Q. What is the IRB?
IRB is the acronym for the Institutional Review Board for the Protection of Human Subjects. The IRB reviews all research conducted by faculty, staff and students that involves human subjects. The purpose of the IRB is to ensure that research with human subjects is conducted ethically. The IRB ensures that the risks to participants are minimized, that selection of participants is equitable and that participants are informed about what participation in the study will entail.
Q. What is considered research by the IRB?
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Q. What is the difference between consent and assent?
Consent: Can only be given by a competent individual who is of legal age and has been given sufficient information about the purpose of the study, the benefits and risks of the study.
Assent: Agreement of a minor to participate in a research study. Assent MUST be accompanied by informed consent of the minor’s parent or legal guardian.
Q. What is the difference between compensation and benefits?
Compensation: Is a payment or reimbursement of the participant’s time or expense. This can even be class credit.
Benefits: Is something that can be related to or resulting from research efforts. Could be a benefit to the subject or to society.
Q. What is the difference between anonymous and confidential data?
Anonymous means that you are not collecting any identifying data from the subjects and that you will have no means to contact or follow-up with the subjects.
When data is confidential, identifiable data will be collected and the researcher can identify the subject. In this case the subject could be contacted for follow-up procedures.
COVID and IRB Applications:
Q. Where can I find information about research and current COVID restrictions?
Q. What modifications should I make to my application?
The researcher should first review the University of Maine COVID-19 Guidance for Researchers. You should modify any in-person research visit that does not have to be conducted on-site to a remote visit. These changes will require a modification submission.
Q. Are there COVID changes that do not require a modification?
The IRB has determined that these activities are not considered a ‘change to the research’ and therefore do not need to be submitted as modifications to research protocols:
- General communications with subjects about COVID-19. These are not study-specific communications, but rather are providing information that is publicly available, e.g., on the University of Maine website or CDC recommendations.
- Screening procedures for COVID-19 infection consistent with procedures on the University of Maine COVID-19 Guidance for Researchers. These are not study-specific procedures.
Q. What documents do I need to submit with my initial submission?
This will vary depending on your study but in general you will need to submit a cover page and an application that includes the narrative, measures you will administer, recruitment script(s), consent form(s) and assent script (for studies with participants under 18 years old).
Initial submissions should be as complete as possible but we understand that submissions aren’t perfect from the start (especially if it is your first submission). Prepare what you believe is needed, and the IRB Office will let you know of any changes or additional documents that are needed for your IRB review.
Q. My study is Quality Improvement; do I need to submit an application?
If your project involves human subjects or their data, the best practice is to check with the IRB to confirm if IRB oversight is required, even if you think your project is Quality Improvement or Quality Assurance. You may simply provide a brief explanation of your study along with some sample measures to firstname.lastname@example.org and the IRB will let you know if an application is required.
Q. Which consent template should I use?
We have several consent form templates on the IRB website to choose from. Select the template you believe is appropriate, and the IRB Office will let you know if something different is needed once they start their review.
Q. Does my project need IRB review?
The project must be research and involve human subjects to need IRB review. Please do not attempt to determine for yourself that your project is not research involving human subjects. You should have the IRB make this determination.
The Common Rule defines “research” as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic is an activity that follows a written plan and adheres to scientifically accepted principles for research design to answer a question. Examples of some activities are surveys, interviews, review of medical charts.
Generalizable knowledge is defined as knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. The results are expected to be generalized to a larger population beyond the site of data collection; the results are intended to be replicated in other settings.
The Common Rule defines a human subject as a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or 45 CFR 46.102(e) (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Q. When should I submit my application?
If your study is exempt or can be expedited you should submit your application at least 30 days before you intend to start your research. This allows the IRB time to review it and it will you give time to make any changes requested by the IRB in a timely manner and still meet you start date. For Full Board review, your proposal should be submitted by the submission deadline listed on the IRB website.
Q. What should be my consideration if I am using Zoom for my study?
You should create a private meeting with a unique meeting ID and password. To protect the privacy of the participants, consider using only audio and not video recording. See Zoom guidance for IRB studies.
Q. What information should be included in the recruitment materials?
The recruitment scripts must have sufficient information so potential participants can make an informed decision about participation. The following items must be included:
- The name and contact information of the Principal Investigator.
- The purpose of the research.
- The time commitment required of subjects.
- The location of the research.
- A clear statement that it is a research project.
- A clear statement that it is voluntary.
Q. My research will be done in another country. Do I need IRB approval from the University of Maine?
Yes, you must get approval from the IRB at the University of Maine. You should also be aware that you many need approval from an IRB or ethics committee from the country where you will be conducting the study, so please plan accordingly.
Q. Do I need approval from the IRB even if my study if not funded?
Yes, you must obtain IRB approval from the University of Maine regardless of funding.
Q. May I begin recruitment of subjects while IRB approval is pending?
No, you need IRB approval BEFORE recruitment or study enrollment begins.
Q. Do I need to submit an IRB application if I am not collecting any identifying information in my research project?
Yes, if you are actively collecting data. All research studies that involve intervention or interaction with human subjects, regardless of whether or not identifying information is collected, must be reviewed by the IRB.
Q. Can the IRB approve a research study retroactively?
No, there is not provision in the Federal regulations that allows the IRB to approve a study that has already been conducted. This is why it is so important to check with the IRB if approval is needed before you start a research study.
