IRB Online Submission 2015
Q1 IRB Online Submission for Review
Name)
Primary Investigator's Name (Last Name, First
Q2 E-mail address of primary investigator
Q3 Nature of Project
 Faculty Research Project
 Student Research Project
Q4 Faculty research supervisor
Note: The faculty research supervisor listed must approve
your project prior to IRB review and approval.
Name
Email (name@methodist.edu)
Q5 If there is more than one faculty researcher, then enter co-researchers information (Name,
e-mail address)
Q6 Project Title
Q7 In a brief statement, complete the following statement: The purpose of this study is:
Q8 Describe the characteristics of the group you are studying (Check all that apply)
 MU students
 Individuals under 18 / minors
 Individuals with mental disabilities
 Pregnant Women
 Illegal Behaviors
 Incarcerated Individuals
 Fetuses
 Educationally disadvantaged individuals
 New drugs or medical devices
 Economically disadvantaged individuals
 Abortuses
 Vertebrae animals
 Other ____________________
Q9 Does your project involve or use a survey?
 Yes
 No
Q10 How will you collect your survey data? (check any that apply)
 Qualtrics
 Paper
 E-mail
 Other ____________________
Q11 If someone begins your survey and does not complete it or does not answer all of the
questions, what will you do with the data?
 Include what has been inputted
 Delete the data
 Do not know
Q12 Where are you getting the e-mail addresses for your survey ?
Q13 Proposed Data Collection Start Date (month, day, year 00/00/00 format)
Q14 Proposed Completion of Data Collection
Q15 Funding Source
 External Grant
 MU Grant
 Non-Funded Project
Q16 Methods and Procedures Describe in detail the study design and all procedures
(sequentially) to be applied to participants
Q17 What in your estimation is the nature of the risk to individuals participating in your study?
 Minimal risk - meaning that the risk of harm anticipated in the proposed research is not
more likely than those risks encountered in daily life, or during routine physical or
psychological examinations/tests
 More than minimal risk - risk exists when the possibility of physical or psychological harm or
harm related to breach of confidentiality or invasion of privacy is greater than what is
typically encountered in everyday life.
Q18 Describe any protections against the risks you propose to implement including how you
ensure data security
Q19 Describe any potential benefits expected from this research project. Benefits can be
directly to the participant and or community
Q20 Describe any monetary or other forms of compensation which will be provided to
participants, and any conditions which must be fulfilled to receive compensation
Q21 Describe any alternatives to participation in the study which might be advantageous to the
participant. If the participants are to receive academic credit for research participation, describe
the alternatives available to earn equivalent academic credit
Q22 Identify the nature of any information to be purposely withheld from participants, and
provide justification for the non-disclosure
Q23 Describe the procedure for post-study debriefing of participants as applicable.
Q24 Describe explicitly how confidentiality of data will be maintained. If any information
with participants identifiers will be released, specify the participants. Include a statement that all
data will be retained for at least three years in compliance with federal regulations
Q25 Do you have a consent form for this project?
 Yes
 No
Q26 Some projects may be exempt from ongoing review by the IRB. Exempt DOES NOT
exempt the project from the review process only that the IRB does not follow up annually with
these projects.Exempt categories DO NOT apply to research involving deception of participants
(i.e., where the researcher deceives the participant with regard to the purpose of the research
and/or the results of the participant's actions in the study), OR projects involving sensitive
behavioral research, OR research involving pregnant women, prisoners, mentally disabled
people, and other participant populations determined to be vulnerable.Based upon reading the
categories below, does your research fall into one of the six exempt categories? (Check all that
apply)
 Research conducted in established or commonly accepted educational settings, involving
normal educational practices provided all seven components are met as outlined in the MU
Institutional Review Board Policies and Procedures Manual.
 Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless: (a) information obtained is recorded in such a manner that human participants and
animal can be identified, directly, or through identifiers linked to the paricipants; and (b) any
disclosure of the human and animal participants' responses outside the research could
reasonably place the participants at risk for criminal or civil liability or be damaging to the
participants' financial standing, employability, or reputation. Sensitive survey research is not
exempt.
 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 through identifiers linked to the subjects
 Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not exempt under paragraph 2 of this section, if: (a) the participants are elected or
appointed public officials or candidates for public office; or (b) federal statute(s) require(s)
without exception that the confidentiality of the personally identifiable information is
maintained throughout the research and thereafter
 Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise
examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or
services under those programs; (c) possible changes in or alternatives to those programs or
procedures; and/or (d) possible changes in methods or levels of payment for benefits or
services under those programs
 Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods
without additives are consumed; or (b) if a food is consumed that contains a food ingredient
at or below the level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level 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
 None of these apply
Q27 Studies may also fall into expedited review categories. Please read the descriptors below
and select any of the review categories that apply to your project.
 Minor modifications or additions to existing approved studies
 Research on individual or group behavior or characteristics of individuals, such as studies of
perception, cognition, game theory, or test development, where the investigator does not
manipulate subjects' behavior and the research will not involve stress to subjects
 The study of existing data, documents, records, pathological specimens, or diagnostic
specimens
 Voice recordings made for research purposes such as investigations of speech defects
 Moderate exercise by healthy volunteers
 Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an
eight-week period and no more often than two times per week, from subjects 18 years of
age or older who are in good health and not pregnant
 Collection (in a non-disfiguring manner) of hair, nail clippings, and deciduous teeth; and
permanent teeth if patient care indicates a need for extraction
 Collection for analysis of excreta and external secretions including sweat, uncannulated
saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the
membrane prior to or during labor
 Recording of data from subjects 18 years of age or older using noninvasive procedures
routinely employed in clinical practice. This includes the use of physical sensors that are
applied either to the surface of the body or at distance and do not involve input of matter or
significant amounts of energy into the subject or an invasion of the subject's privacy. (These
procedures include weighing, testing sensory acuity, electrocardiogram,
electroencephalogram, thermography, detection of naturally occurring radioactivity,
diagnostic echography, and electroretinography. It does not include exposure to
electromagnetic radiation outside the visible range, i.e., x-rays, microwaves.
 Collection of both supra- and subgingival dental plaque and calculus, provided the
procedure is not more invasive than routine prophylactic scaling of the teeth and the process
is accomplished in accordance with accepted prophylactic techniques
 Research on drugs or devices for which an investigational new drug exemption or an
investigational device exemption is not required
 None of these apply
Q28 Date of Submission
Q29 Please attach a copy of your consent form
Q30 If using Qualtrics, please "collaborate"/share your survey with the IRB Chair (found under
"IRB CHAIR") and your instructor. If not, please attach a copy of your survey.
Q31 Please attach a copy of brochures, flyers, or other material that you intend to use to recruit
participants. This includes any letters, and/or email messages.