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PROTECTION OF HUMAN SUBJECTS USED IN RESEARCH
GENERAL GUIDELINES, POLICIES, AND PROCEDURES OF THE TEMPLE
UNIVERSITY INSTITUTIONAL REVIEW BOARD SUBCOMMITTEE B FOR
THE SAFEGUARDING OF THE RIGHTS AND WELFARE OF HUMAN BEINGS
PARTICIPATING IN FUNDED AND NON-FUNDED RESEARCH
Revised: August 2010
TABLE OF CONTENTS
Page
Introduction
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Studies Requiring Review . . . . . . . . . . . . . . . . .
Definition of Human Subjects . . . . . . . . . . . . . . .
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Research Review by the IRB
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Exempt Research Proposals . . . . . . . . . . . . . . .
Expedited Research Proposals . . . . . . . . . . . . . .
Full Committee Review Research Proposals . . . . . . . .
Preparation of the Request for Protocol Review
Face
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Responsibilities of the IRB Subcommittee B Following
the Submission of the Request for
Protocol Review . . . . . . . . . . . . . . . . . . . .
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Responsibilities of the Investigator(s) Following
the Approval of the Request for Protocol
Review by the IRB
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Appendix A:
Request for Protocol Review
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Appendix B:
Permission to Videotape . . . . . . . . . . .
Permission to Audiotape . . . . . . . . . . .
Permission to Photograph . . . . . . . . . . .
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Appendix C: Sample Consent Forms
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Appendix D:
Indemnifying Clauses . . . . . . . . . . . . .
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Appendix E:
Application Check List Form
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INTRODUCTION
Safeguarding the rights and welfare of all human beings (i.e.,
human subjects) who participate in research projects conducted
under the aegis of Temple University is the responsibility of
both the University and the investigator(s). The safeguarding
of the rights and welfare of human subjects is extended to the
intent of the investigator(s) to protect research subjects as
well as comply with the specific requirements established by
sponsors of its research, the standards established by the
Declaration of Helsinki Recommendations Guiding Doctors in
Clinical Research in 1964 (revised in 1975), U.S. Department of
Health, Education, and Welfare Guidelines in 1971 (revised in
1974), The Nuremburg Code in 1947, The Belmont Report in 1978,
and the American Psychological Association codes for pursuit of
social and behavioral research published in 1973.
No one such guideline or code is fully adequate to meet all
research situations. Concerns that the rights and welfare of
human beings are safeguarded from individuals who are conducting
research requires federally mandated review processes to assure
adequate protection of human subjects used in research
protocols. The Institutional Review Board (IRB) Subcommittee B
represents most research conducted on the main campus of Temple
University and has the responsibility to review in representing
the best in ethical concerns for the safeguarding of the rights
and welfare of all human subjects used in research protocols.
Generally, the IRB Subcommittee B reviews research protocols
that are limited to non-medical interventions. Subcommittee A
of Temple University School of Medicine and Temple University
Hospital will review protocols requiring medical interventions
and most research involving human materials.
The length of time required for the review process of submitted
Request for Protocol Review to the IRB Subcommittee B is
variable. The review process for studies that qualify for
expedited review usually require three or more weeks. Request
for Protocol Review requiring full committee review may require
several months for the review process. The full committee of
the IRB Subcommittee B meets approximately every eight weeks for
the review of research protocols requiring full committee
review.
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STUDIES REQUIRING REVIEW
Temple University is charged by federal guidelines and
procedures to review all research involving human subjects or
human materials carried out by its personnel. There is no
distinction between funded and non-funded research activity by
either Federal Guidelines and policies and procedures of the IRB
of Temple University.
To assure the protection of human subjects and to comply with
federal law, Temple University requires that, prior to
initiation, all research projects involving human subjects or
human materials be reviewed and approved by the IRB. This
policy applies to all biomedical and behavioral research
involving human subjects or human materials conducted by
faculty, staff, and students of Temple University. If the
research program or study is a part of an application to a
Sponsoring Agency, the human protocol must be submitted for
either Subcommittee B's or Subcommittee A's review prior to or
when the application is processed by the Office of the Vice
President for Research.
DEFINITION OF HUMAN SUBJECTS
Research involving human subject(s) is defined as research
involved with any living individual about whom any investigator
(whether faculty, staff, or student) conducting research obtains
data through an intervention or an interaction with that
individual or acquisition of identifiable private information.
"Intervention" includes both a manipulation of the human
subject's environment or physical acquisition of data performed
for research purposes. "Interaction" includes any communication
or interpersonal contact between the investigator and the
subject for research purposes. "Private information" includes
all information about an individual or the behavior of an
individual that occurs in a context in which an individual can
reasonably expect that no observation is taking place, and/or
information which has been provided for specific purposes by an
individual who reasonably expected would not be made public.
Such information must be individually identifiable by the
investigator to constitute research involving human subjects.
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RESEARCH REVIEW BY THE IRB
Human research is defined as any activity initiated by Temple
University faculty, staff, or student which has the intent of
securing information from humans for the purpose of advancing
generalized knowledge. There is no distinction whether the
activity is funded or non-funded. The IRB of Temple University
must review all research protocols involving human subjects. It
is assumed by the IRB that the investigator has included in the
submission of the research protocol explicit objectives and
formal procedures of the research so suitable review can be
undertaken.
The IRB has the responsibility of reviewing and the authority to
approve, require modification in, or disapprove any or all
activities or proposed changes in previously approved research
activities. The IRB approves human research based on the IRB's
determination that the following requirements are satisfied:
Risks to human subjects are minimized by using research
procedures which are consistent with sound research design
and which do not unnecessarily expose the subject to risk.
Appropriate procedures already being performed on the
subjects for diagnostic or treatment purposes are not
altered in a way to increase risks to the human subjects.
Risks to subjects must be reasonable in relation to the
anticipated benefits, if any, to subjects and the
importance of knowledge that may reasonably be expected to
result. In evaluating risks and benefits, the IRB
considers only those risks and benefits which may result
from the research (as distinguished from risks and benefits
of therapies subjects would receive even if not
participation in the research).
Selection of subjects must be equitable. In making this
assessment the IRB shall take into account the purpose of
the research, the setting in which the research will be
conducted, and the population from which the subjects will
be recruited. The IRB shall determine if the investigator
by knowledge or unknowingly uses coercion for human
subjects participation in research. Such coercive actions
by an investigator may include using students in his/her
class, assigning extra credit for participation in
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research, waiving other course requirements, etc . All of
these actions would require the IRB to disapprove the
research protocol unless there were unusual extenuating
circumstances.
The IRB must assure that informed consent is sought from
each prospective subject or the subject's legally
authorized representative, in accordance with law. The
informed consent must be appropriately documented.
The IRB must assure that adequate provisions for monitoring
the data collection to insure the safety of subjects.
The IRB must assure that adequate provisions for the
protection of the privacy of subjects and to maintain the
confidentially of data.
The IRB must assure that when a cooperating institution(s),
departments, or cooperating research site(s) are to be
utilized in the investigator(s) research that appropriate
notifications and approvals of use of the institution or
site for research have been acquired.
There are three categories of research protocols that are
reviewed. These are research proposals which are exempt from
review, research proposals which undergo expedited review, and
research proposals which require full committee review.
