California State University,
Long Beach
Policy Statement
94-00
May 16, 1994
Obsolete Policy
PROTECTION OF HUMAN SUBJECTS: POLICIES
This policy was approved by the Academic Senate on March 24, 1994
and approved by the President on June 8, 1994.
I.PREAMBLE
California State University, Long Beach accepts an ethical responsibility
for safeguarding the rights and welfare of human subjects involved
in research.
The University's Institutional Review Board for the Protection of
Human Subjects (IRB) believes in the value of research involving
human subjects and strives to ensure the greatest opportunity for
all investigators to engage in this activity. The IRB further believes
that one vital safeguard of the privilege is the institutional review
of all research projects to minimize the possibility of unacceptable
levels of risk to the rights, welfare and dignity of human subjects.
Although federal requirements mandate the IRB review of projects
seeking or receiving federal funds, we believe that review is equally
appropriate and necessary for unfunded research since the extent
to which a project entails risk for human subjects is a function
of the actual research procedures to be employed, not whether federal
funding is involved.
Whereas direct involvement in a project might shield a researcher
from noticing undesirable risks to human subjects, having others
from a variety of disciplines examine the proposal and procedures
serves as an appropriate safeguard. To assist the individual researcher
in protecting the rights of human subjects and minimize the potential
legal liability of the investigator should a human being be placed
at risk, the IRB acts in the spirit of an advisor and consultant,
rather than as an adversary, with the researcher. Thus, if an ethical
problem exists, the IRB seeks to work with the researcher and will
request that the researcher revise the protocol. In this light the
IRB seeks not to judge the merit or social sensitivity of the research
but only the risks and benefits of the research in relationship
to the protection of human subjects.
II.BACKGROUND
A. History
In 1965, the National Advisory Health Council sent the Surgeon General
of the United States Public Health Service the following resolution:
"Be it resolved that the National Advisory Health Council believes
that Public Health Service support of clinical research and investigation
involving human beings should be provided only if the judgment of
the investigator is subject to prior review by his institutional
associates to assure an independent determination of the protection
of the rights and welfare of the individual or individuals involved,
to the appropriateness of the methods used to secure informed consent,
and of the risks and potential medical benefits of the investigation."
In response, the Surgeon General in 1966 and again in 1969 established
policies and procedures governing the use of human subjects for
all recipients of contracts and grants from the U.S. Public Health
Service.
In 1974, the National Research Act, Public Law 93-348, was signed
into law and established the National Commission for the Protection
of Human Subjects in Biomedical and Behavioral Research. This was
followed by the federal requirement for the formation of Protection
of Human Subjects Institutional Review Boards to insure that a code
of federal regulations relating to the protection of all human subjects
be followed (Code of Federal Regulations, Title 45, Part 46, Department
of Health and Human Services, Protection of Human Subjects, Revised
January 26, 1981).
B. California State University, Long Beach Institutional Review
Board for the Protection of Human Subjects
On July 12, 1983, California State University, Long Beach (CSULB)
President Stephen Horn established the CSULB Institutional Review
Board for the Protection of Human Subjects (hereafter referred to
as IRB). The charge to the Board is:
"(1)To act in conformity with 45 CFR 46 in the review of all grant
and contract proposals prior to and as a part of institutional endorsement
and acceptance by the CSULB Foundation; and
(2) To serve as the review board for all academic programs, demonstrations,
and research which include the participation of individuals who
may be placed 'at risk' because of their participation as human
subjects or as investigators or staff to investigators when such
activities and research arise from the conduct of the academic program
directly, using the principles of 45 CFR 46 as the basis for such
reviews. The review board shall have authority to approve, require
modifications in (to secure approval), or disapprove all activities
covered by these regulations. If the review board disapproves an
activity, reasons for disapproval must be sent to the Vice President
for Academic Affairs, and the investigator must be given an opportunity
to respond."
With this as its charge, the IRB developed the following policies
and procedures to be followed by all members of the academic community
whenever human beings are used in any research activity which exposes
them to circumstances not typically encountered in the standard
and accepted instructional setting.
III.INTRODUCTION
A.Summary Statement
While the IRB values and encourages research, it also realizes the
necessity to protect the welfare and rights of research participants.
The ethical principles used by the IRB when reviewing proposals
will be guided by the ethical principles as set forth in 45 CFR
46, and The Belmont Report: Ethical Principles and Guidelines for
the Protection of Human Subjects of Research, The National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research, Department of Health, Education and Welfare, April 18,
1979. The Belmont Report recognizes the absence in our culture of
any precise decision procedure for resolving all ethical disputes.
