Instructions for Completing the IRB-7
Research Methods Course Protocol Form
IMPORTANT - Please review the following items before you prepare the protocol application. It will facilitate review of the study:
· Review the Researcher’s Guide section of the OVPR website (http://research.uconn.edu/researcher-guide) for information and guidance concerning computer/internet based research, consent, deception, recruitment/advertising, etc.
· Read each item carefully and provide the information requested where it is requested.
· Place your response BELOW each item’s description.
· Finally, please DO NOT remove or alter sections of the form that may not be applicable to your study. The document must be provided to the IRB intact. If a section is not applicable to the research, please put “N/A” in that answer section.
· DELETE this instruction page in the final document.
Please contact the Research Compliance Services at 6-8802/0986 with any questions.
IRB-7 Research Methods Course Protocol
Protocol Version # and/or Date: [The protocol version must be revised each time a modification is submitted to the IRB to change the protocol.]
Course Name and Number:
Course Description/Plan for Human Subjects Research Methods Instruction
Introduction: [Provide course description and the number of students in the course. Include examples of past student projects.]
Procedures, Materials and Methods: Include a description of the range of acceptable project topics. Please identify the categories under which the projects will be approved. See http://research.uconn.edu/policies-procedures. Then address each of the following sections (A-C).]
A. Describe how students will collect data and report results.
B. Describe the training in human participant protection the students will receive from the course instructor. The IRB encourages the use of the CITI Program modules in the IRB Reference Group. See https://www.citiprogram.org/default.asp
C. Describe who will evaluate the projects for compliance with university policies for human subject protection. To facilitate the evaluator’s review of the student projects, the RMC Evaluator’s Checklist is available on the IRB website under Forms.
Inclusion/Exclusion Criteria: [List inclusion and exclusion criteria. Any proposed exclusion based on gender, age, or race must include justification for the exclusion.]
Risks and Inconveniences: [Describe the potential risks and steps taken to minimize risks. Also describe any anticipated inconveniences the participants may experience (time, etc.).]
Benefits: [If there are any anticipated benefits to the individual participants, please list them.]
Economic Considerations: [In most cases there will be no cost to or compensation for participants. If you wish to allow the students to offer a small token of appreciation, contact the ORC staff to discuss appropriate options.]
Privacy/Confidentiality: [Describe procedures for protecting confidentiality of data collected and stored. Describe who will have access to the data, where the data will be kept and for how long.]
Informed Consent
As Course Instructor, you are responsible for taking reasonable steps to assure that the participants the students enroll in their studies are fully informed about and understand the study.
Consent Setting: [Describe the consent process including who will obtain consent, where and when it will be obtained.]
Documentation of Consent: [Indicate use of an information sheet and/or consent form. Provide a copy of the information sheet or consent form template that will be used for this study. The RMC templates are available at http://research.uconn.edu/irb-templates.]
Waiver or Alteration of Consent: The IRB may waive or alter the elements of consent in some minimal risks studies. In most cases the students will be collecting anonymous data using an Information Sheet not a signed Consent Form, please answer the following questions requesting a waiver of signed consent:
Waiver of signed consent (i.e. participants give oral consent only after reading an information sheet):
· Why is the study considered to be minimal risk?
· Does a breach of confidentiality constitute the principal risk to participants?
· Would the signed consent form be the only record linking the participant to the research?
· Does the research include any activities that would require signed consent in a non-research setting?
NOTE: At Reapproval of this RMC protocol, the IRB will require the following information:
1. A description of the studies conducted by students during the approval period including the number of participants enrolled in each study. For example, “ A pen and paper survey of 30 undergraduates about their perception of privacy in the dorms. ”
2. Five (5) Copies of a sampling of Information Sheets/Consent Forms that were used for the studies.
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