PROCEDURES GUIDE TO RESEARCHERS
PIERCE COLLEGE DISTRICT
In response to concern about protection of the rights of human subjects of research,
and in response to federal mandate, Pierce College has established a committee, the
Institutional Review Board (IRB), to review all proposed research involving human
subjects. This review is to insure that:
a. the risks to human subjects are minimized,
b. benefits of the research outweigh risks,
c. the sample selection is equitable, and,
d. subjects are fully informed about the research and voluntarily consent to
participate, and that this consent is documented
Definitions
1. Research: Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to
generalizable knowledge. The general rule is that if there is any element of research
in an activity, that activity should undergo review for the protection of human
subjects. For example, some "demonstration" and "service” programs may include
research activities.
2. Human Subject: Human subject means a living individual about whom an
investigator conducting research obtains (a) data through intervention or interaction
with the individual, or (b) identifiable private information. Intervention includes both
physical procedures by which data are gathered (for example, venipuncture) and
manipulations of the subject or the subject's environment that are performed for
research purposes. Interaction includes communication or interpersonal contact
between investigator and subject. Private information includes information about
behavior that occurs in a context in which an individual can reasonably expect that
no observation or recording is taking place, and information that has been provided
for specific purposes by an individual and that the individual can reasonably expect
will not be made public (for example, a medical record). Private information must be
individually identifiable (i.e., the identity of the subject is or may readily be
ascertained by the investigator or associated with the information) in order for
obtaining the information to constitute research involving human subjects.
3 Minimal Risk: The risk to the subjects is said to be minimal when the "risks of harm
anticipated in the proposed research are not greater, considering probability and
magnitude, than those ordinarily encountered in daily life or during the performance
of routine physical or psychological examinations or tests" (from 45 CFR 46).
Minimal risk is to be determined with regard to the state of vulnerability of the
particular subject or subjects, especially if special populations are used as subjects.
4. Subject at Risk: Any individual who is exposed to the probability of injury, physical
or psychological, as a consequence of participation as a subject in a research
procedure or related activity which departs from the application of those established
and accepted is at risk. Thus, one may conclude that a subject is beyond minimal
risk when participating in a research endeavor in which the risks of harm are greater,
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considering either probability or magnitude, than those risks encountered in daily life.
a. Physical Risk: Any strenuous or unusual physical activity or procedure
required of a subject, use of compounds which might alter the subject's
biochemical milieu, exposure to strong stimulation, or placement in a situation
which could lead to violence. The investigator is responsible for anticipating
circumstances which might endanger the subject's physical well being and for
bringing these circumstances to the attention of the IRB.
b. Psychological Risk: Any experimental condition that induces personality
change or intense changes in a subject's feelings or motivations, or that may
induce such changes which extend beyond the experimental or debriefing
period; subjection to deceit, to demeaning or dehumanizing procedures, to
humiliation or embarrassment. The investigator has the responsibility to
eliminate or minimize the effects of psychological risks to subjects and to bring
these matters to the attention of the IRB.
c. Confidentiality: Right of privacy and of non-release of disclosed personal
information. The investigator should protect subjects against invasion of
privacy and loss of confidentiality. Lack of secure handling of completed
personality tests, questionnaires, interview protocols or data, and recorded
materials augments risk and must be avoided.
5. Informed Consent: Informed consent means knowing consent, the exercise of a
free power of choice without undue inducement, force, fraud, deceit, duress, or other
forms of constraint or coercion. If the subjects are minors or are not capable of giving
consent, parent, guardian, or other legal representative consent is required (refer to
page 28). Use of a written consent form that includes all the basic elements of
informed consent must be documented by a signature of the subject or legally
authorized representative.
6. Anonymity: Anonymity exists when there are no identifiers whatsoever on project
materials that could link the data with individual subjects. Even the research
investigator cannot know the identity of participants.
7 Protocol: A protocol is the researcher's plan for research. A protocol to be
reviewed by the IRB consists of a completed Human Subjects Activity Review Form,
sample informed consent forms, and other pertinent information such as a sample
survey instrument or questionnaire, relevant sections of a grant proposal, thesis or
dissertation, or prospectus, so as to provide complete information regarding activities
involving human subjects.
8. Institutional Review Board (IRB): A committee comprised of the Director of
Research, Vice President for Human Resources, Vice President for Administrative
Services, and Vice President for Learning and Student Success for the respective
college or the Executive Vice President for Extended Learning which considers the
benefits and costs of research, minimize risks to subjects, and ensures informed
consent procedures are followed.
Other definitions may be found throughout the manual in appropriate sections.
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Steps to Follow for the
Researcher at Pierce College
If you are planning to conduct a research project, engage in data collection, or assign
students to conduct research for a class in which human subjects are involved:
Step 1: The Pierce College Manual and Forms
Obtain a copy of Pierce College Guide to Researcher's, the Human Subjects Review
Worksheet, and the Human Subjects Review Summary Form.
Step 2: The Human Subjects Review Worksheet
All categories of research must be reviewed. There are three categories of review:
exempt, expedited, and full board review. The Human Subjects Review Worksheet
will allow you to determine what kind of review is required for your research.
Many, but not all, types of survey and interview studies are in the exempt
category. In these cases, you need only complete the Worksheet and then the first two
pages of the Human Subjects Review Summary Form. The Institutional Review
Board (IRB) has verified that your project is exempt; you will then be notified that
you can begin your research. Some categories of research are not exempt, but they
can be approved through an expedited procedure in which the Associate Dean for
Instruction reviews the Worksheet and the Human Subject Review Summary Form. If
your project requires full board review, your Human Review Summary Form will be
distributed to all IRB members, who will vote on the proposal at a formal meeting. In the
case of full board review, you are encouraged to attend the IRB meeting to answer
questions about your project.
