SOUTHERN ILLINOIS UNIVERSITY EDWARDSVILLE (SIUE)
APPLICATION FOR APPROVAL OF RESEARCH INVOLVING
HUMAN SUBJECTS
APPLICATION FOR ETHNOGRAPHIC RESEARCH
This form is used to apply for approval of ethnographic research. Ethnographic research is defined as
data gathered primarily through the methods of participant observation, surveys and/or interviews for the
purpose of addressing questions pertaining to social and/or cultural issues (as opposed to physical and/or
psychological ones). Ethnography may describe a social situation as a whole, or it may focus on specific
problems or situations within a larger social context.
Although we expect that most ethnographic research applications will be eligible for minimal risk
review, it is possible that your research will pose more than minimal risk of harm to subjects and,
therefore, require review by a sub-committee, if eligible for expedited IRB review, or at a convened
meeting of the Human Subjects Review Committee, if full board IRB review is required. If you have
questions about minimal versus more than minimal risk, please contact the Office of Research and
Projects at 618-650-2958. Please note that ORP may determine that an application submitted as
minimal risk may pose more than minimal risk. If that is the case, we will contact you and request
additional information if necessary.
In any case, please send the following items for IRB review:
 This form, signed, and dated, with original signatures
 Data collection forms, survey instrument, outline of interview questions, if applicable
 Consent forms, assent forms, parental permission forms, if applicable
1. TITLE OF THIS ETHNOGRAPHIC STUDY:
2. INFORMATION ABOUT THE DURATION OF THE STUDY
What is the approximate length of time you anticipate for data collection?
Start date (month/year): ___/___; End date: ___/___
3. INFORMATION ABOUT THE RESEARCHER WHO HAS PRIMARY RESPONSIBILITY
FOR THE CONDUCT OF THIS STUDY (Principal Investigator):
Last name
, first name
E-mail address:
Mailing Address:
Phone number:
Fax number:
Department:
Principal Investigator status:
, middle initial
Faculty
For student research, is this application for a:
Staff
Student
class project
thesis
dissertation?
Faculty Supervisor’s name (if applicable):
Faculty Supervisor’s SIUE email address:
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CO-RESEARCHERS (Provide all the information requested for each co-researcher. Add sheets
if necessary.)
Name
Department
Mail box or address
Telephone
Name
Department
Mail box or address
Telephone
Name
Department
Mail box or address
Telephone
Name
Department
Mail box or address
Telephone
Title
Position
Division
Fax
e-mail
Title
Position
Division
Fax
e-mail
Title
Position
Division
Fax
e-mail
Title
Position
Division
Fax
e-mail
4. INFORMATION ABOUT THE FUNDING FOR THIS STUDY
Provide the following information for each source of support for this project:
None: (Go to Section 5.)
Type of support:
If sub-contract, provide information about prime award:
Name of PI
Title of grant
Agency granting award
Status of support:
Title :
Name of PI:
Name of funding agency:
Inclusive dates of funding: from
to
If award has been assigned a number by the funding agency, enter here:
What agency processed the proposal?
Attach one copy of each complete grant or contract proposal associated with this project.
5. INFORMATION ABOUT POSSIBLE FINANCIAL CONFLICTS OF INTEREST
Has each researcher read and complied with the University's Policy on Conflict of Interest?
Yes
No. (Note: This application will not be reviewed unless all researchers have read and
indicated compliance with this policy. You may read this policy at
www.siue.edu/ORP/ORP_POL/conflict.html.
Do any of the researchers have a Significant Financial Interest related to the proposed research that must
be disclosed as provided in the University's Policy on Conflict of Interest?
Yes
No. If yes, each
researcher having a Significant Financial Interest must comply with this policy, including submission of
a Conflict of Interest Disclosure form. Final review of this application cannot occur until the Conflict of
Interest Disclosure form review is complete. Delays in complying with the University's policy on
Conflict of Interest will result in delays in completing the final review of this application. Please list the
name of each researcher having a Significant Financial Interest below:
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Last
First
Middle
Organization
I have attached a copy of the Conflict of Interest Disclosure form review letter
I will send a copy of the Conflict of Interest Disclosure form letter as soon as I receive it
6. SUMMARY OF RESEARCH AIMS: Using lay terms, summarize what you would like to
accomplish by conducting this study:
(100 words or less is appreciated but not required),
7. SUMMARY OF RESEARCH METHODS: Please provide a brief description of the research
techniques (such as participant observation, interviews, surveys, focus groups, use of public, private,
governmental or other records, administration of tests, etc.) that you will use to conduct this study.
Attach copies of all questionnaires, interview outlines, descriptions of the topics or domains you will
be covering, description of records, descriptions of what will be observed (behaviors, quotes,
identities), etc., to give the reviewers a sense of what you will be learning from and about the
subjects in your research:
a. List all the methods you will use to retain the information (audiotapes, videotapes, photographs,
notebooks, written material, computers, etc.)
b. What portions of the research material you collect are public and not expected by community
standards to be private and why?
c. What portions are confidential?
Explain how you will store the confidential information or materials while you are in the field so
that the privacy and confidentiality of the data are protected.
