Proposal for Approval of Research with Human Participants Application Form

Read and consider the following from the Policy Statement of the St. Lawrence University Institutional Review Board as you complete this form:

In reviewing each proposal for projects involving human participants, the IRB shall determine whether these participants will be placed at risk, and if so whether:
(a) The risks to the participant are so outweighed by the sum of the benefit to the participant or the importance of the knowledge to be gained as to warrant a decision to allow the participant to accept these risks;
(b) The rights and welfare of any such participants will be adequately protected; and
(c) Legally effective informed consent will be obtained by adequate and appropriate means (see below for information regarding the informed consent statement).
(d) The person(s) proposed to conduct the project are competent and qualified.

Please note the following important information when completing the application form:
• A completed application must contain the following: a completed application form, a copy of any informed consent statement(s), all materials to be presented to the participants, and any additional attachments.
• All researchers are invited to attend the IRB review of their proposal, but attendance is not necessary. If you wish to attend, please contact Dr. Karen Dillon O'Neil to inform her of your intentions to attend the meeting and to verify the time and location of the meeting.

If you have any questions or concerns regarding the submission of an application for approval from the IRB, please contact Dr. Karen Dillon O'Neil at (315) 229-5472 or via electronic mail at koneil@stlawu.edu.

Principal Investiagtor (must be faculty or staff): *

Title of Principal Investigator: *

Department of Principal Investigator: *

e-mail for Principal Investigator: *

Phone of Principal Investigator: *

Names and e-mail addresses of collaborators and/or student investigators:

Brief Descriptive Title of Study: *

75 characters maximum

All investigators on the project **must** read the following before agreeing below: I have read the New York State Public Health Law, Article 24-A as amended and all of the instructions regarding completion of this application, and I am submitting a complete description of the research and an Informed Consent Statement to the Institutional Review Board for Human Participant Research for its review. I understand that data collection is not to begin until approval has been granted. In addition, I agree: 1. To include in this application any moral/ethical objection to this study that I may see. 2. To report to the Institutional Review Board any moral/ethical problems that should arise regarding the use of human participants during the course of the study. 3. To report to the Institutional Review Board any change in the research plan that may affect the method of using human participants. 4. To notify the Institutional Review Board at the completion of the study, or to request a continuation of approval of this project if it is not complete by May of this academic year.

Electronic agreement: *

Entering your name(s) above signifies that you agree to the above conditions.

1) Purpose of the Proposed Study - Provide a clear and accurate statement of the goals of the proposed study and how the proposed methodology aids in fulfilling these goals.

Purpose: *

2) Description of Methodology - Provide a clear and complete description of the methodology and any apparatus to be used in this study. Make sure you include in this description the procedures for recruiting participants, obtaining their informed consent, and debriefing them (if applicable) after their participation. You do not need to include any procedures which are not relevant to the involvement of human participants.

Methodology: *

3) Materials - Include a copy of all materials to be presented to the participants, such as questionnaires or stimulus materials. If your study involves interviews, include a copy of the interview protocol to be used.

Materials: *

4) Discussion of Risk - Discuss all of the potential risks of physical and/or psychological harm to the participants from their involvement in this study and the measures you are taking to minimize these risks to the participants. Note that research involving human participants rarely involves no potential risks at all.

Risk: *

5) Informed Consent Statement - Attach a copy of the informed consent statement to be read by the participants which fulfills all of the elements of legally informed consent outlined in the St. Lawrence University Institutional Review Board Policy statement reproduced below. In addition, see the instructions for completing the application which outline specific statements usually necessary in an informed consent statement and provide a sample. A written legally effective informed consent statement must be provided for each participant. (Note: Individuals under 18 years of age cannot participant in research without the additional consent of their legally authorized representative; in addition, all research which involves individuals under 18 years of age must be approved by the New York State Department of Health IRB in addition to the St. Lawrence University IRB.) While the specific form of the statement will follow the particular circumstances of the project, all consent statements must adhere to the basic elements of legally effective informed consent as outlined. "Legally Effective Informed Consent" means the knowing consent of an individual or his/her legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The basic elements of information necessary to such consent include: (a) A fair explanation of the procedures to be followed and their purposes, including identification of any procedures which are experimental; (b) A description of any attendant discomforts and risks reasonably to be expected; (c) A description of any benefits reasonably to be expected; (d) A disclosure or any appropriate alternative or additional procedures that might be advantageous for the participant (Note: This element may be inapplicable to your study). (e) An offer to answer any inquiries concerning the procedures; and (f) An instruction that the person is free to withdraw his or her consent and to discontinue participation in the project or activity at any time without prejudice to the participant. (g) The written agreement entered into by the participant will include no exculpatory language through which the participant is made to waive, or to appear to waive, any of his or her legal rights or to release the institution or its agents from liability for negligence. The legally effective informed consent statement must be signed by the participant or his/her legally authorized representative. (Note: For research which involves only written questionnaires, completion and return of the questionnaire will be considered legally effective informed consent without a signed informed consent statement.)

Additional documents to upload:

If you were unable to use the above spaces to include all information necessary for review, please attach your needed files.

Additional documents:

Ethics Statement

Your application will not be considered without completing this step: *

Checking this box acknowledges you have read the New York State Public Health Law (Article 24-A) and Ethics Statement

Proposal for Approval of Research with Human Participants Application Form

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