Guidance & FAQs
Bucknell’s Institutional Review Board policies are an extension of 45 CFR §46 that institutions receiving federal funding are committed to uphold. Below you will find a number of Frequently Asked Questions about human subjects research and Institutional Review Board processes. Researchers — whether faculty, staff, or students — conducting research involving human subjects for the first time may wish to consult the materials below.
Frequently Asked Questions
Click the plus buttons to the right of each question below for an answer.
Research is defined by the Office for Human Research Protections as any systematic investigation designed to develop or contribute to generalizable knowledge. Certain scholarly and journalistic activities — including oral history, journalism, biography, literary criticism, legal research, and historical scholarship — are normally excluded from the requirement of IRB review, even though there’s a sense in which they involve human subjects. For some projects, it’s not always clear whether they fit this definition. In these cases, just get in touch with the IRB chair.
The OHRP definition excludes classroom exercises that have student learning as their primary purpose. It is thus the responsibility of the instructor to be sure that student projects meet Bucknell’s ethical and scientific standards; members of the IRB are available to consult with students and instructors on such standards and best practices (for more information, see §11 of the IRB Policies & Procedures manual).
According to federal regulations, ‘human subject’ means either a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction or merely identifiable private information or biospecimens itself.
This definition can be tricky to apply in certain cases — for example, when the focus of the study is an organization rather than an individual. Although individuals may be interviewed as part of the study, the data relate to the organization rather than the individual. Such studies would not be considered research with human subjects. Investigators unsure whether their study involves human subjects in a way that would require IRB review should consult with the IRB chair.
Various possible risks are associated with different types of research involving human participants:
- Physical Risks: Biomedical experiments are often accompanied by real risks to health and safety-adverse drug reactions, physical injury, complications of surgery, even death.
- Psychological Risks: Certain questions or experimental interventions can upset some people — e.g., asking about a traumatic experience — or cause other psychological reactions, such as stress, embarrassment, or depression.
- Legal Risks: The disclosure of information about illegal activities can place subjects at risk of prosecution, imprisonment, and so on.
- Financial/Economic Risks: The inadvertent disclosure of information about personal health problems, for example, can put subjects at risk of losing health insurance coverage. Other disclosures could cause a subject's dismissal from their job.
The above list is not meant to be exhaustive. The important point is that human subjects research can pose very real dangers, and it is the responsibility of the investigator to design protocols that minimize these risks and balance them with benefits to these participants.
This isn’t a question that can be answered in absolute terms. Instead, Institutional Review Boards consider the balance between foreseeable risks and anticipated benefits — both for society and, importantly, for the individuals assuming the risk. Greater risks may be justified by greater benefits. On the other hand, if a study is based on flawed science or unsound methodology, the research will not lead to any benefit, and no amount of risk can be accepted.
Everyday life is not without its risks. Research activities are considered to involve minimal risk if the risks to research participants are no greater than those they would encounter in everyday life.
When you submit your proposal, the online system will use your responses to automatically (and provisionally) classify it as requiring one of the three types of review: exempt, expedited, and full. For proposals requiring full board approval, you should expect a 2–3 week turnaround during the academic year (assuming that significant changes are not required). Proposals requiring full review cannot generally be reviewed during the summer, so researchers are advised to plan ahead for summer research projects and be in touch with the IRB chair about timing for late-spring proposal submissions. Exempt and expedited projects are reviewed on a rolling basis throughout the year and are returned in 1–2 weeks (often sooner).
Short answer: Yes. IRB proposals are placed into three different categories of review (full, expedited, and exempt) corresponding to different levels of review required (mentioned above). In fact, “exempt” means something closer to “exempt from continued IRB oversight,” not “exempt from any review.” Investigators are not permitted to determine for themselves that their projects fall into this status. Any project considered to be research that involves human subjects must be submitted for review.
Unfortunately, the IRB cannot provide retrospective approval, as this severely limits the IRB’s ability to protect the rights and interests of human subjects. Thus, if you believe that there is a possibility that your project will result in generalizable knowledge, it’s a good idea to seek IRB approval beforehand just in case you decide to disseminate your results (i.e., treat your project as research). Most journals will not allow human subjects research that has not been properly approved in advance by an IRB to be published.
If your project involves humans as the subjects of your research and aims to contribute to the production of generalizable knowledge outside of a classroom environment, then yes. Honors/senior theses, independent or faculty/staff-sponsored research projects, and similar projects involving human subjects all need to be approved by the IRB. Students can be considered as principal investigators (PIs) or co-principal investigators and will be asked to go through the same review process as faculty and staff (with the addition of a review by their faculty/staff sponsor). If you have any questions about whether your project needs review, just get in touch with the IRB chair.
The IRB can only approve complete and detailed research plans; this would need to include the text of questions for a survey as well as all of the other required components mentioned here. Some interviews are only “semi-structured”, meaning that while some questions may be scripted in advance, other questions will depend on prior answers and may not be explicitly scripted. In such cases, investigators should submit as complete an outline of their interview protocol as they can so that the IRB can effectively evaluate any risks to research participants.
IRB approval is not generally required for projects that have student learning as their primary objective. That is because such projects will not generally constitute “research” as defined by the Common Rule (see above). In certain circumstances, however, classroom projects involving human subjects may constitute human subjects research — e.g., if the research may be expected to lead to papers or public presentations.
