Anyone who is conducting “human subjects research” must submit an application to the IRB; research cannot begin until the IRB has notified the researcher that the project has been approved. The following federal definitions may be helpful in determining whether an activity is considered human subjects research:
A human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (Protection of Human Subjects, 2018).
- Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (Protection of Human Subjects, 2018).
Basically, if a researcher is collecting data from people for a study that is intended to contribute to generalizable knowledge, which usually involves being presented or published, the project needs to be reviewed and approved (or granted exempt status) by the IRB. A series of decision charts to help researchers decide whether they are conducting human subjects research can be found on the OHRP website.
Because IRB approval is required before data collection can begin, the researcher is responsible for submitting an application early enough to begin data collection on the desired date. Depending on when the application is submitted, the type of review required, and the number and magnitude of the modifications required by the IRB for approval, the amount of time between submission and approval can range from two weeks or less to several months. There are three types of review conducted by the IRB, and the amount of time between submission and an IRB decision varies by review type. Full reviews are conducted once a month during IRB meetings, whereas expedited and exempt studies are reviewed on a rolling basis. Please note that response times are likely to be longer during school breaks.
Exemption is granted to studies that qualify as exempt from significant IRB review. Examples of research that qualifies for exemption include research conducted in established or commonly accepted educational settings, involving normal educational practices, data that are collected anonymously (i.e. no identifying information is collected), and research using publicly available data (e.g., record reviews). For a complete list of the criteria for exemption based on federal criteria, please see the Exemption Checklist. Reviews of exempt research are conducted on a rolling basis by the IRB chair and typically take no more than 2 weeks.
Expedited review is conducted for studies that involve no more than minimal risk but do not meet the criteria for exemption. Please see the Expedited Review Checklist for details about the types of studies that qualify for expedited review. Expedited review is conducted by 1-2 committee members on a rolling basis. Expedited review typically takes 2-4 weeks to complete.
Full review is required for studies that do not meet the criteria for expedited review or exemption. Research involving more than “minimal risk” to participants requires full review. Minimal riskmeans that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (Protection of Human Subjects, 2018; Institutional Review Boards, 2015). Full review applications must be submitted by the first of the month in order to be reviewed at that month’s meeting. For example, in order for an application to receive full review in November, it must be submitted no later than November 1. Studies submitted after this deadline will be reviewed at the next month’s meeting. Full IRB meetings typically occur on the third Wednesday of the month; you should expect to receive a decision from the IRB within one week of this meeting.
In general, it is recommended that researchers begin preparing an IRB application up to 6 months before anticipated data collection. This will allow time for a careful consideration of human subjects protection issues relevant to the study/preparation of study materials, attentive completion of the application, and review of the application by the IRB. Remember that you may not receive approval of the initial submission if the IRB believes that there are modifications to your study needed in order to ensure participant well-being, in which case you will need to build in enough time to address these modifications and submit them to the IRB for re-review. IRB approval is necessary before any part of the recruitment and data collection process can begin.
All personnel (faculty, staff, and students) involved with human subjects research, including principle investigators (PIs) and research assistants, are required to complete the CITI Program training in the ethical conduct of human subjects research (which is free to individuals completing the training through the College’s subscription to the program). In order to complete the training, register or log into the CITI Program website, add Wheaton College as your institutional affiliation, and select “Add a course” under “Learner Tools.”
You will be given a series of questions to answer about your role (e.g., investigator, student researcher) as well as the type of research training you need (e.g., applied health science research, social and behavioral research). Once you have access to the correct course(s), you should read through all the required modules and take the accompanying quizzes. Please be aware that this training can take several hours to complete and that a minimum average score on the quizzes is required in order to pass a course and receive CITI certification. You will need to provide the CITI certification numbers of all research personnel on your IRB application. Therefore, it is recommended that you begin the CITI training process well in advance of your anticipated IRB application date. In addition, CITI certification expires after five years, at which point the training needs to be repeated, as ethical guidelines change over time.
If you are conducting human subjects research, according to the definitions above, then yes! Students are required to have a faculty advisor, who helps with the design and conduct of ethical research, listed on the IRB application. Faculty advisors should be aware that they are ultimately responsible for ensuring that their students conduct research in a manner that promotes participant well-being and that they comply with IRB requirements. Therefore, faculty advisors should work with their students on the completion of the IRB application.
Any activities that do not constitute “human subjects research” according to the above definitions do not need to be reviewed by the IRB. According to federal guidelines, the following are examples of projects/activities that do not require IRB approval (Protection of Human Subjects, 2018):
- “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.”
In addition, research activities that are part of a course requirement and involve human participants may not require IRB review and approval. If all of the following criteria apply to a class project, then IRB review and approval are not necessary:
- The activity is designed for learning purposes only
- The results will not be made public through presentation outside of the classroom and will not be published in paper or electronic form
- The activity involves procedure with no more than minimal risk (see definition above)
- Informed consent procedures are in place and followed. Some survey or observational activities may require disclosure procedures instead of informed consent or no consent at all.
- Data will not be identifiable (e.g., by photographs, video, or any personal identifying information)
- Research involving animals is reviewed by the Wheaton College Institutional Animal Care and Use Committee (IACUC). Please contact Dr. Kristen Page for more information about IACUC.
