Forms on file prior to patient’s enrollment into the study, with an
       explanation of any deviations from this requirement.
   8. submit the report along with a current copy of the Informed Consent Forms currently in use for your study,
       and the current version and date of the protocol in use.
        NOTE: The Principal Investigator does not have to present the request for continuation. Such request is made in
              writing.

SERIOUS ADVERSE EVENTS
Refer to separate policies/guidelines and forms for:
         • Local Serious Adverse Events (SAE)
         • Guidelines for Completing Presbyterian IRB IND Safety Report Form - For Adverse Events Occurring at Other Sites


AMENDMENTS, REVISIONS OR ADDENDA TO RESEARCH PROJECTS
Any revisions, amendments, and addenda, to an approved or ongoing research protocol must be reviewed and approved by the
IRB prior to implementation. When changes are necessary in order to increase patient safety, the Chairman of the IRB or
his/her designee may grant approval upon review of the implemented changes. Full approval of all changes must be obtained
from the committee.




                                                             -5-
Revisions to the consent form may be necessary to reflect changes in the protocol. Any revised informed consent form also
requires approval by the IRB before implementation. For additional information and special situations, refer to IRB policy on
Expedited Review.


COMPLETED RESEARCH PROJECTS
The principal investigator is required to notify the IRB when the project is completed. A final progress report, noting any
complications encountered prior to the study's closure, should accompany the completion notice. Copies of any journal articles
that are published should be sent in the Medical Education & Research Department at Presbyterian to be included in the study
file.


FINANCIAL COMPENSATION
The principal investigator is required to provide the IRB with information related to any anticipated financial reimbursement
received by the investigator(s) or paid to the subjects for time required for participation in a research project. If subjects are
paid for their participation, the requirements for payment must be described. The costs to subjects or defrayment of any costs as
a result of being involved in a research study must be described.


SELECTION OF SUBJECTS
The process used for selection of subjects to participate in a research study must be described and approved by the IRB. The
FDA has interpreted this to include any advertisement for subjects. Plans to advertise for research subjects must be submitted to
the IRB for review and approval prior to implementation.


CONFLICT OF INTEREST
An IRB member cannot vote on any part of a research study where there may be conflict of interest. Conflict of interest may be
defined as personal, professional or economic relationships with persons or companies involved with a research study. The IRB
member must inform the Committee that a possible conflict of interest exists and abstain from voting. This abstention is noted
in the minutes.


CHALLENGING THE DECISION OF THE IRB
If a research proposal is not approved by the IRB, the principal investigator may request a hearing before the IRB. Any
research proposal may be resubmitted to the committee for further review.
A negative vote/decision made by the Presbyterian IRB may not be overruled by any acting body or authority at Presbyterian
Healthcare Services. Although other acting bodies or the authorities at PHS may however rule that a research project that has
been approved by the IRB cannot be conducted at a facility because of potential impact or resource requirements (e.g.,
financial, equipment and/or personnel).


RESPONSIBILITIES OF INVESTIGATORS
Investigators are responsible for conducting and supervising research studies. In doing so, they must assure that required
documentation and records are kept, that an Informed Consent is obtained, report adverse events, provide progress reports, and
respond to requests of the IRB. Investigators who do not respond to requests for information or changes within four weeks will
receive a second letter indicating that the approval to conduct a research study is subject to termination if appropriate response
is not received prior to the next IRB meeting.




                                                               -6-
RESPONSIBILITIES OF THE ADMINISTRATIVE STAFF TO THE IRB
The administrative staff of the IRB is the Director of Medical Staff Affairs and a Coordinator of Medical Education &
Research or their designated representative. Their combined responsibilities are as follows:
   1. Manage all communications addressed to the IRB.
   2. Complete and send out all required correspondence to investigators and/or sponsors resulting from actions taken by the
      IRB.
   3. Assure organizational compliance with FDA regulations:
         a. Develop policies and procedures.
         b. Provide information to the IRB and investigators.
   4. Review applications for completeness for the committee prior to each monthly meeting.
   5. Assist investigators and coordinators as needed by explaining policies, procedures, time frames, etc.
   6. Grant interim approval as delegated by the Chairman or Vice-Chair of the IRB.
   7. Take and maintain minutes for IRB meetings.
   8. Provide all necessary materials to the committee members.