Explain how you will store the confidential information or materials after you leave the field so that
the privacy and confidentiality of the data are protected.
NOTE: If you are paying participants through a 3rd party system, such as Amazon Mechanical Turk, it is your responsibility as
the researcher to insure proper payment is made to each participant who begins the survey. Because participants are able to
withdraw from the study at any time without being penalized, they should continue to receive payment.
8. RESEARCH SITES OR LOCATIONS
a. Describe where you will do your research.
b. Have you done research at this site or with this population before?
Yes
No.
If yes, please briefly describe the topics and duration of your previous research:
.
c. Is governmental or community permission to conduct research required in any of these sites?
Yes
No
If yes, please explain how you will obtain this permission.
If there is formal documentation of this permission, please attach it to this application or forward
it to us when it becomes available.
Attached
Will be sent when received
d. Will you conduct research on an American Indian reservation or an Alaska Native corporation?
Yes
No.
Tribal or Corporation approval documents attached
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Tribal or Corporation approval documents will be sent when received
e. Will you have local collaborators (interviewers, interpreters, translators, etc.)? Yes
No
If yes, please explain who these collaborators are and how they will be involved in the research.
Will they need to obtain local ethics committee approval for their role in the study?
Yes
No. If yes, please attach a copy of the approval.
f. Do you plan to return to this site or population in the future to conduct research? Yes
. If yes, please describe your plans:
No
9. SUBJECTS
a. Use the table to list the populations of research subjects you will involve in your research.
Type of Subjects
Approximate number of individuals you intend to involve Age Range
b. Describe why the research subjects are important to your research. Provide an answer for each
subject group, for example, entrepreneurs, customers, teachers, students, dancers, shamans, etc.
c. Will you interact with minors (children) to collect data for your study? Yes
No
If yes, please explain: ____________________________________________________
_______________________________________________________________________
d. Will you interact with or observe prisoners as subjects in your study? Yes
No
(If yes, do not complete this form.) Additional regulations apply when using prisoners in
research. Use the regular IRB application form if you intend to enroll prisoners in your study.
(Note: This also applies if a subject becomes a prisoner during their participation in your study)
e. Will you involve pregnant women as subjects in your study?
Yes
No
Unknown
(If yes, see Appendix A.) Additional regulations apply when using pregnant women in research.
(Note: This also applies if a subject becomes pregnant during their participation in your study.)
f. Will you involve research subjects who are legally incompetent (in the jurisdiction of the
research site) to provide informed consent or who have diminished capacity?
Yes
No
(If yes, confirm that you will obtain their assent to take part and explain who will provide
consent for these subjects.) Additional regulations apply when using subjects who are legally
incompetent in research. (Note: This also applies if a subject becomes legally incompetent during
their participation in your study.)
10. POTENTIAL BENEFITS OF THE STUDY
a. Is it possible that individual subjects or their community can reliably expect a direct benefit from
taking part in this study? Yes
No
If yes, describe any direct benefits that individual subjects can reliably expect from taking part in
this study:
b. Describe the anticipated benefits of this research for the community you will study or for society
in general, and explain how the benefits outweigh the risks of harm to participants:
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11. POTENTIAL RISKS OF HARM: Harm in ethnographic research is usually limited to what may
result from invasion of privacy, stigmatization, or breach of confidentiality. Harms may happen to
individuals and to the groups or communities to which they belong.
a. Does the proposed research pose any risk of harm to participants or their communities?
Yes
No
If yes, please explain how the benefits outweigh the risks of harm to participants:
b. Are there different potential risks of harm for different groups of subjects? Yes
No
If yes, please identify the potential risks for each group.
1. Identify the potential risks of harm that may result from this study:
2. Describe the steps you have taken to minimize the risks of harm.
3. If these harms occur, what plans do you have to manage them?
c. Describe the anticipated risks of this research for the community you will study or for society in
general, and explain how the benefits outweigh the risks of harm to participants:
12. CONFIDENTIALITY OF RESEARCH DATA: The following questions relate to compliance
with laws and regulations relating to the privacy and confidentiality of research data. The purpose of
these laws and regulations is to minimize the risks of invasion of privacy and breach of confidentiality.
a. Will confidentiality of subjects be maintained?
Yes
No
If no, please explain (i.e. Subject prefers to have researcher use their name):
b. Will you retain information that could lead to the identification of the research site?
Yes
No
If yes, explain what consequences this could have:
c. Will you record any direct subject identifiers (such as names or contact information)?
Yes
No
If yes, explain why and describe how you will protect against disclosure of this information, or
explain why this is not necessary:
I will retain the identifiers linked to the data for a period of time. If you check this box,
explain why this is necessary. For example, you may need to keep data with identifiers for
a period of time in order to link interviews or data sets together:
Explain how many months or years you will need to keep the identifiers linked to the data:
Explain how you will maintain the security of the data during this period:
If the link is retained, explain who (other than members of the research team) will have
access to data (e.g., sponsors, advisers, government agencies, etc.). In each case, specify
whether they will have access to study data with identifiers or only to coded data with no
access to the identifying study code:
I will keep identifiers forever. If you checked this box, explain why this is necessary. For
example, do you intend to re-contact subjects or communicate with them over a long period
of time, or are the data are by nature identifiable (recordings, genealogies, etc.)? In
addition, describe how you will protect the data from breach of confidentiality or why this
is not necessary.
