The opportunity to conduct research with participants is exciting and we hope that this is the first of many experiences for you. As a student researcher, we feel that your first submissions to the IRB are an important learning experience that will help you navigate the IRB process in the future as well as help you learn about how to conduct human subjects research. Our staff and Board are willing to answer any questions you have and to provide guidance on how to construct and conduct your study.
As part of the review process, you will have a member of the IRB-SBS staff who will pre-review your protocol. Their job is to assess any problem areas in your study and help you to develop your protocol so that it is ready for the Board. This doesn’t mean they will write the protocol for you, but if you are confused about what you need to include in your protocol, your pre-reviewer will be able to help you. Feel free to contact our staff as you are writing your protocol as well. Frustrating situations can often be solved when proactive communication occurs. For example, check out our Student Support section with information about how to set up a consultation session with Laura Loeb, the IRB-SBS Student Support Specialist. Laura can help you to understand how to set up your study to avoid hurdles and other study pitfalls which can stall an IRB-SBS review. In addition to this section, check out the IRB-SBS 101 section and the Getting Started for more orientation information.
Writing a protocol is a different writing experience than writing a paper for a class, though similar principles apply. As with any document, you must know your audience and how the protocol will be used. In most cases, the Board will not meet with you and their only exposure to your study will be through your protocol. The protocol needs to provide them will all of the tools they need to answer some vital questions: Who is the researcher and what is his or her experience? Who are the participants? What will they do in the study? What risks will they encounter by participating in the study? The questions in the protocol are designed to encourage you to answer these questions for the Board, so when you are responding to the protocol questions, keep these bigger questions in mind.
Our Board members carefully review their protocols and consider all of the factors involved. However, if a protocol is poorly written, poorly organized, does not give enough information (such as missing details on how data will be collected), gives too much information (such as a very lengthy explanation into the theories behind the research), and/or is not written in lay language (such as using jargon or acronyms), it can be frustrating for the Board member to review and can encourage the reviewer to be more critical about the study. Your protocol needs to convince the Board that you are a capable researcher prepared to take on the responsibilities of using participants in a study.
Writing good consent documents or scripts is particularly important. The consent form templates should guide you regarding the type of information that needs to be included. Make sure the information included is concise, clear, and easy to understand; take particular care to check for grammatical errors and punctuation problems. Make sure to tailor the consent text to your study. Ask some of your classmates to read your consent document or script and ask if they had trouble understanding what the consent describes. For more tips on preparing your consent process, please read the Consent section.
All undergraduate and graduate researchers are required to have a faculty sponsor. Your faculty sponsor can be a great asset, so take the initiative to find one who will really be able to help you. For example, if you are studying reading techniques in an elementary school setting, find a faculty sponsor who has some experience in this field. If you are doing anthropology research, do not select a faculty member in the English department unless that person has adequate experience in the type of research you will conduct. The Board may require a change in sponsor if they feel your current advisor is not able to adequately supervise your project.
If you will conduct your study abroad, or in a situation where you will not be able to keep in contact with your faculty sponsor, you will also need an on-site supervisor. Undergraduate researchers are required to secure an on-site supervisor if you are conducting research outside of Charlottesville. For example, if you are working in a clinic in South Africa, the Board will want you to have someone in South Africa available to help you with any issues that may arise, as well as advise you regarding cultural and procedural issues surrounding your study.
Submitting an IRB protocol is not like submitting a paper at the end of the semester where you can wait until the last minute to do so. Reviewing a protocol involves collaborating with multiple people with busy schedules, thus it is not something we can do at the last minute. If your protocol qualifies for expedited review (it is considered minimal risk), then the review process can take place outside of a full board meeting, which doesn’t guarantee a quick response but is usually quicker than a full board meeting. Build in some time to schedule a one-one-one consultation with our Student Support Specialist, Laura Loeb. Check out our Student Support section for more information. If your protocol needs to be reviewed at a full board meeting, the Board meets only twice per month. It is possible that the Board could reject your protocol, which means it would need to be reviewed again at a full board meeting. If you know that you are leaving in May to do a summer study, do not submit your protocol at the end of April and expect the Board to respond quickly, especially if your protocol is complicated and involves using vulnerable participants. If you do not receive a final approval or exemption letter from the Board, then you cannot conduct your study and collect data. Thus, please be proactive and submit your study as soon as possible. The IRB-SBS staff and Board will do its best to work quickly and efficiently so we don’t hinder your chance to do research, but it is important that you also act responsibly and make your IRB protocol a high priority.
The Board considers student research to be training research. It is a chance for you, a new researcher, to learn how to conduct a study, which is a valuable reason to conduct a study but does not necessarily justify putting participants at risk. Hopefully you recognize that your student research is a learning experience that will build into a long career of productive research, and that as your experience grows, so will your opportunities to do riskier studies. Most student projects are not longitudinal studies but instead include a short amount of time where data is collected. As a new researcher, you should consider focusing your data collection to a methodology that will be realistic to conduct. For example, instead of trying to schedule in-depth interviews, observation, etc., consider developing an effective survey, which can be distributed and collected quickly while posing little risk to participants. A simpler protocol is easier for the Board to review and approve (or even exempt), and you are more likely to successfully collect data that will lead to a strong paper.
When the IRB reviews your protocol, we look at the risks in the study, or the potential for harming participants in the study. The Board will weigh the benefits of the study against the risks in the study and will determine if the risks are acceptable or if modifications need to be made in order for the study to go forward. There are some populations that the Board routinely identifies as “risky” because of the nature of their situations. For example, patients with a disease that may ostracize them from a community if that disease is known (i.e. AIDS or HIV positive status), persons who work in illegal trades, victims of crime or victimizers, undocumented immigrants, etc., these participants would be considered risk-sensitive participants if made the target of a study.
In addition, the federal regulations define a special category of participants who are more likely to be at risk because of their inability to consent to a study. These participants are called vulnerable participants and include children, prisoners, adults with diminished capacity to consent, etc. Some participants may be in a situation where they could be coerced or feel coerced into participating in a study; for example, a student may feel pressured to participate in a study conducted by his teacher in order to get a good grade in the class. When you construct your study, you need to consider the participants’ situations, ability to consent, and how participating in the study may affect their lives. You should construct a study that minimizes the risks to the participants; if you need suggestions, talk to your faculty sponsor and/or contact our staff.
For some risk-sensitive and vulnerable populations, the Board will be reluctant to allow you to collect identifiable data from these populations unless you have the training, experience, and support to conduct such a study. For new or inexperienced researchers, this doesn’t mean that you cannot address these topics in a study. For example, instead of talking to HIV patients directly, you can interview doctors and nurses about their experiences working with these patients. You can develop an anonymous survey to distribute to the patients that can be discreetly returned in the doctor’s office. In general, it is important for you to carefully consider the risks that your study may pose to the participants involved and to address these risks in the protocol. The Board will want to see that you have a plan in place to handle a situation should something arise.
On the flip-side, it isn’t necessary to overreact to this section as well. If you are doing an anonymous survey of healthy adults, most likely your risks are minimal and it is okay to declare that there are no risks in your study. Also, don’t overstate the risks in the consent form as you don’t want to alarm your participants unnecessarily.