Missouri State University
Human Subjects Protection
Institutional Review Board
APPLICATION FOR REVIEW AND APPROVAL OF
ACTIVITY INVOLVING HUMAN SUBJECTS
Policy Statement:
The United States Department of Health and Human Services (DHHS) and Missouri State University
have established standards and guidelines to protect individuals who may be at risk as a consequence
of participation in a research activity. The Institutional Review Board for the Protection of Human
Subjects (IRB) is responsible for insuring that adequate safeguards are established to protect any
individual who may be at risk as a consequence of participation in research activities.
Standards for the committee’s reviews are based upon
1. Protection of Human Subjects - Code of Federal Regulations, 45 CFR 46
2. Standards for Privacy of Individually Identifiable Health Information – 45 CFR 160 and 164,
as described in the Missouri State University Health Insurance Portability and Accountability
Act (HIPAA) Policy
Researchers are encouraged to refer to these codes in planning their research.
To what does this policy apply?
All research undertaken by university personnel that involves human subjects in any way, regardless
of the source of funds, must be reviewed and approved by the IRB before the activity is undertaken.
This includes activities in which a faculty member is supervising student research activities, such as
graduate theses and dissertations.
According to 45 CFR 46, “Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
The Health Insurance Portability and Accountability Act (HIPAA) imposes additional requirements
for those involved in the collection, use, retention and destruction of research data that includes
protected health information (PHI). According to 45 CFR 165.501, protected health information is
defined, in part, as individually identifiable health information transmitted or maintained in electronic
or any other form or medium.
All research projects must be renewed annually. Renewals (without changes) are sent directly to the
IRB chair and typically require only a brief review. Any meaningful changes in procedures must also
be reviewed. Applications involving changes in approved procedures are sent to the College
Representative.
Training:
A. Human Participant Protection Training: Faculty, staff and students participating in the design
of projects involving collection of data and/or the analysis of data from human subjects, must
complete the CITI training program. This program consists of modules for Biomedical and
Social/Behavioral Investigators and a Completion Certificate is issued through the CITI program.
URL: https://www.citiprogram.org/default.asp
B. HIPAA Training: If the proposed research involves protected health information (PHI),
researchers also must certify completion of the training required under the Missouri State HIPAA
policy. This training is provided in two modules available on a secure Missouri State web site –
http://www.privacy.missouristate.edu/hipaa.htm - HIPAA Privacy, Security and Research
Training.
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Date submitted:______________ Date received by OSRP:______________ Application #:_______________
MISSOURI STATE HUMAN SUBJECTS REVIEW APPLICATION COVER SHEET
Project Personnel
Lora Hobbs_____________________________
Principal Investigator (Faculty)
College __CHPA______________
Human Subjects Training Certificate
On File w/OSRP Attached
___YES____
______
Department____Religious Studies_____________
Project Involves Protected Health Information
HIPAA Training
Certifications of Completion are in the HR Database
Yes_______ No___X___
Privacy & Security, & Researchers Trng.
Yes_______ No___X___
Co-Workers
Human Participant Training
_See attached list of students in REL 370 Fall 08_
Yes__X____ No_______
Nathan Dunn, Graduate Assistant
HIPAA Training
Yes_______ No____X__
Human Participant Training
________________________________________
Yes_______ No_______
HIPAA Training
Yes_______ No_______
Additional Names and Information on Training are to be Provided on an Attached Sheet
Proposed Project Dates (up to one year): from _10/_15_/_08_ to _10/_15_/__09_
Title __Archive of the Religious Lives of Ozarks Women___________________________________
Funding Agency or Research Sponsor 1) Provost’s Curricular Grant and 2) CHPA Incentive Funding