The application and other forms can be found at the bottom of the main IRB page. All IRB submissions and decision notifications are done through IRBNet.org. If you have not used IRBNet before, you can register for a free account and select Wheaton College as your institutional affiliation. Once you have an account, click on “Create New Project” from the menu on the left side of the page. Follow the instructions to upload a completed application along with other supporting materials (see below). Once you are finished uploading documents, select “Sign this Package” from the menu on the left, and follow the steps. (If you are collaborating with other researchers at Wheaton, or you are a student, it is suggested that you share your submission with the appropriate parties. It is recommended that students grant their faculty advisors full access to make changes to the submission if needed.) Finally, you need to “Submit this Package” in order for the IRB to be notified that your project is ready to be reviewed. Be sure to select “Wheaton College Institutional Review Board,” select the correct submission type, and click “Submit.” Once your submission has been completed successfully, it will appear under “My Projects” with the words “Pending review” in green and a closed lock icon.
Researchers need to include copies of all relevant supporting research materials, including but not limited to informed consent forms, recruitment materials (flyers, scripts, letters, email templates, etc.), surveys, interview protocols, protocols for follow up procedures if an adverse event were to occur, and letters of support from cooperating organizations. More information about the purpose and necessary elements of informed consent can be found on the OHRP website.
If you are submitting an application for exemption or expedited review, be sure to include the appropriate completed Exemption Checklist or Expedited Review Checklist.
Please be aware that incomplete applications (including those missing supporting documents or information on the application form itself) will not be reviewed. Rather, they will be returned to the researcher for completion, which delays the review and approval process. In addition, please make sure that you download your forms directly from this page or IRBNet so that you have the most updated versions.
There are many reasons why applications do not initially receive IRB approval; when this occurs, researchers are asked to make modifications and/or provide information and then resubmit the modified application to the IRB. These requests revolve around the three main ethical principles (beneficence, justice, and respect for persons) that the IRB exists to promote. Some of the most common reasons applications are not approved include the following:
- The application is missing important details about how the study will be conducted (e.g., how participants will be recruited)
- Complete study materials (e.g., consent forms, interview questions) have not been provided
- The protection of participants’ personal information is either not sufficient or is not adequately explained
- There is a risk of emotional or psychological distress during or after participation, but no arrangements for follow-up or referral have been presented
- The informed consent form is not written at or below the 8th grade level
- The informed consent form is missing some of the necessary elements (e.g., sufficient information about the study, potential risks and benefits, IRB contact information)
- The researcher has requested exemption or expedited review, but a completed exemption or expedited review checklist has not been provided
All researchers are required by federal guidelines to obtain approval for research they are involved with from their institution’s IRB. However, in most cases, a study should be reviewed by a single IRB even if researchers from multiple institutions are involved. Applying to more than one IRB for separate approval creates unnecessary work and documentation requirements for the researchers and can result in research delays if the different IRBs request different or conflicting modifications.
Therefore, if researchers from multiple institutions are collaborating, it is recommended that the researchers select one institution’s IRB to be the IRB of record responsible for overseeing the project. Other IRB(s) are asked to agree cede their authority to the IRB of record for the review of this particular study. In order to submit this request, the researchers should complete an IRB Authorization Agreement (IAA) and submit this document to all IRBs involved, including the IRB of record and any IRBs being asked to cede their authority over the study. Exceptions to this policy include research conducted at VA sites, research involving tribal nations, and international research.
Once you have received IRB approval, you are free to begin research activities, including data collection. Full review studies expire one year after initial or renewed approval; if you wish to continue collecting data beyond this point, you need to complete and submit a Renewal Report before the expiration date of your study. (Exempt and expedited review studies do not expire or need to be renewed.) You will receive an email reminder from IRBNet when the study expiration is approaching. Once a study has expired, all research activities must stop immediately and cannot resume until a new application has been completed and approved.
If you would like to many any changes to the research protocol that has been approved by the IRB, you need to submit a modification/amendment to the original project. Changes may include but are not limited to the addition of research personnel, changes in participants, changes in the data collection procedures (e.g., changes to questionnaires or interviews), changes to consent forms or recruitment scripts, and changes to the research questions. Please make the appropriate changes to your application form and/or other research materials and submit these as an “amendment/modification” to the original project. It is helpful to the committee if the researcher provides a cover letter or document detailing the changes in addition to highlighting them in the documents themselves.
If any unexpected adverse events occur during the course of your study, the Adverse Event form should be completed and submitted to the IRB as soon as possible. An adverse event is defined as “any untoward or unfavorable [physical or psychological] medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research” (Unanticipated Problems Involving Risks & Adverse Events Guidance, 2007).
Once you have completed a study, you should submit a Final Report to the IRB.
To make any additional submissions to a project (including renewals, modifications or amendments, adverse event reporting, and final reports), do not create a new project in IRBNet. Rather, log into IRBNet.org, and click on the appropriate project. Then select “Designer” (on the left), “then “Attach New Document,” then “Create New Package,” then “Attach New Document” (again). Choose your document type, upload this form, and “Sign this Package” (on the left). Finally, select “Submit this Package” (on the left), select the IRB, select the correct submission type, and click submit.