                                                            -7-
                                       SUMMARY OF RESEARCH PROTOCOL


Please provide your typed responses to the information requested for the protocol in the following format. Explanation pages
have been provided to help you complete this form.

1.    Project Title
2.    Investigators:
         • Principal Investigator’s: Name, e-mail address, phone number & address
         • Sub-investigators: Name
         • Research assistants or Coordinators: Names, e-mail addresses, phone number & fax number
3.    Agency or organization associated with study.
4.   Expected dates/duration of the study.
5.    Subjects, which should include types and numbers to be involved both locally and nationwide.
6.    A purpose or hypothesis that you hope to prove by doing the study.
7.    Please explain the protocol or method you will use to obtain the data in detail.
8.    Drugs:
      a) Pharmacology
      b) Who will administer the investigational drug?
      c) Who will train the personnel to administer the investigational drug to the subjects?
9.    List any studies competing for a similar patient population.
10. Financial Information
       a. Investigator’s name and amount to be paid
       b. Please site any inducements to be used to increase the subject population in detail.
       c. How/when will the patient be reimbursed?
11. Costs
      a.   Subject/Patient
      b.   Facility or PHS
      c.   List the party, which will be responsible for paying the costs of treatment for any injury.
12 List any ethical considerations in performing this protocol.



     NOTE: The complete protocol must accompany this summary and will be kept in the IRB files at all times.




                                                                -8-
                                          GUIDELINES FOR COMPLETING
                                        SUMMARY OF RESEARCH PROTOCOL


The PHS IRB requests that the following information be included on the summary form. Please remember that we have
the protocol in its entirety on file, so in most cases, information should not be copied verbatim from the protocol. This
summary should provide requested information in a brief, simple manner that adds helps the committee focus ton the
purpose and aspects of the study.


Project Title: Give complete title of research study; if the study sponsor requires protocol numbers, dates, etc., be included in
communications from the IRB, include them in this section.


Investigators: Some study sponsors require that study coordinators/nurses by listed as sub-investigators. They may also require
that they be listed on your 1572. Please check with study sponsor. Enclose CVs/Resumes for all investigators, coordinators
and research assistants.

1. Agency or Organizations – Study sponsor and Contract Research Organization (if different from sponsor).
2. Dates (duration) – Provide dates that enrollment is expected to begin and conclude at this site; give duration or length of
   time the patient will be participating.
3. Subjects - How many patients are to be enrolled nationally/internationally? How many do you expect to enroll locally?
   Include a brief description of the patient population involved in this study (disease type/stage/severity/age limits).
4. Purpose - Why is this study being done? What is the study trying to show/prove/discover?
5. Method - Briefly describe the patient population (if not covered in #5), treatment arms, procedures, follow-up
   requirements, endpoints, etc.
6. Drug (Pharmacology) - Provide a simple, brief description of the action of new drug(s). What class of drug is it? How does
   it work?). It may help to compare/differentiate the new drug to an approved drug.If the drug(s) is FDA approved, indicate
   any deviations from standard/approved dosing, method of delivery, different indication, different patient population, and/or
   use combination with other drug(s).
7. Interaction - Will this study compete with another study at Presbyterian for enrollment? If a patient meets the enrollment
   criteria for more than one study, how will you determine which study the patient will be considered for?
8. Financial information:
   a. For the Investigator - what reimbursement will the investigator get for conducting the study? Does the study sponsor
       offer the site/investigator any financial inducement to encourage increased or accelerated enrollment? If it does,
       describe.
   b. For the Subject/Patient - is any incentive offered that might induce patients to enroll in the study (free study drug,
       mileage reimbursement, free medical care)? Inducements must be described in the informed consent.
   c. Time frame: if the patient will be paid for participation or reimbursed for expenses, when will payment be made? This
       information must be disclosed in the informed consent form. Payment may not be delayed until the study is completed
       or serve as an inducement to stay in the study.




