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WESTERN UNIVERSITY OF HEALTH SCIENCES
Institutional Review Board for the Protection of Human Subjects
REVIEWER’S COMMENTS WORKSHEET
IRB Protocol Application
THIS REVIEW TEMPLATE CONTAINS THE APPLICATION AND ICF FOR YOUR USE AS YOU REVIEW
THIS PROTOCOL. CLICK IN EACH SECTION’S FIELD BELOW THE QUESTION AND ENTER YOUR
COMMENTS. IF YOU DO NOT HAVE A COMMENT FOR A QUESTION, INDICATE SO BY TYPING N/A
WRITE YOUR COMMENTS SO THE IRB OFFICE CAN CUT AND PASTE THEM INTO AN
EMAIL TO BE SENT TO THE PI.
1.
Purpose of the study: What are the goals, specific aims and/or hypotheses of this
project/course? Include pertinent background information and describe how your study
will contribute to existing scientific knowledge. Provide a non-technical synopsis of this
project.
2.
Characteristics of subject population: Include anticipated number, age ranges, sex,
ethnic background, health status, and other inclusion criteria. Describe any exclusion
criteria. Justify the inclusion of any special classes of subjects such as pregnant women,
fetuses, children, mentally disabled, or others who are likely to be vulnerable. WesternU
has a general policy of nondiscrimination on the basis of race, color, national origin,
religion, disability, gender or sexual orientation. Use of minors (under the age of 18)
requires full Board review except for the following instances in exempt projects: 1) when
subjects to be used are students currently enrolled at WESTERNU; or 2) research in
which the only use of minors involves observation of public behavior and the investigator
or his/her assistant(s) is (are) not participating in the activities being observed.
3.
Method of subject selection: Describe the method(s) to be employed in the
identification/recruitment of potential subjects.
4.
Method/procedure of experiment: Describe how the experiment will be conducted.
Include all relevant methodology (design, procedures, questionnaires, and data analysis,
etc.). Include supporting data where applicable.
5.
Risks to subjects: Describe all potential risks: physical, psychological, social, legal, or
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other. Assess the probability, severity, potential duration, and reversibility of each risk. If
there are no obvious risks to the subject, including feelings of threat, embarrassment, or
deception, please so state.
6.
Protection against risks: Describe the procedures utilized to prevent or minimize any
potential risks. Include names and involvement with the project of any physicians or
other professionals.
7.
Benefits: Describe any potential benefits to be gained by the subject as well as benefits
that may accrue to society in general.
8.
Risk-benefit analysis: State why the risks to subjects are reasonable in relation to the
anticipated benefit(s) to the subjects and/or in relation to the importance of the knowledge
they may reasonably be expected to results.
9.
Compensation: If subjects will be paid or given other forms of compensation (such as
class credit), provide details.
10.
Therapeutic alternatives: Describe any therapeutic alternatives that may be
advantageous to the subjects.
11.
Information purposely withheld: State any information purposely withheld from the
subjects, justify and explain how and when full disclosure will be made to subjects.
12.
Informed consent: All studies require an informed consent, unless a waiver is requested
and granted by the IRB. Describe the circumstances under which informed consent will
be obtained, who will seek it, and attach a copy of consent form(s) to be used. Refer to
Section 8 of the IRB Manual entitled "Requirements for Informed Consent" for consent
form format.
12a. Full Board Review – Attach informed consent
12b. Studies with an informational coversheet (that do not require subject
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12c.
signature): Attach informed consent
Request a waiver of informed consent: You must certify that each of the
following criteria is true. Waivers of informed consent are USUALLY reserved for
one-time surveys and chart review/retrospective studies (including analysis of deidentified datasets).
You MUST check all boxes below as being accurate and appropriate in
order to be considered for a waiver of informed consent.
1)
2)
3)
4)
The research involves no more than minimal risk to the subjects
The waiver will not adversely affect the rights and welfare of the subjects
The research could not practicably be carried on without a waiver
Whenever appropriate, the subjects will be provided with additional
pertinent information after participation
13.
Research site: Describe the location/institution where research will be conducted. If
research is being conducted at or in conjunction with an institution that is administratively
separate from WesternU indicate whether letters of cooperation are attached,
forthcoming or unnecessary (if unnecessary, explain why).
14.
Confidentiality: Describe how confidentiality will be maintained
15.
HIPAA: Describe how your study is designed to be compliant with HIPAA regulations, or
if HIPAA regulations are not relevant for this study.
16.
For Dissertation/Thesis Projects Only: Please describe the monitoring plan the
Thesis/Dissertation committee will employ to oversee compliance with human subjects’
guideline on this project. While the monitoring plan will vary, based upon the nature of
the risks to human subjects generated by this project, the plan at a minimum should
insure that proper protocol is being followed in obtaining informed consent from the
subjects/subjects’ guardians and that data collection and storage is sufficient to meet
subject privacy concerns. The IRB also requires that a project update report be filed on a
quarterly basis (update form is available from the IRB Office).
17.
For Student Projects: Please briefly summarize your role on this project (for example:
developing survey, consenting subjects, managing data, analyzing data … or flow
cytometry and PCR lab experiments).
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18.
Bibliography of relevant literature
a.
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Informed Consent Form
Basis for Subject Selection
Overall Purpose of Study:
Explanation of Procedures: (Describe procedures to be followed. Identify any procedures that are experimental.
