Application for IRB Review

Instructions for filling out this form can be found on the BC IRB website.

If you are a Bridgewater College student, staff, or faculty member you must use the on-line submission form. If you do not have an institutional network log-in you should complete this form and submit it with all relevant attachments electronically to the IRB administrator.

New Submission or Revised Submission

Exempt Review

Expedited Review

Full Review(must be submitted at least 1 week prior to the next scheduled IRB meeting)

The completed application and all attachments should be emailed to the IRB Administrator.

Name of Principal Investigator:
Project Title:
Anticipated start date: / Anticipated end date:
Type of Project:
 Faculty Research Project
 Student Honors Project (Faculty Sponsor ______)
 Student Independent Research (Faculty Sponsor ______)
 Course - Embedded Project (Instructor: ______)
 Other (Specify: ______)
Is this project funded by a grant or third party?  Yes  No
If yes, what is your funding source? ______

(For office use only)

IRB #: ______Date Received: ______4/25/2013______

Reviewers: ______

Distrib. Date: ______Revision Date: ______

Name of Principal Investigator:
Ms. Chimene Boone
Student  Faculty Staff Non-affiliate
Local Address:
Phone:
Email:
Department/Major:
Please check to indicate that you are NIH certified and attach yourNIH Certificate to the application.
Faculty sponsor(s), if applicable:
Email:
Department:
 Please check to indicate that this person is NIH certified and attach NIH Certificate to the application.
List the names and academic status of all other investigators who will interact with human participants:
Name / Student / Staff / Faculty / Non-affiliate / NIH Certified (Attach Certificate)
 /  /  /  / 
 /  /  /  / 
 /  /  /  / 
 /  /  /  / 

(For non-BC Principal Investigators)

Please indicate campus contact(s) who will help you gain access to participants, but not interact with participants directly.

Name / Phone / Email / Campus Contact Agreement Attached


Procedural Information

I. Briefly describe the purpose(s) of the study (include research questions and key independent- and dependent variables):
II. List any potential benefits to the participants:
III. Please provide a detailed description of the research method and procedures that involve human participants (Attach any questionnaires, standardized tests or assessments, or interview protocols).
IV. In summary, the research will involve these procedures (check all that apply):
(All procedures should be fully described in Section III.)
 Written questionnaires/surveys
 Telephone surveys
 Online Surveys
 Behavioral tests
 Observation
 Interviews /  Visual Recording (photographs or video)
 Voice-recording
 Data banks or existing archives
 Blood drawing
 Incomplete disclosure or deception (Attach debriefing procedures)
 Other - Please explain:

Participant Information

V. Vulnerable populations to be studied: (the sample should be fully described in Section III):
No vulnerable populations to be studied
 Children (under 18 yrs. of age)
 Pregnant women
 Fetuses or Neonates
 Prisoners or parolees
 Participants whose major language is not English /  Terminally ill participants
 Elderly participants
 Students or employees under your supervision
 Other vulnerable population- Please Specify: ______
Mentally or physically disabled participants
VI. Will you be purposefully recruiting according to any of the following demographic characteristics? (the sample should be fully described in Section III) Check all that apply:
 Gender Total Number of anticipated participants:______
 Age
 Race/Ethnicity
 National Origin
 Sexual Orientation
 Other: __academic class status______
VII. Describe how you will recruit participants (Select all that are appropriate and include examples of all recruitment material):
Email  Newspaper
 Flyers  Online Posts
In-class requests  Other – Specify: presentation at organizational meeting
 Mail
VIII. Will participants be compensated(e.g. awards/course credit) for participation?  YesNo
If compensation will be given, pleasedescribe by what means and how much:
(Note. If compensation involves extra credit in a course, please attach the IRB Course Credit Form for each participating faculty member.)
IX. How will informed consent be obtained? Attach written consent form(s). If Consent is obtained orally, attach script. If waiver is requested, provide justification for request:
 Written
Oral; Reason: ______
Waiver of Consent requested; Reason: ______
Waiver of Documentation of Consent requested; Reason: ______

Protection of Confidentiality Information

X. Will participants generate or provide data about other persons (e.g., friends, family members, teammates)?
 Yes  No
Specify who below:
XI. Briefly describe in the spaces provided below the procedures for protecting the confidentialityof participants both during the project and after the research is completed.
Will names be recorded?  Yes  No
If yes, describe below how confidentiality will be protected.
Will data on recordings be transcribed?  Yes  No
If yes, describe below how confidentiality will be protected.
Describe below where consent forms, survey data, and recordings will be securely stored. (Please note how
consent forms will be stored separately from other data collected)
Describe below how confidentiality will be maintained in reporting results (e.g., using group based findings or using pseudonyms for participants, organizations and/or communities)?
Please indicate that you agree to the following Federal Requirement by checking the box:
Consent forms will be kept securely for a minimum of 3 years. (Data and other material may be destroyed or kept as necessary.)

Minimizing Risk Information

XII. Other than confidentiality risks, list other potential risks this study poses to the dignity, rights, health or welfare of the participants:
XIII. List the procedures you will use to minimize the risks listed above:

Signatures

Researcher's Assurance: I certify that the information provided in this application is complete and correct. I understand that as principal researcher, I have ultimate responsibility for the conduct of the study, adherence to ethical standards, and protection of the rights and welfare of human participants as outlined in the Belmont Report. I agree to: (1) Conduct the study according to the approved protocol; (2) Make no changes to the approved study without prior IRB approval; (3) Use the approved procedure and form(s) for obtaining informed consent; and, (4) Promptly report any significant adverse events to the IRB within 5 working days of occurrence.

______
Principal Investigator's Signature / ______
Printed Name / ______
Date

Faculty Advisor/Sponsor's Assurance: By my signature, I certify that the student or guest researcher has sufficient knowledge to conduct the study in keeping with the protection of human participants. Further, I agree to: (1) monitor study progress; (2) Supervise the researcher in solving problems in the research as they arise; (3) Ensure that the researcher promptly report significant adverse events; (4) Identify an alternate advisor or sponsor in the event that I am unavailable (on leave or sabbatical) and advise the IRB in writing of such arrangements.

______
Faculty Advisor/Sponsor's Signature / ______
Printed Name / ______
Date

Submission Checklist

Application

Questionnaires or surveys, standardized tests or assessments, interview questions

Informed consent forms

NIH Training Certificate (

Recruitment materials (if applicable)

IRB course credit forms (if applicable)

Application form and approval letter from cooperating institution or agency (if applicable)

Campus Contact Agreements (if applicable)

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IRB Application Form, Last Revised 8/15/2011 Page