                                                              -9-
9. Costs:
   a. Subject/Patient - Costs may include cost of drug, device, tests, longer length of stay, extra office visits, lab work, etc.,
       which are not reimbursed by the study sponsor. Insurance companies may not pay for investigational treatments.
   b. PHS – Are there costs of drugs, devices, procedures, diagnostic tests, monitoring, staff time, etc., for which PHS may
       not be reimbursed by the study sponsor, Medicare, Medicaid, HMOs or other insurance companies? Keep in mind that
       the hospital reimbursement may be capitated.
    Are there any screening/follow-up care/treatment or medical tests required by the protocol, which are not considered
    standard care for the involved patient population? If so, identify the particular tests/procedures/treatments that are
    extraneous and explain how the associated costs will be dealt with (i.e., paid for from study funds). There are ways,
    within the hospital billing system, that special accounts can be set up so inappropriate billing of patients and/or
    insurance companies does not occur.
10. Ethical considerations - Examples include current treatments available, increased risks or costs to the patient,
    confidentiality issues.




                                                              -10-
                                           INFORMED CONSENT GUIDELINES


All of the points included in these guidelines as "Elements of Informed Consent" (See Addendum A, Sample Consent Form.)
must be utilized for Presbyterian Healthcare Services patients. When appropriate, any or all of the points listed under
"Additional Elements of Informed Consent" shall also be included. The IRB may require that additional information be
included when providing such information would meaningfully add to the protection of the rights and welfare of human
subjects.

When there is minimal risk to the subject, such as in the collection of excretory specimens, simple venipuncture for small
amounts of blood, or the collection of tissue or samples left over from lab tests, surgery, biopsy, etc., a simplified consent form
may be used. (See Addendum B: Sample Consent Form - “Minimal Risk”.)

When no drug, device or invasive procedure is involved, “Elements of Informed Consent” may be provided in a shorter format.
(See Addendum C: Sample Consent Form - Non Drug/ Device or Invasive Study).

One copy of the consent form is placed in the hospital chart, one placed in the researchers' file concerning the project, and one
given to the subject and/or the subject's legally authorized representative prior to the drug being given or the procedure being
performed.


THE CONSENT FORM

A valid consent requires three elements: information, comprehension of the information, and the patient’s voluntary assent.
Each consent form should assure that all three criteria are present.

Information: the consent form must inform the subject regarding the nature and the purpose of the research, the extent of the
subject's involvement in the research, the risks, the possible benefits, alternatives to the research, and the procedures that
involve the patient directly.

Comprehension: the consent form must be written in a language level understandable to the subject; all medical terminology
should be translated into terms understandable to the subject. Investigators are responsible for ascertaining that the subject or
the subject's legally authorized representative has comprehended the information.

Voluntary Assent: the consent form gives the researcher the subject's legal consent to voluntarily participate in the research.
When necessary, the subject's legally authorized representative (parent, guardian, or court appointed representative) consents
on behalf of the subject. The form must make clear the voluntary nature of the consent. The consent expressed by the form
must be solicited and secured only under circumstances that provide the prospective subject or the representative sufficient
opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. Where
some or all of the subjects are likely to be vulnerable to coercion or undue influence (such as persons with acute or severe
physical or mental illness or persons who are economically or educationally disadvantaged) the research project shall include
appropriate additional safeguards to protect the rights and welfare of the subjects.

The consent form must not include any exculpatory language through which the subject or the representative is made to or
appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, or PHS or its
agents from liability for negligence.




                                                               -11-
ELEMENTS OF INFORMED CONSENT


In providing informed consent, the following information must be provided to each subject and/or the subject's legally
authorized representative:

