This research protocol outlines the requirements and procedures for obtaining approval to conduct research involving human subjects. It requires: 1. Describing the subjects and research procedures, including data collection methods and obtaining informed consent. 2. Completing a human subjects risk level assessment to determine if the research poses no risk, minimal risk, moderate risk, or high risk to participants. 3. Addressing any issues related to vulnerable populations like minors or those subject to undue influence. The document provides forms and guidelines to help researchers properly protect human rights and obtain necessary approvals before collecting data.

1. RESEARCH PROTOCOL FOR REVIEW OF PROTECTION OF HUMAN RIGHTS
This protocol must be approved by the Human Rights in rights of the subjects will be guarded in written
Research Committee before data are collected. Read the materials and publications arising out of the
Human Rights in Research policy in the appropriate research.
Handbook for your program before completing this form. c) How you will provide for debriefing of subjects
Submit your original of the completed protocol (including following their responses to or involvement in your
all relevant documentation) to the Academic Doctoral research. Describe information given to subjects
Office. regarding how any questions they have regarding the
research can be addressed. Where applicable,
describe what will be done in the event of research-
related injury.
Your name
3. Read the attached Human Subjects Risk Level
Assessment Form carefully and mark all items in each
Date
risk category that are pertinent to your research.
Transfer the totals from the form to the following
categories:
No Risk Minimum Risk
Program
Moderate Risk High Risk
(Return the completed Human Subjects Risk Assessment
Form with this protocol.)
Title of Proposed Research
4. If your research involves vulnerable populations,
include the following in the description of your
research procedure:
! If Your Subjects are Minors. Describe how you
will obtain each child's assent as well as that of the
Readers or Supervisor
child's legal guardian. Note: At any level of risk,
informed consent must be obtained from both the
parent or guardian and the minor before research
Risk Assessment is begun. If consent is given by the minor, but not
by the parent or guardian, research is not to be
Select from your proposal the relevant information under conducted. Describe the means to be taken to
each of the following headings and attach it to this reduce risks and to safeguard the subjects.
protocol. Describe why alternative, less-risky methods of
research would not be possible.
1. Describe the subjects.
! If Your Subjects Are Vulnerable to "Undue
2. Provide a summary of your research procedure Influence" For example, anyone over whom you
indicating all of the following: have authority, or anyone in your care, is
vulnerable to your influence. Describe how the
a) Methods of data gathering to be used (interview, subject's right to decline participation without
questionnaires, and so on). You must attach copies negative consequences will be preserved.
of all research instruments to be used, Describe the means to be taken to reduce risks
and to safeguard the subjects. Describe why
b) How "informed consent" will be obtained. You must alternative, less-risky methods of research would
attach any letters or forms that will be used to not be possible.
secure voluntary informed consent. In this section
include: ! Other "Vulnerable Populations" For example,
• A description of how you will obtain written those who are institutionalized or are unable to
consent; make their own decisions are vulnerable.
• Or, if written consent is not possible, how you Describe the vulnerability of the subjects and how
will obtain verbal informed consent; the risk caused by this vulnerablility will be
• how you will indicate to subjects that their minimized. Describe the means to be taken to
participation is voluntary and that they are free reduce risks and to safeguard the subjects.
to withdraw at any time; Describe why alternative, less-risky methods of
• how you will ensure anonymity and research would not be possible.
confidentiality of responses;
• and, where applicable, how the anonymity and

