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 (OHPR) 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 need to provide:

• 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.

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.

Step 4: Complete Human Subjects Testing Training

You are required to complete educational training on the protection of human research subjects prior to any IRB submissions for approval.

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.
• 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 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.
• 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) offers a Certified Principal Investigator course.

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

Provide the certificate of completion or a screenshot of the course completion page along with your proposal and other required forms and documents to irb@tccd.edu.

Step 5: Read and Follow the Research Proposal Guidelines

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

• Research Proposal GuidelinesListen

Step 6: Complete Research Proposal Submission Form and required documents

• Complete the TCCD IRB Research Proposal Submission Form, located on the last page of the Research Proposal Guidelines document.
  

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

• Include the below documents with your submission form:
  1. Approved finalized copy of your research proposal (typically Chapters 1, 2, and 3 of your dissertation) with an introduction, statement of the problem, the purpose/significance of the study, hypothesis, methodology, research questions, scope, conceptual/theoretical framework, assumptions-delimitations-limitations, definition of terms used and summary.
  2. Signed finalized IRB research study approval document from your degree granting institution.
  3. Signed Site Location approval letter.
  4. Completion of HRS Training Certification/Documentation. (of all investigators in the study).
  5. Informed Consent Document.
  6. Any Recruiting Materials (Flyers, emails, etc.).
  7. Data Instruments (survey(s), questionnaire(s), interview guides(s).
  8. Additional forms when applicable to the nature and scope of the proposed research. Email TCCD IRB at irb@tccd.edu if you think any of the following forms apply to you:
     • Continuing Review Form
     • Faculty Advisor Assurance Form
     • Adverse Event
     • Ethnographic Fieldwork
     • Off-Site Location
     • Other IRB Authorization Agreement
     • Research Study Modification Request
     • Vulnerable Populations – Children
     • Vulnerable Populations – Pregnant Women, Fetuses and Neonates
     • Vulnerable Populations – Prisoners

Step 7: Review Your Proposal

• Principal Investigator Proposal ChecklistListen
• TCCD IRB members utilize Review Checklists when evaluating submitted proposals. Email irb@tccd.edu if you would like access to the checklists. 

Step 8: Collect Documents

• Signed finalized IRB research study approval letter from your home institution
• A copy of your approved research proposal study
• Signed Location Site Approval Letter
• HRS Training Certification/Documentation
• Signed TCCD IRB Research Proposal Form
• Any additional forms as applicable to the nature and scope of the proposed research

Step 9: Submit the Proposal

Email irb@tccd.edu all the documents and completed forms collected from Step 8.

Ensure that your submission is complete, as incomplete proposals may delay the review process.

Step 10: 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 11: 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 12: 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.