1. Title of the study and the name(s) of the principal investigator(s).
2. Contain a statement that the study involves research, an explanation of the purpose of the research, and the expected
   duration of the subject's participation.
2. Complete disclosure of all procedures in which the subject will participate, and identification of those procedures, which
   are experimental.
3. A fair disclosure of any reasonably foreseeable risk (psychological, physical, legal, social, economic, etc.) and/or
   complications and/or discomforts which may occur, with some indication of their relative frequency.
5. A description of any benefits to the subject or to others which may reasonably be expected from the research. If there are
   no benefits to the subject, there should be a statement to that effect in the consent from.
7. A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
8. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and
   the possibility that the IRB, the FDA, or other agencies or sponsors, may inspect the records.
9. An explanation of what the subject can expect in the event that injury occurs including any compensation and an
   explanation as to whether any medical treatment is available and if so, what they consist of, or where further information
   may be obtained.
10. Any additional costs (i.e., additional medical care) or incentives (i.e., free medications) that the patient may expect due to
    study participation must be disclosed.
10 A statement that the subject “may ask questions about the research at any time and an explanation of whom to contact for
   answers(The contact information for the local primary investigator and the IRB) to pertinent questions about: a) the
   research, b) research subject's rights, and c) in the event of a research - related injury to the subject.”
11 The statement that “participation is voluntary, that refusal to participate will involve no penalty of loss or benefits or
   medical care to which the subject is otherwise entitled and (the subject) may discontinue participation at any time without
   penalty or loss of benefits to which the subject is otherwise entitled.”
12 The statement that explains that “by signing the consent, the patient is not waiving any legal rights to which they are
   otherwise entitled.”
13 A statement indicating that the subject has received a copy of the informed consent.
14 Signature lines and date lines: there must be a minimum of five (5) signature lines:
        a)   Subject's legal signature.
        b)   Witness line, which reads "Witness to Signature".
        c)   Person Obtaining Consent.
        d)   Medical Translator with date of service.
        e)   Physician/investigator line, which reads "Physician's /Investigator’s Signature".
    The witness or person obtaining consent and investigator may be the same person and would, therefore, sign on all
    applicable lines. A fifth optional line is suggested for the subject's legally authorized representative to sign, if
    appropriate. Date lines should be provided for each signature.

15 If the consent form is longer than one page, a place for patient initials must be included on each page other than the
   signature page. Each page should be numbered (e.g.: Page 2 of 4).

16. A version number and/or date should be specified and the version/date changed as revisions are made. This ensures that the
    IRB and the investigator are utilizing/referring to the most recent form.




                                                              -12-
                              ADDITIONAL ELEMENTS OF INFORMED CONSENT

When appropriate or applicable, one or more of the following elements of information shall also be provided to each
subject:

   A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is
   or may become pregnant) which are currently unforeseeable. The subject should be instructed to inform the investigator
   immediately if the subject should become pregnant.

   Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the
   subject's consent.
   Any additional costs to the subject that may result from participation in the research.
   The consequences of a subject's decision to withdraw from the research and procedure for the orderly termination of
   participation in the research.
   A statement that significant new findings developed during the course of the research which may be related the subject's continu-
   ed willingness to participate in the research will be provided to the subject.
   A statement that subject will not benefit financially from any product(s) or patents coming from his/her specimen (tissue,
   blood, DNA, etc.)
   A statement how, for what period of time either their specimen and/or information about them, albeit confidential will be stored.
   A statement saying that with DNA testing advances, the subject’s confidentiality is not absolute.
   The approximate number of subjects involved in the study.
   If genetic studies are to be conducted on either blood or tissue samples, this must be disclosed. The consent should include the
   following information:
       •    How long the specimens will be retained.
       •    The subject remains the owner of such samples and may request their destruction at any time.
       •    Whom to contact regarding the specimen to request their destruction.
       •    A statement that “confidentiality of the results of the genetic testing are not absolute.”




                                                                -13-
ADDENDUM A
Sample Consent Form


                                      PRESBYTERIAN HEALTHCARE SERVICES
                                               CONSENT FORM


Protocol Title

1)      You have been invited to participate as a subject in a research for the study                         , which is being
        conducted by                                    as principal investigator and such qualified assistants as he/she may
        need and employ. At all times during the research these assistants will be under the direct supervision of            .

2)      This study involves medical research being conducted for the purpose of (describe what the study is designed to
        discover or establish). The expected duration of your participation in this study is (indicate how long the subject will
        receive treatment and the length of any follow-up period).

3)      The procedures in which you would participate in are (Be specific, include all tests and procedures that will be done
        due to participation in this study. Include the number of times and at what intervals each procedure or test will be
        performed).