2. Topics or questions raised are politically, emotionally,
Human Subjects Risk Level Assessment Form culturally, spiritually, or psychologically sensitive.
This checklist is provided to help the researchers, reviewers, and Individual or group presentations, phone calls, or
the Human Rights in Research Committee to consider thoroughly questionnaires will be used to solicit participation in the research.
the research proposal in light of the potential risk to human The research objective is not revealed at the outset to the
subjects and does not in itself determine the decision or subject in a direct and straightforward manner as in the case of
recommendations of the Committee. It is not the intent of the research which requires that the subject be naïve regarding the
Committee to use this risk level assessment tool to comment on research in order to participate objectively.
the merits, quality, or design of the research beyond the potential Subjects are required to reflect upon their own behavior,
risks to human subjects. values, relationships, or person in such a way that one might be
influenced or affected, and/or anxiety or concern might be raised
Based on your research purpose, population, and methods, regarding the subject matter of the inquiry.
check all items in each category that apply to your research
and indicate the totals in #3 on other side. It is not uncommon The subject may have regrets, concerns, afterthoughts, or
for items to be checked in more than one category, and it may reactions to the research method after the procedure is
take only one risk factor to actually place the entire research completed.
procedure in a particular category. You may be able to argue in The subject may become tired, weakened, or be mentally
supporting documentation for the value of a research procedure or physically affected as a result of the research and/or method.
which justifies the assessed risk level; or you might describe The research may inconvenience subjects by causing a
research procedures which reduce the potential impact of an delay or intrusion into their routine or schedule.
acknowledged risk factor.
The survey, interview, or research methodology will intrude
on the person's activities or take more than 5 minutes of the
No Risk Level Criteria
subject's time.
People will be observed randomly in a public place where
there is no personal identification of subjects. Total:
Subjects are not aware of the observation and do not have
direct contact with researcher. High Risk Level Criteria
The subject is queried or led to reveal highly personal
Only public information will be utilized such as phone
information in areas such as significant relationships, trauma,
books, directories or other published lists.
sexuality, potentially immoral, unethical or illegal behavior.
Data are collected without any identifying information.
The content focus or the research methodology itself will
There is no possible or imaginable way to trace responses back
raise issues that are highly charged politically, emotionally,
to subject.
culturally, psychologically, socially or spiritually.
Data will be used collectively in a statistical manner and no
The research will involve a minor who does not have the
one individual's response can or will be tracked.
authority and/or ability to give fully informed consent for
Total: participation.
The research will intentionally, or by design, involve
Minimal Risk Level Criteria persons who may be of legal age yet who are dependent on
Subjects are interviewed or otherwise contacted to solicit others due to a chronic or crisis health concern, developmental
participation. delays, advanced age, a language barrier, and/or incarceration in
Inquiries are made regarding basic identifying information an institution, which may impair the subject's ability to give fully
such as age, gender, ethnicity, and so on. informed consent.
Subjects are asked to answer general questions regarding Subjects will be selected to participate based upon a
non-personal information. particular disorder or health concern.
Subjects are to give opinions or viewpoints on The subject is likely to be affected emotionally, socially, or
commonplace matters such as locality, general trends, or other psychologically through the research over the short and/or long
benign topics. term to such an extent that debriefing or other reparative
The research will not in any way influence or affect the interventions are planned into the research design (not solely for
subject socially, psychologically or spiritually. preventative purposes).
The collection of required information will not take more The research design calls for deception of the subject at
than 3 to 4 minutes of the subject's time. any level.
Total: The research involves physical manipulation, contact or
touching either with the researcher or between subjects, physical
exercise, and/or any medical procedure.
Moderate Risk Level Criteria
The subject is asked to reveal personal information The research itself or the information obtained from the
regarding individual viewpoints, background, behaviors, attitudes subjects may have immediate and/or long term political, legal,
or beliefs. economic and/or social consequences for the subjects.
Subjects will be selected to participate based upon a Involvement in the research will require more than 60
particularly unique characteristic (e.g., they all hold the same minutes of the individual's time or significantly influence the
position in an organization; they have similar training or, they person's routine and/or activities.
come from a similar background). Total:
Subjects will be selected to participate based upon an
extraordinary life experience.

3. SAMPLE CONSENT FORMS
Adapt the following as appropriate for your research or course practice exercise.
Informed Consent Cover Letter
Develop a cover letter that includes an appropriate adaptation of the following elements:
The research in which you are about to participate is designed to investigate (identify your research purpose) and is being
conducted by (give your name or name the organization sponsoring the research). In this research you will (tell the
subjects what they will be asked to do). Please be assured that any information that you provide will be held in strict
confidence. At no time will your name be reported along with your responses. Please understand that your participation in
this research is totally voluntary and you are free to withdraw at any time during this study.
“I acknowledge that I have been informed of, and understand, the nature and purpose of this study, and I freely consent to
participate.”
Name
Signed Date
Use of Questionnaire
Develop a cover letter that you will include with the questionnaire that includes an appropriate adaptation of the following
elements:
The research in which you are about to participate is designed to investigate (identify your research purpose) and is being
conducted by (give your name or name the organization sponsoring the research). In this research you will (tell the
subjects what they will be asked to do). Please be assured that any information that you provide will be held in strict
confidence. At no time will your name be reported along with your responses. Please understand that your participation in
this research is totally voluntary and you are free to withdraw at any time during this study. By your completion of this
questionnaire, you are giving informed consent for the use of your responses in this research project.
Permission to Participate in Test Administration Practice
I, (give your name), am currently enrolled in a graduate level course which involves learning the appropriate use of (name
the practice test or procedure). I am requesting your permission to participate in taking a (name the appropriate action) so
that I can practice administering this assessment tool. This test involves (tell them what you will ask them to do) and will
require about (give approximate time). Since this is an administration for practice purposes, please understand that I
cannot discuss any test results. Such results would not be considered valid due to my limited experience with such tests
and could provide misleading information. Thank you for your participation and help in this learning experience.
Name of participant
Signature of participant Date
Signature of parent or guardian, if applicable
Permission to Participate in a Class Exercise
I, (give your name), am currently enrolled in a graduate level course involving learning the appropriate use of (circle one:
interview technique, verbal questionnaire, written survey, role play, simulation, other: ). I am requesting your
permission to participate in this exercise which involves (tell them what you will ask them to do) and will require about
(give approximate time). Thank you for your participation in this learning experience.
Name of participant
Signature of participant Date
Signature of parent or guardian, if applicable