IRB Online Submission 2016-17

2017-2018 Methodist University Institutional Review Board Submission Form

1.All applicant(s) names (First Name Last Name)

______

2.E-mail address of All applicants AND their role

Name______Email______Role: Student / Faculty / Staff

3.Nature of Project (Select all that apply)

_____Faculty led research

_____Student led research

_____Staff led research

_____New Project

_____Ongoing project with no changes

List previous IRB Project Number and date of approval ______

_____Ongoing project with changes

List Previous IRB Project Number and date of approval______

List changes in question 13

4.Research Subject/Title ______

5.In a brief statement, complete the following sentence: The purpose of this study is:

______

6.Are you specifically studying or collecting data from any of the following groups: (Check all that apply)

_____MU students_____Incarcerated Individuals

_____Individuals under 18 / minors_____Individuals with mental disabilities

_____Pregnant Women_____Illegal Behaviors

_____Fetuses_____Educationally disadvantaged individuals

_____New drugs or medical devices_____Economically disadvantaged individuals

_____Abortuses_____Vertebrae animals

_____I am not studying any of the above groups ______

7.Does this project fall under the purview of any other Institutional Review Board or similar agency?

_____No

_____Yes, Please identify the agency / institution below ______

8What 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.

METHODOLOGY

9.Does your project utilize a survey instrument?_____ Yes______No

If no, then skip to question # 13

10.How will you collect the survey data?______

11.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

12.If you are collecting survey data, where will you get the distribution list or e-mail addresses for your survey? Select all that apply.

_____Office of Institutional Research

_____Specific Department or Program (Identify) ______

_____Students from a set of classes (ENG 1010, ...). Identify the classes ______

_____I will use information from my work setting to distribute the survey.

Identify the workplace. ______

_____Other: Specify ______

Methods and Procedures

13.Describe, in detail, your research methodology. The methodology must be detailed enough so that it can be replicated from your description. The description should include the study design, all procedures (sequentially), and devices(by name) to be applied to participants, and tools to be used during the analysis of the data.

______

14.Proposed Data Collection Start Date (mm/dd/yyyy format)______

Reminder - You may not begin collecting data until the IRB has given a final designation for this project.

15.Proposed Data Collection End Date (mm/dd/yyyyformat)______

16.Describe any funding sources for this project including MU grants (e.g., MU Journey, Center for Research and Creativity, Leadership Fellow, Study Abroad)

Non-Funded Project (3)

MU Grant: Identify all grant sources below (2) ______

External Grant: Specify all grant sources for this project below (1) ______

17.Describe all data security protections you propose to implement. Examples include: Encryption of data, separation of master list from data, password protection for computer, locked file cabinet, locked office door. ______

______

18.Describe any potential benefits expected from this research project. Benefits can be direct or indirect to the participant or to the community.

______

19.Describe any compensation (monetary or other forms of compensation) which will be provided to participants, and any conditions which must be fulfilled for participants to receive compensation.

______

20.If the participants are to receive academic credit for research involvement, describe the alternative(s) available to them to earn equivalent academic credit if they choose not to participate.

______

21.Identify the nature of information to be deliberately withheld from participants and provide justification for the non-disclosure.

______

22.Describe the procedure for post-study debriefing of participants (as applicable).

______

23.Describe explicitly how confidentiality of data will be maintained. If you plan to share your data this must be reflected in your methodology. According to federal regulations, all data must be retained for at least three years. Include a statement here acknowledging that data collected will be retained for at least three years in compliance with federal regulation.

______

24Some projects may be exempt from ongoing review by the IRB.Exempt status 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 ofparticipants (i.e., where the researcher deceives theparticipant 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) IF YOU ARE USING A SURVEY A YOUR PRIMARY DATA COLLECTION METHOD, PLEASE CHECK THE FIRST BOX BELOW AT THE VERY LEAST.

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 participants; 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 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 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

25.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.

26.Do you have a consent form for this project?

_____Yes_____ No

27.If yes, please e-maila copy of the participant consent form you plan to use to along with this submission form. Note e-mail surveys should have a message that contains the same elements as a consent form. Please see the MU IRB website for further information.

Is a copy of the consent form attachedto email

_____Yes_____ No

28.If your project is a survey, please email a copy of your survey to the IRB AND your instructor. Copy of survey e-mailed to IRB and faculty supervisor (if student led research).

_____Yes_____ No

29.Please e-mail a copy of any brochures, flyers, or other material that you intend to use torecruit participants. This includes letters, email messages, electronic communication of any sort and any other form of communication

Copy of recruitment materials e-mailed to IRB and faculty supervisor if student led research.

_____Yes_____ No

30.Please list and e-mail the IRB any other documentation (Literature review, protocol basis for project, research proposal) that you feel the IRB will need to make a complete review of your project.

______

Final Step:

Save and email this IRB Project Submission and all required documents to to begin the review process. Please plan ahead as the review process takes a minimum of 7-10 days even for exempt items. The review process can be much longer depending on the nature and expertise needed to review the project.