4)       You will be exposed to certain risks and discomforts as a result of your participation in this research study. They are
        as follows: (Use lay terminology, provide a complete list of psychological, physical, legal, social, economic, etc. risks.
        Give some indication of the relative frequency).

5)      (Indicate any costs to the subject that may result from participation in the research. Insurance companies may not pay
        for medical treatment that is investigational and if so, this should be indicated. Also indicate if there are any incentives
        due to study participation -free medications, medical care or reimbursement for travel/time).

6)      The benefit(s) that may reasonably be expected to result from being a subject in this research project is: (Provide in lay
        terminology - if there are no benefits to the subject this must stated).

7)      There are alternate forms of treatment, which are available to you. They include the following: (Provide complete
        disclosure in lay terminology - if there are no alternative forms of treatment available, this must be stated).

8)      The risks and/or possible complications have been described above. In the event that the patient sustains an injury as a
        result of study participation, they should immediately notify: Dr. (Give the name, telephone number and address of the
        ‘Practitioner’) will initiate the appropriate medical treatment dependent on the type of injury, which could include the
        following: (List any anticipated types of treatment that may be needed and/or provided). The cost of this treatment will
        be paid for by (indicate who will be responsible for paying for the treatment). If the subject or third party payer will
        have financial responsibility, this must be stated. NOTE: Since this is investigational study, it is possible that insurance
        companies will not pay for such treatments this should be stated.

9)      Your records will be maintained in such a manner that you will not be identified as part of this study. (Describe
        methods to be used for disclosure of information, which will assure confidentiality). Your records may be reviewed by
        the FDA, the Presbyterian Healthcare Services Institutional Review Board and (give name of the study sponsor(s) and
        any other group which might review patient records).

10)     You or your legally authorized representative may ask questions and request information about this research study as
        part of your rights as a research subject under New Mexico State law. You may ask Dr. (give principal investigator’s
        name, phone number and address) and/or you may call or write PHS Institutional Review Board at PO Box 26666,
        Albuquerque, New Mexico, 87125-6666; Phone: (505) 841-1225.



                                                               -14-
11)     Your participation in this study is voluntary and you may revoke this consent and withdraw from participation in this
        research project at any time. If you refuse to participate in this research project there will be no penalty or loss of
        benefits or medical care to which you are entitled. By signing this Consent Form, you are not waiving any legal rights
        to which you are otherwise entitled.

12)     You will receive a copy of this informed consent to keep.

“I have read this document and it has been explained to me. I have had an opportunity to ask questions and they have been
answered to my satisfaction. If I have any further questions I may call (give name and phone numbe). With this
understanding, I hereby consent to participate in this study.”


                                                                    __________________
                     PATIENT’S SIGNATURE                                   DATE


               (If appropriate, otherwise N/A)
              PARENT'S OR GUARDIAN'S SIGNATURE                              DATE

The above individual hereby verifies that he/she is the natural and / or legal guardian of print subject’s name here,
and as such has the legal authority to consent to the research outlined above for the subject.


        Relationship to patient:



                    WITNESS TO SIGNATURE                                    DATE



                    MEDICAL TRANSLATOR                                      DATE


            INVESTIGATOR'S (Physician’s) SIGNATURE                          DATE




                                                                                                 Patient’s Initials:




                                                             -15-
ADDENDUM B
Sample Consent Form, Minimal Risk

                                       PRESBYTERIAN HEALTHCARE SERVICES
                                                CONSENT FORM

Protocol Title


You have been invited to participate in a study that will try to determine (state what the study is designed to discover or hopes
to establish). You have been asked to participate because (state why the subject was selected for this study).

By participating in this study you are agreeing to:
(Describe the procedure that will be done with the frequency with which it may occur. Indicate any discomfort that may be
experienced; i.e., blood drawn and any chance of injury, i.e., bruising, clotting, hematoma). You will neither be paid nor
charged anything for participating in this project. While no direct benefits to you are expected from this study, the results will
be made available to your doctors. You will not be personally identified if the results of this study are published and your
participation will be kept confidential. You may withdraw from the study at any time simply by refusing (the procedure) or
telling your doctor. Withdrawing from the study will not affect your other medical care.