Exempt Research Proposals
The Office of the Vice President for Research of Temple
University in consultation with the IRB is responsible for
reviewing the preliminary determination of research
investigations and for making final institutional determination
whether research protocols qualify for exemption. Therefore,
the investigator must submit to the IRB a proposal so that a
determination for exemption can be made.
The following categories of research are normally exempt from
full committee IRB review but must be reported to the IRB for
determination of exempt status [Please note that studies using
children (i.e., minors) or special populations are ineligible
for exempted review]:
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Research conducted in established or commonly accepted
educational settings, involving normal educational
practices.
Research involving educational tests (i.e., cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observations of public behavior.
No research will be exempted if the information obtained is
recorded in a way that the subject can be identified or
through identifiers linked to the subject; or, any
disclosure of the human subject's responses outside of
research could reasonably place the subject at risk of
criminal liability, civil liability, or damage financial
standing, employability, or reputation. Further, no human
research involving elected or appointed public officials or
candidates for public office can be exempted [federal
statute(s) require(s) confidentiality without exception of
the personally identifiable information will be maintained
throughout the research and thereafter].
Research involving existing data or documents that are
publicly available or if the information is recorded by the
investigator in a manner that human subjects cannot be
directly identified or through identifiers linked to the
subjects.
Exempt research protocols will be forwarded to the appropriate
Sponsoring Agency if deemed exempt by the IRB and the Office of
the Vice President for Research. All nonexempt research
proposals will be forwarded to the IRB for review.
Expedited Research Proposals
The Office of the Vice President for Research will in
consultation with the appropriate IRB Subcommittee chairperson
determine whether the research protocol meets the requirements
necessary for expedited review process. Other members of the
IRB are called upon as necessary to ensure sound judgement of
the expedited review. The eligibility of some research for
review through the expedited procedure is in no way intended to
negate or modify the federal guidelines or procedures.
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The IRB uses the expedited review process to review minor
changes in previously approved research during the period for
which approval is authorized. The only other research for which
the IRB uses expedited review procedure is that which involves
no more than minimal risk to subjects as demonstrated by the
research protocol and indicated by the appropriated IRB
Subcommittee chairperson and the Office of the Vice President
for Research.
Expedited review is conducted by the appropriate IRB
Subcommittee chairperson or by one or more of the experienced
IRB members designated by the chairperson to conduct the review
and the Office of the Vice President for Research. The IRB
member(s) conducting the expedited review exercises have all of
the authorities of the IRB except that the reviewer(s) may not
disapprove a research protocol. The reviewer(s) shall refer any
research protocols which the reviewer would have
disapproved to the full committee for review. The reviewer(s)
shall also refer research protocols to the full committee
whenever the reviewer(s) believes that full committee review
would be warranted.
When the expedited review procedure is used, the appropriate IRB
Subcommittee chairperson or member(s) conducting the review
inform the full committee in writing of research protocols that
have been approved. At a convened IRB meeting, any member may
request that any research protocol which has been approved under
the expedited procedure be reviewed by the IRB in accordance
with non-expedited procedures. A vote of committee members will
be taken for review with a simple majority required for full
committee review.
Research that qualifies for expedited review includes:
Recording of data from subjects 18 years or age or older
using noninvasive procedures routinely employed in clinical
practice. This includes 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. It also includes such procedures as
weighing, testing sensory acuity, electrocardiography,
electroencephalography, thermography, detection of
naturally occurring radioactivity, diagnostic echography,
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and electroretinography. It does not include exposure to
electromagnetic radiation outside the visible range (for
example, x-rays, microwaves).
Collection of hair and nail clippings in an undisfiguring
manner, deciduous teeth and permanent teeth if patient care
indicated a need for extraction.
Collection of excreta and external secretions including
sweat, uncannulated saliva, placenta removed at delivery,
and amniotic fluid at the time of rupture of the membrane
prior to labor.
Voice recordings made for research purposes such as
investigations of speech defects [Please see Appendices for
the Permission to Audiotape form].
Moderate exercise in healthy volunteers.
The study of existing data, documents, records,
pathological specimens, or diagnostic specimens.
Research on individual or group behavior of characteristics
of individuals, such as studies of perception, cognition,
game theory, or test development, where the investigator
does not manipulate subject's behavior and the research
will not involve stress to subjects.
Research on drugs or devices for which an investigational
new drug exemption or an investigational device exemption
is not required.
Full Committee Review Research Proposals
Research proposals scheduled for full committee review are
distributed to all members of the IRB prior to the meeting.
When consultants or experts are used to provide special
expertise to the IRB in its review of a protocol, the research
protocol is distributed to the consultants or experts prior to
the meeting.
For a research proposal to be approved, it must receive the
approval of a majority of those members present at the convened
meeting. Where research is deemed to be of particular
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sensitivity an unanimous decision is viewed as essential.
No IRB may have a member participating in the IRB's initial or
continuing review of any project in which the member has a
conflicting interest, except to provide information requested by
the IRB. Where research activities were initially approved
under expedited review procedures and subsequently reviewed by
the full
committee, the decisions reached at the convened meeting will
supersede any decisions made through the expedited review.
In order to facilitate protocol review, the IRB Subcommittees A
and B requests that the protocols, consent forms, and
attachments be prepared carefully and completely according to
these guidelines. The protocols become part of the permanent
records maintained by IRB and therefore, are subject to
inspection and review by various government and granting
agencies.
PREPARATION OF THE REQUEST FOR PROTOCOL REVIEW
The following are general guidelines, procedures, and practices
in preparing the Request for Protocol Review for Subcommittee B
of Temple University main campus [Please see Appendices for
complete request form or call (215) 707-8757 for the request
form]. The Request for Protocol Review for Subcommittee A of
Temple University Medical School is available by also calling
(215) 707-8757.
FACE SHEET
This is the administrative form used by the IRB Subcommittee B
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for most research conducted on the main campus of Temple
University. Please supply all of the requested information
including required signatures.
Please provide a reasonable starting date and estimated duration
for the proposed research. The funding agency may require
additional forms to be completed when submitting the research
protocol for review.
Each part of the Request for Protocol Review will have a brief
clarification of the information which is required under each
section. Clarification responses are in bold.
Part I.
A.
Characteristics of Potential Subjects
About how many subjects will you need?
The response is a numerical number which must closely
approximate the number of subjects to be used in the
research protocol.
B.
Describe the potential subjects in terms of gender, age
range, ethnic group, economic status, and any other
significant descriptors.
The response must be specific as to the requested
information. Subjects that may be particularly vulnerable
populations include [this list is not inclusive]:
Minors
Mentally impaired persons
Pregnant women
Prisoners
Individuals in nursing homes Chronically disabled persons
Terminally ill patients
Single parents (including
minors)
Armed forces personnel
Students
Impoverished persons
Sick persons
Battered adults
Abused children
Persons who are HIV positive or who have AIDS
If subjects are to be excluded because of age, gender,
economic status, ethnic origin, etc., reasons for exclusion
must be documented by the investigator(s).
Research involving subjects that are particularly
vulnerable will require full committee review.
Please Note:
Research proposals submitted to NIH require
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significant justification if the investigator(s) excludes
female or minority subjects in the research design. If at
all possible, the subject population should resemble that
of the demographics of the University or the regional area
where the research is being undertaken.
