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					                   Olive View – UCLA
             Education & Research Institute
               Institutional Review Board




                      Investigator’s Handbook




Version Date July 2009 CURRENT
                                 TABLE OF CONTENTS



Section 1 – Introduction

Section 2 – Application Submission

Section 3 – The IRB Review Process

Section 4 – Informed Consent Requirements

Section 5 – The Informed Consent Process

Section 6 – HIPAA

Section 7 - Risk/Benefit Assessment

Section 8 – Selection and Recruitment of Subjects




Version Date July 2009 CURRENT
SECTION 1
INTRODUCTION
The Olive View-UCLA Education & Research Institute (ERI) Institutional Review Board’s
operating procedures details policies and regulations governing research with human subjects. It
includes requirements for submitting research proposals for review by the Institutional Review
Board.

Sections of the manual describe and explain the various aspects of the review process and
regulatory requirements. Investigators should familiarize themselves with the contents of the
manual. In addition, they should carefully review the sections of the manual that address their
specific research activities before submitting proposals to the IRB.

This manual presents the most current information for reference by potential investigators and
their staff. Since the field of human subject protection is constantly evolving, sections of the
manual may be subject to change. The IRB support staff will keep the ERI research community
apprised of all developments.

What is Research?

Virtually all federally funded research with human subjects is governed by federal regulations
patterned on those of the DHHS, found at Title 45 Code of Federal Regulations Part 46 (45 CFR
46).

Research is defined in 45 CFR 46 as, "a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable
knowledge." Human subjects are defined by the regulations as "living individual(s) about
whom an investigator (whether professional or student) conducting research obtains (1) data
through intervention or interaction with the individual, or (2) identifiable private information."
The Institutional Review Board (IRB) at Olive View is commonly referred to as the IRB and is
required by federal regulations to review all human subject research, regardless of funding, to
ensure the rights, welfare, and protection of all subjects.

Research: A Shared Responsibility

The review of research performed by faculty, students, or employees is conducted by the IRB.
Currently, ERI has one IRB responsible for all research projects at Olive View-UCLA Medical
Center. The IRB is comprised of faculty representatives from various academic disciplines at
Olive View, non-scientific members, and community subject representatives who are not
affiliated with the medical center. The IRB operates within the federal guidelines with respect to
the review and approval of research protocols involving human subjects.

The goal of the IRB is to develop and process in which subjects voluntarily decide to participate
in a study based on an intelligent and knowledgeable assessment of the risks and benefits of the
research.


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The ERI, investigators and their research staff, and the IRB share the collective responsibility for
the ethical conduct of research. This collaboration must exist in a culture of trust, complete
openness, and honesty by upholding the highest ethical principles in the conduct of research. By
upholding the highest standards, we build public support for the pursuit of greater knowledge in
a safe research environment.

The IRB is charged with a twofold mission:

1) to determine and certify that all projects reviewed by the committee conforms to the
regulations and policies set forth by the Department of Health and Human Services (DHHS)
regarding the health, welfare, safety, rights, and privileges of human subjects; and

2) assist investigators in conducting ethical research which complies with the DHHS regulations
in a way that permits accomplishment of the research activity.


The Foundation of 45 CFR 46: THE BELMONT REPORT

In 1974, Congress passed the National Research Act. The act created the National Commission
for the Protection of Human Subjects of Biomedical and Behavioral Research. The National
Commission wrote the Ethical Principles and Guidelines for the Protection of Human Subjects of
Research - commonly called the Belmont Report. The Belmont Report is considered to the be
the cornerstone for ethical principles upon which the federal regulations for the protection of
subjects are based (45 CFR 46). Three important principles were defined in the report as basic to
the protection of human subjects. They are:1) respect for persons, 2) beneficence, and 3) justice.

Scientific research has not only produced substantial benefits, it has also resulted in serious
ethical questions. The three principles of the Belmont Report are detailed below.

        Respect for Persons. This includes two ethical considerations: first, individuals should
        be treated as autonomous agents; and second, persons with diminished autonomy are
        entitled to increased protection. Person with diminished autonomy are considered
        vulnerable subjects/population. Vulnerable populations are those groups that may
        include persons with limited autonomy. They include such groups as children, mentally
        disabled, individuals with dementia and other cognitive disorders and prisoners. Extra
        precautions to protect those individuals who are immature or incapacitated are required,
        perhaps to the extent of excluding them from participation in certain research. Pregnant
        women are also recognized by the regulations as a vulnerable population. The extent of
        protection depends on the risks and benefits of the research. Additional protections
        pertaining to research development and related activities involving fetuses, pregnant
        women, and human in vitro fertilization are contained in Subpart B. Additional
        protections pertaining to biomedical and behavioral research involving prisoners as
        subjects are contained in Subpart C. Additional protections for children involved as
        subjects in research are contained in Subpart D.

        Beneficence. The principle of beneficence means that researchers are responsible for

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        maximizing the potential benefits to research subjects and minimizing potential risks of
        harm. Benefits to the subjects, or in the form of generalized knowledge gained from the
        research, should always outweigh the risks.

        Justice. The principle of justice means that subjects are selected fairly and that the risks
        and benefits of research are distributed equitably. Investigators should take precautions
        not to systematically select subjects simply because of the subjects’ easy availability,
        their compromised position, or because of social, racial, sexual, economic, or cultural
        biases institutionalized in society. Investigators should base inclusion criteria on those
        factors that most effectively and soundly address the research problem. Specific groups,
        such as the economically disadvantaged or illegal immigrants, need to be protected from
        being manipulated to participate in research due their status.




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SECTION 2
APPLICATION SUBMISSION
The IRB Application Packet includes a Study Abstract form, a sample consent form, and
instructions. The IRB Administrator will be happy to answer any questions you may have
regarding the participation of human subjects in research or the review of applications by the
IRB.

The Basic Application - Initial Review of a New Application

The most common form of IRB application includes the following items:

1.      IRB Application Form: The IRB Application Form is the document requesting IRB
        review of your proposal. Please complete each section as applicable to your submission.
        The information you provide in the application must include sufficient detail to facilitate
        an effective review by all members of the IRB.
2.      Study Abstract: IRBs are required by the federal regulations to include members from
        various backgrounds, at least one member from the community-at-large, and at least one
        non-scientific member. The study abstract should not be more than one page and should
        explain your research for the lay reader.
3.      The Informed Consent Form/Assent Form: There are sample consent forms for medical
        research and a sample assent form for research with children between the ages of seven
        and 13. All consent/assent forms are required to reflect the IRB format and style. Only
        ERI IRB reviewed, approved, stamped, and dated consent forms can be used to consent
        subjects. If you are conducting the same research study at another site, you are required
        to obtain IRB approval from the ERI IRB in order to conduct the research project at Olive
        View-UCLA Medical Center. Due to the large Hispanic population at Olive View-
        UCLA Medical Center, all consent forms are required to be translated to Spanish.
        Translation must be certified. This ensures that non-English speaking and reading
        subjects are able to participate in the research process while adhering to the Belmont
        Report’s principle of justice.
4.      IRB questions to answer: Each question should be answered with sufficient information
        for effective review by all members of the IRB including non-specialists. Attaching
        sections of the grant application or study protocol is not an acceptable substitute.
5.      The Research Protocol: A detailed research protocol is required for the complete IRB
        review of your research. All submissions should include a scientific protocol that
        includes a complete explanation of the following information:
        a.      Background
        b.      Objectives of the research
        c.      Significance
        d.      Thorough description of how human subjects will participate in the research
        e.      Eligibility requirements for subjects
        f.      Design/methodology
        g.      Treatment regimen(s) (for medically invasive research)
        h.      Clinical information (when applicable) (for medically invasive research)
        i.      Analysis of the collected data
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        j.      References
6.      Investigation Drug Form (if applicable)
7.      Investigational Medical Device (if applicable)

