Week 8

Think Lightbulb.pngCITI Training & IRB Approval

In order to conduct research that involves that use of human subjects, you will need to receive approval for your research from the Institutional Review Board (IRB).  In this module, you will learn about IRB and how to apply for IRB approval.

Objectives:

After successful completion of this module, faculty will be able to:
  • Explain the purpose of IRB approval.
  • Describe the process for IRB submission.
  • Complete the necessary documents to apply for IRB approval.

Institutional Review Board (IRB)

Ethical considerations in research are critical.  Ethics are the norms or standards for conduct  thatboard2.jpg distinguish between right and wrong.  They help to determine the difference between acceptable and unacceptable behaviors.  Why are ethical considerations so important in research?  First, ethical standards prevent against the fabrication or falsifying of data and therefore, promote the pursuit of knowledge and truth which is the primary goal of research.  Ethical behavior is also critical for collaborative work because it encourages an environment of trust, accountability, and mutual respect among researchers.  This is especially important when considering issues related to data sharing, co-authorship, copyright guidelines, confidentiality, and many other issues.  Researchers must also adhere to ethical standards in order for the public to support and believe in the research.  The public wants to be assured that researchers followed the appropriate guidelines for issues such as human rights, animal welfare, compliance with the law, conflicts of interest, safety, health standards and so on.  The handling of these ethical issues greatly impact the integrity of the research project and can affect whether or not the project receives funding.

One of the most important ethical considerations in research is the use of human subjects.  To address these considerations, most institutions and organizations have developed an Institutional Review Board (IRB).  An IRB is a panel of people who help to ensure the safety of human subjects in research and who assist in making sure that human rights are not violated.  They review the research methodology in research proposals to assure that ethical practices are being utilized.  The use of an IRB also helps to protect the institution and the researchers against potential legal implications from any behavior that may be deemed unethical.

Examples of some of these issues include voluntary participation and informed consent.  These principles are followed to guarantee that all human subjects are choosing to participate of their own free will and that they have been fully informed regarding the procedures of the research project and any potential risks.  Ethical standards also protect the confidentiality and anonymity of the subjects.

Ethical Training to Conduct Research (CITI Training)

scale2.jpgGCU requires all researchers to successfully complete research ethics training prior to applying for IRB approval. Researchers who have not completed CITI training can access the information here: CITI (Collaborative Institutional Training Initiative). Registration instruction and other information to prepare for CITI training can be found here: CITI Training Registration Instructions. For researchers who have completed CITI training, have your completion reports for the Basic and RCR courses saved in PDF format as these reports must be submitted alongside the IRB application. Be sure to check the completion dates as CITI training is valid for five years. The training program involves web-based instruction in the ethics of research with human subjects.  CITI Training is free to GCU researchers and requires approximately 10-15 hours to complete. Researchers must submit completion reports for the Basic Research Course and the Responsible Conduct of Research Course as part of the IRB application in IRBNet. 

Registering with IRBNet

Before you can complete an IRB application, you need to register on IRBNet to create an account. You can register at IRBNet. Registration is an easy process. If you have any difficulty, you may watch the IRBNet registration video below for more information.

Obtaining IRB Approval

Following is a list of the steps required at GCU to submit for IRB approval:

>>>     IRB Checklist    <<<

All faculty researchers and doctoral learners are required to obtain approval from the GCU's Institutional Review Board (IRB)  in accordance with GCU's ethical standards as well as U.S. federal regulations. Researchers may not begin recruiting participants or implementing data collection activities until they receive official notification of IRB approval. The IRB Resource Center  will help ensure the IRB submission process goes as smoothly as possible. To begin the process or to review the necessary steps, please go to:  GCU Institutional Review Board.

Video tutorials are also available

Steps to Complete IRB for the Week 8 Assignment

  1. Register for CITI Training.
  2. Complete CITI Training and download certificates.
  3. Register at IRB.net
  4. Complete the IRB application (follow the IRB Checklist), uploading all necessary documents (e.g., copies of CITI certificates, site authorization letter, consent forms, data collection instruments and protocols, etc.). If you have not received site approval, complete as many of the IRB application steps as you can. Once you receive site approval, you can then submit the IRB application.

Think Gears.pngAssignment:

Create an IRB.net account and upload your CITI Completion Report. Complete as many of the relevant IRB documents as possible.  Provide a screenshot of the IRB account and copies of the relevant documents that you have submitted thus far.


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