    “I have read this document and it has been explained to me. I have had an opportunity to ask questions and they
    have been answered to my satisfaction. If I have further questions, I may contact Dr. (Print name) at (phone
    number and address of treating physician here). With this understanding, I hereby consent to participate in this
    study.”

                                                                      __________________
                     PATIENT’S SIGNATURE                                     DATE


                (If appropriate, otherwise N/A)
             PARENT'S OR GUARDIAN'S SIGNATURE                                 DATE

The above individual hereby verifies that they are the natural and / or legal guardian of print subject’s name here, and
as such has the legal authority to consent to the research outlined above for the subject.


    Relationship to patient:



                    WITNESS TO SIGNATURE                                      DATE



                    MEDICAL TRANSLATOR                                        DATE



             INVESTIGATOR'S (Physician’s) SIGNATURE                           DATE


Presbyterian IRB
Guidelines and Policies                                     Page 16
                                                                                            Patient’s Initials:


ADDENDUM C
Sample Consent -Non Drug/Device or Invasive Studies


                                   PRESBYTERIAN HEALTHCARE SERVICES
                                            CONSENT FORM


TITLE OF RESEARCH PROJECT


You are invited to participate in a study conducted by (name of investigator and affiliation). We hope to learn (state
what the study is designed to discover or establish). You were selected as a possible participant in this study
because (state why the subject was selected).

If you decide to participate, you will describe the procedures to be followed including their purposes, how long they
will take, and their frequency. Describe the risks, discomforts, inconveniences, and benefits reasonably to be
expected. If benefits are mentioned, add the following statement, ‘We cannot guarantee that you will receive any
benefits from this study.’

(Describe appropriate alternative procedures that might be advantageous to the subject, if any. Any standard
treatment that is being withheld must be disclosed.)

Any information that is obtained in connection with this study and that can be identified with you will remain
confidential and will be disclosed only with your permission or as required by law. If you give us your permission
by signing this document, we plan to disclose state the persons or agencies to whom information will be furnished,
the nature of the information to be furnished, and the purpose of the disclosure.

(If the subject will receive compensation, describe the amount or nature. If there is a possibility of additional cost to
the subject because of participation, describe it. If there is risk to subjects, add the following): If you have any
questions regarding your rights as a human subject and participation in this study, you may call or write PHS
Institutional Review Board, at PO Box 26666, Albuquerque, NM (505) 841-1225 for information.

Your decision whether or not to participate will not prejudice your future relations with Presbyterian Healthcare
Services and the (named cooperating agency or institution, if any). If you decide to participate, you are free to
withdraw your consent and to discontinue participation at any time without penalty.

If you have any questions, please ask us. If you have any additional questions later (give a name, phone number
and/or address) will be happy to answer them. You will be given a copy of this form to keep.




Presbyterian IRB
Guidelines and Policies                                 Page 17
     “I have read this document and it has been explained to me. I have had an opportunity to ask questions and
     they have been answered to my satisfaction. If I have further questions, I may contact Dr. (Print name) at
     (phone number and address of treating physician here). With this understanding, I hereby consent to
     participate in this study.”

                                                                                   __________________
                          PATIENT’S SIGNATURE                                             DATE


                  (If appropriate, otherwise N/A)
               PARENT'S OR GUARDIAN'S SIGNATURE                                          DATE

The above individual hereby verifies that they are the natural and / or legal guardian of print subject’s name
here, and as such has the legal authority to consent to the research outlined above for the subject.


     Relationship to patient:



                        WITNESS TO SIGNATURE                                             DATE



                        MEDICAL TRANSLATOR                                               DATE



               INVESTIGATOR'S (Physician’s) SIGNATURE                                    DATE




                                                                                                            Patient’s Initials:




Adopted: 3/84                                                                                   \Policies\IRB\Informed Consent
Revised: 5/85, 6/86, 19/88, 5/89, 5/95, 9/96, 10/99, 11/00, 06/01/7/10



Presbyterian IRB
Guidelines and Policies                                                  Page 18

				
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