It does, however, indicate certain ideals and certain general ethical
principles which may conflict with research proposals involving
human subjects, and it also notes possible ways in which researchers
may unknowingly place undue risk on human subjects or a class of
human subjects. This document provides the basis for looking upon
an independent review as a worthwhile step in designing research
involving human subjects. When a conflict of basic ethical principles
can occur, an articulation of competing values is called for, and
having an independent review panel such as the IRB provides an appropriate
forum for this important deliberation.
IV.POLICY
A.Definitions
"Research" is defined in the new federal rules (Title 45, code of
Federal Regulations, Part 46) as "a systematic investigation, including
research development, testing and evaluation, designed to develop
or contribute to generalizable knowledge. Activities which meet
this definition constitute research for purposes of this policy,
whether or not they are conducted or supported under a program which
is considered research for other purposes. For example, some demonstration
and service programs may include research activities."
"Human subject" is defined as "a living individual about whom an
investigator (whether professional or student) conducting research
obtains (1) data through intervention or interaction with the person,
or (2) identifiable private information."
B.Application of Policy*
This policy applies to all faculty, all staff, all administrators,
and all students whenever they are supervising or conducting any
research activity involving human subjects, regardless of whether
the participants are members of the University community. Non-University
personnel also come under the purview of this policy when their
research or related activities utilize members of this University
community. Both funded and non-funded research activities are included
in this policy.
The University does not bear responsibility for research conducted
by the above groups of investigators while they are functioning
in another capacity, e.g., while functioning as an entrepreneur
or as employee of a firm.
Research activities which involve investigators from other institutions
are to be managed in the following manner:
1.If the subjects, in whole or part, are to be drawn from the University,
the CSULB investigator is responsible for submitting the proposal
to the IRB for review and approval.
2. If the subjects are not drawn from the University, then:
a.The principal investigator submits the proposal to the appropriate
reviewing agency; except that;
b.If there is no identified principal investigator, or if the principal
investigator's institution does not have an IRB approval by the
U.S. Department of Health and Human Services, the CSULB investigator
is responsible for submitting the proposal to the IRB for review
and approval.
*Note: Also see Section VI for policy concerning instructional demonstrations
and activities for which no research product is intended.
C.Responsibilities
Final responsibility for the protection of human subjects and adherence
to ethical standards rests with the University; however, the primary
responsibilities for the protection of human subjects and adherence
to ethical standards remain with all persons (faculty, students
and staff) involved in these activities.
Consequently, it is required that all persons at CSULB involved
in activities involving human subjects be familiar and comply with
the provisions of this document.
It is the responsibility of heads of units (Department Chairpersons,
Directors and Deans) to bring to the attention of their faculty,
staff and students the existence of this policy. It is the responsibility
of the principal investigator to submit in a timely manner a protocol
and consent form for review to the IRB.
V. UNIVERSITY INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN
SUBJECTS
A.Institutional Review Board Membership
The IRB shall have members with varying backgrounds to promote complete
and adequate review of research activities. The IRB shall be sufficiently
qualified through the experience and expertise of its members, and
the diversity of the members' backgrounds including consideration
of the cultural backgrounds of members and sensitivity to such issues
as community attitudes, to promote respect for its advice and counsel
in safeguarding the rights and welfare of human subjects. The IRB
may not consist entirely of men or entirely of women, or primarily
of members of one discipline.
In addition to possessing the professional competence necessary
to review specific research activities, the IRB shall be able to
ascertain the acceptability of proposed research in terms of institutional
commitments and regulations, applicable law, and standards of professional
conduct and practice. The IRB shall, therefore, include persons
knowledgeable in these areas. If the IRB regularly reviews research
that involves a vulnerable category of subjects, the IRB shall include
one or more individuals who are primarily concerned with the welfare
of these subjects.
The membership of the CSULB Institutional Review Board for the Protection
of Human Subjects shall be:
At least one non-University representative conversant with general
principles of research involving human subject participation, selected
by the President;
One tenured member of the University faculty at the rank of full
or associate professor conversant with ethics and ethical systems,
selected by the Academic Senate;
Two tenured members of the University faculty with significant experience
in research, selected by the Academic Senate;
Four tenured members of the University faculty with significant
expertise in human subjects research, at least one with expertise
in such medically relevant issues as physically invasive procedures,
physical therapy and pharmacology, and at least one with expertise
in survey research and assessment, selected by the Academic Senate;
The Chair of the Scholarly and Creative Activity committee; The
Director of University Research; and, The Vice President for Academic
Affairs (or designee).
The period of service for the non-University representative and
for members appointed by the Academic Senate shall be for single,
staggered two-year terms. A member will be eligible for reappointment
after one year of absence.
The Director of University Research shall maintain the roster of
membership, insuring that the Vice President for Academic Affairs
is made aware of resignations or other reasons for nonparticipation.