Step 3: The Human Subjects Review Summary Form
To avoid delays in the approval process, it is critical that you give clear and complete
answers to all the questions on the summary form. Some helpful information is provided
on the second page of these instructions to assist you in your answers. In particular,
investigators often have misunderstandings about issues of privacy and informed
consent, so please read the information provided in these instructions:
1. Informed Consent: Required Components and Example Structure
(from "Suggestions on Completing the Summary Form")
2. Template for Informed Consent and Sample of Participant Consent Form
3. Requirements for Informed Consent
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Steps to Follow for the
Researcher at Pierce College
(Cont.)
Step 4: The Approval Process
After you complete the Human Subject Review Summary Form, sign it and submit a
copy of the form to your department chair or instructor (or other relevant supervisor) for
informational purposes.
Submit to the Associate Dean for Instruction the Human Subjects Worksheet and the
required number of Human Subject Review Summary Forms for your review
category - exempt, expedited, or full board review.
For all three categories of review, you must wait for official notification of
approval from the IRB before you initiate the project.
Step 5: Changes in Project After Initial Approval
Any significant changes to the project after approval must be submitted immediately to
the IRB for approval.
Step 6: Progress Report
If the project goes on for longer than one (1) year, you must submit a brief progress
report each year on the anniversary date of submission.
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PIERCE COLLEGE HUMAN SUBJECT REVIEW WORKSHEET
Principal Investigator
Instructor (for student researchers, only)
Project Title
I. Does your research qualify for an exemption from a Full Board review?
EACH OF THE STATEMENTS BELOW DESCRIBE A CONDITION FOR
EXEMPTION FROM A FULL BOARD REVIEW AS WRITTEN THE CODE OF
FEDERAL REGULATIONS, Title 45, Part 46.10 –
(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101)
CHECK THE STATEMENT APPLICABLE TO THE PROJECT:
Statements below do not apply to this research project.
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (i) research on regular and
special education instructional strategies, or (ii) research on the effectiveness of
or on the comparison among instructional techniques, curricula, or classroom
management methods.
Research involving the use of educational test (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior unless: (i) information obtained is recorded in such a manner that the
human subjects can be identified, directly or through identifiers linked to the
subject; and (ii) any disclosure of the 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, employability, or reputation.
Research involving the use of educational test (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under paragraph (2) of this section, if: (i) the human
subjects are elected to appointed public officials or candidates for public office; or
(ii) federal statute(s) without exception that the confidentially of the personally
identifiable information will be maintained throughout the research and thereafter.
Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a manner
that subjects cannot be identified, directly or though identifiers linked to the
subjects.
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PIERCE COLLEGE HUMAN SUBJECT REVIEW WORKSHEET
Research and demonstration projects which are conducted by or subject to the
approval of the department or agency heads, and which are designed to study,
evaluate or otherwise examine: (i) public benefit or service programs; (ii)
procedures for obtaining benefits or services under those programs, (iii) possible
changes in or alternatives to those programs or procedures; or (iv) possible
changes in methods or levels of payment for benefits or services under those
programs.
Taste and food quality evaluation and consumer acceptance studies, (i) if
wholesome foods without additives are consumed or (ii) if a food is consumed
that contains a food ingredient at or below the level of and for a use found to be
safe, by the Food and Drug Administration or approved by the Environmental
Protection Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.
Research that is not subject to federal regulation, that is not supported by a
federal department or agency, or is not otherwise subject to regulation.
Research that does not involve intervention or interaction with an individual and
does not involve collection of identifiable private information.
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PIERCE COLLEGE HUMAN SUBJECT REVIEW WORKSHEET
II. Nature of data collected: (circle 'yes' or 'no' for each question):
1. Are any subjects under 18 years of age?
Yes
No
If enrolled as college student, considered adults if nor more than minimal risk to
the subject. See pages 28 - 31.
2. Are any subjects confined in a correctional or detention facility?
Yes
No
3. Is pregnancy a prerequisite for serving as a subject?
Yes
No
4. Are fetuses in utero subjects in this research?
Yes
No
5. Are subjects used that may not be legally competent?
Yes
No
6. Are personal records (medical, academic, etc.) used without written consent?
Yes
No
7. Are data from subjects (responses, information, specimens) directly or indirectly
identifiable and place subject at risk (criminal or civil liability) or damaging to
subjects' financial standing, employability, or reputation?
Yes
No
8. Will specimens obtained from an autopsy be used?
Yes
No
9. Will subjects be asked sensitive questions about sexual experiences?
Yes
No
10. Will questions be asked about alcohol or drug use?
Yes
No
11. Will alcohol or drugs be administered?
Yes
No
12. Will blood/body fluids be drawn?
Yes
No
If you answered 'Yes' to any of the questions above,
then your project is NOT exempt.
If you answered yes on any of questions 1-5, see attached
section entitled "Special Subject Populations" (page 28 – 31) for
additional protections required.
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PIERCE COLLEGE HUMAN SUBJECT REVIEW WORKSHEET
III. Does your project qualify for expedited review?
To qualify for expedited review, your project must involve subjects 18 years of age or
older, there must be no more than minimal risk to the subject, and the only involvement
of human subjects must be in one of the following categories:
(Check the category of research that applies to your project)
Collection of excreta and external secretions including sweat, uncannulated
saliva, placenta removed at time of delivery, and amniotic fluid at the time of
rupture of the membrane prior to or during labor.
Recording of data using noninvasive procedures routinely employed in clinical
practice. This includes the use of physical sensors that are applied to the surface
of the body. However, the procedure must NOT involve input of matter or
significant amounts of energy to the subject. The procedure must NOT be an
invasion of the subject's privacy. This category includes activities such as
weighing, tests of sensory acuity, electrocardiography and
electroencephalography, and measures of naturally occurring radioactivity. This
category does NOT include exposure to electromagnetic radiation outside the
visible range (e.g.. X-rays).