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Other: explain
d. Will you retain any data (for example, use of illegal drugs, underage drinking, child or elder
abuse, genetic test results, etc.) that could reasonably place the subjects in your study at risk of
criminal or civil liability or be damaging to their financial standing, employability or reputation?
No
Yes
If yes, describe these data and confirm that you will apply for a federal Certificate of
Confidentiality:
e. Is it possible that you might be obliged or compelled (for example, in response to a subpoena for
evidence) to disclose data that could be linked with an individual or group? Yes
No
If yes, explain these circumstances and confirm and that you have included information about
these exceptions to confidentiality in the consent process:
13. CONSENT/AUTHORIZATION: Your responses in this section are used to provide the reviewers
with information about what kinds of consenting procedures you will use in your study.
a. Explain how you will introduce yourself as a researcher to potential subjects. If you already
know them, please explain the circumstances.
b. How will you inform people about your research and obtain their consent to participate? If you
will use more than one method, provide information for each.
I will use written consent and assent forms (please provide forms in the language that
subjects read as well as in English after the English language versions are approved).
English versions attached
Non-English versions will be sent after English version is approved.
I am requesting a waiver of written consent and will use an oral consent process. If you plan
to use an oral consent process and to work informed consent procedures into your
introduction to a group, or the beginning of an interview, please provide a general script or a
list of points you will cover. Waivers of written consent are governed by federal regulation.
Please check the category that is applicable to your study:
The only record linking the subject and the research would be the consent document and
the principal risk would be potential harm resulting from a breach of confidentiality.
Each subject will be asked whether the subject wants documentation linking the subject
with the research, and the subject's wishes will govern; or
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.
Please note that the Committee may request that you provide subjects with an information
sheet, a card with contact information on it, or some other summary of the research in written
form. If you have such a document, please attach it.
I am requesting a complete waiver of written and oral consent (for example, for observation
in public spaces, review of public records, etc.). Waivers of written and oral consent are
governed by federal regulation. Please respond to each of the following by identifying the
parts of the research for which you are requesting a waiver and explain how your request for
a waiver addresses each of these concerns:
1. The research involves no more than minimal risk to the subjects and their privacy
because
2. The waiver will not adversely affect the rights and welfare of the subjects because
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3. The research could not practicably be carried out without the waiver because
4. Will you provide information to the subjects about the study after their participation?
Yes
No
c. Is the population you will be working with generally literate? Yes
No
d. If confidentiality of subjects’ names is to be maintained, are you aware of any circumstances
under which you might be obliged or compelled (for example, in response to a subpoena for
evidence) to disclose data that could be linked with an individual or group?
Yes
No
N/A ____
If yes, explain these circumstances and confirm and that you have included information about these
exceptions to confidentiality in the consent process:
14.
OTHER:
Are there any other issues that are important to your research that you would like to report to the
IRB?
Yes
No
If yes, please explain:
15.
SIGNATURES:
The undersigned acknowledge that: 1. this application represents an accurate and complete description
of the proposed study; 2. the study will be conducted in compliance with the recommendations of and
only after approval has been received from the Human Subjects Review Committee (HSRC). The
principal investigator is responsible for reporting any serious or unexpected adverse events or problems
to the HSRC, for requesting prior HSRC approval for modifications, and for requesting continuing
review and approval.
A. Investigator:
____________________________________________________________
Signature
Date
B. Faculty Supervisor (required only for student researchers)
___________________________________________________________________________
Printed name
Signature
Date
C. The Chair, Dean, or Director signing below acknowledges that this proposed activity has received
intra-mural review and approval of scientific merit and investigator qualification.
____________________________________________
Signature
______________________
Date
HUMAN SUBJECTS REVIEW COMMITTEE USE ONLY
The IRB Board has reached the following decision with regard to the research proposed in this
The Human Subjects Review Committee has determined that this study meets the requirements of the
Common Rule 45 CFR Part 46 requirements for:
waiver of documentation of consent
Yes
No
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waiver of consent
Yes
No
NA
_____________________________________________
______________________________
Human Subjects Review Committee Signature
Date
Period of approval is from_____________________ through________________________
APPROVAL IS VALID ONLY AS LONG AS APPROVED CONDITIONS ARE FOLLOWED
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Appendix A
a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies,
including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to
pregnant women and fetuses;
(b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the
woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose
of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
(c) Any risk is the least possible for achieving the objectives of the research;
(d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the
pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than
minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by
any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part;
(e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the
father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent
need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the
pregnancy resulted from rape or incest.
(f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably
foreseeable impact of the research on the fetus or neonate;
(g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions
of subpart D of this part;
(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
(i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to
terminate a pregnancy; and
(j) Individuals engaged in the research will have no part in determining the viability of a neonate.
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