B.Institutional Review Board Responsibilities
1. The IRB shall consider only the risks and benefits of the research
in relationship to possible harm of the human subjects involved.
Research merit, and social sensitivity, or other socio- political
considerations shall not enter into judgements concerning a protocol.
Issues and concerns about research which arise in the IRB but which
go beyond or are unrelated to protection of human subjects are to
be referred to the Scholarly and Creative Activity Committee for
its consideration, if appropriate, or for forwarding via the Academic
Senate Executive Committee to the appropriate body.
2.The responsibility and authority for promulgating, implementing
and administering a policy that will protect the dignity, rights
and welfare of human subjects shall be delegated to the IRB.
3. The IRB will evaluate all research activities involving human
subjects. The IRB will evaluate the protocol and informed consent
form for the purpose of establishing compliance with the provisions
of this document. In this light, the IRB shall evaluate a protocol
to determine whether:
a.The protocol is complete;
b.The documentation of the potential risks to the dignity, rights
and welfare of the subjects is adequate;
c.The proposed safeguards against the risks are adequate;
d.The objectives could be achieved with less potential risk;
e.The procedures to obtain informed consent are appropriate and
the forms used are complete, clear and non-coercive;
f. For research which involves more than minimal risks, the benefits
to the subjects shall outweigh those risks.
4.On the basis of its review, the IRB has the authority to require
modifications of a protocol and the project itself and to give ultimate
approval or denial to the project. When the IRB approves or disapproves
a protocol, it will furnish a written statement to the investigator.
The decision to approve a protocol requires a majority of the quorum
at the time of the vote.
5. The IRB shall meet at least once a month throughout the academic
year. Meeting times and dates shall be established and published
for the year at the beginning of each academic year.
6. The IRB shall monitor and conduct reviews (if needed) of approved
research activities involving human subjects in order to assure
compliance with these regulations.
7. The IRB shall report to the Vice President for Academic Affairs
annually as required by the enacting Executive Order of July 12,
1983.
8. The Director of University Research shall:
a. Maintain a complete and accurate record of the proceedings of
all meetings of the IRB and shall annually report these activities
to the Vice President for Academic Affairs.
b. Insure that the IRB is provided full and accurate information
on the regulations governing protection of human subjects; that
at least one copy of the complete regulations be available at all
meetings of the Board; and that the assurances required by regulation
or, in cases of internal activities, the assurances directly paralleling
those which would have been required by regulation, are properly
prepared, signed, and delivered to the responsible authority; and,
c. Call meetings of the Board as required in the normal conduct
of business or at the request of the Vice President for Academic
Affairs or the Associate Vice President for Academic Affairs--Instructional
Programs.
C.Institutional Review Board Action
The IRB when reviewing a protocol will take one of the following
actions:
1. Approve the protocol as exempt;
2. Approve the protocol as submitted;
3. Approve the protocol as contingent on minor revisions;
4. Request outside review of the protocol and then reconsider;
5. Require significant modification of the protocol before approval;
6. Request the investigator to discuss problems with the IRB;
7. Reject the protocol.
VI.INSTRUCTIONAL DEMONSTRATIONS AND ACTIVITIES
A.Often a faculty member will wish to give an instructional demonstration
or activity within or outside the classroom which involves the use
of human subjects, typically including for example, the students
in the class. All courses other than independent study or independent
research or thesis research that involve human subjects are intended
to be included in this section.
B.The responsibilities for proper conduct of these instructional
demonstrations or activities are to be borne by the individual faculty
member and are not subject to review by the IRB. The instructor
shall be aware of the potential risks to the dignity, rights or
welfare of subjects, make them known to the potential subjects,
and, if more than minimal risk is involved, inform the subjects
of their rights as embodied in this document. (See CSULB Faculty
Handbook, Appendix C, Documents on Professional Standards and Ethics
and Related Documents.)
C.The responsibility for informing students of the potential risks
in such non-standard instructional activities lies with the instructor.
Students shall be informed in writing during the first week of class
of the potential risks involved in such activities and should be
encouraged to pursue possible alternatives with the instructor if
the risks appear excessive.
D.The responsibility for providing properly maintained and supervised
equipment rests with the department or service offering the courses.
This responsibility includes availability of personnel properly
trained to operate such equipment as well as any emergency equipment
necessary in the case of an accident. It is expected that all departments
will have emergency procedures established at all times. (Also see
University Administrative Policies and Procedures Handbook, Section
8. Safety).
VII.REGULATIONS
The University adopts the specific procedural regulations of the
United States Department of Health and Human Services where applicable.
In the case of conflict between DHHS and some other set of relevant
regulations, the more restrictive of those applicable shall be employed.