Collection of hair or nail clippings in a nondisfiguring manner. Collection of teeth
from patients whose care requires the extraction. Collection of both supra- and
subgingival plaque and calculus, provided that an accepted prophylactic
technique is used that is no more invasive than routine prophylactic scaling of the
teeth.
Voice recordings made for research purposes such as investigations of speech
defects.
Moderate exercise by healthy volunteers
Research on individual or group behavior or characteristics of individuals, such as
studies of perception, cognition, game theory, or test development. However, the
research must NOT involve stress to the subjects and must NOT be intended to
produce a relatively lasting change in behavior.
Involve the study of existing data, records or diagnostic specimens.
(adapted from 45 CFR 46).
If your project involves more than minimal risk, OR if it does not fall into one of
the six categories above, then full board review is required.
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Pierce College Human Subject review Summary Form
College procedures require Institutional Review Board (IRB) review and approval of
research involving human subjects. If a project is EXEMPT, a completed copy of the
first two pages of the Human Subject Review Summary form must be submitted to
Director of Research. If a project qualifies for EXPEDITED review, two copies of the
entire form should be submitted to Director of Research. For all other projects, submit 5
copies of this entire form to Director of Research.
Principal Investigator
Academic Title
Instructor (for Student research only)
Dept/Div
Zip Code
Telephone
Project Title
Anticipated Start Date
Anticipated Termination Date
Is the project seeking funds?
Granting Agency:
Yes
No
PI on grant:
TYPE OF PROJECT: Check the review procedure required (attach Human Subject
Review Worksheet).
Exempt
Expedited
Full Board Review
ABSTRACT: Briefly describe the purpose, procedures and research design (be sure to
include what the subjects will do):
Principal Investigator: The information provided in this form is accurate and the
project will be conducted in accordance with applicable Federal, State and College
regulations.
Signature
Date
Faculty Sponsor: (If principal investigator is a student.) The research is in accordance
with applicable Federal, State and College regulations.
Signature
Date
Institutional Review Board: This project has been properly filed as required by
Federal, State, and College Procedures.
Signature
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Pierce College Human Subject review Summary Form
I. DATA COLLECTION
A. Check the method(s) of research to be used:
Survey (Submit a copy)
Check how administered:
Self
Telephone
Personal Interview
Other
Observation of Behavior
Examination of Public Records
Taste Evaluation
Examination of Pathological or Diagnostic Specimens
Experimental
Other: Describe
B. Is data
anonymous or
confidential? (See instructions). Describe how
anonymity or confidentiality will be maintained (e.g. coded to a master list and
separated from data, locked cabinet, office, restricted computer, etc.?) Who
will have access to the data?
II. DESCRIPTION OF THE POPULATION:
A. Approximate number
B. Age Range
C. How will subjects be selected or recruited?
D. Will subjects be compensated (including money, services, or extra credit)? If yes,
how much, when and how.
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E. Are any of the subjects not competent to give consent (e.g., minors, prisoners,
institutionalized)? If yes, how will consents be obtained? From whom? Are there
procedures for gaining assent? (Submit copy of Assent Form.)
F. Will a written consent form be obtained?
Yes
No
If yes, please attach consent for (refer to the components of a consent form
included in the instructions.) If no, how will consent be obtained? Why is this
method being used?
G. Will any ethnic group or gender be excluded from the study pool?
Yes
No
If yes, explain:
IF YOUR PROJECT IS EXEMPT, YOU MAY STOP HERE. IF YOUR PROJECT
NEEDS EXPEDITED OR FULL BOARD REVIEW, THEN COMPLETE THE REST OF
THIS FORM.
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Pierce College Human Subject review Summary Form
III.
DECEPTION. If any deception (withholding of complete
information) is required for the validity of this activity, explain
why this is necessary and attach a debriefing statement.
IV. ASSESSMENT OF RISKS AND BENEFITS.
A. Describe any potential risks and describe how you will minimize these risks.
These include stress, social, legal, discomfort, invasion of privacy, or
embarrassment, and side effects.
B. In the event that any of these potential risks occur, how will it be handled (e.g.,
compensation, counseling, etc.)?
C. Will this study interfere with any subject’ normal routine (e.g., school attendance,
medical treatment, etc.)?
D. Describe the expected benefits to society and to the individual subjects?
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Pierce College Human Subject review Summary Form
E. If blood or other specimens will be taken:
Which specimens?
What are the qualifications of the person who will draw the specimen?
How often?
How much:
Describe the procedure for drawing the specimen.
V. PROJECT CHECKLIST
A. Will any investigational new drug (IND) be used?
Yes
No
B. Will any other drugs be used?
Yes
No
If yes to A or B, list for each drug: 1) The name of the drug; 2) the source for the
drug: 3) the dosage; 4) any side effects or toxicity; 5) how it will be administered;
6) by whom it will be administered (see comment below).
C. Will alcohol be ingested by the subjects?
Yes
No
If yes, what type? Refer to the guidelines for administration of ethyl alcohol in
human experimentation available from the
D. Will audio-visual tapes, audiotapes, or photographs be taken?
Yes
No
If yes, which of the above? Where will tapes or photographs be stored? When
will this material be destroyed? How will confidentiality be maintained?
Comment to Section V – Project Checklist. Research involving “investigational new
drugs” (INDs) are subject to different federal regulation: 21 C.F.R. § 312.34 (treatment
use of an IND); 21 C.F.R., Part 50 (informed consent); and 21 C.F.R., Part 56 (IRBs).