All investigators should carefully review the requirements for submission of applications to the
IRB. Submission of incomplete proposals may result in the delay of the review and approval
process. The application will not be considered for review if the application submission is
incomplete and or does not fulfill the IRB guidelines. Investigators should carefully review their
application in order to ensure that appropriate forms and documents are submitted for IRB
consideration.


If the Research Involves Advertisements, Posters, Flyers, Press Releases, etc., to Recruit
Subjects:

The IRB is required to review any advertisements, flyers, internet postings (with the internet
address), etc., for subject recruitment, correspondence to subjects or other cooperating
individuals such as referring physicians or facilities. In addition, the IRB reviews all press
releases intended to facilitate recruitment of subjects. Contact documents are not approved or
valid without an IRB approval stamp, date, and number. Only IRB approved documents may be
used in the conduct of research.

If possible, please include recruitment materials with your initial application. If the material is
not ready at the time of initial application, investigators may submit the material for expedited
review by the Chair or designated IRB official. Requests for approval of recruitment materials
following initial IRB review of the protocol should allow sufficient time to allow for any
necessary revisions prior to publication.

Any type of advertisement or contact material should not make any claims, either explicitly or
implicitly that the research is superior to any current practice. Information should be limited to:

1.      The name of the investigator and contact information, including the name of Olive View-
        UCLA Education & Research Institute;
2.      a simple and concise description of the purpose of the research;
3.      general eligibility criteria for participation;
4.      a truthful description of the possible benefits which may result from participation in the
        research. If there are no benefits, indicate whether subjects are paid for their participation
        or receive free treatment.

If the Research Includes Surveys, Questionnaires, etc.:

The IRB is required to review all research instruments such as surveys, questionnaires, etc.
Please include the instruments, if available with your initial application. Investigators may
submit draft versions of study instruments for IRB review. The IRB is required to review any
modifications to research instruments. Please submit to the IRB when requesting changes to
previously approved instruments. If the IRB approves the project prior to the review of the

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finalized instruments, the instruments cannot be used until they are reviewed and approved by
the Committee.

Drug and Device Brochures:

The IRBs are required to examine the Investigator’s Drug Brochure and/or device manual in
order to adequately assess the risk/benefit ratio for subjects participating in the research. In
addition, please complete the Investigation Drug Form and/or Investigational Medical Device
Form and submit with the initial application.

Emergency Care & Compensation for Injury

There are special considerations for emergency care and compensation for injury to subjects
participating in privately sponsored drug and device studies. (Please see Section 4, "Informed
Consent Requirements: Description of Informed Consent Forms, Emergency Care and
Compensation for Injury," for more information.)

Exemption Application

A study may qualify for an exemption if it is research activity that does not require IRB review
and approval. The ERI, however, is still obligated to review all such activities, whether funded or
not, and certify that the research meets the federal requirements for an exemption. In order to
fulfill federal requirements for the proper review of research, investigators cannot "self-exempt"
from IRB review. The ERI has determined that evaluation and certification of exempt status is
performed by the IRB Chair. If the activity does not qualify for a Claim of Exemption, the
investigator is notified by the ERI. The exemption application does not necessarily mean that the
investigator is exempted from the informed consent requirements

The following materials are required when submitting an Exemption Application:

1.      Exemption Application
2.      An abstract of the research, purpose and objectives of the study.
3.      Consent forms or a statement indicating that the activity qualifies for a waiver of
        informed consent under the guidelines outlined in Section 4, "Informed Consent
        Requirements";
4.      Recruitment materials, i.e., advertisements, flyers, phone scripts, etc.
5.      Approval from participating institutions, i.e., schools or agencies, if applicable.

Modifications to Currently Approved Research

All modifications to currently approved research are required to have IRB review and approval
prior to implementation. Minor changes that do not increase the risk to research subjects may
receive an expedited review. Modifications to approved protocols that may affect the risk to
subjects are forwarded to the full Committee for review. When submitting a modification, please
include a cover letter explaining the requested modifications, and any modified items such as
consent forms, protocols, investigator brochures, study instruments, recruitment tools, etc., with

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the application.
An addendum may require full Committee review if the modification is significant and impacts
the risks and benefits to subjects in the research. Changes in the risks or benefits to subjects may
require modifications to the consent form and re-consenting of subjects.

The IRB may only approve modifications submitted during a current approval year to the end of
that period. For example, if a new or renewal approval is issued on January 1, 2000, it will have
an expiration date of December 31, 2000. If an addendum is approved during this time, the
approval still lasts only until December 31, 1997. Please incorporate all addendums into the
renewal application, protocol, and when applicable the informed consent forms for IRB
consideration during the annual review.

Changing Investigators

When changing investigators, please include an Application Form and a letter from the principal
investigator indicating the change in responsibility and a letter from the new investigator
accepting responsibility for the research. Changes in investigators usually qualify for expedited
review.

Annual Review and Renewal

The federal regulations do not allow the IRB to approve a study for more than one year. For
multi-year research, the principal investigator is responsible for submitting a renewal application
prior to the expiration of the current IRB approval. The ERI mails a renewal application to
investigators approximately 90 and 60 days prior to the expiration of the current IRB approval. If
the approval expires prior to submission of the continuation application, the investigator is
required to suspend subject contact and data collection until the continuation is approved by the
IRB. For therapeutic studies where subject safety is a concern, the FDA allows some flexibility
towards the continued treatment for currently enrolled subjects. However, no new subjects may
be contacted, recruited, or enrolled until the investigator obtains current IRB approval.

The continuation application should incorporate all of the addenda and modifications submitted
to and approved by the IRB during the previous approval periods. Please include a cover letter
indicating the modifications to the study during the previous approval period.

Continuing review and approval is necessary if recruitment of subjects stops but previously
enrolled subjects continues to participate in the research or the study is in data analysis at Olive
View-UCLA Medical Center.

