Instructions for Completing the IRB-7 Protocol Application Form

March 2012

The Office of Research Compliance has revised the IRB-7research methods course protocol application form. The most significant change involves the removal of the form field text boxes. This has been a source of frustration for investigators because the form fields were difficult to edit and spell check. In response to investigator concerns, the form fields have been removed and replaced with tables where applicable. The protocol application is now a fully editable Word document and is capable of tracking changes. The form is no longer a protected document. See below for instructions pertaining to the new forms.

IMPORTANT - Please review the following as you prepare the protocol application:

  • So that the IRB can properly process your submission quickly and efficiently, please attach the IRB Face Page available at
  • The form now uses the underscore key “___” as a guide for where to provide certain requested information. In cases where the underscore key is used to indicate Yes/No, please erase the underscore and place an “X” next to Yes or No. In cases where the underscore key is used to indicate where to place requested information, please erase the underscore and type in the requested information.
  • Now that the form fields have been removed, please place your response below each item’s description.

Please note that the IRB WILL NOT return an application form because the text was not placed in the right spot; however, the removal of the form fields is going to make reviewing the application more challenging so we ask that these general guidelines be followed to the extent possible.

  • DO NOT submit a handwritten application.
  • Finally, please DO NOT remove or alter sections of the form that may not be applicable to your study (i.e. do not submit a protocol application with section II deleted if your study is not funded). 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 from the template in the final document.

Please contact the Office of Research Compliance at 6-8802/0986 with any questions, concerns or complaints.

IRB-7 Protocol Applicationfor the Involvement ofHuman

Participantsina Research Methods Course(RMC)

Institutional Review Board, Research Compliance Services

SECTION I : General Information

Course Name and Number: ______

Course Objective (2-3 sentence summary):

Course Instructor: ______

Is the Course Instructor a Teaching Assistant (TA)? ___ Yes___ No

If Yes, provide name of Faculty Contact: ______Phone: ______

Course Instructor Contact Information

IRB decision letters will be sent to the Instructor at the department address unless another address is specified here. You may designate a correspondent as the alternate contact however the Course Instructor remains responsible for the information provided on the form. The Course Instructor and TAs must have completed the CITI-Program Training. See the IRB website for instructions.

Course Instructor, Teaching Assistant, Correspondent Information:

Course Instructor / Teaching Assistant / Correspondent (primary point of contact for correspondence, if applicable)
Name (First, Last, Degree):
Department:
Mailing Address:
Preferred Phone #:
Preferred E-Mail Address:

Teaching Assistants (not named above):

Name: / Preferred Phone: / E-Mail Address:
1.
2.
3.
4.

Note: Add additional rows to the table as needed.

Study Location:
Place an “X” in the column. / Storrs (and/or the five regional campuses, School of Law, or School of Social Work)
Other (Please identify):

If the study is to take place in a controlled facility (school, nursing home, etc.) the student must submit an IRB-1 for Expedited or Full Board review.

SECTION II : Human Participants

How many participants will be enrolled for each student project?

If you are enrolling more than one population describe the total enrollment for each.

Participant Population(s):

Describe the participant population(s) including gender, ethnicity, and age range.

Recruitment:

Describe how participants will be identified and recruited. Attach copies of all advertisement/recruitment materials for IRB review. If recruiting at off-campus sites, written permission may be required.

Special Population(s):

Identify any special participant population(s) that you will be specifically targeting for the study.

Check all that apply: (Place an “X” in the column next to the name of the special population.) / UConn Students / Members of the Armed Forces
UConn Employees / Other (Please identify):
Economically/Educationally Disadvantaged

UConn Students or Employees:

Are you recruiting students who are in a class you teach or for which you have responsibility? ___ Yes ___ No

Are you recruiting employees who report to you? ___ Yes ___ No

If ‘Yes,” explain why this population is necessary to the study:______

SECTION III:Course Description/Plan for Human Subjects Research Methods Instruction

Introduction

Providecourse description and the number of students in the course.Include examples of past student projects.

Design, Procedures, Materials and Methods

In the section provided after #3, below, include a description of the range of acceptable project topics.Please identify the categories under which the projects will be approved. See Also include the following:

  1. Describe how students will collect data and report results.
  2. 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
  3. 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 major 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.

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.

SECTION IV: 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 will it will be obtained.

Documentation of Consent

Provide a copy of the information sheet or consent form template that will be used for this study. The RMC templates are available at

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.

Course Instructor Certification

I hereby certify that:

1. I have completed the required CITI Program training in human participant research, and will train my students in the basics of human participant protection as it relates to the projects in the course.

2. I will review the student research in this course and to the best of my ability and knowledge, apply the standards for the protection of human participants set by the University of Connecticut and approved by the IRB for this protocol.

Original Signature of Course Instructor / Date

IRB-7 RMC Protocol Application, Version 6/20141