So, you’re ready to start your research journey– congratulations! This will be an exciting journey that is bound to be a fulfilling learning experience, regardless of your career or academic goals. To become approved to pursue your research project, you’ll need to submit your research study to the Institutional Review Board (IRB). The IRB reviews research involving human participants to ensure that ethical standards are upheld. Then, your proposal will be reviewed by IRB staff members to ensure that your research proposal meets the definitions of human subjects research and that adequate measures are in place for the protection of both participants and researchers. Proposals may also be reviewed by designated reviewers or a full board, depending on the level of review (exempt, expedited, or full board). Certain proposals may be considered exempt or expedited if the involvement of human subjects falls into a given category and is approved by the IRB Chair and confirmed by the Principal Investigator. Studies that are not determined to be exempt or expedited are subject to full board review at an IRB meeting. Exempt review applies to low-risk research like anonymous surveys. Expedited review covers slightly more involved studies (like interviews or surveys with identifiers), while full board review is required for studies involving greater than minimal risk or vulnerable populations. Ask your mentor or IRB staff if you're unsure what level your project requires. The Teachers College IRB website has a surplus of detailed resources to guide and assist in your research endeavors, so this blogpost will focus on guidance for upcoming lab managers by summarizing those resources for you, providing advice on how to get started with your project, and how to acclimate to an existing project in your lab group.
Before beginning a project, many researchers start with a literature review where the author(s) organize and summarize relevant literature on a given topic. While you will likely not submit a literature review to the IRB, unless there are human subjects involved or privacy concerns, this is a helpful exercise, particularly for pre-doctoral researchers who are still learning how to read research literature and develop original projects. Overall, literature reviews help researchers justify the significance and ethical necessity of their project, especially when balancing risks and benefits to participants.
This literature is typically from peer-reviewed journals and includes review papers, empirical papers, and other articles that have undergone the peer review process. The peer review process is one of the best quality assurance measures the research community has to ensure that published works are robust, accurate, original, and credible. A literature review is a useful tool to not only understand the current state of a given research topic, but also to organize your thoughts on how to fill a relevant gap in that literature through your new project. Reviewing papers is a useful exercise for those new to a lab or research group as well. Check out the papers published by those in your group to better understand the methods your group tends to use, any field-specific writing conventions, and paradigms under which they tend to conduct their research. Students hoping to enter a doctoral program may also find conducting a literature review useful as they consider the questions they might want to explore during graduate school and prepare for any interviews. For more on literature reviews, check out TC’s Graduate Writing Center and their in-person and virtual resources.
After reviewing the current state of literature on your topic, you’re ready to think about study design! Study design is highly dependent on your topic, project, and the type of data you hope to collect (i.e., qualitative or quantitative). Talk to folks in your lab, review the past papers published by your group and other relevant authors, and think carefully about the question you hope to address. This question will be at the heart of your study design, so having a clear, straightforward question is essential. Often, you will need to be much more specific and detailed than you initially thought. For example, how would you test the influence of stress on academic performance? You could take so many approaches! A stronger question might ask: how do standardized test scores compare between NYC high school students who are given a stress-reduction treatment versus those who are not? With this question in mind, the study design becomes much clearer, and it is easier to understand what the data will look like. Clear study questions help the IRB to assess scientific merit and minimize unnecessary participant risk. To further explore the study design process, see this TC IRB blog on behavioral research design processes. As a pre-doctoral student, make sure that your project is realistic, given the 2-4 year timeline that most students in this stage have. In other words, you are not doing a dissertation quite yet! So, you may want to hold off on a longitudinal study or one that will require you to apply for extensive funding opportunities. Instead, consider joining an ongoing project in your lab group or designing a study using existing data or that builds off of a previous project.
After thoroughly understanding the methods that you will use in your project, your next step is to reflect upon any ethical considerations that are relevant to your work. Are you recruiting human subjects? Using animal subjects (if so, the IACUC, or the Institutional Animal Care and Use Committee at Columbia University, is where you’ll find relevant information)? Introducing a treatment or intervention? If your research uses human subjects, you’ll submit an IRB protocol. IRB guidelines refer to three main principles that you will need to keep in mind to best protect any subjects in your research:
- Beneficence: Will your research benefit others? Or do what is best for the subject?
- Autonomy: Can each subject make their own decisions and remain free from coercion?
- Justice: Is everyone treated equally and offered the resources they need?
These principles can be satisfied through a variety of practices, such as debriefing and informed consent, which are explored further here and in your required CITI training for human subjects research. The IRB evaluates how these practices are described in the consent documents and protocol. Thus, careful, thoughtful planning is crucial before you submit your proposal to the IRB. Ethical guidelines are also discussed in further detail on the TC IRB website, which can be found here under the tab labeled “The Belmont Report”. The TC IRB also provides a thorough list of information to know before you begin your proposal. The “Before you Begin” guide, linked here, describes all the information you will need to collect before submitting to the TC IRB. TC IRB also has a thorough list of common FAQs, ranging from IRB submission to review and approval– you can find the FAQs linked here.
Once you’ve carefully considered your research design and ethics, it is time to prepare your submission materials. The TC IRB submission portal requires the following documents, if relevant to your study:
- The IRB Application Template
- Data Security Plan -> this is often forgotten by early career researchers!
- Informed Consent Form
- Parental Permission Form
- Assent Form Template
- Study Instruments (e.g. surveys, interview questions, Study Instrument Materials Examples etc.)
- Recruitment Materials (e.g. IRB Recruitment Flyer Template, handouts, etc.)
- Data Sharing Form Template (if applicable; please note that this document will need to be reviewed by the Office of the General Counsel BEFORE IRB review can be completed)
- Data Release Form (if applicable)
- School Permission (if applicable)
- Site Permission (if applicable)
- HIPAA (if applicable)
- Guide for Working with Your own Students (if applicable)
Templates for each of these documents can be found on the TC IRB website. Be sure to translate your consent documents and recruitment materials into the language best suited to your study population, if needed. Additionally, as a pre-doctoral student, you will need to include your faculty mentor’s name and contact information in your IRB submission. Your documents should be reviewed by your faculty sponsor as well. The IRB will then use these documents to assess your study and any potential risks to human subjects. If revisions are needed, IRB will contact you before approving your protocol. While you may be eager to start your project, you must wait until you receive approval before you begin recruiting subjects!
With all of these aspects in mind, you are ready to submit your first IRB proposal! If you are a Teachers College student, visit this link to get started. If you need further assistance, the TC IRB website has many resources to assist you, as well as office hours. Have questions before you submit? Bring your draft documents to the IRB office hours or reach out to IRB staff for guidance. We’re here to support ethical research from the start! Consider reaching out to fellow students, lab managers, and research assistants, too! Information from your academic community can be immensely helpful as you begin this journey. Happy researching!
Additional resources:
https://pmc.ncbi.nlm.nih.gov/articles/PMC7923912/
https://about.citiprogram.org/
https://www.tc.columbia.edu/institutional-review-board/faqs/
https://www.tc.columbia.edu/institutional-review-board/training--certification/