Completion/Termination

In order to formally complete a study file, the IRB requests that investigators officially notify the
ERI when a study is terminated or completed or after data analysis is complete. Investigators
should complete and submit Final Report Form when closing out a study.

Training Grants, Program Projects/Multiple Project Grants, Center Grants

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The federal regulations require that the IRB or their designee certify that human subject related
research funded by an "overall" grant such as a training grant, program project, multiple project
grant or center grant have current IRB approval. Please submit one copy of the following:

1.      Complete IRB application packet.
2.      A cover letter indicating that no funds will be transmitted to the individually supported
        sub-projects proposing to conduct research with human subjects until the sub-projects
        have received current approval from the IRB; and
3.      A list of the entire human subject related projects supported by the grant. The list should
        include the following:
        a.      The name of the principal investigator(s);
        b.      The IRB numbers of the project(s);
        c.      The title of the project(s);
        d.      The current approval periods for the project(s).

The IRB has delegated certification authority to the ERI. As a result, the ERI will certify
whether the human subject related projects under the "overall" grant have current approval and
perform an administrative approval of the funding submission.




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SECTION 3
THE IRB REVIEW PROCESS
The review of research by the is conducted in accordance with a Multiple Project Assurance
(MPA) which is an agreement with the federal government, approved by the National Institutes
of Health, Office for Human Research Protection (OHRP). The MPA stipulates that ERI will
protect the rights and welfare of human research subjects through a review process detailed in 45
CFR 46. Through the MPA, the IRB retains the authority at Olive View-UCLA Medical Center
for the approval of research with human subjects. IRB review applies to research conducted by
faculty with a current PSA appointment, either on the premises or utilizing the facilities or
resources of the ERI or Olive View-UCLA Medical Center. The review requirements apply to
all research conducted under the auspices of the ERI, regardless of funding source or support.

In addition to review by the ERI’s IRB, the Department of Health Services (DHS) has created a
Research Oversight Committee (ROC). This committee is responsible for the review of research
applications that have been reviewed and approved by the five IRBs which function within DHS
and the affiliated medical schools, but which are found to meet one or more of the seven criteria
which have been defined by DHS as reasons why additional departmental review is required.
The following criteria requiring ROC review are as follows:

1.      Proposals which are approved by the IRB with dissenting votes occasioned by concerns
        related to the protection of human subjects
2.      Proposals which involve community sensitivities
3.      Proposals which present high risks and minimal benefits to the human subjects of the
        research
4.      Proposals which include the use of L.A. County resources without adequate
        reimbursement from the funding source
5.      Proposals which are high profile and likely to attract press or media attention.
6.      Proposals which request waiver of consent.

The ERI Research & Education Operations Committee (REOC) reviews all approved IRB
projects at its monthly meeting. Any study determined as requiring ROC review will be
forwarded by the REOC to the ROC. A list of all approved studies is also forwarded to the
hospital’s Professional Staff Association (PSA).

The Institutional Review Board

In order to maintain a review process that is responsive to the concerns of all involved, the
federal regulations require that the IRB membership reflect experience, expertise and diversity in
academic, research and professional background, racial and cultural heritage, and a sensitivity to
community attitudes. When the IRB reviews research involving a vulnerable category of
subjects, such as cognitively impaired individuals or prisoners, it is required to include one or
more individuals qualified to represent that group, either through personal experience or
experience working with that population.

The Committees are responsible for ensuring that all approved research complies with the letter
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and spirit of the human subject protections regulations as well as the three principles previously
defined in the Belmont Report, respect for persons, beneficence, and justice. The IRBs examine
recruitment procedures, proposed remuneration (in cash or in kind), the informed consent
process, and evaluate the risks and potential benefits to subjects outlined in each protocol. The
review will help ensure that investigators recruit subjects in an equitable, non-coercive manner
that subjects are fully informed about the risks and benefits entailed in participation, and that
subjects are not exposed to disproportionate risks.

The review of IRB applications is considered a process. It begins when the investigator submits
and application for review. When the application is reviewed by the IRB, the investigator will
receive written notification detailing the committee’s action. The investigator will receive
notification that the study was approved with no changes; was approved with revisions, or was
tabled. Although the IRB has the authority to disapprove a study, this is not common.
Correspondence received from the committee stating that the study is approved pending
conditions is typical and should not be viewed as a negative comment about the content of the
research nor is it necessarily analogous to disapproval of the study. In certain circumstances the
Chair may appoint a committee member to work with the investigator to revise the application to
meet the necessary requirements.

The IRB has the authority to approve, to require modification in, and to disapprove proposed
human subject research. The IRB also has the authority to suspend or revoke its approval of
ongoing research [45 CFR 46.113]. Failure to comply with IRB requirements is considered
serious misconduct and may be subject to sanctions including possible termination of approved
research.

Issues Considered by the IRB

The IRB will consider the following issues when reviewing requests to involve human subjects
in research:

1.      Study Design: The IRB will examine the study design insofar has an impact on the rights
        and welfare of the human subjects. The OHRP indicates in the, Protecting Human
        Subjects, Institutional Review Board Guide Book, that, "...if a research study is so
        methodologically flawed that little or no reliable information will result, it is unethical to
        put subjects at risk or even inconvenience them through participation in such a study."
        Many experts agree that the IRB should approve only research that is both valid and of
        value. The committee may request an expert consultant review or defer to scientific
        review committees in order to determine whether a study design places subjects at
        unnecessary risk.

        The federal regulations allow the IRB to approve a study design that involves deception
        or withholding of information if the strategies are justified and the protocol provides for a
        post-study debriefing of the subjects. The IRB may grant a waiver of the debriefing
        requirement if the debriefing may prove harmful to the subjects. (Please see Section 4,
        “Informed Consent Requirements: Deception and the Withholding of Information", for
        more information.)

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        Risks and Benefits: The IRB will assess whether the risks to subjects are reasonable in
        relation to the anticipated benefits, if any, to the subjects, and the importance of the
        knowledge reasonably expected to result from the research. The Committee will consider
        only those risks and benefits that may result from the research. The federal regulations do
        not allow the IRB to evaluate the possible long range effect of applying the knowledge
        gained through the research. [45 CFR 46.111] (Please see Section 5, "Risk/Benefit
        Assessment" for more information.)

        The IRB is required to review any possible benefits a subject may derive from
        participation in research, and/or the benefits of new knowledge that may justify asking a
        person to undertake the risks of the study. Payment for participation in research is not
        considered a benefit.

        Equitable selection of subjects: The selection of subjects should be equitable and free of
        coercion. The IRB will consider the purpose of the research and the setting of the
        research. The Committee will closely examine research involving vulnerable subject
        populations, such as children, prisoners, subjects with cognitive disorders, or
        economically or educationally disadvantaged subjects. Investigators should indicate in
        their submission how they will avoid the appearance of coercion in the recruitment of
        subjects. They should also detail any extra precautions taken to safeguard the rights and
        welfare of subject populations.