VIII.APPEAL OF IRB DECISIONS
If a protocol is disapproved by the IRB, the reason(s) for disapproval
shall be provided in writing to the investigator. The investigator
may appeal the decision on procedural matters only to the Vice President
for Academic Affairs. The investigator has twenty (20) instructional
days following written notification by the IRB to appeal in writing
to the Vice President for Academic Affairs. Upon receipt of the
written appeal, the Vice President for Academic Affairs has twenty
(20) instructional days to review the appeal and confer with the
IRB. However, the ultimate decision for approval of a protocol rests
with the IRB.
IX.LEGAL ASSURANCES
A.Legal Liability of the University for Acts of Committee Members
Duly appointed committee members who, while acting in the course
and scope of their committee assignments, carry out their obligations
in good faith and exercise good judgement, are to be provided defense
by the University in the event of legal action, and coverage under
the State of California liability policy in the event of an adverse
decision.
B.Legal Liability of the University for Acts of Principal Investigators
Employees or former employees may request the University to defend
them against any claim or action against them for injury due to
negligence within the scope of their employment. Employees, who,
while acting in the course and scope of their employment, carry
out their obligations in good faith and exercise good judgment,
will be provided defense by the University in the event of legal
action, and coverage under the state of California liability policies
in the event of an adverse decision. However, the University will
not defend an employee if it is determined that the action or omission
involved was not within the employee's scope of employment, that
it was based upon actual fraud, corruption or actual malice, or
that the providing of such defense would involve a conflict of interest.
Therefore, in order to minimize the risk of incurring unnecessary
liability, all employees are expected to adhere to all University
policies and procedures. Failure to do so may result in the State
of California electing not to defend or indemnify.
Specifically, faculty members may find that the University is more
clearly committed to their defense in connection with research that
has been approved by the IRB than for that which has not. This principle
applies to research in any of the three categories. Standard, Expedited,
or Exempt. Therefore, researchers who judge their research to be
"exempt" would nonetheless be well advised to obtain IRB approval
of that judgment, as required by this document. Doing so assures
researchers that they are in full compliance, as well as protect
their human subjects.
C.Submission to General Counsel
If any reviewing body believes that the proposed activity violates
any law, may possibly violate any law, or may otherwise contain
some significant legal issue, the protocol shall be submitted to
the Vice President for Academic Affairs for forwarding to the Office
of General counsel for evaluation. Other criteria for judging the
need to submit a protocol to General Counsel may include:
1.The involvement of minors.
2.The involvement of adults whose competence to give consent may
be subject to question.
3.The necessity for the investigator to perform acts requiring license
under provisions of the law.
X.ENFORCEMENT
The Vice President for Academic Affairs shall be responsible for
the enforcement of decisions of the IRB.
XI.REFERENCES
For guidance, concerned parties should consult:
A."The Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research," National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research,
Department of Health, Education and Welfare, April 18, 1979;
B.The American Psychological Association, Ethical Principles in
the Conduct of Research with Human Participants, 1982, and;
C.Code of Federal Regulations, Title 45, Part 46, Department of
Health and Human Services, Protection of Human Subjects, Revised
June 18, 1991.
Copies of these references are on file in the Office of University
Research.
PROTECTION OF HUMAN SUBJECTS: PROCEDURES
GENERAL INFORMATION
Research involving human subjects may not begin until approval is
obtained from the CSULB Institutional Review Board for the Protection
of Human Subjects (IRB).
APPLICATION FOR IRB APPROVAL OF RESEARCH PROTOCOL
An Application with the required number of copies must be submitted
to the IRB through the Office of University Research. This Application
is to include the information described below. All materials must
be typed. Incomplete Applications will not be evaluated.
Get actual form from Office of Research Foundation Building, Ste.
310 (985-5314)
I.THE APPLICATION
A.The basis for review and approval of research involving human
subjects will be an Application submitted by the researcher to the
IRB.
B.The following numbers of copies of the Application must be submitted:
Twelve (12) copies for research in the "Standard Review" category;
six (6) copies for research in the "Expedited Review" category,
or; one (1) copy for research in the "Exempt Review" category. Applications
and all copies are submitted to the IRB through the Office of University
Research [Foundation Building, (310) 985-5314]. Communication with
potential human subjects may not begin until approval of the Application
has been obtained through the Office of University Research. Therefore,
researchers would be well advised to wait for IRB approval before
purchasing/duplicating the final sets of materials needed in conducting
the study.
C.Changes or supplemental information added to the Application which
are initiated by the researcher after the Application is in review
may necessitate withdrawal of the original Application and submission
of a new one.
