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IRB Form One.docx

Policies and Procedures: Institutional Review Board (IRB)

Approved 5/10/05, revised 5/16/07, revised 4/28/10, revised 9/24/10, revised 8/14/14, revised 8/10/15

College of St. Benedict and St. Johns University

Institutional Review Board (IRB)

IRB Form 1 (Full or Expedited Review)

Directions for Submission of Application: Please answer all questions completely. Responding to each question on this application fulfills one of the requirements for the ethical conduct of researchers. If a question does not pertain to your study, indicate not applicable (NA) following the question. DO NOT DELETE OR MODIFY questions from this application.

Project Title: __________________________________________________________

Principal Investigators Name: ____________________________________________

Department/Affiliation: _________________________________________________

Email address: _________________________________________________________

Anticipated Start Date for the Research: ___________________________________

Note: IRB approval is good for 1 year. If the research extends beyond 1 year, a renewal form (IRB Form 3) must be submitted.

Is the Principal Investigator a student? _____Yes _____ No

If the Principal Investigator is a student, a Faculty Advisor must be listed. In addition, the IRB application must be submitted to the IRB chair by the Faculty Advisor.

Faculty Advisors Name: _________________________________________________

Department: _________________________________________________________

Email address: ________________________________________________________

List all Co-investigators:

NameEmail AddressStudent, Faculty, or Other

IMPORTANT: All student researchers working on this project must complete the online ethics training course called Students in Research through the Collaborative Institutional Training Initiative (CITI) before they can be involved in data collection. See the IRB website for instructions on how to access the training, or contact the IRB chair at irb@csbsju.edu for more information.

Part I: Discerning the Type of Review: Full or Expedited?

NOTE: Before completing the section below, check to make sure your research is not exempt from IRB review. Consult the IRB website or IRB Form 2 (for exempt research) for information about the types of research that may be exempt. If you believe your research is exempt from IRB review, submit Form 2 to the IRB chair.

If your research does not qualify for exemption under any of the criteria listed on Form 2, place a check next to the type of review you believe is appropriate for your project:

_____ EXPEDITED REVIEW

Surveys considered minimal risk, research on individual or group behavior or characteristics where research does not cause stress to subject and confidentiality is maintained, research involving deception that poses no more than minimal risk, performance of non-invasive tests, collection of data using noninvasive procedures, collection of blood samples by finger stick or venipuncture by trained personnel, research using existing documents, records, pathological specimens, or diagnostic specimens.

_____ FULL REVIEW

Research with greater than minimal risk, research of a sensitive nature, research with vulnerable populations (children, prisoners, pregnant women, cognitively impaired individuals, non-English or English as second language speakers, or economically/educationally disadvantaged individuals), research involving invasive procedures, research inducing physical pain or potential injury.

Does your research involve any of the following? (please check all that apply)

____ Greater than minimal risk

____ Research of a sensitive nature

____ Research with vulnerable populations

____ Research involving invasive procedures or inducing pain or potential injury

Part II: Project Description

Federal rules require that the IRB include individuals with varied backgrounds and education. Therefore, this section is to be written in clear and simple language using terms understandable across disciplines.

1. List your research question(s).

2. Citing previous research, describe the relevant literature and/or theory that supports your research question and design. (Note: This section should be approximately 1 page in length.)

Part III: Study Population and Sample Characteristics

3. How many subjects will participate in the research?

4. What are the ages of the potential participants? (Check all that apply)

_____0-7 years _____8-17 years_____18-65 years _____ >65 years

Note: Ages 0-7 require full review and a legal guardian informed consent; ages 8-17 requires full review and a child assent form along with the legal guardian informed consent form; ages 18 and older require an adult informed consent form unless a waiver is indicated.

5. Some populations are considered vulnerable to coercion or require special protections. Will any of these populations be invited to participate in the research? (Check all that apply.)

_____ children (under age 18)

_____ prisoners

_____ pregnant women

_____ cognitively impaired individuals

_____ non-English speakers

_____ economically/educationally disadvantaged individuals

_____ other (please describe):

If you checked any of the boxes in Question #5, Provide rationale for using these vulnerable populations and detail the safeguards that will be included in the research to protect their rights and welfare.

Part IV: Participant Identification and Recruitment

6. How will potential participants be identified and recruited? (please check all that apply)

____ PRIA (Psychology Signup Pool)

____ Email/Facebook/Social Media

____ Physical Flyers

____ Personal Requests

____ Other (explain)

Include below or in an addendum the text of any email or PRIA announcements, and/or an electronic copy of advertisements, bulletin board notices, telephone scripts, and other recruitment materials.

7. Will compensation be provided to participants?

_____No

_____Yes (please describe)

NOTE: incentives (payment or gifts for participation) are taxable and require adherence to business office guidelines. Indicate how you will address the taxability of incentives.

8. Are you working with an individual (athletic director, coach, supervisor, etc.) or group to access potential participants for this study?

____No

____Yes (Please list the individuals or groups)

NOTE: a letter of agreement must be submitted to the IRB chairperson from the cooperating individual or organization. A simple online form for obtaining letters of agreement can be found at https://www.csbsju.edu/forms/UUR08HNO2P.aspx

Part V: Methods, Materials, and Procedures

The purpose of this section is to give the IRB a complete understanding of the processes involved in conducting this research. This helps to ensure that the rights of study participants are protected.

9.

Describe the research procedures. What will participants do while participating in this study? List tasks/activities that participants will be asked to complete in a step-by-step manner. You may use a numbered list or bullets to help describe your procedures.

Within the description, include all materials and equipment you will use for data collection (videotape, audiotape, surveys, lab equipment, etc.).

Include an estimated time it will take participants to complete each task/activity.

Also include a brief explanation of how each activity will help to answer your research questions listed earlier.

Note: If you will be using survey or interview methods in your research, please submit an electronic copy of surveys, interview questions, or handouts with your application (a link to the survey or other materials is not sufficient files containing the complete materials must be emailed to the IRB chair.)

Part VI: Data Collection and Anonymity

10. Will any of the data collected include names or other identifiers (including video or audio recordings of the participants) that indicate who is in the study?

_____No (see below)

_____Yes (see below).

If you answered No, above:

The raw data is anonymous and can normally be kept indefinitely. If you plan to destroy the data, please explain why here. Otherwise, proceed to the next section.

If you answered Yes, above:

Please explain why these identifiers are necessary:

11. How will non-anonymous data (including names, photos, audio or video recordings) be collected, and stored? Describe in detail the procedure and how participants identity will be protected throughout.

12. If codes are used to substitute for participant names, describe the process for assigning the codes, who will have access to the codes, and who will secure and maintain the code list. (For example, coding might be used to link survey data about an individual with that individuals lab data this links two sets of data).

13. While any anonymous data can normally be kept indefinitely, the raw data and coding key from this research, which contains identifying information, should be destroyed in as timely a manner as possible. When will all data containing participant identifiers be destroyed?

_____when the study is complete

_____within three (3) years

_____other:

Provide rationale for the length of time selected above:

Part VII: Risks and Benefits