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SUGGESTIONS ON COMPLETING THE HUMAN SUBJECTS
REVIEW SUMMARY FORM
PRIVACY: DEFINITIONS OF TERMS
Anonymous: Subjects' names are unknown to the researcher, not requested and not
given. If the only time the researcher asks for a name is for a signature on a
consent form, the research should attempt verbal consent of the subjects.
Confidential: Subjects' names are known to the researcher and are usually coded to a
master list and/or kept separate from the data and results. This is usually used
when the researcher must match test results with surveys or if there will be a
follow-up survey. The researcher has a real need to know subjects' names.
Directly Identifiable Data: Information obtained that cannot be separated or coded, so
the individual's name or other identifying information is attached. The researcher
should still provide confidentiality to the subjects.
INFORMED CONSENT MATERIALS FOR SUBJECTS: REQUIRED COMPONENTS
AND EXAMPLE OF STRUCTURE
Paragraph 1.
a. Introduce yourself and who you represent and your advisor, if applicable and
who, if anyone, is funding the research.
b. Introduce your purpose, what you intend to resolve or evaluate.
c. Include a note that the research has been reviewed and approved by the
Pierce College Institutional Review Board (and other review boards, if
applicable).
Paragraph 2.
a. State exactly what you want the subject to do, how long it will take, and what
benefits the subject or society may receive by the subject's participating in the
research. Include a description of procedures to be followed and identification of
any procedures, which are experimental. This may be a long paragraph with
many sub-points or it may be short for those doing mail surveys.
b. If applicable, list the costs incurred by the subjects or if the researcher will absorb
the costs such as test results, transportation to and from remote locations, state
this.
c. List the plan for payment if subjects are to be paid (including the receipt of extra
credit.)
d. Clearly state that the subject does not have to participate in the research and that
if once consenting to participate, they may still withdraw at any time. If the
research involves a procedure, which once begun, must be completed for the
safety of the subject or for the subject to receive payment, this should be clearly
stated.
e. State whether the information will remain anonymous or confidential and
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when any written material, visual or audiotapes will be destroyed.
Paragraph 3.
a. List any foreseeable risks to the subject associated with the research. Risks
include embarrassment, emotional stress of relating traumatic life events,
physical side effects of drug or diet treatments.
b. List measures taken by the researcher to lessen the risks.
c. List foreseeable circumstances under which the subject's participation may
be terminated by the researcher without regard to the subject's consent.
d. If there is more than minimal risk, include a description of what actions will be
taken should the risk occur.
e. If appropriate, include a statement describing other beneficial alternative
treatments or options.
Paragraph 4.
a. Offer to answer the subject's questions now or at a later date (be sure to
list your telephone number, and your supervisor or advisor's number, if
applicable).
Miscellaneous Information:
1. If any of the above sounds inappropriate for your study, then you may not need
that type of information. Call chair IRB Committee if you have questions.
2. The Consent Form must be written in a language understandable to the subject.
If your subject's primary language is other than English, ensure that you also
enclose a translated Consent Form.
3. If your subjects are under age 18 and non-students, you must have a Consent
Form for the parents/guardians and an Assent Form for the child. These are two
separate forms. You must have parent/guardian consent prior to asking the
child's assent.
4. Have a place for signature and date for subject.
5. Note that the subject must receive a copy of the Consent Form.
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Template for Informed Consent (adults)
(Title of Study)
You are invited to participate in a research study, which will (state purpose of
research). This study is being conducted by (state names(s), use "Ph.D. ", not "Dr. ")
of Pierce College. We don't want anyone to be in the study unless they understand what
it is about. Please read this form and ask questions you may have before agreeing to
participate in the study.
If you decide to participate, you will be asked to (describe activities, duration and
frequency of each activity, location of each activity, and whether any activity is
experimental. If audio or videotapes will be used, indicate this).
There are some possible risks (or no risks) involved for participants. These are
(describe all risks, discomforts, and inconveniences reasonably to be expected.
Describe what will be done to lessen the risks. If there are costs to the subjects,
indicate these). (Describe any alternative procedures or courses of treatment, if
applicable). There are also some benefits (explain benefits to subjects and to
humanity. If subjects will be paid money or will be otherwise compensated,
indicate amount and schedule of payment.)
Any information that is obtained in connection with this study and that can be identified
with you will remain confidential and will be given out only with your permission (state
how confidentiality will be maintained, including review and approval of and
erasure of audio and video tapes). (If you will be releasing information to anyone
for any reason, you must state the persons or agencies to whom the information
will be furnished, the nature of the information to be furnished, and the purpose
of the disclosure.)
Your participation is entirely voluntary and your decision whether or not to participate
will involve no penalty or loss of benefits you might otherwise receive. If you decide to
participate, you can stop participating any time without penalty. (If money or other
compensation will be affected by withdrawal, state how.)
(If project is more than minimal risk, or for special subject populations, other
information may be required.)
If you have questions about the research at any time, please call (give project staff
member's name and telephone/address.) If you have questions about your rights as a
research subject, or if you have a visual or other important impairment and require this
material in another format, call _______________. To contact (project staff member's
name) or the Office for the Protection of Human Subjects by TDD, call ____________.
You will be given a copy of this form to keep.
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Template for Informed Consent (adult) Page 2
(Title of Study)
Your signature below indicates that you (1) have read and understand the information
provided above, (2) that you willingly agree to participate, (3) that you may withdraw
your consent at any time and stop participating at any time without penalty, and (4) that
you have received a copy of this consent form.
Signature
Date
NOTE: Language may be altered to obtain parental consent for participation of
their child (e.g., "If you decide to allow your child to participate in this study, the
child will be asked to ... "). Children and/or adolescents may sign this form if they
understand the information provided, or a more simple consent form may be
given. If subjects are mentally handicapped, the language should be appropriate
to their understanding and a signature of a competent adult acting on behalf of
the subject is required.
