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Prior to conducting your study, submit this form, your project description, and a copy of relevant forms, questionnaires, experimental protocols, or other materials to Thom Bonagura at . The purpose of the form and proposal is to provide members of the IRB/IACUC Review Board with information to help them judge the ethical aspects of the project and to document compliance with federal regulations for research with human participants. (Some guidelines for the project description are on p. 4.)
Date of Submission:
Name of Researcher(s):
Title of the Project:
Proposed Duration of the Project (specific dates):
Note: IRBs may only give approval for up to 1 year. For longer, multi-year projects, you will need to complete a “continuation review” form prior to the beginning of the second year.
Evidence of Ethics Training: students and faculty mentors are required to provide evidence that they have completed ethics training. Please attach necessary documentation.
I. Category of Project (check one)
Faculty or Staff Research Project
Department:
Student Research Project (This includes projects affiliated with faculty research.)
Course number and name:
Name of Professor:
Class Research Project (Faculty only)
Course number and name:
II. Reasons for Review (check all that apply)
Interaction or intervention with human participants
Uses human participants outside the campus community
Uses vulnerable populations (elaborate in Section IV below)
Above minimal risk or sensitive issues
Identity of participants or other private identifying information remains in the data set
Classroom project: You may not need IRB/IACUC review.
Asking for an exempt letter.
Asking for expedited review.
Asking for full board review.
III. List the names of all research team members and document that each person has completed ethics training through the National Institutes of Health (http://phrp.nihtraining.com/users/login.php). Attach certificate for any students who will have contact with participants; if the project is above minimal risk, document the qualification of members to address the risk:
IV. Summary Description of Participants
a) Will the participants be restricted to members of the Buena Vista University community (faculty, staff, students, and alumni)? yes no
If no, explain.
b) Approximately how many persons (specify # if gender matters: males , females )?
c) Which of the following describe(s) this population (Check at least one).
Adults (over the age of 18 years; includes BVU undergraduates)
Students (preschool through senior high school)
Minors (under the age of 18 years)
Mentally or physically challenged individuals
Minority groups (specify)
Other vulnerable populations (specify)
d) How will the participants be contacted and recruited? (give details in your project description)
Flyers and notices on bulletin boards
Public announcements (newspaper, radio)
Direct contacts (you contact them they contact you)
e) Will the participants receive anything from you because they participated in the study?
yes, course credit (part of grade or extra credit)
yes, money or gift card ( nontaxable, taxable - worth )
yes, food (address food allergies or other dietary issues in proposal)
yes, other (e.g., raffle chances or toys)
nothing else but our gratitude and appreciation of their time and effort
V. Information about Research Project
a) How will the data be obtained (check all that apply)?
interviews ( in person, over phone, email/Web, other)
paper and pencil tasks; computerized experimental tasks
observation ( in public places, in private, confidential places)
recordings ( audiotaped, videotaped)
other
b) How and where will the data be stored?
For how long?
If the data will later be destroyed, specify how and when.
c) Will the data be transferred to public access archive? yes no If so, when?
d) The Review Board needs to document any conflict of interest issues. Please name the source of funding for your project:
VI. Consent, Withdrawal, and Promises to the Participant
a) Will the participant (or a proxy) give consent for participation in the project? yes no
(If no, please address this issue in your project description.)
b) Who is giving the consent? Participant
Parent or Guardian
Other (explain in your project description)
c) What information or promises will be made available to the participant?
yes no The purpose of the research known in advance
yes no The risks and benefits of the research
yes no How to locate the researcher for later comments or questions
yes no Assurances that the participant may withdraw during the project at any time without penalty
yes no The results will be furnished to the participant
yes no The participant will be debriefed at the end of his or her participation
d) Choose 1:
Assurances that the investigators will not know the participants’ identities (anonymous collection of data)
Assurances that the investigators will know the participants’ identities at data collection but the data will be untraceable to the participant (anonymous storage of data)
Assurances that the investigators will know and maintain the participants’ identities in the data set but keep the information confidential (e.g., secure storage, release of data in summary form only)
Investigators will know participants' identities, and the information may be used in the disclosure of the results.
e) If your project takes place at another site besides the university, please note the proper permissions have been obtained: (Attach written permission from the listed sites)
Name of site(s)
Schools: principal teacher parents students
Business: owner/boss workers
Agencies: supervisor/director staff
Other:
VII. Please indicate who should be contacted about the outcome of the review:
Requirements for Project Descriptions
Your project description helps the Review Board to understand your project. Further, your project description documents your ethics in accord with federal regulations and guidelines. A clear, well-written description facilitates the review. Your description must address these 9 points:
1. In 3 to 5 sentences, please give information about the purpose and rationale for the project.
2. Please briefly describe the procedure that the participant will experience, from start to finish.
3. Elaborate on information provided in section IV of the proposal form. Specifically, describe your recruitment procedure. Provide any oral or written recruitment information (e.g., flyers, email text) that you will use.
4. Discuss your informed consent process and elaborate on the information provided in section VI of the proposal form. Attach any consent forms, recruitment scripts, and/or letters to parents/guardians/ supervisors. If you are not obtaining written or oral permission from participants, please inform us how you will affirm/document that participants have been informed of their rights, freely gave consent to participate, and are 18 years old or older.
Remember, your consent form must:
. inform participants of their rights
. describe the benefits and risks of participation
. include your contact information should they have concerns after participating
. verify that the participant is 18 years of age or older
. explain how the data will be protected and put to use, including whether and how confidentiality will be maintained
5. Address the issues of risks to the participant. Discuss how you are guarding against any physical or psychological harm that might come to the participants. Disclose any conflict of interests (e.g., your funding, doing the research for profit).
6. Discuss the benefits (to participants, you, or the research field) resulting from your project. Because we are an educational institution, please describe educational benefits (as in debriefing participants about your hypotheses, research issues, or findings) that you will give to participants.
7. If your project uses deception (for example, using a false cover story or falsely stating the purpose of the research to the subject) how do you justify this technique? How will you debrief the participant? Note: not disclosing the hypotheses in an experiment before data collection is not considered deception, but presenting a different hypothesis than the one actually tested is considered deception.
8. To what use will you put the information you obtain in this project? Please state how you will protect the data you have collected (e.g., maintaining confidentiality).
9. Check List before submitting (Select those completed)
Please proof your proposal form and your project description. The quality of the writing does address your care in attending to ethics of doing research with human participants.
Please be sure that information on the project proposal form is consistent with your consent form, debrief form, and project description.
Students are asked to receive permission/final proofing of the proposal from their professor or supervisor before sending the proposals to the Board. Professors and supervisors are asked to proof proposal forms and project descriptions to facilitate the review process.
Thank you!
Additional Information and attachments:
Modified from Grinnell College v112012