        Identification of Subjects and Confidentiality: The IRB is required to review the method
        for prospective identification of subjects. They will examine the means of identifying and
        contacting potential subjects and the methods for ensuring the subjects' privacy and
        confidentiality. Investigators are required to submit plans for ensuring the confidentiality
        of subjects. (Please see Chapter ___, "Informed Consent Form Requirements:
        Confidentiality"; Chapter ___, "Selection & Recruitment of Subjects"; Chapter ___,
        Responsibilities of Principal Investigators: "Confidentiality" and "Certificates of
        Confidentiality"; and Chapter ____, "Special State of California Requirements", for more
        information.

        The Informed Consent Process: The IRB will carefully review the informed consent
        process: when, where, and how consent is obtained and any provisions for the ongoing
        consent of subjects. (Please see Chapter 4, "Informed Consent Requirements" for more
        information.)

        Qualifications: The IRB will examine the qualifications of students and/or faculty
        investigators. Procedures requiring special skills on the part of the investigators,
        licensure, accreditation, and/or experience in qualifying the investigator for the
        performance of the proposed procedures are reviewed by the Committee. In addition, the
        Committee will consider the facilities and equipment used to conduct the research and
        maintain the rights and welfare of the subjects.

        Additional Review: The IRB will determine whether a project requires more than annual

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        review and may require an appropriate monitoring procedure that could include
        monitoring of the consent process, observation of the research procedures, and review of
        research related records. In some instances, the IRB may refer review of the research to
        an additional committee assigned by the IRB to monitor individual projects.




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SECTION 4
Informed Consent Requirements
The purpose of this section is to assist the investigator by providing guidance on how to obtain
valid informed consent from potential research subjects. The informed consent process is
fundamental to ensuring the continuous and adequate disclosure of research related risks and
benefits. Written informed consent is also required by federal regulations and State law.

The Process of Informed Consent

In the past, it was generally accepted that written informed consent, obtained at a single contact
between an investigator and a subject, was sufficient to meet legal and ethical obligations to
patients and research subjects. This view was abandoned in the 1970’s. Informed consent is now
understood as an on-going process which starts with the initial presentation of a research activity
to a prospective subject by the investigator and continues through the research activity until the
subject ends his/her participation or the study closes.

Research subjects are rarely aware of research activities prior to an initial presentation by the
principal investigator or a member of the principal investigator’s study team. The initial phase of
consent requesting participation in a research activity commonly begins with the first contact
between the subject and the investigator. Many subjects make their decision regarding whether to
participate in research during the initial contact. As a result, the greatest potential for
misunderstanding exists in the initial consent process. Researchers are encouraged to provide
sufficient time for a potential subject to reflect on the nature of participation during the important
initial presentation of a research activity. When subjects are presented with numerous research
and clinical options, the consent process should include a clear description of the possible
ramifications resulting from each option presented. The presentation should not include specific
"leading" information about whether to participate in any particular project.

By providing a potential subject with understandable information in an initial session regarding
complex research issues, potential subjects will have an improved comprehension of the
elements within the consent form and provide a more informed consent for participation in the
research.

The second step in the consent process is the presentation of the consent form to subjects. The
investigator should separate the research consent form from other clinical information or hospital
admission forms. Subjects should not be asked to sign hospital admission paperwork or hospital
consent documents for clinically indicated procedures at the same time as the presentation of the
research consent form.

A member of the study team should ensure that the subject reads the consent form. After the
subject reads the consent form, the member of the study team should ask the subject if he/she
understands the information contained in the form. In situations where the ability of the subject
to understand the form is in question, for example, the form includes complex scientific
information or the subject is possibly educationally or mentally challenged, the member of the
study team may wish to ask questions of the subject to ensure an understanding of the basic
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elements of the consent form. In performing an assessment of the subject’s comprehension of the
consent form, an investigator should request that the subject indicate the risks of participation,
how the subject may withdraw, and what alternatives exist to participation in the research. The
decision-making capacity of subjects with psychiatric disorders or cognitive deficits (such as
dementia) should be evaluated by a practitioner not otherwise affiliated with the research.

All efforts should be made to offer potential subjects sufficient time to consider the information
contained in the consent form. The subject should be given an opportunity to take the consent
form home and sign the form on a return visit or the subject may be left alone to consult
enrollment with family or friends. If the individual decides to participate, he/she would sign the
consent form, the principal investigator would co-sign the form, and if the research involves
more than minimal risk, the Committee may require a witness to document the process by also
signing the form.

The consent process does not end with the signing of a consent form. Research is an on-going
process which involves the constant re-evaluation of current information and procedures.
Therefore, investigators are ethically obligated to keep subjects apprised of all issues related to
their participation in the study. For example, a sponsor may, during the course of a study, decide
to supply a drug free-of-charge to subjects following their participation in the research. The new
information should be presented to research subjects in a written form and the subjects should be
asked to sign a copy of the form or to sign a revised consent form. Likewise, adverse events may
occur during a research activity that would directly affect whether prospective or enrolled
subjects would wish to continue in a particular research activity. Subjects must also receive the
new information as a part of the continuing consent process. Investigators should note that the
IRB requires Committee review and approval prior to an investigator providing subjects with
new research information.

Information also may arise regarding the study which should be shared with previously enrolled
subjects after their completion of the study, or a specific treatment or procedure. For example,
dysfunctional families may participate in qualitative research examining parenting techniques.
Following data analysis, the investigator finds that a specific technique is superior to the other
study arms of the project. As a health care and educational institution, Olive View-UCLA
investigators are morally obligated to provide this valuable new information to research subjects.

In conclusion, it is difficult to be confident that volunteers truly understand the nature of their
participation in research when they are confronted with volumes of complex scientific details in
a brief and isolated consent session. By rejecting the outmoded belief that informed consent
starts and ends with a consent document, investigators and subjects will work as partners in a
healthy process of an equal exchange of information and scientific discovery. As a result,
subjects will have an improved understanding of the risks and anticipated benefits (to
themselves, others, and society) of participating in the research. Creating an ongoing consent
process will facilitate an exchange of information between subjects and investigators in a
scientific environment of increasing complexity. In providing subjects with a continuing consent
process we will ensure that subjects are completely informed about their participation in the
research. By providing subjects with the opportunity to give effective and on-going informed
consent, in a process that incorporates the free exchange of information between both the

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researcher and the subject, investigators will continue to set the standards for the conduct of
ethical research.

Writing the Consent Form

The consent form is intended to serve as only one aspect of an on-going dialogue between the
investigator and the subject. Subjects are autonomous and should voluntarily give their consent
to participate in research. As a result of their voluntary participation, subjects reserve the right to
withdraw their participation from the research without prejudice. Therefore, the consent form
should serve as just one element in an equal exchange of information between the investigator
and the subject and not a binding contract between two parties.