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SAMPLE
Participant Consent Form
I am Sarah Smith of Pierce College, Department of Psychology. I am conducting
research on responses to peer cheating on exams and asking for your participation. The
purpose of this study is to discover the scope of power students' feel they have in
stopping cheating in the classroom. The Pierce College Institutional Review Board
has approved this research project.
I am asking that you complete the five-page questionnaire, which should take no longer
than 15 minutes, and, if you have the time, participate in a small focus group. Both the
survey and focus group are anonymous. You may complete the survey now and the
focus group is scheduled to meet Monday, August 13, from 4-5 p.m. in the XXXXXXXX
Room. If you would like to participate, but do not have the time to complete the survey
now, you may complete it prior to joining the focus group. You do not have to participate
in this research. However, if you choose to participate in the focus group, I ask that you
remain for the entire hour. Again, all the information you share will remain anonymous
and cannot be traced back to you or any other individual.
All questions focus on cheating behavior you have observed in others. I am not asking
you, and do not want you to discuss cheating behavior in which you may have engaged.
Because of this focus, there are no anticipated risks of embarrassment or punishment to
you. During the focus group, I will continuously remind participants that they may not
use specific names of fellow students. If any participant fails to respect the privacy of
others, they will be asked to leave the focus group.
Your participation will be a great help in attempting to empower students' to stop
cheating in the classroom. I will be happy to answer any questions that you have now
or feel free to call me any time before or after the research. My phone number is 992XXXX.
You will receive a copy of this consent form should you agree to participate in my
research. Thank you for your time.
Sarah Smith
Department of Psychology
Date
Participant
Date
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REQUIREMENTS FOR INFORMED CONSENT
Informed consent is the knowing consent of an individual or his/her legally authorized
representative, which is obtained without undue inducement, or element of force, fraud,
deceit, duress, or other forms of constraint or coercion. A consent form documents
informed consent and is designed to protect the investigator and the College against
legal liability.
One of the most common reasons for delay of approval of a protocol is an inadequate
consent form. The consent form should be a statement addressed to the subject and
should read as such. Ordinarily, it is best worded in the second person. It must be in
language the subject can understand. Avoid or define technical terminology, adjust for
educational background and ages, and provide translations in other languages when
subjects do not understand English. Separate forms may be required for different
subject groups (parents, children, et cetera).
Obtaining Informed Consent
Research investigators are responsible for obtaining informed consent and for insuring
that no human subjects will be involved in the research prior to obtaining their consent.
In obtaining informed consent, investigators must avoid the possibility of coercion or
undue influence. Unless otherwise authorized by the IRB, investigators are responsible
for insuring that effective-informed consent shall:
1. Be obtained from the subject or the subject's legally-authorized representative;
2. Be in language understandable to the subject or the representative;
3. Be obtained under circumstances that offer the subject or the representative
sufficient opportunity to consider whether the subject should or should not
participate; and
4. Not include exculpatory language through which the subject or representative is
made to waive or appear to waive any of the subject's legal rights, or releases or
appears to release the research investigator, the sponsor, the College or its agents
from liability for negligence.
A written consent form includes the following elements. Some are required in all
consent forms, and others are applicable only to some research. Special provisions are
required when subjects are from special populations (refer to page 26), attached.
Required Elements of Informed Consent
1. Readability: The consent form should be easily understood by its intended
subject population (suggested level is 7*-10* grade).
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2. The Beginning Section
a. Who is conducting the research;
b. The nature, purpose, and duration of the research, including the fact that it is
research as b opposed to treatment; and
c. The use(s) to be made of the data.
3. The Middle Section
a. Methods (including a description of procedures to be followed and the expected
duration of the subjects' participation);
b. Risks;
c. Methods which will be taken to reduce
risks;
d. Benefits;
e. Monetary or other forms of compensation, if any; and
f. Conditions of participation, if any.
4. The End Section
a. A statement of the extent to which the data are confidential, and a
description of the procedures to be employed for maintaining confidentiality;
b. The fact that the subject can withdraw his/her consent at any time without
prejudice;
c. An offer to answer questions about the research and information on whom to
contact should questions arise later;
d. Information to contact the Office for the Protection of Human Subjects at dark
if they have questions about their rights as research subjects;
e. Information that the subject may contact the Office for the Protection of Human
Subjects at dark to request the consent in an alternate format (e.g., large type;
audiotape) if the subject has a visual or other impairment;
f. The Clark translation service (TDD) number for hearing impaired
(360-992-2835);
g. An indication that the subject will receive a copy of the consent form; and
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h. A place for signatures.
Additional Elements if Appropriate
1. If subjects will be paid or otherwise compensated all information concerning
payment, amount and schedule of payment;
2. If subjects receive academic credit all information concerning credit should be
stated in the syllabus, as well as alternatives to participating in the research;
3. A statement that the particular treatment or procedure may involve risks to the
subject which are currently unforeseeable;
4. Identification of any procedures which are experimental;
5. A disclosure of appropriate alternative procedures or courses of treatment, if any,
that might be advantageous to the subject;
6. Anticipated circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's consent;
7. Any additional costs to the subject that my result from participation in the
research;
8. The consequences of the subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject;
9. A statement that significant new findings developed in the course of the research
which may relate to the subject's willingness to continue participation will be
provided to the subject; and
10. The approximate number of subjects involved in the study.
Types of Consent Documents
The consent form may be (1) a written document that contains the required elements of
informed consent, to be read by the subject or the subject's representative or by the
investigator to the subject; or (2) a short written form stating that the basic elements of
informed consent have been presented orally to the subject or representative.