C.
Indicate any special subject characteristics, such as
persons with mental handicaps, prisoners, pregnant women,
etc.
Please see list in Part I, Section B. Use of such subjects
will require a detailed rationale and documentation as to
why these subjects are to be used in the research protocol.
D.
What is the general state of health of the subjects
(physical and mental)?
What parameters are to be used to determine the state of
health. Reasons for using subjects that are not healthy
must be documented by the investigator(s).
E.
Describe how you will gain access to these potential
subjects?
Please be precise as to the methods used to gain access to
potential subjects. If advertisement(s) are to be used,
please append the Request for Protocol Review with
advertisement document.
F.
How will subjects be selected or excluded from the study?
Inclusion and exclusion criterion need to be stated. If
there are multiple inclusion and exclusion criterion,
append these to the Request for Protocol Review.
G.
If subjects are from an institution other than Temple
University, please indicate the name of the office
responsible for granting access to the subjects.
Statement is self-explanatory. Please attach letter(s) for
permission for access to subjects to the Request for
Protocol Review. The IRB has the responsibility of
assuring that cooperating institutions and/or research
sites have appropriately reviewed and approved applications
for the use of human subjects.
H.
If the subjects are children, anyone suffering from a known
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psychiatric condition, or legally restricted, please
explain why it is necessary to use these persons as
subjects.
The investigator(s) must document why such persons are
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necessary for the research.
Part II.
A.
Experimental or Research Procedure
Please describe the intended experimental or research
procedure. This should include a description of what the
subject will experience or be required to do. Please
attach a copy of all questionnaires or instruments to be
used.
Summarize the purpose of the study, the hypotheses which
are to be tested and a statistical analysis procedure if
necessary. Provide a succinct and clear description of
past findings which led to the plan of this research study.
A summary of relevant research reports may be included in
this section. Describe the experimental procedures in
sufficient detail so that the IRB will have a clear
understanding of the experimental design and procedures.
B.
Will the subjects be deceived in any way?
describe below.
If yes, please
Research using deception will require full committee
review. Justification and documentation as to why
deception must be used must be provided by the
investigator(s) to the IRB.
C.
To what extent will the routine activities of the subject
be interrupted during the course of the study?
This section is self-explanatory. Justification for
significant disruption of the subjects daily routine must
be documented by the investigator(s).
D.
Indicate any compensation for the subjects.
Compensation is not required. If subjects are to be
compensated, describe any inducements to be provided to the
subjects whether monetary or prizes, gifts, or provided
services or benefits. Further, compensation for subjects
that are excluded by the investigator or by withdrawal must
be clarified. Explain how and when subjects will receive
compensation or inducements for participation in the
research.
Part III.
Data Confidentiality
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A.
What procedure(s) will you use to insure confidentiality of
the data. How will you preserve subject anonymity?
The Office of the Vice President for Research and the IRB
of Temple University requires that confidentiality be
maintained for subjects. The IRB must be informed of the
steps that will be taken to assure confidentiality
especially when personally identifiable information is
being recorded. Specifics concerning the coding of data,
storage of data, and access to data must be documented by
the investigator(s).
In some cases, Sponsoring Agencies may have access to data
for review. If such review is mandated the IRB must be
notified.
Part IV.
A.
Consent Procedures
Attach a copy of consent form to be used. If non-written
consent is to be used, attach a statement describing
exactly what the subjects will be told.
The consent form should be a succinct statement which gives
reasonable information about the study including the
purpose, procedures, benefits, risks (and discomfort to the
subjects), duration of the study, and alternative therapy
if applicable so that the subject may make a meaningful
decision about participation. The following items must be
covered in the consent form:
The Consent Form must be on Temple University letterhead and
should be titled Consent Form. The Consent Form should be
subtitled with the name of the study. The name(s) and phone
number(s) of the responsible investigator(s) should appear under
Consent Form. The Consent Form should be written in clear,
understandable English or appropriate language which explains
the purpose of the study and precisely states what will be done
to the subject. [For a Consent Form in language other than
English a translation must be provided to the IRB.] The Consent
Form must provide adequate information concerning the study so
that the subject may decide whether or not to participate. The
Consent Form may not use language that by which the subject is
made to waive, or appear to waive, any of his/her legal rights
or to the release Temple University or its agents from liability
for negligence. Each adult subject must receive a signed copy
of the Consent Form. Guardians signing for minors or those
individuals who cannot provide informed consent must receive a
signed copy of the Consent Form. The principal investigator
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must retain in his/her confidential files copies of the consent
forms signed by each subject for at
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least five (5) years following the completion of the
research study or longer if required by the Sponsoring
Agency.
The following points must be covered in the consent form:
Purpose of research - The purpose of the research should be
expressed in lay terms clearly indicating the purpose and
nature of the research. The subject should be told why
he/she is being asked to participate in the research.
Selection of subjects - The subject must be informed of the
reasons why he/she is being asked to participate in the
research. Inclusion and exclusion criterion must be made
know to the subject.
General experimental procedures - The subject must be
informed of the general experimental procedures and exactly
what his/her participation will involve. Information
concerning the duration of the research procedures,
location of the where the experimental procedures will be
performed, pre- and post-evaluations of subjects, types and
number of test, randomization procedures, photographing,
video-taping, or audio-taping requirements, amount of
blood, urine, or saliva to be taken, and follow-up studies
must be clearly stated in the Consent Form. Please refer
to appendices for forms granting permission to videotape,
audiotape, and photograph.
Risks - Research may have inherent and/or unforseen
hazards, discomforts, or inconveniences. The disclosure of
inherent and/or unforseen hazards, discomforts, and
inconveniences must be clearly stated in the Consent Form.
If you’re doing fMRI Studies, use the language below:
“The brain scan that is done as part of this research
protocol is not intended to detect any brain disease of
abnormality. Research brain scans are not examined by a
clinical radiologist to look for abnormalities. The
brain scan for this research will only look at a portion
of your brain activity as it relates to this research.
The Investigators, the fMRI operators and other members
of the research team are not qualified to interpret the
scan for any diagnostic or therapeutic value.
Therefore, the fMRI scan being done for this research
study will not be analyzed to detect any medical
condition. The scan will not be available to you or
your physician.”
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Benefits - Any benefits to the subject should be explained
in the Consent Form including compensation. Compensation
payment schedules must be included if appropriate in the
Consent Form.
Confidentiality - Although the study team has placed
safeguards to maintain the confidentiality of my personal
information, there is always a potential risk of an
unpermitted disclosure. To that degree, all documents and
information pertaining to this research study will be kept
confidential, unless required by applicable federal, state,
and local laws and regulations to be disclosed. I
understand the records and data generated by the study may
be reviewed by Temple University and its agents, the study
sponsor or the sponsor's agents (if applicable), and/or
governmental agencies to assure proper conduct of the study
and compliance with regulations. I understand that the
results of this study may be published. If any data is
published, I will not be identified by name.
Disclaimer/Withdrawal - The subject must be informed that
he/she is free to decide whether or not to participate in
the study. The subject must be informed that nonparticipation in the research or withdrawal from the
research will not prejudice future interactions with the
investigator or Temple University. There must be
assurances that the subject is not coerced for
participation or coerced not to withdraw from the research.