Delays in IRB approval most commonly result from the submission of an inadequate consent
form. The design of the consent form should carefully reflect the process of informed consent,
i.e., introduce the investigator to the subject; indicate why the subject is requested to participate
in the study; articulate the purpose of the study; clearly separate the research procedures from
any standard treatment; inform the subjects of the risks and benefits of participation; and
ultimately document the subject’s willingness to participate in the project. Oftentimes the
consent form is too technical and includes scientific jargon which can prove incomprehensible
and ultimately intimidating to a subject.

Studies have found that most subjects read at a sixth grade level or lower. Therefore, consent
forms should avoid or define technical jargon or terminology, adjust for educational background
and age, and provide translations for subjects who are not facile in English. The IRBs may
require separate forms for different subject groups, such as parents, children, healthy control
subjects, etc.

Consent forms that contain medical language, social science terminology, and metric equivalents
for quantities are routinely returned to investigators for modification. If the subject cannot
understand the consent form they cannot give knowing consent for their participation in the
research. The IRBs suggest that investigators have a colleague or staff person, not familiar with
the field of research, review the consent form for content and readability prior to submitting the
form for Committee review.

A typical problem for research requesting the inclusion of blood draws or biopsies is the use of
metric measurements in the consent form. Most subjects do not understand metric measurements,
i.e., how much blood is in 10 ccs. Therefore, the Committees commonly request the translation
of metric measurements into teaspoons, tablespoons, etc. In a similar spirit, biopsies should be
described or equated with a commonly recognized amount.




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SECTION 5
Informed Consent Process
Before meeting with the potential subject:

The Principal Investigators should:

1.      Verify that the consent form to be used is approved by the IRB, active (the day s/he is
        consenting the subject is within the stamped approval period) and is the most current
        version. The regulatory binder should be checked so that no amendments, or consent
        modifications have occurred.

2.      Check that all text in the consent form is legible (including the IRB stamp) and that all of
        the pages are included.

3.      Ensure that s/he knows the correct date (the day the Principal Investigator and subject are
        completing the consent).

Meeting with the subject:

The PI, Co-investigator(s), or designated study personnel listed on the cover page of the IRB
protocol application are the only staff members approved to obtain informed consent.

1.      The Investigator, Co-Investigator or study personnel will explain the nature of the study,
        its purpose, procedures, expected duration and the benefits and risks of participation in
        accordance with Federal regulations.

2.      The potential subject will be informed of his/her rights to privacy and that the study data
        will be submitted to the sponsor, the Federal Oversight Agencies and to drug regulatory
        authorities for review (if applicable). The subject will also be informed of other entities
        that will have access to his/her research records including, but not limited to the FDA,
        CRO monitors and IRBs.

3.      A review and discussion of the consent occurs between the PI/Co-I/designated study
        personnel and the subject where s/he is encouraged to ask questions.

4.      The subject is given the opportunity to review the consent alone or to review it with study
        personnel.

5.      f a subject is unable to read or if the PI/Co-I is concerned of his/her reading
        comprehension, the PI/Co-I should read it to him/her.

6.       If the subject does not speak or read English, then a certified IRB approved translation
        form must be provided in the appropriate language.

7.      Subjects are encouraged to take the informed consent home and discuss it with family
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        and significant others.


Filling out the consent form:

1.      The subject must sign and date the current approved consent form. The subject should be
        sure to complete any initial lines, checkboxes, or blanks that appear on the form.

2.       In certain studies where the IRB has approved consent by a subjects legally authorized
        representative, the representative should sign the consent form on the last page. (e.g. a
        study where a subject is not competent or capable for signing for him/herself).

3.      The principal investigator, co-investigator or other study personnel who obtains the
        consent must sign and date the ICF.

4.      All signatures must enter the date on the ICF themselves.

After completing the consent form:

1.      The consent form must be reviewed for completion and accuracy.

2.      Two copies of the IRB consent form should be made (ensuring ALL copies are legible).
        The original signed ICF document is placed in the subject’s study file. A copy of the ICF
        document must be given to the subject.

3.      A progress note, dated the same day the ICF was signed, must state that the subject
        willingly signed the informed consent form to participate; demonstrated understanding of
        study risks and benefits involved and signed HIPAA Authorization form. It is also best to
        put the time alongside the date in the event any study procedures occur later that same
        day.

Possible example of what the progress note text should include:
Subject reviewed and signed the informed consent form with (PI/Co-I)                          . The
overall design of the study, risks, benefits and the voluntary nature of participating in the study
were discussed. Subject had the opportunity to ask questions to the site investigator and
demonstrated understanding of study, risks, benefits and voluntary nature of study. The subject’s
condition does not preclude his/her ability to sign informed consent. An original consent was
placed in the subject’s study file. Subject was given a copy of the consent form.


Re-consenting

Re-consenting may be required for various reasons including but not limited to cases where:

The original consent form was not properly executed (missing date, time, checkboxes, etc.)
The study has been amended (i.e., changes in the study procedures that affect current subjects)

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Additional information (drug safety) becomes available which may affect a subject’s willingness
to continue in the study.


Revised Consent Forms and Re-consenting Subjects

When an informed consent form is modified and stamped/approved by the IRB, the principal
investigator will receive the original of the revised consent form. In turn, all coordinators must
make sure each active subject signs the modified/revised consent form. Example: if an
amendment adds an ECG to the 3rd week visit, but the subject is already in his 6th week, there is
no need to re-consent that subject. However, if the subject were only in his/her 1st week, he/she
would need to be re-consented. Additionally, if a new subject is entering the study, he/she must
sign the revised consent.

This re-consent must be documented in the subject's study file; a copy must be given to the
subject

Updated/ No Changes in Consent Form at time of Continuing Review

The protocol and ICF are submitted to the IRB for Continuing Review within a specified time
period following the initial approval (usually on a yearly basis). At the time of continuing
review, if approved, the IRB stamps the informed consent for the given period of time, again,
usually 1 year. Once the continuing review is approved and the consent is stamped by the IRB,
any future study subjects who are re-consented MUST sign the updated informed consent form.
However, if no changes are made to the consent, active subjects do not have to re-sign the
updated consent form.

Example:
      A consent form has an IRB stamp dated 11/01/2004 – 10/31/2005
      Subject X is consented and enrolled on 8/15/2005 (within the approved timeframe).

The protocol undergoes annual review and a new consent is released with an IRB stamp dated
10/15/2005 – 10/14/2006.

         If subject X is still active in the study and the informed consent form remains
         exactly the same (except for the IRB stamp period), then subject X does not
         need to be re-consented. The original consent obtained on 8/15/2005 remains
valid.
Again, it is important to remember to document in the subject’s study file medical record that he/she was re-
consented. The progress note should use text similar to that used for the original consent.

Subject reviewed and signed the revised informed consent form with (PI/Co-I.) All
changes/revisions to the consent form were discussed. Subject had the opportunity to ask
questions to the site investigator and demonstrated understanding. An original revised consent
was placed in the subject’s study file. Subject was given a copy of the revised consent form.