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Documentation of Informed Consent
Investigators shall be responsible for insuring that informed consent is documented by
the use of a written consent form approved by the IRB and signed by the subject or the
subject's legally-authorized representative, unless this requirement is specifically waived
by the IRB.
INVESTIGATORS SHALL INSURE THAT EACH PERSON SIGNING THE WRITTEN
CONSENT FORM IS GIVEN A COPY OF THE FORM.
For projects of minimal risk involving the use of questionnaires, the required elements of
informed consent may be included in an introductory paragraph to the instrument,
followed by a statement that completion and return of the questionnaire will constitute
consent to participate.
Oral Consent
Only in special and/or unusual circumstances can the consent of the subjects be
obtained orally. Waiver of prior written informed consent must be approved by the IRB.
A waiver of prior written informed consent might be granted in the case where (1) the
risk to the subject is minimal, (2) use of primary procedures for obtaining consent would
invalidate important research objectives, or (3) alternative means would be less
advantageous to the subject. Oral presentation of the elements of informed consent
should be used only when it is the most appropriate means of conveying relevant
information to the subject, thus adapting the presentation to the subject's capacities.
The presentation may be made in either of two ways:
(1) A written consent document that sets forth the required basic components of
informed consent may be read to the subject or the subject's representative, and
the investigator will allow the subject or representative ample time to read and
consider the document before it is signed; or
(2) The IRB may approve a short written form describing the particulars of required
informed consent that are to be presented orally to the subject or representative.
Where oral consent is allowable, investigators shall insure that:
1. A witness is present at the oral presentation;
2. The short form is signed by the subject or the representative;
3. The witness signs both the short form and a copy of the written summary of
the oral presentation;
4. The person obtaining consent signs a copy of the summary;
5. A copy of both the short form and summary is given to the subject or the
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representative; and
6. The written summary of what is to be said to the subject or the representative
receives the prior approval of the IRB.
Waiver or Alteration of Informed Consent
The IRB may approve a consent procedure which does not include, or alters, some or
all of the elements of informed consent, or waives the requirement to obtain informed
consent, provided the following sets of conditions exist and are documented:
1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the
subjects;
3. The research could not practicably be carried out without the waiver or alteration;
and
4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
Waiver of Documentation of Informed Consent
The IRB may waive the requirement to obtain a signed consent form for some of all of
the subjects if one of the following conditions exists:
1. The consent document is the only record linking the subject and the research,
and the principle risk would be potential harm resulting from breach of
confidentiality. Subjects will be asked whether or not they want documentation
linking them to the research, and their wishes will prevail; or
2. The research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required outside of
the research context.
In cases where documentation is waived, the IRB may require the investigator to
provide subjects with a written statement regarding the research (see page 27 Cover
Letter for Non-sensitive Questionnaires.)
Retention of Signed Consent Documents
Investigators are responsible for filing the consent documents signed by research
subjects appropriately and for retaining signed consent forms for three (3) years after
termination of the project.
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Confidentiality/Anonymity
By current federal and Pierce College policies, subjects in research projects give their
informed consent to participate. In the informed consent procedure, subjects are often
given assurance of protection against loss of confidentiality or assurance of total
anonymity. Despite the assurances and subsequent efforts, subjects might be
identified. Two legal conditions are at stake:
1. Loss of confidentiality can occur when a court requires that research files be
submitted as evidence in a legal matter. The court decides who has access to
the files and whose identity will be revealed; and
2. Loss of confidentiality can occur under the so-called “Freedom of Information
Act.” Under this act, citizens can gain access to files of federal agencies, except
as provided by law.
Pierce College is obligated to protect subjects’ identities when the promise of protection
is made in obtaining their consent to participate. This obligation can be fulfilled in the
following ways:
1. If the research files are arranged so that the investigators cannot know the
identity of the participants, then loss of confidentiality cannot occur by court
order. This can be accomplished by routinely destroying master code lists.
Confidentiality may not be preserved by locating the master code lists outside the
jurisdiction of the court; i.e., in another country. Anonymity may be assured
when there are no identifiers whatsoever on project materials which could link the
data with individual subjects.
Investigators can be held in contempt of court for failing to submit the research
files or for destroying the master code lists only because of knowledge of the
intent of the court. Investigators will not be held in contempt of court for not
revealing the identity of the subjects when they routinely take steps to keep the
identity of subjects unknown to themselves (i.e., subject responses are
anonymous).
2. If identifying information is not sent to a federal agency, then loss of
confidentiality cannot occur under the Freedom of Information Act. Participants
should be informed if identifying information will be sent to a federal agency.
Certificate of Confidentiality
In instances where the research protocol falls within the "sensitive areas" listed below, a
certificate of confidentiality should be obtained from the Office of the Assistant Secretary
for Health, DHHS. This certificate affords an additional guarantee of anonymity and
confidentiality for research subjects. Since the assurance of confidentiality and
anonymity promised on a consent form cannot be considered absolute, the certificate
will protect the research records from subpoena.
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If any of the following conditions exist the Confidentiality Certificate does not authorize
refusal to reveal identifying information concerning research subjects: (i) the subject
consents in writing to disclosure to identifying information; (ii) release is required by the
Federal Food, Drug, and Cosmetic Act; (iii) authorized personnel of DHHS request
identifying information for audit or program evaluation of a research project funded by
DHHS or for investigation of DHHS grantees or contractors and their employees or
agents carrying out such a project. The Confidentiality Certificate does not govern the
voluntary disclosure of identifying characteristics of research subjects.
Research is considered "sensitive" if it involves the collection of information from the
following categories:
1) Sexual attitudes, preferences, practices;
2) Use of alcohol, drugs, or other addictive products;
3) Information that, if released, could reasonably be damaging to an individual's
financial standing, employability, or reputation within the community;
4) Information normally recorded in a subject's medical record which, if disclosed,
could reasonably lead to social stigmatization or discrimination;
5) Information pertaining to a subject's psychological well-being or mental
health.