D.The Application is to include the following information and documentation:
1. Principal Researcher (Name):
Position (professor, M.A. thesis student, etc.):
Department:
Address :
Daytime Telephone Number:
2. (If student,) Thesis Advisor/ Faculty Supervisor (name):
Faculty University Telephone Number:
3. Title of proposed research study:
4. Describe the purpose(s) of the study (including research hypotheses,
if applicable).
5. Describe the characteristics of the sample of human subjects:
a.Approximate number of each sex;
b.State age(s): Will any children be involved? If not, state "No
Minor Subjects." If yes, what is the legal parent/ guardianship
status?
c.Developmental disabilities? mental illness? adults having legal
guardians?
d.Other subject characteristics relevant to the study.
6.How will subjects be selected? From what source(s), such as hospital,
institution, school, class, shopping mall, etc.? Attach letters
of approval from all participating organizations on their official
letterhead.
7.When and where will the activities involving human subjects take
place? Be specific, give exact locations.
Note: The beginning date must be after approval by the IRB. (Allow
a minimum of 3 instructional days for Exempt Review; 7 instructional
days for Expedited Review, and refer to the schedule of monthly
IRB meeting dates for Standard Review.) IRB approval normally covers
a twelve-month period, even if the anticipated time-span of participation
by human subjects is less than twelve months. If the anticipated
participation will take more than twelve months,please so state,
and approval will be granted for that longer span.
8.What will you do with the human subjects? Describe the details
of research methods and procedures that involve the subjects.
9.Identify and attach any copyrighted tests, questionnaires, or
other materials to be used. If security or copyright prohibits attaching,
explain. If none, state "No copyrighted materials."
10.Identify and attach any specially designed tests, questionnaires,
or other materials to be used. If none, state "No special tests
or questionnaires designed especially for this research."
11.What risks, if any, does this research present to the dignity,
rights, health, welfare, or well-being of the subjects? Describe
the safeguards for protection against or minimization of risks:
12.Describe any benefits to the subjects which may reasonably be
expected from the research, including summary of research findings
where appropriate (as for professionals, students in the discipline,
and participating organizations). Describe benefits, if any, to
others.
13.Describe the procedures you will use to obtain Informed Consent.
Attach your proposed consent form(s). Include the text of oral explanations,
if applicable, and any additional Informed Consent forms required
by the participating organizations. Instruct potential subjects
to both print and sign their names.
14.If applicable, describe the nature of any debriefing of subjects:.
If not, state "No debriefing."
15.Briefly describe the training and experience that qualifies you
to carry out the proposed research .
16.Student thesis research, independent study, or independent research
require completion of the Faculty Supervisor Form.
II. INFORMED CONSENT
A. Definition.
1.Three major ethical concerns underlie the requirements for Informed
Consent. All three must be dealt with in the documentation and process
of obtaining Informed Consent from individuals or their legally
authorized representatives. Informed Consent is necessary whether
the research is designed primarily for the direct benefit of research
participants or for the advancement of knowledge.
a.One concern is to respect the ability and desire of individuals
to decide whether they want to participate in research. Adequate
information about the research must be provided. Individuals who
are to be subjects of research or experimentation must understand
as completely as possible what will be done to or asked of them.
b.A second concern requires that individuals or their representatives
understand the nature and extent of potential benefits and risks
to themselves.
c.The third concern is that Informed Consent must be given freely,
without pressure or inappropriate inducement. In other words, possible
participants must be able to exercise free power of choice without
unethical inducements or any element of force, fraud, deceit, duress,
or other form of constraint or coercion.
B.Consent Form.
1.The informed consent of subjects is ordinarily to be documented
by a signed consent form. See Special Circumstances, below, for
exceptions.
2.The consent form must be written so that it is comprehensible
to the subjects in their preferred language. The exact wording should
be appropriate to the particular research situation as well as to
the level of understanding of the subjects. Their age, maturity,
status, and condition must be taken into account.
3.The information in the consent form must be consistent with the
corresponding items in the Application.
4.The consent form should contain all of the following information.
If it does not, the IRB is to be provided with an explanation as
to why specific parts are missing:
a.A statement that the study involves research, and an explanation
of the purpose of the research;
b.A description of the procedures to be followed; a description
of the expected duration of the subject's participation;and identification
of any procedures which are experimental;
c.A description of any reasonably foreseeable risks or discomforts
to the subjects;
d.A description of any benefits to the subject or to others which
may reasonably be expected from the research;
e.A statement describing the extent to which anonymity (subject
identity not known) and/or confidentiality (subject identity known
only to researcher) of participation and records will be maintained;
f.A statement to the effect that participation is voluntary, and
that the individuals should not feel pressured in any way to participate
by the researcher or anyone else. Furthermore, if they agree to
participate, subjects are completely free to discontinue participation
at any time. Indicate that agreeing or refusing to participate will
have no effect on their usual position, status, or role in the setting
from which they were recruited. If appropriate, indicate that there
will be no gain or loss of benefits to which they would otherwise
be entitled in that setting.
g.A statement of whom to contact for answers to pertinent questions
about the research and about the rights of participants in research.