Q. What if I am not sure if my activity needs IRB review?
Email a brief summary of the activity to email@example.com and the IRB will respond with a determination.
Q. If I submit a grant proposal do I have to submit an IRB application at the same time?
You can submit the IRB application at the same time as the proposal. Depending on the sponsor you may also submit the IRB application at the time of award. We strongly encourage you to check with the sponsor on their requirements.
Principal Investigator and Study Team Management:
Q. I am leaving the University; what happens to my IRB study?
The PI should close out the applications or notify the Office of Research Compliance in writing that the study will be transferred to another qualified PI at the University of Maine.
Changes in the PI should be submitted to the IRB prior to the new PI assuming oversight of the study. The change must be submitted at least 14 business days prior to the departure of the former PI. If the former PI is leaving the institution but will remain a study team member, please contact the IRB office. See “How do I submit a change in PI?” below.
If the study is funded the PI should also notify the Office of Research Administration.
Q. How do I submit a change in PI?
The change in PI should be submitted as a modification. The request will be reviewed at a Full Board meeting unless the original study was expedited and continues to meet criteria for review under expedited procedures.
The research team should consider whether study documents are affected by the change in PI, such as the consent forms and recruitment materials. If participants are still enrolled in the research study, the IRB recommends that the research team provides a written update to the participants, such as an information sheet or letter, to inform them of the change in PI and to update them regarding changes in relevant contact information (e.g., for study-related questions).
Q. What is the faculty sponsor’s role for student projects?
The main expectation is that the sponsor assists students during the IRB process. The sponsor must review the application before submission to ensure that the application is thorough and accurate. The faculty sponsor must also monitor the students during the study to ensure that the student is following the procedures described in the application and that if any unexpected or adverse events occur they are promptly reported to the IRB. If the Faculty Sponsor is leaving the institution and the study is still active another qualified Faculty Sponsor must be appointed; see “How do I submit a change in PI?” above.
Q. How do I add study personnel to my approved IRB study?
If you simply need to update personnel on an approved study, you do not need to edit the approved application. An email to firstname.lastname@example.org referencing the study title and number along with name of person(s) to be added, years of human subjects research experience, role on the project, and email is sufficient. If the CITI training was not completed through UMaine please also provide the CITI training certificate.
Some personnel changes may also require a change to other sections of the application such as the consent document, and recruitment materials. In such cases, the application should be modified to include these changes and submitted as a modification for review.
Q. Who should be listed as study staff on the application?
All study staff members who are reasonably engaged in the design, conduct or analysis of the study should be listed in the application. If the staff or students will have direct contact with subjects or access to subject identifiable data, they must be listed in the application. The person must also have completed all the required IRB training.
Q. Do all personnel have to be listed on the consent form?
No. The PI must be listed on the consent form. Beyond that, we suggest no more than 3 people the research participant is most likely to encounter during the conduct of the study.
Co-Investigators are not required to be listed on the consent form.
Ongoing Study Management:
Q. How do I submit a continuing review?
You will need to submit the continuing review form that was emailed to you along with the status report and consent forms to email@example.com. If you are also requesting a modification, you will also need to submit the edited application and follow the modification instructions on the IRB website. Do not wait until the Study Expiration date to submit your continuing review, as the study will very likely enter lapse state.
Q. I did not submit my continuing my review and my study has lapsed, what does this mean?
The IRB Office sent you reminders for a continuing review and you did not respond to the IRB. Please submit the continuing review documents or study closure immediately.
Research activities must stop while the study is lapsed. This includes recruitment, consent, interactions with participants, and collection of data. Advertisements currently running in the media must be pulled. Data collected during a lapse in IRB approval cannot be used. Continuation of research activities without IRB approval is a violation of federal regulations.
Q. When should I close my IRB application?
When all research activities are complete. We recommend you keep your study open until journal manuscripts have been submitted and accepted, just in case further data analysis is needed.
Q. Do I need to report to the IRB when a study is completed?
Yes, the regulations require “prompt reporting to the IRB of changes in research activity.” Completion of a study is a change in activity and should be reported to the IRB.
Q. Can I reactivate a previously closed study?
Yes. See Reactivating a Closed Study for guidance.
Working with Outside IRBs:
Q. Will the University of Maine rely on a foreign IRB?
We will not rely on an IRB that is outside of the United States.
Q. What is the difference between Single, Reviewing and Relying IRB?
Single IRB: One IRB of record (also called Reviewing IRB), selected on a study-by-study basis, that provides the regulatory and ethical review for all sites participating in a multisite study.
Reviewing IRB: The IRB providing regulatory oversight (IRB of Record) for any participating sites that have waived oversight to this IRB.
Relying IRB: The IRB of a participating site that has waived regulatory oversight to another IRB (the Reviewing IRB).
IRB Required Training:
Q. Federal regulations require that all researchers receive ethics training. How do I meet this requirement?
All staff, students and faculty who submit an application for IRB review must complete the online CITI training.
Q. What if not all personnel have completed CITI training but I really need to get started on my research?
That is okay. You can submit the application with just those people that have completed the training and get approved to start your research. Once additional personnel complete the training, you can submit an email to firstname.lastname@example.org requesting to add those individuals, following the instructions to request a modification to a previously approved study.
Q. I completed the CITI Responsible Conduct in Research (RCR) course. Does this meet the IRB training requirement?
No. All personnel must complete the Social/Behavioral or Biomedical IRB course. See instructions for selecting the correct IRB training.
If you have any further questions, contact the IRB office.