IRB Proposal Process

Step 1: Determine if you need to submit an IRB proposal

Check if you need to submit an IRB proposal by determining:

• Is your project considered research?
• Does your research involve human subjects?

TCCD follows the guidelines from the Office for Human Research Protection (OHRP) (opens in a new window) to define research and human subjects:

• Research: the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
• A human subject is a living person. A researcher typically obtains the following information regarding human subjects: (a) data through an intervention or interaction with the participant and/or (b) identifiable participant information

Step 2: Acquire a final approval from your institution’s IRB

Approval from your institution’s IRB is required before submitting your proposal to TCCD IRB. You will be required to  attach/upload the following documents in the proposal submission form:

• A signed approval letter of your finalized research study from your institution’s IRB.
• A copy of your finalized proposal that includes introduction, problem statement, purpose, hypothesis, methodology, research questions, scope, framework, assumptions and limitations, key term definitions, and a summary.

Note:

• In making the decision to conduct an IRB review of submitted proposals, the IRB prioritizes proposals that promote TCCD’s mission and have the potential to contribute valuable knowledge supporting the long-term success of its faculty, staff, and students.
• If your school changes your research subject, method, or focus after we approve your research proposal, you will have to submit a new proposal for approval.

Step 3: Obtain site permission before research begins

Provide a signed written approval letter demonstrating site permission from all locations that are proposed in your study. You will be required to attach/upload your approval letter in the proposal submission form.

The TCCD Institutional Review Board does not give permission to conduct research on our campuses. You will need to contact the appropriate location, campus, department, or program for permission to conduct your research.

Note:

• Site permission is required before submitting IRB approval.
• A request for site permission may or may not be granted.
• Participation in any research is strictly voluntary, and individuals may or may not wish to participate.

Internal researchers (TCCD employees) must also obtain site permission before conducting research at TCC. Fair use prohibits internal researchers from using internal documents. Per TCCD’s Acceptable Use Guidelines, all resources are college property and must be used only for business purposes supporting the college and its students.

If you want a sample letter, review the Location Site Permission Request and Approval Letter Templates (PDF)Listen 

Step 4: Complete Human Subjects Testing Training

In accordance with federal regulations, all individuals submitting a human subjects research project through the TCCD IRB must complete human subjects protection training before submitting for approval.

This requirement applies to all investigators, key personnel, coordinators, and faculty sponsors involved in protocol development, informed consent, data collection or analysis, and participant interaction.

You will be required to attach/upload completion certificates(s) or a screenshot(s) of the course completion page in the proposal submission form.

TCCD IRB accepts the following Human Research Subject (HRS) trainings:

Human Research Protection Training

OHRP offers a variety of free online trainings for the research community on human research protections based on the principles of the Belmont Report and the requirements of the revised Common Rule (or 2018 Requirements).

Report and the requirements of the revised Common Rule (or 2018 Requirements).

• Training is free of charge.
• Complete - Human Research Protection Foundational 5-lesson training course (opens in a new window)
• Training certificates are valid for 3 years and may be renewed by taking the training again.

Human Subjects Research (HSR)

The Collaborative Institutional Training Initiative (CITI) Program (opens in a new window) offers training in a variety of areas including research design and ethics, compliance, safety, and professional development.

• There is a fee for CITI training courses.
• Complete Social-Behavioral-Educational (SBE) Comprehensive course (opens in a new window).
• Training certificates are valid for 3 years and may be renewed by taking the training again.

Certified Principal Investigator Course

The Association of Clinical Research Professionals (ACRP) (opens in a new window) offers a Certified Principal Investigator course.

• There is a fee for ACRP training courses.
• Complete - Ethics and Human Subject Protection: A Comprehensive Introduction (opens in a new window)
• Training certificates are valid for 2 years and may be renewed by taking the training again.

Step 5: Review the Research Proposal Guidelines and Forms

Review the guidelines and submission form carefully to ensure you follow the guidelines for your proposal application and submission:

• Research Study Proposal Guidelines & Forms (PDF)Listen

Step 6: Complete Research Proposal Submission Form and required documents

Complete the IRB Research Proposal Submission Form, located on the last page of the Research Proposal Guidelines & Forms (PDF)Listen.

• You may save your progress and return to this form later to continue where you left off.
• Please ensure all required fields and supporting documentation are completed and uploaded prior to final submission. Incomplete submissions or missing documentation may delay Institutional Review Board review and processing.

Note: Submission of this form affirms that you have thoroughly reviewed the Research Study Proposal Guidelines & Forms, and that you agree to comply with all applicable institutional policies and procedures.

Step 7: Wait for IRB Review and Determination

Once the IRB receives all of the required documents, the board will begin the review. The IRB makes every effort to review proposals within four weeks of their receipt.

Proposals submitted during the summer or during TCCD holidays may be delayed.

Actions of the IRB

The IRB will notify you via email (irb@tccd.edu) the decision regarding your proposal.

The IRB may take one of the following four actions regarding the proposed protocol:

• Approved
• Approved Subject to Restrictions
• Deferred
• Disapproved

Since a proposal may not be approved as submitted, you should allow sufficient time for the committee to re-review your proposal.

Step 8: Begin your Research

Once TCCD IRB approves your proposal, you can begin your research, maintain related research records, request research modifications if required, and report any adverse events.

The following forms must be completed and submitted to the IRB if any change happens during your research:

• The Study Modifications/revisions Form is required whenever any changes are made to an approved project.
  • Note: All changes must be submitted and approved by the IRB prior to their implementation unless the change is necessary to protect the safety of participants.
• The Adverse Event Report is required when any unintended, but not necessarily unexpected, result of a research intervention that is unpleasant or dangerous.
• The Continuing Review Form is required if you are still working on your research study after eleven months. This document will help you re-evaluate your project's risk, benefits, informed consent, and participant safeguards.
  • Note: You must obtain continued IRB approval prior to your one-year research anniversary. Federal regulations state that IRB approval is only valid for one year.

Step 9: Submit Research Study Closure Report

A research study is complete when human subject interaction is complete, and all data collection and analysis of private information outlined in the approved IRB research proposal is finished.

Research Study Closure Report

A Research Study Closure Report is required for all human research studies. This notifies the IRB that its oversight responsibilities are over.

TCCD IRB members will email you the Research Study Closure Report.

Closure reports should be submitted to the IRB within 30 days of study close-out by completing a closure report application.