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SECTION 6
HIPAA
HIPAA is the Health Insurance Portability and Accountability Act of 1996. This federal law has
an "Administrative Simplification" title within it that includes provisions for Privacy and
Security of personal health information, as well as for electronic standards for communicating
claims data, and unique identifiers for healthcare providers and organizations. The provisions of
HIPAA that most affect research are the Privacy Rule, and a corresponding Security Rule.

A HIPAA covered entity is an organization that, by virtue of providing healthcare services and
billing for them using electronic means, is subject to the provisions of HIPAA. The Olive View-
UCLA Medical Center and the OV-UCLA Education & Research Institute are consider "hybrid
covered entities" meaning that provides healthcare services but also has other functions, such as
education and research.

During the ICF process the subject must also sign the Olive View-UCLA Education & Research
Institute’s HIPAA Authorization form (if applicable). The same investigator, or co-investigator,
who conducts the ICF process will explain to the subject that by signing the HIPAA form s/he
authorizes his/her medical information to be shared with those parties listed on the form for the
purposes of the research study. If the subject does not agree to sign the HIPAA form, s/he
cannot participate in the research study. The HIPAA form does not require the signature of a
witness or an investigator. The original HIPAA form should be kept with the original consent
document in the subject’s study file.

It is the investigator’s responsibility to ensure that each subject participating in the study gives
his/her consent to participate and that he/she authorizes the sharing of his/her protected health
information (as indicated on the HIPAA Authorization form).

Protected Health Information (PHI)

Protected Health Information is a type of individually-identifiable information that arises out of a
healthcare service context. The protections of the HIPAA Privacy Rule apply to PHI. Not all
individually identifiable information is PHI, however. Specifically, in a research context, a study
only uses or produces PHI if it is using medical records as a source of information, or is
providing a healthcare service to the research participant.

When is research subject to HIPAA?

If the research involves review of person-identifiable medical records, or the study results in new
information that is added to medical records (such a test of a new diagnostic or therapeutic agent
or device), then it is using or creating PHI and is subject to HIPAA Privacy Rule provisions.
Research subject to HIPAA will require the following:
A signed HIPAA authorization will be required for newly consented study participants starting
April 14, 2003, or the project must have a Waiver of Authorization approved by the IRB.
Participants who signed consents prior to April 14, 2003 do not need to be re-consented.
Although federal regulations allow the HIPAA language to be included in the consent, California
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law requires a separate “stand alone” HIPAA authorization form, which is also available in a
Spanish language version.

Confidentiality of the information must be protected by physical security, access controls such as
password-protected computer applications, and by the general principles of "minimum
necessary" and "need to know".

How HIPAA affects language in Informed Consent Documents

For research studies that use or create PHI, HIPAA mandates that seven additional elements be
explained in a separately signed authorization for use of personal health information:

        1. Description of information to be used.
        2. Name of person(s) or class of persons (e.g., project staff) who will use the information
        3. Name of persons or organizations to whom PHI information will be released. (e.g.,
           study staff, project sponsors and the central coordinating offices of multi-center trials)
        4. Expiration date or event that ends authorization to use PHI (e.g., completion of the
           research), or statement that authorization does not expire.
        5. Statement of right to revoke authorization (part of withdrawal from study procedures).
        6. If information will be disclosed to other organizations, statement that information may
           no longer be protected.
        7. A statement that individual may inspect or copy the records (researcher may stipulate
           records are not available until after study complete)


HIPAA Effective Date

Compliance was required as of April 14, 2003. Newly enrolled participants in research studies
affected by HIPAA will need to sign a separate HIPAA authorization form. Permissions and
authorizations executed prior to April 14, 2003 remain in place, and there is no need to re-
consent participants already enrolled in studies as of that date.

De-identified Information

De-identified information is the term used for personal health information that has had
identifying characteristics removed. This form of data was historically called "anonymous" but
the authors of HIPAA recognized that health information is so rich in potentially identifying
characteristics that it can never be truly anonymous; there will always be some potential for re-
identification of an individual. HIPAA contains a "safe harbor" provision that states information
is not subject to HIPAA restrictions on PHI if 18 different elements are removed.

Minimum Data Set

A minimum data set is a partially de-identified dataset that has 8 elements removed rather than
18. Because a minimum data set retains information that could be used to relatively easily re-
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identify an individual (such as medical record numbers and dates of hospital admissions),
research involving use or disclosure of a minimum data set has to be accompanied by a Data Use
Agreement specifying the researcher's agreement to use the data only for approved research
purposes, and that the researcher will not attempt to re-identify individuals. Although HIPAA
does not require IRB review of research that uses HIPAA minimum data sets, ERI researchers
should submit a HIPAA Application for Waiver and Authorization for Use to receive
documentation of project approval for presentation to the Medical Records Department.

ERI provides a separate HIPAA form with each approved English and Spanish informed consent
form. The form includes the study title, IRB number and investigator’s name. Exceptions to this
standard language are subject to review and approval by the ERI.

Additional Information on HIPAA and Research

For additional information on HIPAA and research visit http//:privacyruleandresearch.nih.gov.




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SECTION 7
Risk/Benefit Assessment
Investigators submitting research proposals for IRB review should understand that the
Committee is responsible for assessing the risks vs. anticipated benefits of research as one of its
primary functions. In addition, once risks and benefits have been assessed, the IRB is responsible
for ensuring that the risks of study participation are minimized to the greatest extent possible
while the benefits of study participation are maximized. This is clearly stated in all codes of
research ethics and is incorporated throughout the federal regulations that govern the IRB.

The following definitions of risk, minimal risk and benefit, which are used to assess risks and
benefits as they pertain to research conducted at Olive View-UCLA Medical Center are defined
by the DHHS as follows:

Risk: The probability of harm (physical, psychological, social, or economic) occurring as a
result of participation in a research study. Both the probability and magnitude of possible harm
may vary from minimal to significant. The federal regulations define only "minimal risk" (see
below).

Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater, in and of themselves, than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests [45 CFR 46.102(i)].

Benefit: A valued or desired outcome; an advantage.

Although these terms may appear straightforward, evaluations of risk and benefit are made more
complex both by subtle distinctions between therapeutic and research activities, and by
evaluations of actual risks in the lives of normal and vulnerable classes of subjects (i.e.,
prisoners, children, cognitively impaired individuals, etc.).

It is important for investigators to understand that the comparison between risks and benefits is
not a comparison between identical concepts. Because the term "Risks" is normally expressed as
probabilities while the term "Benefits" is normally expressed as fact or a current state of affairs,
investigators may find it difficult to compare these concepts in a meaningful fashion. Therefore,
it is more convenient for researchers to think of these terms as evolving probabilities. For
example, the risks of participation in research can be expressed as a probability that subjects may
be harmed by research procedures while anticipated benefits may express the probability that
subjects and society may benefit from research procedures. By considering risks and benefits as
probabilities, the IRB evaluation process is also simplified.

