Office Use Only PROPOSAL CODE
IRB Proposal Submission Form
Submission Date:
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Principal Investigator:
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E-mail:
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Position of Principal Investigator
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Faculty Advisor (if student):
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Anticipated Start Date:
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Anticipated End Date:
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Anticipated Level of Review:
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If more than one Investigator, names of other Investigators and their positions: Click here to enter text.
1. Proposal Title: Click here to enter text. 2. Briefly describe the questions/hypotheses you will address: Click here to enter text.
3. In two or three paragraphs, briefly provide a rationale for your research project based on prior literature. Write so non-specialists will comprehend your project: Click here to enter text.
IRB Proposal Submission Form
July 2009
4. Describe in detail the design of your project, or how you will analyze your data: Click here to enter text
5. Describe in detail all methods including the procedures and measures you will employ. Please attach appendices with the precise instruments, if applicable. Click here to enter text 6. Are you planning to use deception in your study? If so, justify its use: Note:The IRB discourages the use of active deception in research. Click here to enter text
7. Are you planning to include a debriefing session at the conclusion of your study? If so, provide a rationale for using a debriefing and a precise description of the debriefing. Choose an item 8. Describe in detail all demographic information (age, gender, ethnicity, etc.) that you will collect: Click here to enter text.
9. Describe the population that you will include in your research proposal and why you chose that population. Indicate whether you have any special knowledge of or experience with this sample population: Click here to enter text. 10. Estimate the approximate number of participants you expect to include: Click here to enter text.
11. Describe in detail how you will recruit your participants. Participating Emmanuel students must be 18 years of age or older. Describe the process you will use to ensure this age restriction is met. Indicate if you are using students in the Psychology Department Participant Pool. Please write verbatim the information you will post to recruit your participants: Note: If you are recruiting participants from another institution, you may need to get approval from that institution’s IRB, as well as from the Emmanuel College IRB. If the institution does not require its own IRB review, you may be asked to provide written documentation of the institution’s support for your project. In most circumstances it is inappropriate for an investigator to use their own students as participants because of the possibility of coercion. Exceptions may be allowed, but the investigator would have to substantiate the need to use their own students as participants and propose an acceptable plan in accordance with IRB requirements and policies. IRB Proposal Submission Form
July 2009
Click here to enter text. 12. Please describe how you will obtain participants' approval. If you are obtaining consent/permission/assent, please attach the form(s) as appendices. The IRB is federally mandated to ensure that the consent process is free of coercion or undue influence. For research involving permission and assent, a complete description of the process must be included. The consent/permission form should be written at the level of an 8th grader. Please see the consent form template and sample consent form provided at the back of the guidebook. Click here to enter text. 13. If you believe the IRB should waive the requirement of a signed consent form and you are not going to collect the form, please justify your decision here. If you are not going to distribute consent forms at all, please justify your decision here: Click here to enter text. 14. Please describe any foreseeable risks that your research project could pose and assess their likelihood and seriousness. Note: Risk is a very broad concept for which Principal Investigators should seek counsel from the IRB, if there are any questions. The IRB will examine the project to ensure that a wide range of risk issues are addressed- from the risk of information and identity disclosure to feelings of discomfort generated by questions on a survey to physiological discomfort or danger. There are other risks, but the preceding is intended to underscore the breadth of the concept.
Click here to enter text. 15. If risks are involved, describe procedures for protecting against or minimizing any potential risks identified above and assessment of likely effectiveness and seriousness: Click here to enter text. 16. Describe any benefits that will accrue to participants themselves or to society: Click here to enter text. 17. Will you be recording or collecting any identifiable, private information about individual participants that would allow an individual to be identified (for instance unusual ethnicity, birthdate, etc.)? Choose an item 17.1 Will you be collecting audiotapes, videotapes, or still photography in your research? Choose an item. IRB Proposal Submission Form
July 2009
17.2 If you answered yes to either question, describe a.)which media will be used and b.) how you will protect the privacy of your participants and maintain confidentiality, including provisions for secure storage of data after the completion of your research. (On the consent/permission form, you will need to inform participants or guardians of your intent to record, and you will need to describe what will happen to these records). Click here to enter text.
17.3 If you answered yes, please read and sign below: I understand that I am obligated to protect and keep confidential any identifiable, private information gathered about individual participants through the conduct of my research. I agree to keep such information confidential, unless I obtain the participant’s express written permission to do otherwise or unless I am legally compelled to provide the information. Signed: ___________________________________ Date:________________________ 17.4 If you answered no, you will need to ensure that you protect the privacy of your participants and maintain confidentiality, including provisions for secure storage of data. Please describe how you will accomplish this: Click here to enter text. 17.5. Does this proposal involve any of the following populations: Choose an item. 18. Is this project being reviewed by any other review board? If yes, provide name and location of other institution. Choose an item. 19. Are you going to collaborate with any Emmanuel department or external agency or organization. If yes, please attach a letter of approval from the Emmanuel department or external agency. Choose an item.
IRB Proposal Submission Form
July 2009
After the IRB has approved a project, two hard copies of all forms related to the project with the investigators’ signatures must be brought to Ms. Diane Bissaro in the Dean’s Office (ADM 209). Both copies must be stamped by Ms. Bissaro. One will be filed in the IRB office and the investigators must retain the second. Note: All correspondence must be deposited in the IRB Administrative Assistant’s files. A study cannot begin until this correspondence has been filed. Investigators with questions concerning the development, submission, or status of their proposal should
IRB Proposal Submission Form
July 2009
Assurances: If a Consent Form is used, it is understood that it must be kept on file for three years. Participants must be given a copy of the consent Form. The IRB may request copies of signed Consent Forms for all participants participating in this research. It is understood that Emmanuel College students should be initially recruited as participants by public announcement and not by personal solicitation. If any project exceeds a period of one year in duration, it must be reviewed and receive IRB approval before the beginning of the second and any successive years of the project. It is understood that Investigators must comply with the federally mandated educational training requirement. This is done by taking the online “Course in the Protection of Human Research Participants,” which is found at https://citiprogram.org. There are CITI modules for Biomedical researchers, Social/Behavior/Educational researchers, and a module for student researchers and their research advisor. It is understood that any required financial disclosure documents must be signed before the project is approved. In signing this statement, I certify that I have already completed the CITI training. I also certify to the accuracy of the information provided in this document and in any attachments or other supporting documents, and I reassert my intention to abide by the College’s policies and procedures governing research involving human participants. Signature: ___________________________________________________ Date: _________________ Signature: ___________________________________________________ Date: _________________ Signature: ___________________________________________________ Date: _________________ Signatures of all project investigators are required. ------------------------------------------------------------------------
(for IRB use only)
___ Proposal Submission Form ___ Consent/Permission/Assent Form ___ Research Instruments ___ Recruitment Materials ___ Authorizations Signature of IRB Chair: ________________________________________ Date: __________________ Joyce F. Benenson, Ph. D. IRB Proposal Submission Form
July 2009
e-mail: benensjo@emmanuel.edu Recorded at IRB Full Meeting on Date: ____________________________
IRB Proposal Submission Form
July 2009