_X___ New Project
_____ Renewal or Continuation
____ Change in Procedure for Previously Approved Project
____ Resubmission ____
RECOMMENDATION OF COLLEGE IRB MEMBER
_____ Category I, Exempt, Sub-part A, Section 45.101 45 CFR 46, exempt category ___.
_____ Category II, Expedited Approval, Sub-part A, Section 46.110; expedited category ___.
_____ Category III, Full Committee Review.
__________________________________
IRB College Representative
_____ Approved as Exempt
_____ Approved
__________________
Date
ACTION OF THE IRB CHAIRMAN
_____ Expedited Approval
______Recommended for Full Review
RESULTS OF FULL IRB REVIEW
_____ Deferred (see attached comments) _____ Disapproved (see attached comments)
_________________________________________
Chairman of IRB
Last Updated: July 1, 2016
________________________
Date
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INSTRUCTIONS FOR THE
MISSOURI STATE HUMAN SUBJECTS PROTECTION APPLICATION
The application consists of (a) the cover sheet (above), (b) the body of the application that addresses the areas
noted below (using the areas as subheadings; 2-4 pages maximum), (c) Human Participants Protection training
certificate(s) (if applicable), (d) HIPAA training certificates (if applicable), (e) copies of questionnaire
instruments to be used (if applicable), (f) copies of Informed Consent forms to be used, and (g) letter(s) of
support/permission from data collection site(s) (if applicable) (where appropriate, include IRB approved protocol
from other involved institution here).
Application Content Areas
1.
Brief description of the purpose of the proposed project, including specific goals
Students enrolled in Religion 370: “Women and Religion” in Fall 2008 will develop both an online and
Meyer Library archive of The Religious Lives of Ozarks Women. The centerpiece of this project will be
the digitally audio-recorded and transcribed oral histories of women who have impacted religious life in
the Ozarks. This may also include women who have roots in the Ozarks, but are impacting religious
life outside the Ozarks. Ozarks women who have impacted religious life and are now deceased may be
included, as well, if we can gain access to family members or contemporaries who are willing to talk
about these women’s lives. It is anticipated that these archives will serve as a seedbed for the
development of a more expansive archive as future students, as well as other researchers and historians,
contribute to the site which will preserve the stories of many of the women who have contributed,
formally and informally, to the rich religious heritage of the Ozarks.
2.
Research protocol:
 Description of participants to be used:
Students will be interviewing women who have lived in the Ozarks at some time and who have
been actively involved in religious life either in or disseminating from the Ozarks. The boundaries
of the Ozarks include the area bordered on the north by the Missouri River, the east by the
Mississippi River, the south by the Arkansas River and the west by the Grand and Neosho Rivers.
Each student will be required to interview one woman. Currently, 27 students are enrolled in the
class, plus I intend to conduct an interview, so our sample size would be 28. Students will select
their subject from either 1) a woman with whom they already have familiarity or 2) a woman from
a list I have been collecting as this project has been developing. Each participant will be asked to
be interviewed for 60-90 minutes by the student researcher.

Procedures:
Progression of research:
1) Students will complete the CITI Human Subjects Research Online Training.
2) Students will read and discuss Donald Ritchie’s chapter on Conducting Interviews from Doing
Oral History, as well as the Introduction and first chapter of Robert Wuthnow’s book, Growing Up
Religious.
3) Students will determine the woman they would like to invite to share her story, contact her with
their request, and make arrangements to meet should the woman agree to participate. Students will
be urged to meet with the women on the women’s”turf,” so to speak.
4) Students will be oriented to a packet of materials that contains an Informed Consent / Release
Form, Biographical Data Form, potential interview questions and a Recording Log.
5) Students will be oriented to the operation technology they will be using (digital audio recorder,
digital video recorder, and/or camera).
6) Students will be given sample questions (see attached) that they might ask, based on:
a) Robert Wuthnow’s questionnaire (for Growing Up Religious),
b) the questionnaire developed for the Telling Traditions Project (oral history collection of Jewish
women in the Ozarks),
c) questions developed by the course instructor.
Students will then develop their own list of questions that seem suitable for the woman they are
interviewing.