IRB Considerations

There are a number of steps discussed by the DHHS that the IRB must follow when assessing
risks and anticipated benefits.


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The IRB is required to:

1.      Identify the risks associated with the research, as distinguished from the risks of therapies
        the subjects would receive even if not participating in the research;
2.      determine that the risks will be minimized to the extent possible;
3.      identify the probable benefits to be derived from the research;
4.      determine that the risks are reasonable in relation to the benefits to subjects, if any, and
        the importance of the knowledge to be gained;
5.      assure that potential subjects will be provided with an accurate and fair description of the
        risks or discomforts and the anticipated benefits;
6.      determine intervals of periodic review, and, where appropriate, determine that adequate
        provisions are in place for monitoring the data collected, and, where the subjects are
        likely to be members of a vulnerable population, determine that appropriate additional
        safeguards are in place to protect the rights and welfare of these subjects.

Because the IRB is required to follow the above listed procedures, investigators should address
these considerations in their consent form.

Identification and Assessment of Risks

When considering risks, the IRB considers only those risks associated with the research (i.e.,
physical, psychological, social, legal, emotional). Investigators should be aware that risks would
include immediate risks of study participation, risks of randomization (especially to placebo
groups), risks of breach of confidentiality, and risks of long term effects.

For biomedical research, the IRB is required to determine and differentiate between the risks
associated with the research and the risks associated with standard diagnostic or therapeutic
interventions or therapies subjects would undergo regardless of participation in research. Since
the IRB does not establish or determine what constitutes standard of care, it is important for
investigators to clearly distinguish procedures which are standard of care from those which are
conducted solely for research purposes in the protocol and the informed consent form.

Physical Risks

Some biomedical research presents risk of physical injury to subjects. Although most of these
risks are transient, some adverse effects of study participation (especially those which result from
medical procedures, drug research or device research) may result in permanent injury to subjects.
For all research with the potential to cause physical harm investigators are encouraged to think
through all risk possibilities, however rare, so that they can be resolved quickly and effectively
minimize the harm to subjects. By clearly detailing procedures to address situations of physical
harm, the IRB can be assured that the investigator has made efforts to minimize physical risks to
the greatest extent possible.

Psychological Risks

Some research has the potential to cause undesired changes in thought processes and emotion

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including episodes of depression, confusion, and hallucination resulting from drugs, feelings of
stress, guilt and loss of self-esteem. As is the case with physical risks, these effects are usually
transient. For all research with the potential to cause psychological harm investigators are
encouraged to think through all risk possibilities, however rare, so that a course of action can be
planned to quickly and effectively minimize the distress to subjects. By clearly detailing
procedures to address situations of psychological harm, the IRB can be assured that the
investigator has made efforts to minimize psychological risks to the greatest extent possible.

Social and Economic Risks

Some research proposals involve the handling of sensitive information which may result in
injury to subjects through a breach of confidentiality. These breaches may result in
embarrassment within a subject’s business or social group, loss of employment, or criminal
prosecution. The IRB is especially concerned about information regarding drug and alcohol use,
mental illness, sexual behavior and illegal activities. For these situations investigators should
clearly detail strong safety precautions to ensure that the research does not cause social or
economic risks to the subjects.

Research may also pose direct economic risk to study subjects. Procedures billed to insurance
companies may require a significant co-payment on behalf of the subjects, insurance companies
may refuse to pay for "investigational" therapies, subjects may be responsible for transportation
costs, and subjects may lose wages during research participation. Investigators should attempt to
minimize economic costs to subjects. If the research may involve additional actual costs to
individuals, the anticipated costs should be described to subjects during the consent process.

Minimal Risk

Much of the IRB review process is governed by the concept of minimal risk. Assignment of
research for expedited review, approval of waiver of consent, and the conduct of research
involving vulnerable research populations may be dependent upon whether the research places
subjects at minimal risk or greater than minimal risk (significant risk). Investigators should note
that studies proposing procedures which pose less risk than standard procedures may not
necessarily be determined to be of minimal risk to subjects. Investigators should pay particular
attention to the term minimal risk as it is applied throughout this manual. NOTE: When the risks
are unknown, they are considered more than minimal.

Benefits

The benefits of research fall into two categories: benefits to individuals and benefits to society.

Research frequently provides subjects with treatment, diagnosis or examination for an illness or
abnormal condition. In these cases the research involves evaluations that may benefit the subjects
by ameliorating their condition or provide a better understanding of their disorder. Investigators
should clearly detail these potential benefits for the IRB, in the application, and subjects, in the
consent form, while not overstating these benefits. The investigator should also attempt to
maximize benefits to the greatest extent possible for potential subjects.

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Although research may not always provide a benefit to society, researchers are encouraged to
design research projects so that information, in the form of generalizable knowledge, can
contribute to societal benefit whenever possible. Investigators should clearly detail these
potential benefits for the IRB, in the application, and for subjects, in the consent form, while not
overstating these benefits. Research which does not provide benefit to individuals is required to
provide a reasonable likelihood of resulting in benefits for society.




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SECTION 8
Selection & Recruitment of Subjects
Selection of Subjects

Distributive justice, the third principle of The Belmont Report requires the fair selection of
subjects and the equitable distribution of the risks and benefits of research. The systematic
selection of subjects because of easy availability, their compromised position, or because of
social, racial, sexual, economic or cultural biases institutionalized in society results in an uneven
distribution of the benefits and the burdens of research. The IRB will closely examine research
that requests the recruitment of subjects solely due to their easy availability, compromised
position, or susceptibility to manipulation. For example, students, patients, or laboratory
employees are compromised to the extent that their grades, access to health care, or jobs are
dependent on those investigators recruiting them for research. The protocol should clearly
articulate how the recruitment will avoid the appearance of coercion when selecting subjects who
are in a dependent relationship to the investigator.

In order to allow for the fair and equitable distribution of the burden of research and to ensure
that certain populations, such as prisoners or patients in mental institutions, were not recruited
solely because of their easy availability, the National Commission for the Protection of Human
Subjects recommended a hierarchy of preference in the selection of subjects for research: adults
before children; competent individuals before incompetent individuals; and non-institutionalized
persons before institutionalized persons. To adequately assess the risks and benefits of
participation in research, the IRB requires accurate information regarding the number of subjects
to be recruited and tested. In addition, the IRB will closely examine the characteristics of the
subject population, such as age, gender, and population diversity outlined in the protocol and the
procedures for identifying and recruiting subjects.

The mandate for the equitable distribution of the risks and benefits of participation in research to
include women and minorities was addressed by the NIH, in the Outreach Notebook for the NIH
Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research, published in
1994. The guidelines indicate that researchers should include minorities and women in study
populations, "so that the research findings can be of benefit to all persons at risk of the disease,
disorder, or condition under study." The IRB will ask for a clear and compelling justification if
women and/or minorities are not appropriately represented or are excluded from the research.