Injury/Complications - If applicable, subjects should be
advised as to availability of nonavailability of medical
treatment or compensation for injury incurred as a result
of participating in the research. For research involving
more than minimal risks, there may be obligations by Temple
University to cover, in part, medical treatments, etc. In
studies where no threat of injury exists, no additional
statement is needed.
Subject rights - The following statement regarding the
rights of research subjects must appear in all consent
forms:
" If I have any questions about my rights as a research
subject, I may contact the Institutional Review Board
Coordinator at (215) 707-3390. The IRB Coordinator
may also be reached by email: irb@temple.edu or
regular mail:
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Institutional Review Board Coordinator
Temple University Research Administration
Student Faculty Conference Center
3340 North Broad Street – Suite 304
Philadelphia, PA 19140"
Questions - The subject should be encouraged to ask
questions. The Consent Form should state that the subject
can ask questions and these questions will be answered.
Indemnifying Clauses - Some types of research will require
indemnifying clauses. Please refer to appendices for
examples of indemnifying clauses.
Certification by the IRB - The Office of the Vice President
for Research will stamp and date the approved Consent Form
prior to its use. The approval will be for one year
following the date of certification. If at any time the
investigator(s) alters the IRB approved research protocol,
the Office of the Vice President for Research and the IRB
must be notified and the Consent Form may have to reflect
the alterations of the research protocol. Once appropriate
changes have been made in the revised Consent Form, the
Office of the Vice President for Research will stamp and
date the revised form.
B.
Describe how you will handle consent procedure for minors,
mentally challenged persons, and persons with significant
emotional disturbances.
A Consent Form written for and signed by the guardian must be
submitted to the IRB as per instructions in Part IV, Section A.
Whenever possible, provide a consent form written in lay
language understandable by the minor, mentally challenged
person, and person with significant
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emotional disturbances.
Part V.
A.
Benefits of the Study
How will any one subject benefit from participation in this
study?
The benefit(s) to the subject, if any, should be explained.
If there is no benefit to the subject this should also be
explained. A study that has no benefits to the subject and
places the subject under risk will be critically reviewed
by the IRB.
B.
How will society, in general benefit from the conduct of
this study?
The benefit(s) to society, if any, should be explained. If
there is no benefit to society this should also be
explained. A study that has no benefit for society and
places the subject under risk will be critically reviewed
by the IRB.
Part VI.
A.
Risks/Discomforts to Subjects
Describe any aspect of the research project that might
cause discomfort, inconvenience, or physical danger to the
subjects.
The investigator must provide documentation of risks,
discomfort, inconveniences, and physical danger that may
occur to a subject participating in the research protocol.
Documentation of emergency procedures, etc. should be
included where appropriate.
B.
Describe any long range risks to the subjects.
Answer this section similarly to the responses in Part VI,
Section A.
C.
What is the rationale for exposing the subjects to these
risks?
The investigator must provide a detailed rationale for
exposing the subjects to risks, discomforts,
inconveniences, and physical danger. The IRB cannot make a
decision concerning approval of the Request for Protocol
Review without such detail.
21
RESPONSIBILITIES OF THE IRB FOLLOWING SUBMISSION OF
REQUEST FOR PROTOCOL REVIEW
Two (2) members of the IRB Subcommittee are assigned as the
primary reviewers of the submitted Request for Protocol Review.
If the Request for Protocol Review requires full committee
review, copies of the protocol are sent to each member of the
IRB. It is the responsibility of the primary reviewers to lead
the discussion concerning the protocol being reviewed at the
scheduled meeting of the IRB. Following discussion of the
Request for Protocol Review, the IRB Subcommittee B determines
whether human subjects are or are not at risk, and decides to:
(a) approve the protocol as submitted; (b) approve the protocol
contingent on specific revisions; (c) to table the protocol for
substantive changes and/or resubmission to the Office of the
Vice President for Research and the IRB; or (d) disapprove the
protocol. Actions of the IRB Subcommittee B will be recorded in
the minutes of scheduled meetings.
The chairperson of the appropriate IRB subcommittee will notify
the investigator of the decision as soon as possible after the
meeting.
University policy and Federal Regulations require that all
research studies involving human subjects be reviewed every 12
months. The IRB Subcommittee B will perform such requirements.
In some cases, depending upon the risks to human subjects, the
IRB Subcommittee B may review research studies on a more
frequent schedule.
At anytime the IRB becomes aware of investigator abuse of human
subjects, it is the responsibility of the IRB to immediately
revoke the approval of the investigator(s) research study.
Further, any student research involving human subjects in degree
granting processes must be approved the IRB prior to graduation.
RESPONSIBILITIES OF THE INVESTIGATOR(S) FOLLOWING APPROVAL
OF THE REQUEST FOR PROTOCOL REVIEW BY THE IRB
It is the responsibility of the investigator(s) to immediately
inform the Office of the Vice President for Research and the IRB
Subcommittee of any change in the research protocol, injury(ies)
and untoward response(s) of human subjects, and termination of
the research.
The IRB Subcommittee B will review most protocol changes by
expedited review. Changes in research protocols may mandate
changes in the Consent Form. The approved revised Consent Form
will be stamped and dated by the Office of the Vice President
22
for Research. The Consent Form will be certified for use for
one year following the date of certification. If changes in the
research protocol are instituted, the process for research
protocol approval and the certification of the Consent Form will
be immediately initiated by the investigator(s) as previously
described.
Any and all injury(ies) and untoward response(s) that occur
during a research protocol must be immediately reported to the
Office of the Vice President for Research at (215) 707-8757 and
followed with detailed documentation to the events. Actions
taken to remedy either the injury or untoward responses must
also be included.
Investigators must inform the Office of the Vice President for
Research when a project is terminated. This process can be
accomplished by a letter.
23
APPENDIX A
REQUEST FOR PROTOCOL REVIEW
FORWARD THREE (3) COPIES OF ALL MATERIAL - COVER PAGE, PROTOCOL,
CONSENT FORMS, QUESTIONNAIRES, INSTRUMENTS, ETC. TO:
INSTITUTIONAL REVIEW BOARD
STUDENT FACULTY CONFERENCE CENTER
3340 NORTH BROAD STREET – SUITE 304
PHILADELPHIA, PENNSYLVANIA 19140
24
INTRODUCTION TO THE RESEARCH REVIEW PROCESS
Federal Regulations require that funded research involving human subjects must be approved by
a human rights committee. The regulations further stipulate that if a college or university
receives any federal research funding, all human subject research that is conducted at the college
or university must also comply with the federal research regulations.
The Temple University Institutional Review Board (IRB) is the human rights committee that is
charged with the responsibility of insuring that the rights of human subjects are protected in all
Temple University research. It should be clear that the IRB is not a peer review committee that
serves to critique or limit research. The IRB serves only to insure that the rights of subjects and
potential subjects are protected. It is the primary intent of the IRB to insure that the potential
subject is provided with sufficient information to enable him/her to make a free and informed
decision about his/her participation in the research project.
You are asked to provide information about your proposed research project on this form. The
IRB will use this information in its review process. If you have any questions about the IRB
process, please feel free to contact the IRB coordinator at irb@temple.edu. Thank you for your
cooperation in this matter.
I. CHARACTERISTICS OF POTENTIAL SUBJECTS
A.
About how many subjects will you need? Please include the number of females and
males you wish to recruit.