Include a statement of where the research will be conducted, when the research will be conducted, and how much time, per
session and in total, will be required of the subject. If the research involves incomplete disclosure or deception, all subjects
must be debriefed as soon as possible after participation. Include a statement concerning when and where the debriefing
session will be held. If debriefing may be harmful to subjects, the investigator may request a waiver of the debriefing
requirement.)
Potential Risks and Discomforts: (A risk is a potential harm that a reasonable person, in what the investigator
knows or should know to be the subject's position, would be likely to consider significant in deciding whether or not to
participate in the research. Risks could be physical, social, psychological, legal, or economic. Give a description of any
reasonably foreseeable risks or discomforts to the subject. When appropriate, include a statement that the particular treatment
or procedure may involve risks to the subject [or to the embryo or fetus, if the subject is or may become pregnant] which are
currently unforeseeable.
For any research activity involving the consumption of food or application of chemicals or other products to the skin [cosmetic
research], the following statement must be included): If you are known to have a sensitivity to any food or food ingredient, or
have had violent allergic reactions to drugs, chemicals, or food ingredients, you should not participate in this study.
Potential Benefits: (A benefit is a valued or desired outcome. Benefits associated with participation in research
generally can be classified as those that accrue to the subject directly, e.g., improvement of health status, and those that accrue
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to society, e.g., acquisition of knowledge. Describe benefits to the participant or others that could reasonably result from this
research. Financial compensation or other forms of remuneration are not considered a benefit to be derived from
research participation and should be included in a separate section describing compensation.)
Alternatives to Participation: (Describe appropriate alternative procedures or courses of treatment, if any, that may
be advantageous to the subject. If the prospective subjects are students who would participate in exchange for receipt of
academic credit, the consent form must describe an alternate way the student can earn the academic credit if he/she chooses not
to participate. The option(s) must be comparable to research participation in terms of time, effort and educational benefit. This
is not the same as "extra credit," which is a compensation for participation.)
Compensation for Participation: (If the subject will receive compensation, describe the amount or nature of the
compensation [extra grade credits, money, free medical treatment, etc.]. The nature and amount of compensation must not
constitute undue inducement to participate, i.e., the compensation alone should not serve as sufficient inducement for the
subject to volunteer. If students are given extra academic credit for participation, the amount/nature of the extra credit with
respect to the award of grades must not be unduly influential.)
Assurance of Confidentiality: Describe the extent, if any, to which confidentiality of records identifying the
subject will be maintained. In addition, the following statement must be included): Data and records created by this project
are the property of the University and the investigator. You may have access to information collected on or about you by
making a written request to the principal investigator. This right of access extends only to information collected on or about
you and not to information collected on or about others participating in the project. (This statement does not clearly spell out
whether copies will be provided. In most cases, the investigator and the University would probably be willing to provide
copies to the subject of data collected on him/her. It leaves open the flexibility, however, in a particular circumstance to deny
copies. An example of such situations might be on a sponsored research project where information developed could be
considered as proprietary information or required by contract with the sponsor.)
(If your project involves the investigation of a drug (Phase I-IV), non-approved use of a drug or substance, or investigation of a
medical device or substance that is subject to FDA regulations, you must add the following statement): Representatives of the
United States Department of Health and Human Services or the United States Food and Drug Administration may inspect your
_____insert "medical records" or "research records", as appropriate____ to assess the results of this ____insert "drug
treatment", "medical device therapy", or "research", as appropriate.
Statement of Injury or Special Costs: (If there is a possibility of special costs to the subject because of
participation, describe them. If there is a possibility of a research-related injury or other reason for medical treatment, the
following paragraph must be included):
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In the event that this research activity results in an injury, you should contact ____investigator's name____at the following
telephone number(s)____________. Treatment will be available, including first aid, emergency treatment and follow-up care
as needed. You and your third party payer (such as health insurance, Medicare) must provide payment for any such treatment.
This paragraph does not mean that you are releasing or waiving any legal right you might otherwise have against the
investigator or WESTERNU as a result of your participation in this research activity. (If a commercial sponsor has agreed to
provide compensation in case of injury to research subjects, the extent/limitations of the compensation must be stated clearly.
WESTERNU standard compensation statements are not to be used when a commercial sponsor has agreed to provide
compensation for subject injury.)
Withdrawal from the Study: Your participation is voluntary. Your decision whether or not to participate will not
affect your ____insert "grade" or "treatment" or "present or future relationship with the university (or other named
organization)" as appropriate____. If you decide to participate, you are free to withdraw your consent and to discontinue
participation at any time. (When appropriate, include a statement that any significant new findings developed during the
course of the study that may relate to the subject's willingness to continue participation will be provided to the subject. The
investigator must provide both the subject and the IRB with a written statement concerning any significant finding(s) that may
potentially influence a subject's decision to continue participating in the study. In this circumstance, the investigator must renegotiate informed consent. When appropriate, describe any anticipated circumstances, e.g., adverse reactions, non-adherence
to protocol instructions, under which the subject's participation may be terminated by the investigator without regard to the
subject's consent.)
Offer to Answer Questions: You should feel free to ask questions now or at any time
during the study. If you have questions about this study, you can contact ____Give
your name and telephone number and the name and telephone number of any coinvestigator. If the principal investigator is a student, the name and telephone
number of his/her adviser must also be included. ____If you have questions about the
rights of research subjects, contact the WESTERNU IRB Office, (909) 469-5636.
Additional Comments