That is: researcher and faculty member for questions regarding the
study; CSULB Office of University Research for questions regarding
the rights of research participants.
Where applicable, the consent form should also include:
h.An explanation as to whether any compensation and/or medical treatments
are available if injury occurs and, if so, what they consist of
, or where further information may be obtained.
i.A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject.
C. Special Circumstances.
1.Types of special circumstances
a.Oral presentation with short written version. In some circumstances,
the elements of Informed Consent have to be presented orally (as
in cases of illiteracy or visual impairment). A short version of
the consent document should be substituted for the usual version,
indicating that all of the elements of informed consent have been
presented orally to subjects or their legally authorized representatives.
The short version is to be signed by the subject or representative
and by a witness to the oral presentation. (The proposed short version
and the written verbatim script of the oral presentation must be
part of the Application in order to receive IRB approval.)
b.No Prior Consent. Circumstances occasionally arise (especially
in observational studies in the social sciences) in which obtaining
prior written consent would defeat the purpose of the research,
or in which participants would have no reasonable expectation of
privacy.
c.Consent-Related Risk. In some cases in which the regular written
Informed Consent form is used, signing the form would put the subject
at risk (for reasons not directly related to the research).
d.Purpose not Revealed. In some special circumstances, revealing
the purposes of the research can render it useless. For such research,
indicate on the consent form that there is information about the
research which the subjects will receive at its completion. It should
be particularly noted that this refers to the informed consent requirements
concerning explanation of the purpose of the research (item 4.a.,
above). It is not an exception to the rule that all subjects must
be informed about the research procedures that involve them directly.
For example, the researcher studying people's behavior when they
are startled must inform the subjects that they will be startled
and by what means, but that (if it is the case) the startling events
will occur at unexpected times.
2.Modified Procedures. In any of the above special circumstances,
modified procedures may be proposed in the Application, if and only
if all four of the following conditions exist. (A complete explanation
must be included in the Application.)
a.The research involves no more than minimal risk to the subjects;
and
b.The waiver or alteration will not adversely affect the rights
and welfare of the subjects; and
c.The research could not practicably be carried out without the
waiver or alteration; and
d.Whenever appropriate, subjects will be provided with additional
pertinent information (debriefing) after participation.
D.Additional protections for all children, and for adults who are
under legal guardianship or otherwise require special concern (for
example, for those who are developmentally disabled, or mentally
ill.)
1.Children (and adults described above) may not participate without
prior informed consent of parent/guardian. However, parental consent
while necessary is not sufficient. All children, and such adults,
must themselves be given the opportunity freely to assent or to
decline to participate in the research. Mere failure to object should
not be construed as assent. Researchers are cautioned to be sensitive
to the possible implied pressure of parental consent and/or the
subject's relationship and rapport with the researcher.
2.In accordance with federal regulations (45 CFR 46, Subpart D-
Additional Protection for Children Involved as Subjects in Research)
the IRB may determine that the research is designed for conditions
or a subject population for which parental or guardian permission
is not a reasonable requirement to protect the subjects, (for example,
neglected or abused children). In such cases the IRB may choose
to waive the consent requirements. However, an appropriate mechanism
for protecting the subjects must be used and the researcher must
document to the IRB that the waiver is not inconsistent with federal,
state or local law. The choice of an appropriate mechanism would
depend upon the nature and purpose of the research, the risk and
anticipated benefit to the research subjects, and their age, maturity,
status and condition.
E.Retention of Records. Researchers must keep the signed Informed
Consent forms for all subjects for three years to protect themselves
in the event that future problems may arise with any research participants.
III. PERMISSION OF PARTICIPATING AGENCIES
Prior to submitting your IRB application, you must obtain written
permission from any agency, school, clinic, or other organizational
entity whose cooperation is required in obtaining access to subjects
and conducting the study. Such permission must be presented on printed
agency letterhead and must be signed by an agency official. The
letter of permission must indicate that the official approves of
agency involvement as described in the IRB application. Include
this letter of permission with your IRB application materials.
PROTOCOL CATEGORIES
There are three categories for review by the IRB under which researchers
must choose to submit their application. These categories relate
to the expediency of the review process and the nature and the level
of potential risk to the subject. Any protocol deemed inappropriate
for a given category will be transferred by the Director of University
Research to the appropriate category.