B.
Describe the potential subjects in terms of gender, age range, ethnic group, and any
other significant descriptors.
C.
Indicate any special subject characteristics, such as persons with mental handicaps,
physical handicaps, prisoners, pregnant women, etc.
D.
Are you aware of any special health problems with the subject pool?
E.
Describe how you will gain access to these potential subjects.
F.
How will subjects be selected or excluded from the study?
G.
If subjects are from an institution other than Temple University, please indicate the
name of the officer responsible for granting access to the subjects.
25
H.
If the subjects are children, anyone suffering from a known psychiatric condition, or
legally restricted, please explain why it is necessary to use these persons as subjects.
II. EXPERIMENTAL OR RESEARCH PROCEDURE
A.
Describe the objectives and/or goals of your research.
B.
Please describe the intended experimental or research procedure. This should
include a description of what the subject will experience or be required to do.
Please attach a copy of all questionnaires or instruments to be used.
C.
Will the subjects be deceived in any way? If yes, please describe below.
D.
To what extent will the routine activities of the subject be interrupted during the
course of the study?
E.
Indicate any compensation for the subjects.
III. DATA CONFIDENTIALITY
A.
What procedure(s) will you use to insure confidentiality of the data? How will you
preserve subject anonymity?
IV. CONSENT PROCEDURES
A.
Attach copy of consent form to be used (Please note that if consent form is more
than one (1) page, the title of the study must be on the signature page.
OR
If non-written consent is to be used, attach a statement describing exactly what the
subjects will be told.
B.
Describe how you will handle consent procedure for minors, mentally challenged
persons, and persons with significant emotional disturbances.
26
V. BENEFITS OF THE STUDY
A.
How will any one subject benefit from participation in this study?
B.
How will society, in general, benefit from the conduct of this study?
VI. RISKS/DISCOMFORTS TO SUBJECTS
A.
Describe any aspects of the research project that might cause discomfort,
inconvenience, or physical danger to the subjects.
B.
Describe any long range risks to the subjects.
C.
What is the rationale for exposing subjects to these risks?
27
APPENDIX B
PERMISSION TO VIDEOTAPE
PERMISSION TO AUDIOTAPE
PERMISSION TO PHOTOGRAPH
28
This form must be on Temple University letterhead
Permission to Videotape
Investigator's Name:
Department:
Project Title:
Subject:
Log #:
Date:
(Choose one)
I give
for the following purpose (s):
permission to videotape me. This videotape will be used only
CLINICAL
This videotape will be used as part of my treatment. It will not be shown to anyone but my
treatment team, my family, and myself.
EDUCATION
This videotape may be shown to education professionals outside of
educational purposes. At no time will my name be used.
for
RESEARCH
This videotape will be used as a part of a research project at
. I have
already given written consent for my participation in this research project. At no time will my
name be used.
MARKETING/PUBLIC INFORMATION
This videotape will be used to promote
to educational or health
professionals, referral sources, and/or the general public. At no time will my name be used.
OTHER
Description:
WHEN WILL I BE VIDEOTAPED?
I agree to be videotaped during the time period:
to
.
HOW LONG WILL THE TAPES BE USED?
29
I give my permission for these tapes to be used from:
to
.
(Include a statement that data will be stored for three (3) years after completion of the study. If
you wish to store longer, than permission must be received from the IRB.)
WHAT IF I CHANGE MY MIND?
I understand that I can withdraw my permission at any time. Upon my request, the videotape(s)
will no longer be used. This will not affect my care or relationship with
in any way.
OTHER
I understand that I will not be paid for being videotaped or for the use of the videotapes.
FOR FURTHER INFORMATION
If I want more information about the videotape(s), or if I have questions or concerns at any time,
I can contact:
Investigator's Name:
Department:
Institution:
Street Address:
City:
Zip Code
Phone: Office
State:
Home
This form will be placed in my records and a copy will be kept by the person(s) named above. A
copy will be given to me.
30
Please print
Subject's Name:
Date:
Address:
Phone:
Subject's Signature:
(Or signature of parent or legally responsible person if subject is a minor or is incompetent to
sign.)
Relationship to Subject:
Subject cannot sign because:
but consents orally to be videotaped under the conditions described above.
Witness Signature
Date
Witness Signature
Date
31
Letterhead
Permission to Audiotape
Investigator's Name:
Department:
Project Title:
Subject:
Log #:
I give
for the following purpose (s):
Date:
permission to audiotape me. This audiotape will be used only
(Choose one)
CLINICAL
This audiotape will be used as part of my treatment. It will not be shown to anyone but my
treatment team, my family, and myself.
EDUCATION
This audiotape may be shown to education professionals outside of
educational purposes. At no time will my name be used.
for
RESEARCH
This audiotape will be used as a part of a research project at
. I have
already given written consent for my participation in this research project. At no time will my
name be used.
MARKETING/PUBLIC INFORMATION
This audiotape will be used to promote
to educational or health
professionals, referral sources, and/or the general public. At no time will my name be used.
OTHER
Description:
Permission to Audiotape - Page 2 of 3
WHEN WILL I BE AUDIOTAPED?
I agree to be audiotaped during the time period:
to
.
HOW LONG WILL THE TAPES BE USED?
32
I give my permission for these tapes to be used from:
to
.
(Include a statement that data will be stored for three (3) years after completion of the study. If
you wish to store longer, than permission must be received from the IRB.)
WHAT IF I CHANGE MY MIND?
I understand that I can withdraw my permission at any time. Upon my request, the audiotape(s)
will no longer be used. This will not affect my care or relationship with
in any way.
OTHER
I understand that I will not be paid for being audiotaped or for the use of the audiotapes.
FOR FURTHER INFORMATION
If I want more information about the audiotape(s), or if I have questions or concerns at any time,
I can contact:
Investigator's Name:
Department:
Institution:
Street Address:
City:
Zip Code
Phone: Office
State:
Home
This form will be placed in my records and a copy will be kept by the person(s) named above. A
copy will be given to me.
33
Permission to Audiotape - Page 3 of 3
Please print
Subject's Name:
Date:
Address:
Phone:
Subject's Signature:
(Or signature of parent or legally responsible person if subject is a minor or is incompetent to
sign.)
Relationship to Subject:
Subject cannot sign because:
but consents orally to be audiotaped under the conditions described above.
Witness Signature
Date
Witness Signature
Date
34
Letterhead
Permission to Photograph
Investigator's Name:
Department:
Project Title:
Subject:
Log #:
Date:
I give
permission to photograph me. This (these) photograph(s) will
be used only for the following purpose (s):
(Choose one)
CLINICAL
This (these) photograph(s) will be used as part of my treatment. It will not be shown to anyone
but my treatment team, my family, and myself.
EDUCATION
This (these) photograph(s) may be shown to education professionals outside of
for educational purposes. At no time will my name be used.
RESEARCH
This (these) photograph(s) will be used as a part of a research project at
. I have already given written consent for my participation in this research project. At no time
will my name be used.
MARKETING/PUBLIC INFORMATION
This (these) photograph(s) will be used to promote
to
educational or health professionals, referral sources, and/or the general public. At no time will
my name be used.
OTHER
Permission to Photograph - Page 2 of 3
35
Description:
WHEN WILL I BE PHOTOGRAPHED?