A copy of the certificate should be given to the IRB administrator, Director of
Research.
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Sample Cover Letter for
Non-Sensitive Questionnaires
Dear :
We would greatly appreciate your assistance with this research project on vacations.
We are studying people's experience with several popular tourist attractions. This
research will help provide insight into why people travel to various destinations, and
may provide some insights as to your own motives for traveling.
All you need to do is complete this short questionnaire, which should take about 10
minutes. Your participation is totally voluntary. If at any time you choose not to
participate, you may discard the questionnaire. All responses are completely
anonymous and confidential; your name will not appear anywhere on the survey.
Completion and return of the questionnaire will constitute your consent to participate.
Please detach this letter and keep it for your records before you return the
questionnaire. If you have any questions regarding the research project, feel free to
contact one of us using the phone numbers listed below. Thanks again for your help.
Sincerely,
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Special Subject Populations
Definitions
CHILD
Child means any person younger than 18 years of age unless s/he has
been legally emancipated. (However, college or university students 1517 years of age may be considered adults for the purpose of
participation in a research project with no more than minimal risk.)
PARENT
Parent means a child's biological or adoptive parent.
GUARDIAN
Guardian means a person who is authorized by law to consent to
generalmedical care on behalf of a child or handicapped individual.
PERMISSION Permission means the agreement of the parent(s) or guardian to the
participation of the child, handicapped individual, or ward in the
research
ASSENT
Assent means an affirmative agreement to participate in research; mere
failure to object does not constitute assent.
Children
When research subjects are children, additional considerations must be met by the
researcher. Two limitations are: (1) Some research which would fall into exempt
category if the subjects were competent adults is not exempt, and (2) some research
involving more than minimal risk to the subjects if prohibited. Additional requirements
pertain to informed consent.
For the purpose of these rules, a child is any person younger than 18 years of age
unless s/he has been legally emancipated. A young person is legally emancipated if
s/he is married or if a court has declared him/her emancipated. People younger than 18
who are living independently of their parents are not, for this reason alone, legally
emancipated. However, college or university students 15-17 years of age may be
considered adults for the purpose of participating in a research project with no more
than minimal risk.
1. Categories of Exempt Research When the Subjects are Children
Some types of research (refer to "Research Qualifying for Exemption") are
considered exempt even when children are subjects; whereas, some types of
research considered exempt when subjects are competent adults are not exempt
when children are subjects. Research in categories I (involving research
conducted in established or commonly accepted educational settings), 2
(involving the use of educational tests), 5 (involving the collection or study of
existing date), and 6 (involving the examination of public benefit programs are
exempt when subjects are children. Research in category 3 (involving survey or
interview procedures) is not exempt when children are subjects.
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Research in category 4 (involving observation of public behavior) is exempt only
if the researcher does not participate in the activities being observed. All other
research with children must be reviewed by the IRB.
In all cases, the assent of the children, and consent of parent(s) or guardian,
must be obtained prior to conducting the research (see number 3 below for
information regarding assent/consent).
2. Special Considerations in Research When Subjects are Children
a. Research that poses only minimal risk to the subjects: The only special
consideration required for this type of research is that adequate provisions
must be made for obtaining assent of the children and permission from their
parent(s) or guardians, as described in number 3 below. (Minimal risk is
defined in section entitled, "Guide to Researchers, Pierce College.)
b. Research that poses more than minimal risk, but which promises to
benefit the individual child directly, or involves a monitoring procedure likely to
contribute to the child's well-being. Such research will be permitted if:
(1) The risk is justified by the expected benefit to the child;
(2) The relationship between the risk and benefit is at least as favorable to the
child as that presented by other available approaches; and
(3) Adequate provisions are made for obtaining assent of the children and
permission from their parent(s) or guardians, as described in number 3 below.
c. Research that poses more than minimal risk and does not promise
to benefit the individual child directly. Ordinarily, such research is
permitted only if:
(1) The risk is only slightly greater than minimal;
(2) The research will subject the child to experiences that are reasonably
commensurate with those inherent in the child's actual or expected
medical, dental, psychological, social, or educational situation;
(3) The research is likely to yield generalizable knowledge about the child's
disorder or condition which is of vital importance to understanding or
ameliorating the child's disorder or condition; and
(4) Adequate provisions are made for obtaining assent of the children and
permission from their parent(s) or guardians, as described in number 3
below.
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In addition, if the child is a ward of the state or any other agency, institution, or entity,
s/he may be a research subject only if the research is (1) related to his/her status as
a ward, or (2) conducted in a school, camp, hospital, institution, or similar setting in
which the majority of the children involved as subjects are not wards. An advocate
must be appointed for each child who is a ward. This advocate must be a person who
has the background and experience to act in, and agrees to act in, the best interests
of the child for the duration of the child's participation in the research and who is not
associated in any way (except as advocate or member of the IRB) with the research,
the investigator, or the guardian organization. The requirement for an advocate is in
addition to the requirement that permission be obtained from any other person acting
on behalf of the child as guardian or in loco parentis.
d. Other research posing more than minimal risk: Research with children
that exposes the subjects to more than minimal risk and that does not satisfy
the conditions set out in 2.b. or 2.c. above, cannot be approved by the IRB.
However, the federal regulations governing research with human subjects
provide a special procedure for seeking approval for such research by the
Secretary of DHHS.
3. Informed Consent
a. Assent of the Children: Assent must be obtained from the child if the child is
6 years of age or older. However, the IRB may waive the assent requirement
if some or all of the children lack the capacity to give meaningful assent, or
the research holds out the prospect of direct benefit that is important to the
health or well-being of the children that is available only in the context of the
research.