In order to ensure that the burdens of research are evenly distributed, the IRB is required to
consider more than the risks associated with the research procedures. The IRB will also consider
the impact participation in research poses on the daily life of the potential subject. For example,
the Committee will consider reimbursement of subjects for inconvenience posed by the research,
such as: the time required to participate; travel involved and/or parking costs; restrictions on diet
or other activities; etc. Investigators should include provisions in the protocol for addressing
these concerns, especially for research that poses little or no direct benefit for the subjects.

Recruitment of Subjects


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Recruitment is the dialogue that takes place between an investigator and a potential subject prior
to the initiation of the consent process. In some ways, recruitment is the introduction to the
consent process. Recruitment may take the form of a flyer, a newspaper advertisement etc., or a
verbal exchange between an investigator and a potential subject. Investigators that are
responsible for both the primary care of a patient/client and wish to consider enrolling the
patient/client into a research project should carefully differentiate for the patient/client the
alternatives and options of participation in the research without undue prejudice or pressure.

Respect for potential subjects begins with recruitment procedures that ensure the voluntary
participation of the subject. Potential subjects should not feel coerced into participating in
research, nor must they fear the loss of some benefit to which they are otherwise entitled if they
choose not to participate. A person in authority, such as a teacher recruiting students or a
physician recruiting patients, should take special precautions to ensure that a potential subject’s
decision to participate in research is not based on subtle pressures such as grades or a fear of loss
of benefits, like medical treatment.

Investigators proposing to recruit their students or patients as research subjects should justify in
the protocol the necessity for the inclusion of the dependent subject. In addition, the IRB will
closely scrutinize the precautions in place to prevent the appearance of coercion in the
recruitment of the subjects.

Investigators build a strong foundation for ethical research by ensuring and preserving the
privacy and confidentiality of potential research subjects. In order to avoid a breach of the
potential subject’s privacy, investigators should not ask institutions, or their employees such as
physicians or case workers to directly identify potential subjects for a research study. Instead, an
investigator should ask the physician, case worker, etc., to first approach potential subjects (or
their parent/guardian, as appropriate) and inform them of the research. A potential subject’s
privacy and confidentiality may be compromised simply by being identified as a potential
participant in a study (for example, of cancer, AIDS, schizophrenia, or sexual deviance) or by
identifying a patient/client’s disorder to an investigator for the purposes of recruitment into
research without the patient’s consent.

An investigator should not ask institutions or individuals to release records or anecdotal
information either for the purposes of identifying potential subjects or for examination by the
investigator, unless the information is in the public domain. For example:

Ms. Smith is diagnosed with emphysema by Dr. Jones. Dr. Jones has not yet informed Ms. Smith
about her disease. Dr. Brown is conducting research on emphysema. Dr. Brown asks Dr. Jones
for the names and telephone numbers of all patients with emphysema. Dr. Brown contacts Ms.
Smith to recruit her for his emphysema study. Ms Smith is shocked not only that Dr. Brown has
her name and personal medical information but that she has learned of her emphysema from
someone she does not know. Dr. Jones has breached Ms. Smith’s confidentiality by giving her
name without permission to Dr. Brown. Dr. Brown has breached Ms. Smith’s privacy by
contacting Ms. Smith without her permission.

Oftentimes, in order to protect the privacy of the potential subject and decrease any appearance

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of coercion, the Committee will request the use of a flyer or a contact letter posted in the waiting
room or the lobby of the facility to inform potential subjects about the research. The flyers or
post-cards, etc., would include a description of the study and a telephone number for potential
subjects to call if they are interested. Through this process, investigators avoid the appearance of
coercion in the initial recruitment stage, while potential subjects maintain their privacy by
initiating contact with the investigator.

Recruitment tools:

A recruitment tool informs potential subjects of a research activity and provides them with an
opportunity to contact the researcher. A recruitment tool may include but is not limited to
post-cards, flyers, advertisements, press releases, brochures, and postings on the internet.
Investigators are encouraged to use the following guidelines when developing recruitment tools:

1.      Information should not be misleading to subjects, especially when a study involves
        vulnerable populations;
2.      Include the name, affiliation, and address of the investigator;
3.      the purpose of the research;
4.      the eligibility criteria for participation;
5.      an honest and direct description of the risks and benefits of the study;
6.      whom to contact for further information;
7.      no claim should be made as to the superiority, safety, or effectiveness of drugs or devices
        used in research.

NOTE: All recruitment materials are required to have IRB review and approval prior to
implementation.

NOTE: When recruiting subjects from another institution, investigators are required to gain
approval from that institution’s, Institutional Review Board (IRB). If the institution does not
have an IRB, investigators are required to obtain a letter of compliance on the facility’s
letterhead with a statement that the agency/institution will, "review, abide by, and comply with
the procedures approved by the OV-UCLA EDUCATION & RESEARCH IRB."

Payment for Participation in Research

The nature, amount and method of payment or other remuneration should not constitute undue
inducement to participate (i.e., the payment alone should not serve as sufficient inducement for
the subject to volunteer). Investigators should consider reimbursement for the inconvenience
posed to subjects or other costs to subjects resulting from participation in the research, such as:
parking fees, travel, lost time from work, baby-sitters, etc.

Since subjects reserve the right to withdraw their participation from the research without
prejudice, payment to subjects should be prorated, i.e., partial participation in a research activity
would obligate partial payment. The IRB will review both the amount of the payment and the
proposed method of disbursement to ensure that neither includes problems of coercion or undue
influence.

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Recruitment of Children

The ethical requirement of respect for persons, as outlined in The Belmont Report, applies to
children as well as adults. Children, however, are in a dependent relationship to adults and easily
manipulated in an academic or clinical setting. A child’s dependent relationship entitles them to
extra protections and are thus considered a "vulnerable subject population.” Investigators should
take every precaution to insure that a child’s decision to participate in research is both voluntary
and free from coercion. A child’s refusal to participate should not be met with a negative
response or punishment.

The IRB strongly recommends that investigators address the following when submitting
applications that include the recruitment of children:

1.      investigators should acknowledge and create a mechanism for addressing and minimizing
        the coercion implicit in requests to participate from parents, teachers, or other adult
        authorities, such as the investigator or the research staff;
2.      investigators should make provisions to minimize the fear of ridicule, social pressure, or
        peer pressure to participate;
3.      incentives or rewards for participation may be used but should not be so valuable, within
        the value system of the child, as to sway their legitimate reluctance to participate.

Permission of the School:

School officials and/or teachers do not have the authority to give consent for the participation of
children in research. Only a parent or guardian may allow a child, with the child’s assent, to
participate in research. The IRB requires submission of proof of approval of the school district
prior to allowing investigators to contact, recruit, or enroll children into a study. Investigators
should contact school district officials regarding the appropriate procedures for obtaining
permission to conduct research in individual schools.




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