I agree to be photographed during the time period:
to
.
HOW LONG WILL THE PHOTOGRAPHS BE USED?
I give my permission for this (these) photograph(s) to be used from:
to
(Include a statement that data will be stored for three (3) years after completion of the study. If
you wish to store longer, than permission must be received from the IRB.)
WHAT IF I CHANGE MY MIND?
I understand that I can withdraw my permission at any time. Upon my request, the
photograph(s) will no longer be used. This will not affect my care or relationship with
in any way.
OTHER
I understand that I will not be paid for being photographed or for the use of the photograph(s).
FOR FURTHER INFORMATION
If I want more information about the photograph(s), or if I have questions or concerns at any
time, I can contact:
Investigator's Name:
Department:
Institution:
Street Address:
City:
Zip Code
Phone: Office
State:
Home
.
36
Permission to Photograph - Page 3 of 3
This form will be placed in my records and a copy will be kept by the person(s) named above. A
copy will be given to me.
Please print
Subject's Name:
Date:
Address:
Phone:
Subject's Signature:
(Or signature of parent or legally responsible person if subject is a minor or is incompetent to
sign.)
Relationship to Subject:
Subject cannot sign because:
but consents orally to be photographed under the conditions described above.
Witness Signature
Date
Witness Signature
Date
37
APPENDIX C
SAMPLE CONSENT FORMS
38
THIS CONSENT FORM MUST BE TYPED ON TEMPLE UNIVERSITY LETTERHEAD.
The name of the drug used in this study and the name of the
investigators have been removed.
Participant's Name:
DATE
Title: Double Blind Study on the Effect of Drug A
Administration on the Hormones of the Hypothalamic-PituitaryAdrenal Axis During Exercise-Induced Stress in Normal Male
Subjects
Investigators:
Investigator I, - Biokinetics Research Lab (215) 204-xxxx
Investigator II, - General Clinical Research Cnt (215) 221-xxxx
Investigator III, - Biokinetics Research Lab (215) 204-xxxx
Purpose of Research: This research will determine the effect of
Drug A (a drug that mimics Hormone A of your thymus gland) on
your hormonal responses of your hypothalamic-pituitary-adrenal
axis to near maximal exercise for 10 minutes and during the
following recovery.
General Research Design:
I understand that I am being asked to participate in a research
study at the Biokinetics Research Laboratory of Temple
University. This study will evaluate the effect of an
experimental drug called Drug A (50 mg) or a placebo on the
hormonal responses of my hypothalamic-pituitary-adrenal axis
during and following an exercise stress at 90% of my maximal
oxygen consumption. Drug A or placebo will be injected in a
volume of 1.0 mL into the subcutaneous or the "fatty" area just
below my skin. This study will be blinded so that neither I nor
the investigators will know if I am receiving the placebo or
Drug A. I have a 50% chance of receiving either the placebo or
the Drug A. Following the administration of Drug A or placebo,
I will sleep in the Biokinetics Research Laboratory and remain
in the facility the entire next day. At about 4:30 pm a
catheter will be placed into a vein on the back of my hand or
forearm. At about 5:30 pm, I will be asked to run on a
motorized treadmill at 90% of my maximal oxygen consumption for
10 minutes in intervals of 30 seconds of running and 30 seconds
of standing recovery. Blood will be drawn four (4) times: prior
to, at the completion of the treadmill run, and at 30 and 120
minutes following the exercise. The volume of blood drawn at
each time will be
approximately 35 mL. Following the blood draw at 120 minutes
39
post-exercise, I will remain in the Biokinetics Research
Laboratory until 9:00 the next morning at which time I will be
discharged from the research project. This research project
will
allow the investigator to characterize the effect of Drug A on
the hormonal response to near maximal exercise in normal males.
Approximately twenty (20) subjects will participate in this
study.
Procedures to be Followed:
Pre-admission to study (Visit 1): A complete medical history
and physical exam will be performed. Clinical laboratory tests
including blood (about 20 mL) and urine tests will be performed.
These test will include standard clinical chemistry tests, blood
cell differentials, and tests for HIV-1 antibody (AIDS),
hepatitis B, and a drug screen. Lung function (breathing
tests), a resting ECG, and a body composition determination via
underwater (hydrostatic) weighing will be completed. I
understand that the results of these tests will be forwarded to
my physician by my written request. I understand that if my
pre-admission evaluations qualify me to participate in this
research project, I will be assigned a seven (7) digit code for
these tests and all subsequent evaluations. I understand that
all of the collected research data will be kept confidential and
the only reference to my data will be by the 7-digit code. I
understand that I will not receive any compensation for these
pre-admission tests.
Stress test with maximal oxygen consumption (Visit 2): I
understand that I will be asked to run on a motorized treadmill
to volitional exhaustion seven days following pre-admission
qualification to the research project. I understand that my
heart rate and blood pressure responses to the maximal oxygen
consumption test will be monitored. I understand that the risks
of a maximal oxygen consumption test are small. They include
too high or too low blood pressure, too rapid or too slow heart
rate response, or a possible myocardial infarction (heart
attack). Should any abnormal exercise event occur, I understand
that the exercise test will be stopped, and, if necessary, I may
be transported to the emergency room of Temple University
Hospital. I understand that the results of this test will be
forwarded to my physician upon written request. I understand
that I will not receive any compensation for this evaluation.
Entry into the study (Visit 3): I understand that six (6) days
following the stress test with maximal oxygen consumption I will
be admitted to the study facility by 12:00 noon and will remain
in the study facility for about 45 hours. I understand that
40
just prior to receiving my injection of study medication a
sample of blood (approximately 35 mL) will be drawn. I
understand that at about 7:30 pm I will be administered 50 mg/mL
of Drug A or a placebo by a physician. I understand that I will
sleep overnight in the study facility. I understand that I will
be provided a
nutritionally balanced dinner the night of entry into the study,
breakfast for the next two mornings, lunch the following day,
and dinner the following night two hours after my treadmill run.
I understand that at about 4:30 pm on the day after admission to
the study facility, I will have an indwelling catheter placed in
a vein in the back of my hand or my forearm. I understand that
I will have blood drawn four (4) times: prior to, at 15 minutes
of treadmill running, and at 30 and 120 minutes post-exercise.
I understand that I will sleep over a second night in the study
facility, will have 20 mL of blood drawn and a urine sample
collected at 8:00 am, and will be discharged from the study at
9:00 am the following morning.
I hereby authorize Investigator I, Investigator II, and
Investigator III and such assistants as may be selected by the
investigators to perform my medical history and physical exam
with a blood drawn, urine collection, lung tests, and body
composition determination; determine my maximal oxygen
consumption; and, administer Drug A or the placebo, complete the
metabolic determinations of my maximal oxygen consumption during
treadmill exercise and perform the four (4) blood draws as
outlined in this investigation.
The procedures of this investigation have been explained to me
by Investigator I. Any questions that I may have concerning the
study will be answered at any time during the working day by
calling Investigator I at (215) 204-xxxx or at home at (215)
xxx-xxxx. I understand that if I have further medical
questions, I can contact Investigator II at (215) 204-xxxx or
Investigator III at (215) 221-xxxx.