I. "STANDARD REVIEW" CATEGORY
A. Research is required to be submitted under the Standard Review
category if one (or more) of the following conditions is involved:
1.More than minimal legal, physical, or psychological risk, or
2.Children under the age of 18, and adults who are under legal guardianship
or otherwise require special concern (for example, developmentally
disabled, mentally ill), or
3.The identity of subjects can be linked to information provided
by them, by others, or by way of the research procedures.
B. Research under Standard Review will be reviewed by the IRB at
its regularly scheduled monthly meeting. Twelve copies of an Application
under Standard Review must be submitted to the Office of University
Research two weeks prior to the meeting.
C. The IRB may request the researcher to discuss problems at a meeting;
request an outside review of the application; and/or require significant
modifications before approval is given.
II. "EXPEDITED REVIEW" CATEGORY
A.Research which does not require a Standard Review, but which may
involve minimal risk, should be submitted under the Expedited Review
category. Examples of activities appropriate for Expedited Review
are the following:
1. Surveys, interviews, and questionnaires in which the participant's
identity and responses are confidential.
2. Recording of data from subjects 18 years of age or older using
noninvasive procedures routinely employed in clinical practice.
The use of physical sensors that are applied either to the surface
of the body or at a distance and do not involve input of matter
or significant amount of energy into the subject or an invasion
of the subject's privacy.
3. Weighing, testing sensory acuity, electrocardiography, electroencephalography,
thermography, detection of naturally occurring radioactivity, diagnostic
echography, and electroretinography. Not including exposure to electromagnetic
radiation outside the visible range (for example, x-rays, microwaves);
4. Voice recordings made to study speech/language disorders;
5. Moderate exercise by healthy volunteers;
6. The study of existing data, documents, records, pathological
specimens, or diagnostic specimens, in which the identities of subjects
are kept confidential, but in which subjects are not anonymous.
7. Research on individual or group behavior or characteristics of
individuals, such as studies of perception, cognition, game theory,
or test development, where the investigator does not manipulate
subjects' behavior and the research will not involve stress to subjects.
B.Research under Expedited Review will be reviewed by a subcommittee
of the IRB within seven instructional days after receipt of six
copies of a complete Application in the Office of University Research.
III."EXEMPT REVIEW" CATEGORY
A.Research which does not require either a Standard Review or an
Expedited Review is reviewed by the IRB under the Exempt Review
category. All research involving survey or interview is exempt without
exception when the respondents are elected or appointed public officials
or candidates for public office. In compliance with 45 CFR 46, Protection
of Human Subjects, January 26, 1981 (revised, 46.101 [1] - [5]),
Exempt Review is appropriate for research activities in which the
only involvement of human subjects will be in any of the following:
1. Collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly
available or if the information is made available to the researchers
in such a manner that human subjects cannot be identified, directly
or through identifiers linked to them.
2. Established or commonly accepted educational settings, involving
normal pedagogical practices, such as:
a.Regular and special education instructional strategies,
b. Comparisons among instructional techniques, curricula, or classroom
management methods.
3.The use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, unless the
research entails any one of the following:
a. Information is made available to the researchers in such a manner
that human subjects can be identified directly or through identifiers
linked to them. If confidentiality cannot be assured, submit for
Standard Review; if confidentiality is assured, submit for Expedited
Review; or
b. Any disclosures of the human subjects' responses outside the
research could reasonably place the subjects at risk of criminal
or civil liability or be damaging to the subjects' financial standing
or employability (Standard Review required); or
c. Sensitive aspects of the subject's own behavior, such as illegal
conduct, drug use, sexual behavior, or use of alcohol (Standard
or Expedited Review required, depending on the degree of risk);
or
d. The human subjects are children, or developmentally disabled
or mentally ill adults who have legal guardians (Standard Review
required);
4. Observation, including participant observation of adults, of
public behavior in settings where the subjects have no reasonable
expectation of privacy, unless the subjects are children, or adults
who must be given Standard Review. Even for adult subjects, however,
observational research must be reviewed under Standard or Expedited
Review (depending on the degree of risk) if all the following exist:
a. Observations are recorded in such a manner that the subjects
can be identified, directly or through identifiers linked to them;
and
b. Observations recorded about the individual, if they became known
outside the research, could reasonably place the subject at risk
of criminal or civil liability or be damaging to the subject's financial
standing or employability; and
c. The research deals with sensitive aspects of the subject's own
behavior such as illegal conduct, drug use, sexual behavior, or
use of alcohol.
B.Research under Exempt Review will be reviewed by the Director
of Research on behalf of the IRB, and will be approved or referred
to a more appropriate category, normally within three instructional
days after receipt of one copy of a complete Application in the
Office of University Research.