The federal regulations do not set a minimum age at which a child's assent
must be solicited, but instead say that assent is required whenever, in the
judgment of the IRB the children are capable of providing assent, taking into
account their ages, maturity, and psychological state.
b. Permission from Parent(s) or Guardian: If the research poses only minimal
risk, or it poses more than minimal risk but promises to benefit the child
directly, permission must be obtained from at least one of the child's parents
or the child's guardian.
If the research poses more than minimal risk and no direct benefit to the child,
both parents or the child's guardian must give permission for the child to
participate in the research. However, the permission of a parent who is
deceased, unknown, incompetent, not readily available, or who does not have
legal responsibility for the care and custody of the child is not required.
If a research protocol is designed for conditions or for subject population for
which parental or guardian permission is not a reasonable requirement to
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protect the children (for example, neglected or abused children), the IRB may
waive the requirement that parental permission be sought, provided that there
is an appropriate alternative mechanism for protecting the children which is
not inconsistent with federal, state, or local law. The choice of an appropriate
alternative mechanism depends on the nature and purpose of the activities
described in the protocol, the risk and anticipated benefit to the children, and
their age, maturity, status, and condition. In such cases the researcher should
propose an alternative mechanism, explaining why it will protect the children.
The IRB will then review the adequacy of this proposal.
c. Information that Must be Provided in Requests for Assent and
Permission; Documentation of Informed Consent: When parents or
guardians are asked for permission and children are asked for assent, they
must be given the same information that is generally required when informed
consent for participation in research is sought, and their permission and
assent must be documented in writing. The general requirements are
discussed in the section entitled, "Requirements of Informed Consent."
The assent form for children should, of course, be written in language
appropriate to their age and understanding. If the parents are not also
research subjects themselves, it may be appropriate to have them sign the
same form their children sign. If the parents are also research subjects,
ordinarily a separate form should be drafted for them, addressing their won
participation as well as that of their children.
In circumstances in which the IRB may alter or waive the usual requirements
for securing and documenting informed consent when the subjects are
competent adults (see page 16, Informed Consent), the IRB may waive or
alter the requirements for seeking permission and assent when children are
subjects.
Pregnant Women and Fetuses
Pregnancy encompasses the period of time from confirmation of implantation (as
evidenced by missed menses or a medically-acceptable test) until expulsion or
extraction of the fetus. Fetus means the product of conception from the time of
implantation until a determination is made, following expulsion or extraction, that it is
viable.
1. Activities Directed Toward Pregnant Women
No pregnant woman may be involved in a research activity unless (1) the
purpose of the activity is to meet the health needs of the mother and the fetus will
be placed at risk only to the minimum extent necessary to meet such needs, or
(2) the risk to the fetus is minimal.
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2. Additional Consent Requirements
Research activity permitted above may be conducted only after fully informing
the mother and father of any possible impact on the fetus and obtaining informed
consent from the legally competent mother and father. Consent by the father
need not be secured if:
a. The purpose of the study is to meet the health-needs of the mother;
b. The identity or whereabouts of the father cannot be reasonably
ascertained;
c. The father is not reasonably available; or
d. The pregnancy resulted from rape.
3. Research Directly Involving Fetuses Any research directly involving
fetuses requires consultation with the IRB.
Prisoners
Prisoner means any individual involuntarily confined or detained in a penal institution.
The term applies to those sentenced to such an institution, those detained in other
facilities as alternative to prosecution, and those detained pending arraignment, trial, or
sentencing. Prisoners may be under constraints because of their incarcerations which
would affect their ability to make a truly voluntary decision whether or not to participate
as subjects in research. Additional safeguards are required, therefore, when prisoners
are proposed as subjects.
1. IRB Membership Regarding Research with Prisoners
A majority of the IRB shall have no association with the prison(s) involved. At
least one member of the IRB shall be a prisoner or prisoner representative with
appropriate background and experience. If the research is reviewed by more
than one IRB, only one need have a prisoner representative.
2. Types of Research Permitted
When using prisoners as subjects, only the following types of research are
available:
a. Study of possible causes, effects, or processes of incarceration or of
criminal behavior;
b. Study of prisons as institutional structures or of prisoners as
incarcerated persons;
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c. Study of conditions particularly affecting prisoners as a class, including
research on relevant social and psychological problems such as
alcoholism, drug addiction, and sexual assault; and
d. Study of practices, both innovative and accepted, which have the intent
and reasonable probability of improving the health or well-being of
the prisoner subjects.
In all cases, the research is to present no more than minimal risk and
inconvenience to subjects. In cases c. and d. above, consultation with the IRB
is necessary to determine possible need for approval by experts in penology
medicine and ethics. Any proposed biomedical research requires consultation
with the IRB.
3. Additional Considerations
When using prisoners as subjects, the following additional concerns must be
addressed:
a. Selection of subjects within the prison is to be fair to all prisoners and
immune from arbitrary intervention by prison authorities or
prisoners. Unless providing justification otherwise, control subjects
must be selected randomly from an appropriate population of
prisoners;
b. Any advantages accruing a prisoner subject, when compared to
standard prison conditions, are not to be of such magnitude as
to impair the prisoner's ability to weigh appropriately the risks
of research participation in the limited-choice environment of
prison;
c. The risks involved should be commensurate with risks that would be
accepted by nonprisoner volunteers;
d. Adequate evidence exists that parole boards will not take into account a
prisoner's participation or non-participation in research and
prisoners are informed in advance that participation or nonparticipation in the research, will have no effect on parole decisions;
e. Information is provided to prisoners in language they can understand;
and
f. Where the IRB finds there may be a need for follow-up examination or
care of subjects after participation, adequate provision is made,
taking into account the lengths of subjects' sentences, and
subjects are informed.
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