I understand my treatment with Drug A during the study may
result in my experiencing reactions consisting of itch, mild
rash, intermittent redness of skin, swelling around the eyes,
local irritation at the site of injection which may be
characterized by pain, burning sensations, itching, redness and
swelling. Allergic reactions to Drug A can occur in rare
instances.
Unforseen reactions may also occur.
I understand that circumstances may arise which might cause the
investigators to terminate my participation in the study before
its completion. These circumstances would include any situation
in which the investigators believed that further participation
41
would be dangerous to me. I understand that if my participation
in the study is terminated at any time for any reason, a
complete physical exam and laboratory evaluations will be
performed.
I understand that the results of this study may be published but
my identity will not be disclosed without written consent by me
on a separate form. I understand that as a participant in this
study, my records relating to my treatment will be kept
confidential and reviewed only by the medical staff, the study
sponsor and possibly the Federal Drug Administration. I agree
to permit Temple University to keep, publish, or dispose of the
results of my treatment results.
I understand that the data of this study will not be released to
me until the termination of the study.
Although the study team has placed safeguards to maintain the
confidentiality of my personal information, there is always a
potential risk of an unpermitted disclosure. To that degree,
all documents and information pertaining to this research study
will be kept confidential, unless required by applicable
federal, state, and local laws and regulations to be disclosed.
I understand the records and data generated by the study may be
reviewed by Temple University and its agents, the study sponsor
or the sponsor's agents (if applicable), and/or governmental
agencies to assure proper conduct of the study and compliance
with regulations. I understand that the results of this study
may be published. If any data is published, I will not be
identified by name.
I understand that the possible benefits of this study are: a)
to better understand the hormonal response to near maximal
exercise; b) to determine if the administration of Drug A
influences these hormonal responses; and c) to provide data to
determine if future studies on the hormonal status following
near maximal exercise are feasible.
I understand that I will not be charged for any of the medical,
blood, urine, metabolic or body compositional evaluations
outlined in this investigation.
I understand that I may refuse consent or withdraw from the
research project at any time without penalty or loss of medical
care to which I am entitled.
I understand that I will be compensated $250 for my time for my
two (2) night stay in the Biokinetics Research Laboratory, the
treadmill run at 90% of my maximal oxygen consumption, the four
(4) blood draws associated with the treadmill run, and the blood
draw the morning after my second night stay. I understand that
42
I will be compensated $100 if the investigator(s) terminate my
participation from the study because of an unexpected event
occurring during or for 120 minutes following the treadmill run
at 90% of my maximal oxygen consumption.
I understand that if I am injured as a result of my involvement
in this study, only physician's fees and medical expenses in
excess of my medical and hospital coverage or other third party
coverage will be paid with no additional cost to me. I
understand that financial compensation for such injury is not
available. If I need to, I can contact Investigator I,
Biokinetics Research Laboratory, Broad and Montgomery Streets,
Philadelphia, PA 19122, office phone (215) 204-xxxx, home phone
(215) xxx-xxxx, Investigator II, Biokinetics Research
Laboratory, Broad and Montgomery, Philadelphia, Pennsylvania
19122, office phone (215) 204-xxxx or Investigator III, General
Clinical Research Center, 3401 N. Broad Street, Philadelphia, PA
19140, office phone (215) 221-xxxx. For questions about my
rights as a research subject, I may contact the Institutional
Review Board Coordinator at (215) 707-3390. The IRB Coordinator
may also be reached by email: irb@temple.edu or regular mail:
Institutional Review Board Coordinator
Temple University Research Administration
Student Faculty Conference Center
3340 North Broad Street – Suite 304
Philadelphia, PA 19140
I have read and understood this consent form and I voluntary
agree to participate in this research project. I understand
that I will be given a copy of the signed consent form.
Signature of the Subject
Date
Signature of Witness
Date
Signature of Investigator
Date
43
THIS CONSENT FORM MUST BE TYPED ON TEMPLE UNIVERSITY LETTERHEAD.
Investigators names have been removed.
Title: Determination of Resting and Ambulatory Energy Cost
Following Weight Loss and Weight Training
Investigators:
Investigator I, Biokinetics Research Laboratory, 204-xxxx
Investigator II, Biokinetics Research Laboratory, 204-xxxx
Investigator III, Biokinetics Research Laboratory, 204-xxxx
INTRODUCTION
This study will determine the effect of a six week diet of 1000
to 1100 calories per day and weight training on the resting
energy expenditure and the ambulatory energy cost of walking at
2.0, 2.5, 3.0, 3.5, and 4.0 mph and bicycling at 25, 50, and 75
Watts. Four experimental groups will participate in this study.
Group One will be a control group that neither diets nor weight
trains for six weeks; Group Two will consume a protein enriched
low fat diet of 1000 to 1100 calories per day for six weeks;
Group Three will weight train for six weeks with no diet
modification; and Group Four will diet (1000 to 1100 calories
per day) and weight train for six weeks. All participants in
the study will be allowed to undergo the diet and/or weight
training programs if they are not assigned to either of those
experimental groups. The resting energy expenditure, ambulatory
energy costs, and upper and lower body strength assessments will
be made prior to, at the end of three weeks of the experiment,
and at the end of six weeks of the experiment.
This study will help to quantify both the metabolic and muscle
strength changes associated with dieting and with weight
training.
CONSENT
I hereby authorize Investigator I, Investigator II, Investigator
III, and such assistants as may be selected by the investigators
to complete the metabolic determinations of my energy cost while
at rest, during exercise, and during recovery and my muscular
strength as outlined in this investigation.
I hereby authorize the aforementioned investigators to complete
a body composition assessment by the densiometric method of
underwater weighing to determine my non-fat mass.
I understand that this is a research study designed to determine
if dieting and weight training lower the resting energy
expenditure, ambulatory energy expenditure, and muscular
strength.
44
I understand that the risks of an exercise walking test and
bicycling tests are small. They include too high or too low
blood pressure, too rapid or too slow heart rate, or a possible
myocardial infarction (heart attack). Should any abnormal
exercise event occur, the exercise test will be stopped and, if
necessary, I may be transported to the emergency room of Temple
Hospital.
I understand that the strength assessments may result in muscle
soreness.
I understand that risks of the underwater weighing are minimal.
I understand that I am in a water environment and the risk of
swallowing of water, choking on water, or possibly drowning may
occur.
I understand that the possible benefits of this study are: a)
to better understand the changes in metabolic efficiency (energy
expenditure) during weight reduction; b) to provide data to
determine the energy cost of ambulatory activities such as
walking and cycling that one may use to maintain weight loss
following dieting; and c) to determine if weight training will
increase or maintain non-fat mass during dieting.
The procedures of this investigation have been explained to me
by Investigator I. Any questions that I may have concerning the
study will be answered at any time during the working day by
calling 204-xxxx.
I understand that the data will not be released to me until the
termination of the study.
Although the study team has placed safeguards to maintain the
confidentiality of my personal information, there is always a
potential risk of an unpermitted disclosure. To that degree,
all documents and information pertaining to this research study
will be kept confidential, unless required by applicable
federal, state, and local laws and regulations to be disclosed.
I understand the records and data generated by the study may be
reviewed by Temple University and its agents, the study sponsor
or the sponsor's agents (if applicable), and/or governmental
agencies to assure proper conduct of the study and compliance
with regulations. I understand that the results of this study
may be published. If any data is published, I will not be
identified by name.
