Welcome to the Institutional Review Board (IRB) Procedures page for Transylvania University, your comprehensive resource for navigating the process of ethical research approval. Here, you'll find detailed information, templates, and links for applying for IRB approval. Also included on this page are effective strategies for recruiting participants and the proper protocols for reporting adverse events. Our goal is to support you in ensuring your research meets the highest ethical standards, protecting the rights and welfare of your participants while facilitating impactful and responsible research studies.*
Along your educational journey, supplemental material (external to this website) may be linked for additional clarification or consideration. This supplemental material is recommended and required if you plan to apply for an IRB. At the end of the module please choose one of two options, to Review Previous Modules or take the IRB Procedures Exam.
There is a table of contents to improve the navigability of this material.
If you have questions about the material provided please email irb@transy.edu.
Table of Content
Conducting research is a scholarly activity that is valued by Transylvania University. Faculty members have a responsibility to make students aware of ethical concerns in research. Those who engage in research or supervise research projects must ensure that their participants’ involvement in the project is voluntary and that the benefits for participation outweigh the risks. Researchers engaging in data collection such as surveys, interviews, or experimental work must protect their subjects, themselves, and Transylvania University by obtaining approval for research projects from the Institutional Review Board (IRB). In addition, certain classroom exercises or projects may need to be approved by the IRB.
The purpose of the IRB research review procedure is:
To protect the subjects involved in research against foreseeable injury
To protect the University, its faculty, staff, and students who conduct research from foreseeable liability
To meet Federal regulations regarding University research (Title 45: Public Welfare – Part 46 – Protection of Human Subjects)
Prior to the collection of data, all researchers (including faculty, staff, students, as well as outside research companies and other educational institutions and their representatives) must submit their research protocol to be reviewed and approved by the University Institutional Review Board in accordance with University Policy and Federal Regulations. Special rules apply to classroom demonstrations or exercises.
Participation in research at other institutions by Transylvania University faculty or students must be approved by that institution’s IRB. Documentation of the application for approval must be submitted to IRB using the system outlined below.
Click the PDF above to read the Transy IRB Guidelines and Procedures in its entirety. The information below will help you complete your application materials and provide important information you need in order to apply.
Click the image above to navigate to the Transy IRB application. You can also download a copy of the application here.
Once you submit an application there are three different levels of review that the IRB may perform: a Full Review, an Expedited Review, or an Exempt review. the level of review is based largely on the potential risk to participants.
An exempt IRB review is for research involving very minimal risk. These studies meet criteria for exempt review (click here to see the list of exemption criteria) and are exempt from ongoing IRB oversight but still require an initial review to confirm they qualify for exemption.
An expedited IRB review, on the other hand, is for research involving no more than minimal risk, but does not meet the criteria for an exempt review. This review is conducted by one or two IRB members rather than the full committee, making the process quicker.
A full board IRB review is required for research that poses more than minimal risk to participants, involves vulnerable populations, includes sensitive topics, or uses deception. It involves a thorough review by the entire IRB committee.
This video offers more detailed explanations of the criteria for each level of review. It also explains the Office for Human Research Protection's (OHRP) definition of research. This is important to know in deciding whether or not your study requires IRB approval.
This video walks you through the process of applying to the IRB.
Best practices would have us guide you to complete the application via the download above and prepare all of your ancillary materials (consent/assent form, advertising materials, etc.) before using the online application.
This is a student application for a qualitative research study.
This is a faculty application for a quantitative experiment.
Here are six key elements of a good informed consent form used for adults who participate in research. Remember though, that obtaining informed consent is a process. The form is an important element, but you want to communicate this information to your participants in a way that ensures they understand. Talk with them and answer their questions as you go over the form with them if possible. For information about consent forms and to see examples of well-written forms see this webpage.
When working with children or minors over the age of 7, federal guidelines dictate that a consent form be used for parents/guardians in conjunction with a child assent form. Obtaining a child's assent demonstrates respect for the child's autonomy and acknowledges their developing capacity to make informed decisions while also helping them understand the nature of the study and what you will be asking them to do.* For information about consent and assent forms see this webpage or click this link for a sample form.
Debriefing participants after that have provided you with their time is an essential part of the research process. A careful debriefing provides you with an opportunity to address any potential misunderstandings or distress caused by the study. Additionally, debriefing helps participants feel valued and respected, fostering a positive perception of research participation.
Data privacy and security are crucial in research to protect participants' personal information from unauthorized access and misuse. Ensuring data privacy and security builds trust between researchers and participants, complies with legal and ethical standards, and prevents potential harm that could arise from data breaches or misuse. By safeguarding data, we maintain the integrity of the research process and respect the rights and confidentiality of our participants.
In your IRB application, it is very important that you clearly outline the steps you will take to secure your participants' privacy.
Ethical considerations in recruitment and compensation are vital to ensure the integrity and credibility of research. Recruitment should be conducted transparently and respectfully, with clear communication about the study’s purpose, procedures, and criteria. Compensation should be fair, appropriate, and timely, without exerting undue influence on participants.
If you are conducting research at Transy using Transy facilities, resources, or students, but have IRB approval from another institution, the Transy IRB must have a record of your project. Use this form to REGISTER your study with the Transy IRB.
It is standard practice that renewals of research happen regularly. Expedited studies should be renewed or reviewed by the IRB every 3 years unless otherwise instructed. Fully Reviewed studies should be reviewed and renewed yearly. See above for the Transy IRB forms for renewal and amendment. Use the online application to submit your renewal of research or amendment to research.
Serious adverse events (SAEs) in research refer to any undesirable experiences associated with the conduct of a study that result in significant harm or poses a substantial risk to participants. These events must be promptly reported. Types of events that need to be reported include death, life-threatening situations, hospitalization (initial or prolonged), persistent or significant disability or incapacity, and any other condition that investigators deem to pose a significant threat to participant health and well-being. In the case of a participant experiencing any adverse event, it is the researcher's responsibility to stop the study immediately and contact the IRB before resuming. See the above document for how to report an SAE.
At the end of your research, it is imperative that you let the IRB know the study objectives have been met and that you will no longer be recruiting participants or collecting data. See the Transy IRB closure form above and then use the online application here to submit your closure form.
Note: References are hyperlinked to original sources. Written text that ends with an "*" was created in part using OpenAI. (2023). ChatGPT 4o [Large language model]. https://chat.openai.com/chat or Anthropic. (2023) Claude Opus [Large language model]. https://claude.ai/chats