If a project does not require IRB approval, it is the responsibility of the instructor to ensure that work involving human subjects meets Bucknell’s ethical and scientific standards, even those that may not normally come under federal review. Some instructors voluntarily submit a “general protocol” describing a set of classroom exercises involving human subjects for IRB review and approval (for more information, see §11 of the IRB Policies & Procedures manual). Students and faculty are invited to consult with the IRB chair or other members of the IRB for advice on best practices for human subjects research.
Research participants can legally sign their own consent forms only if they are 18 years of age or older. The participation of minors in research requires the signature of a parent or guardian, as well as the “assent” (agreement to participate) of the minor. Investigators need to bear in mind that some Bucknell students, particularly in the first-year class, are under 18. When using Bucknell students as subjects, it is generally impractical to get timely parental consent, and participation in classroom exercises should normally be limited to students over the age of 18.
Classroom projects should generally restrict their subject pool to normal, healthy individuals who are free to make their own decisions. Individuals with cognitive impairments, prisoners, and a number of other special populations receive additional protections under federal law. Please see §8 of the IRB Policies & Procedures manual for further discussion.
No. Signed copies of a consent form are not necessary in the case of online surveys or similar interventions. Instead, investigators should present participants with an informed consent statement and ask participants to click a button to proceed. See the Sample Informed Consent Forms document above for example language.
Investigators may also request a waiver from the requirement of documenting participants’ consent at all in certain circumstances; see §6.1 of the IRB Policies & Procedures manual for details.
Not necessarily. Certain grant-funded cooperative research projects do require investigators to designate a single IRB (sIRB) as the overseeing body. For other projects, investigators may either submit their project for review by each institution’s IRB (making clear in their proposal that this is occurring) or ask for one institution’s IRB to serve as the reviewing/overseeing IRB for the entire project. This involves completing a short agreement that is signed by officials at each institution. For more information on inter-institutional collaborations, please visit the Inter-Institution Research Collaborations page.
Policies vary, but for projects that use as their subjects individuals in organizations other than Bucknell (e.g., corporations, non-profits, churches, K–12 schools, or other universities), researchers should first seek permission from a responsible authority at the organization.
If the other organization is a university or hospital that has its own IRB, it is the obligation of the investigator to comply with all IRB policies of Bucknell and the other organization. Depending upon how the other organization deals with such projects, this may mean submitting a proposal for review by the other IRB.
Mitigating risks to human subjects of the social–behavioral research common at Bucknell often means protecting their private information from being disclosed in such a way that it can be connected with their identity. The best way of doing this is by not even collecting subjects’ names or other identifying information in the first place. This is the protection offered by anonymity. As it represents the strongest form of protection of subjects’ privacy, the IRB recommends that research with human subjects be conducted anonymously whenever possible.
Of course, anonymity is not always possible or practical — for example, in research involving focus groups or face-to-face interviews, or when researchers need to recontact subjects at a later date. In such cases, steps should be taken to ensure that responses remain confidential (meaning that the identities of subjects are known but are kept secret to anyone outside of the research).
Even anonymous surveys can be compromised by poorly designed data collection procedures. For example, if subjects hand in completed, anonymous survey paper forms directly to a survey assistant, that person can associate the name and face of the person with the survey responses; the survey is no longer anonymous. Ballot boxes or electronic surveys can be readily implemented to ensure that the researcher has no way to associate the subjects with their responses.
Deception involves withholding information from subjects that might affect their decision to participate in the study. The IRB regards very seriously any use of deception, since withholding information violates the fundamental ethical principle of autonomy. If we have respect for subjects as autonomous individuals, we also respect their right to make a decision about their participation based on full information. Nonetheless, there are certain types of research that would be impossible without deception (e.g., research in social psychology), and deception is acceptable under federal regulations as long as appropriate protections are provided. See §6.2 of the IRB Policies & Procedures manual for more detail.
Bucknell subscribes to the Collaborative Institutional Training Initiative (CITI) that provides researchers with training on conducting human subjects research (and other subjects). Each researcher — whether faculty, student, or other research assistant — planning to work with human subjects (including existing data derived from human subjects) is required to complete the Basic Course for Social–Behavioral Research. Certification is good for two years and may be renewed via a “Refresher Course.” For more information about completing this training, please see the Training Requirements page for more information about how to register for the correct course and save your certificate once you complete the course.
Minor changes to an approved project — e.g., adding a researcher, changing survey items, or modifying subject pools or recruitment methodologies — are straightforward: simply email the IRB chair with a request that describes these changes. Please put your IRB tracking number in the subject field of the email. More major changes that might change risks posed to subjects may require an additional review to consider the revised protocol. For such changes, please use the “renewal” form in the IRB submission system to describe the changes and update your approval. If you are unsure in which category your proposed changes would fall into, just get in touch with the IRB chair.
Only projects requiring full board approval need to be renewed (and only while data collection is ongoing); to do so, just fill out the renewal form in the online submission system. You will be asked to submit information about your progress thus far (including the number of subjects involved and any new information about risks) as well as any proposed changes. Exempt and Expedited projects do not need to be renewed (unless there are substantive changes in your protocols).