APPLICATION FOR IRB APPROVAL OF RESEARCH PROTOCOL
Type information on this form. Or, if you prefer, follow the format
using a computer text editor. Do not underline answers, but differentiate
them from the questions. Form available on diskette (bring formatted
diskette to Office of Research
Circle one: Standard Review (12 copies) Expedited Review (6 copies)
Exempt Review (1 copy)
(see Protocol Categories on pp. 15-17.)
1. Principal Researcher (Name):
Position (professor, M.A. thesis student, etc.):
Department:
Address :
Daytime Telephone Number:
2.(If student,) Thesis Advisor / Faculty Supervisor(name):
Faculty University Telephone Number:
3. Title of proposed research study:
4. Describe the purpose(s) of the study (including research hypotheses,
if applicable):
5. Describe the characteristics of the sample of human subjects:
a. Approximate number of each sex:
b. Age(s):
Will any children be involved? If not, state "No Minor Subjects."
If yes, what is the legal parent/ guardianship status?
c. Developmental disabilities? mental illness? adults having legal
guardians?
State "None" or explain:
d. Other subject characteristics relevant to the study.
6. How will subjects be selected? From what source(s), such as hospital,
institution, school, class, shopping mall, etc.? Attach letters
of approval from all participating organizations on their official
letterhead.
7. When and where will the activities involving human subjects take
place?
Note: The beginning date must be after approval by the IRB. (Allow
a minimum of 3 instructional days for Exempt Review; 7 instructional
days for Expedited Review, and refer to the schedule of monthly
IRB meeting dates for Standard Review.) IRB approval normally covers
a twelve-month period, even if the anticipated time-span of participation
by human subjects is less than twelve months. If the anticipated
participation will take more than twelve months, please so state,
and approval will be granted for that longer span.
Begins on: Ends on:
Location(s):
8.What will you do with the human subjects? Describe the details
of research methods and procedures that involve the subjects.
9. Identify and attach any copyrighted tests, questionnaires, or
other materials to be used. If security or copyright prohibits attaching,
explain. If none, state "No copyrighted tests or questionnaires."
10.Identify and attach any specially designed tests, questionnaires,
or other materials to be used. If none, state "No tests or questionnaires
designed specially for this research."
11.(a) What risks, if any, does this research present to the dignity,
rights, health, welfare,or well-being of the subjects?
(b) Describe the safeguards to protect against or to minimize risks:
12.Describe any benefits to the subject(s) which may reasonably
be expected from the research, including summary of research findings
where appropriate (as for professionals and participating organizations.)
Describe benefits, if any, to others.
13.Describe the procedures you will use to obtain Informed Consent.
Attach your proposed consent form(s) and include the text of oral
explanations, if applicable, and any additional Informed Consent
forms required by the participating organizations.
14.If applicable, describe the nature of any debriefing of subjects:.
If not, state "No debriefing."
15. Briefly describe the training and experience that qualifies
you to carry out the proposed research .
16. Student thesis research, independent/directed study, or independent/directed
research require completion of the Faculty Supervisor Form.
Submit Application packet to the Office of University Research,
University Foundation Building, Suite 310. Telephone (310) 985-
5314; FAX (310) 985-8665.
FACULTY SUPERVISOR FORM
California State University, Long Beach
TO: Institutional Review Board for the Protection of Human Subjects
FROM: Faculty Supervisor:
Department of:
Telephone Extension:
NAME OF STUDENT:
TITLE OF THESIS OR PROJECT:
IF MASTERS THESIS:
My signature below certifies that the Thesis Committee has formally
approved the Thesis Proposal, and that the Application to the IRB
has also been approved.
_______________________________________________________
Thesis Chair Signature Date
IF DIRECTED RESEARCH/INDEPENDENT STUDY:
My signature below certifies that I, as Faculty Supervisor, have
approved the proposed research and the Application for Protocol.
_________________________________________________________
Faculty Supervisor Signature Date
(1/24/94)
RENEWAL APPLICATION FOR CHANGE OF RESEARCH DATES
California State University, Long Beach
TO: Institutional Review Board for the Protection of Human Subjects
FROM: (name)
(department)
(telephone)
TITLE OF RESEARCH:
PREVIOUSLY ASSIGNED PROTOCOL NUMBER:
REVIEW TYPE: (Circle one) Standard Expedited Exempt
PREVIOUS DURATION (DATES) OF ACTIVITY: Begin End PROPOSED DURATION
(DATES) OF ACTIVITY: Begin End
BRIEF EXPLANATION OF REQUEST:
_________________________________________________
signature of researcher date
----------------------------------------------------------------------------------------------------------------------------------
IRB USE: Approval Granted for the Period: New Protocol Number: Approval
Denied for the Reason:
____________________________________________________
Director, Office of University Research date
(1/24/94)
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