I understand that I may refuse consent or withdraw from the
study at any time.
45
I understand that the results of this study may be published,
but my identity will not be disclosed without my separate
consent.
I understand that circumstances may arise which might cause the
investigator to terminate my participation in the study before
its completion. These circumstances would include any situation
in which the investigators believed that further participation
would be dangerous to me.
I understand that neither the Biokinetics Research Laboratory of
Temple University nor the investigators will provide special
services, free care, or compensation for any injuries resulting
from this research. Treatment for such injuries will be
provided under the same financial arrangements as those under
which treatment is usually provided.
I understand that I will not be charged for any of the metabolic
evaluations outlined in this investigation.
I understand that I will not receive any fees for my
participation in this investigation.
I understand that my completion of the experimental protocols
will allow me to use the Adult Fitness Center of Temple
University until August 30, 1991 at no cost to me.
I am in good health, and do not know of any medical problems
that may interfere with my participation in this study.
I voluntarily consent to participate in this study.
I understand that if I am injured as a result of my involvement
in this study, only physician's fees and medical expenses in
excess of my medical and hospital coverage or other third party
coverage will be paid with no additional cost to me. I
understand that financial compensation for such injury is not
available. If I need to, I can contact Investigator I,
Biokinetics Research Laboratory, Broad and Montgomery Streets,
Philadelphia, PA 19122, office phone (215) 204-xxxx, home phone
(215) xxx-xxxx. For questions about my rights as a research
subject, I may contact the Institutional Review Board
Coordinator at (215) 707-3390. The IRB Coordinator may also be
reached by email: irb@temple.edu or regular mail:
Institutional Review Board Coordinator
Temple University Research Administration
Student Faculty Conference Center
3340 North Broad Street – Suite 304
Philadelphia, PA 19140
46
Subject
Witness
Investigator
Date
47
THIS CONSENT FORM MUST BE TYPED ON TEMPLE UNIVERSITY LETTERHEAD.
Sample General Consent Form
TITLE:
Investigator(s) Name, Department, Phone Number (if student
include the advisor's name, Department, Phone Number).
We are currently engaged in a study of (general topic of study).
To help us gain further insights into this area we will ask you
to (describe what the subject's will be requested to do and what
will happen to them.)
If procedures expose the subjects to any physical and/or
emotional risk, discomforts, and/or inconveniences, please
describe the risks, discomforts, and/or inconveniences.
The data you will provide will be recorded anonymously and your
participation and anything you say during the session will be
held in the strictest confidence. (If data is not recorded
anonymously and/or participation is not held in strictest
confidence, tell subjects how the data will be stored and who
will have access to the data).
Although the study team has placed safeguards to maintain the
confidentiality of my personal information, there is always a
potential risk of an unpermitted disclosure. To that degree,
all documents and information pertaining to this research study
will be kept confidential, unless required by applicable
federal, state, and local laws and regulations to be disclosed.
I understand the records and data generated by the study may be
reviewed by Temple University and its agents, the study sponsor
or the sponsor's agents (if applicable), and/or governmental
agencies to assure proper conduct of the study and compliance
with regulations. I understand that the results of this study
may be published. If any data is published, I will not be
identified by name.
We welcome questions about the experiment at any time. Your
participation in this study is on voluntary basis, and you may
refuse to participate at any time without consequence or
prejudice.
For questions about my rights as a research subject, I may
contact the Institutional Review Board Coordinator at (215) 7073390. The IRB Coordinator may also be reached by email:
irb@temple.edu or regular mail:
Institutional Review Board Coordinator
Temple University Research Administration
Student Faculty Conference Center
48
3340 North Broad Street – Suite 304
Philadelphia, PA 19140
Signing your name below indicates that you have read and
understand the contents of this Consent Form and that you agree
to take part in this study.
____
Participant's Signature
Date
_______________________________________________________________
Investigator's Signature
Date
APPENDIX D
INDEMNIFYING CLAUSES
49
The following statement (as amended as appropriate) must be
included in informed consent only if the study drug/device could
effect women of childbearing age, the unborn fetus, or a woman
breast-feeding a child.
PREGNANCY: Due to the effects of this drug/device, there
could be serious harm to unborn children (or children who
are breast-feeding) and it could also jeopardize the health
of the mother. In addition, it is possible that harmful
side effects that are not yet know could occur to both the
mother and unborn or breast-feeding child. For this
reason, if you are pregnant, we want you to tell us and we
will not include you in the study. If you are capable of
becoming pregnant, you will be giving a pregnancy test
prior to entry into the study. Further, you understand
that while you are taking this drug/device you should not
become pregnant, and if you do become pregnant, you must
discontinue the drug/device and consider termination of the
pregnancy.
The following statement (as amended as appropriate) must be
included in the consent form if the data is reviewed by a
Sponsoring Agency.
CONFIDENTIALITY: Any information obtained in connection
with this project and which could be identified with you
will be kept strictly confidential. However,
representatives of the United States Department of Health
and Human Services (or appropriate Sponsoring Agency), or
the United States Food and Drug Administration may inspect
your research records to assess the results of this
research. The information obtained in this study may be
published in scientific journals or presented at scientific
meetings, but your identity will be kept strictly
confidential.
The following statement (as amended as appropriate) may be need
to be included in the consent form if the research intervention
could result in untoward physical, psychological, or medical
responses (such protocols may be required to be reviewed by the
IRB Subcommittee "A" of Temple University Hospital).
I understand that if I am injured as a result of my
involvement in this study, only physician fees and medical
expenses in excess of my medical and hospital coverage or
other third party coverage will be paid with no additional
cost to me. I understand that no financial compensation
for such injury is not available. If I need to, I can
contact
Principal Investigator, Address, Home Phone Number, Office Home Number.
50
For Questions about my rights as a research subject, I may
contact the Institutional Review Board Coordinator at (215) 7073390. The IRB Coordinator may also be reached by email:
irb@temple.edu or regular mail:
Institutional Review Board Coordinator
Temple University Research Administration
Student Faculty Conference Center
3340 North Broad Street – Suite 304
Philadelphia, PA 19140
51
APPENDIX E: APPLICATION CHECK LIST FORM
52
APPLICATION CHECK LIST
Please complete this form prior to submitting the Request for
Protocol Review to the Office of the Vice President for Research.
Face Sheet
Name of the researcher, home department, and school.
Full title of the project.
Date submitted to the Office of the Vice President for
Research.
Appropriate Research Category checked.
Proposed starting date and estimated duration of the research
project included.
Study location designated (with attached letters for
permission for use for Off-Campus Sites).
Funding Agency cited if applicable.
Signature of Faculty Advisor for Student Projects.
Application
Justification for the use of minors and/or other special
populations.
Clear description of the Experimental Procedures and Design.
Assurances of maintaining Data Confidentiality.
Consideration of Subject and/or Societal benefits.
Considerations of risk, discomfort, inconvenience, or physical
danger to the subjects [both short-term and long-term risks].
All Consent Forms on Temple University Letterhead including:
Consent Form and Permissions to Videotape, Audiotape, and/or
Photograph.
Copies of all questionnaires and, where applicable, data forms
to be used by the researchers are attached to the
application.
Letters of agreement of participation from Off-Campus
Co-Investigators attached to the application.