IRB-Application For

For Office Use Only
Date reviewed: / IRB Case No:
IRB Reviewer:
Action:

APPLICATION FOR NEW RESEARCH PROJECT INVOLVING HUMAN PARTICIPANTS

WHEATON COLLEGE INSTITUTIONAL REVIEW BOARD (IRB)

In accordance with US Federal regulations and Wheaton’s Assurance to the United States Office of Human Research Protections (OHRP), the Wheaton College IRB reviews requests to conduct research involving human participants. The OHRP requires that all researchers who interact with human participants be familiar with the regulations 45CFR46. It is the investigator’s responsibility to give complete information regarding the procedures of the study protocol,including the informed consent process. If the principal investigator is a student, the application must be approved and signed by the applicant’s faculty sponsor or the department chair.

SENDcompleted application,containing all required signatures and all supporting materials,as a single document to:Meg Kirkpatrick, Associate Provost and Executive Secretary of the IRB, Park Hall 108.

The IRB will notify each applicant of the IRB’s decision. If you have questions, please contact the IRB Executive Secretary at (508) 286-3642.

Include with this application all of the required documentation listed below:

Please type or print responses. Failure to provide all required information will result in the return of this application for correction prior to IRB review.

1. / Project Title:
2. / Principal Investigator's Name:
Department: / Phone:
Mailing Address:
City: / State: / Zip Code:
Email:
/ I have completed the on-line NIH Ethics Training modules or comparable within the last three years.

For Students Only:

Faculty Sponsor:
Department: / Phone:
Is this a class project? / / Thesis: /
Other?
Identify the source of your training in Research Ethics (e.g., PSY 202 Quantitative Research Methods):
3. Project Start Date:
4. Is a proposal for external support being submitted? /
Agency or Sponsor: / Deadline:
If "yes" you must submit one complete copy of the proposal with this application.
5. Project Description: Provide a brief, nontechnical summary of the proposed research:
What is its purpose? What question does it seek to answer?
6. Participant Selection: All individuals involved will be informants.
Specify the age range of participants: / From: / To:
Will there bevulnerable participants? (as specified in 45CFR46) / /
Will participants be students at Wheaton College? / /
Maximum number of participants:
What are the inclusion/exclusion criteria? What criteria must participants meet to be included in the study? Also, specify any criteria that would exclude a participant from the study.
7. Recruitment: How will participants be selected, enlisted, or recruited? Will an incentive to participate be provided; i.e., will participants be rewarded for their participation? (Attach all recruitment materials.)
8. Informed Consent Process: Describe the informed consent process. (Include statements about who will consent the participant and where the consent discussion will occur).
Informed Consent Process: Describe the process ofdebriefing:
9. Procedures: Provide a step-by-step description of each procedure, including the frequency, duration, and location of each procedure. Describe the study design, including: a sequential description of what will be asked of/done to participants; kinds of data to be collected; and follow-up procedures, if any. Append any and all relevant materials.
10. Confidentiality and Anonymity: Is identifiable information being recorded? Please describe the specific steps that you are taking to protect participants' privacy and safeguard confidentiality.
11. Risks: Describe all known and anticipated risks to the participant, paying close attention to the potential physical, emotional, and psychological effects of all procedures. Include risk of psychosocial harm (e.g., deception, emotional distress, embarrassment, breach of confidentiality, etc.), economic harm (e.g. loss of insurability), and legal jeopardy (e.g., disclosure of illegal activity).
12. Benefits: Describe what expected, direct benefits, if any, the participants may derive from participation in your study. The possibility of benefits to society should be clearly distinguished from the possibility of benefit to the individual participant, if any. If there is no direct benefit to the individual participant, say so. Do not list monetary payment or course credit as a benefit.

Please save completed form to your desktop before printing.

RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR:

Any additions to or changes inprocedures in this protocol must be submitted to the IRB for written approval prior to the changes being put into practice.
Any problems connected with the use of human subjects once the project has begun must be brought immediately to the attention of the IRB Executive Secretary.
The principal investigator and his orher designee(s) are responsible for retaining informed Consent Documents for a period of three years after the completion of the project.

The principal investigator may not initiate any research involving human subjects until written notification of IRB approval of this research protocol has been received. Formal approval by the IRB may include specific directives concerning the responsible conduct of research for particular aspects of the project, or may specify steps necessary for compliance in certain contingencies. The investigator must indicate to the Executive Secretary the acceptance of such modifications before research may begin.

SIGNATURES:

A. I certify to the best of my knowledge the information presented is an accurate reflection of the proposed research project and that I intend to comply with the letter and spirit of the Wheaton College Policy on the Protection of Human Subjects in Research.

Principal Investigator / Date

B. Approval by faculty sponsor (required for all students): I confirm the accuracy of this application, and I accept responsibility for the conduct of this research, the supervision of human subjects, and maintenance of informed consent documentation as required by the IRB.

Faculty Sponsor / Date

C.Approval by Department Chair (required for all students):I confirm the accuracy of the information stated in this application. I am familiar with,and approve of, the procedures that involve human subjects.

Department Chair / Date

Rev. 12/19/2014