7) Students will transcribe the interviews. Interviewees will be given the opportunity to read make
changes to the transcription, should they choose.
8) Students will write a 2-3 page narrative summary based on the interview.
9) Students will turn in the interview packet, interview transcription and narrative summary for
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grading and final editing.
10) The digital recording, transcription, narrative summary, interview log, a digital photo of the
subject and any related photos or articles will be given to my grad assistant / web developer who is
creating the online version of the archive.
11) All hard copy materials, as well as the recording of the interview transferred to cd-rom, will be
handed over to the Meyer Library for placement in their archives.
12) The final results from the research will be the birth of both and Online and Meyer Library
Archive of the Religious Lives of Ozarks Women.

How information will be used / disseminated / shared:
Transcribed interviews, taped interviews, recording log, narrative summary, a digital photograph of
the subject and any other related materials (photos, news clippings, etc) will be placed on the online
archive. All hard copy materials will be deposited in the Meyer library archives. In addition, we
hope to invite all the participants, as well as the public, to an open house in the Meyer archives
once all materials are placed (most likely, spring of 2009).
3.
Benefits:
The benefit for the interviewees is that their stories will be told and preserved for not only the current
generation, but generations yet to come. Sometimes the most difficult part of this type of research is
convincing people that their life stories and valuable, worth sharing and worth preserving. Having the
opportunity to share their life stories with an objective outsider may serve as good affirmation to them
that their stories are worth sharing and preserving. The benefit for humankind is that of documenting
and preserving the stories of the religious lives of women in the Ozarks, an understudied region of the
United States. These preserved materials may serve as primary research material for the areas of:
Ozarks studies, women’s studies, and religious studies
4.
Risks:
There are no great risks to individuals. It will be clearly stated to interviewees that they can choose not
to answer any question(s), so there will be no gathering of information that the interviewee chooses not
to disclose. It is conceivable that a risk would be potential in some information that interviewees may
share about themselves, others involved in their life story or religious institutions. See # 6 below.
5.
Analysis of Risk:Benefit Ratio:
A central premise of public history is knowledge as a community asset. Therefore, the sharing of
information from the lives of those who have contributed to public history is essential. We will make
every effort to minimize any foreseeable risk that may result from information shared. See # 6.
6.
Procedures for Minimizing Risk:
1. Student interviewers will become acquainted with potential risk factors, not only through completion
of the CITI Training for Human Subjects Research, but also through class instruction and discussion of
potential risks, as well as management of those risks.
2. Interviewees receive clear communication that they can choose not to answer any question(s) and
that they do not have to use names of people or institutions, should that be their choice.
3. Interviewees will be given the option to read the transcription of the interview and the narrative
summary of the interview before either is archived. They will be allowed to offer changes to the
content, especially in order to minimize any risk socially.
4. Because the interviews will be taped digitally, we will also be able to more easily make needed
deletions of names, etc. following the interview.
5. As I read through transcriptions of interviews, I will also be attentive to revelations interviewees
may make in the course of dialogue that they may want to re-consider and work with the student
interviewer to clarify the interviewee’s desires.
7.
Procedures for obtaining informed consent:
Students will read through the informed consent form (see attached) with the interviewee and ask if
they have any questions.
9.
The project proposal shall end with the following:
I hereby agree to conduct this study in accordance with the procedures set forth in my project
description, to uphold the ethical guidelines as set forth in the Code of Federal Regulations 45 CFR 46,
45 CFR 160 and 164, and the Missouri State University HIPAA Policy, and to report to the IRB any
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outcomes or reactions to the experiment which were not anticipated in the risks description which might
influence the IRBs decision to sustain approval of the project.
___________________________________
Department Head
___________________________________
Date
___________________________________
Principal Investigator
___________________________________
Date
________________________________
________________________________
Graduate Assistant
Date
Other Investigators: SEE ATTACHED CLASS ROSTER
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