Human Subjects Frequently Asked Questions (FAQs)

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.

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Consent: 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 and the benefits and risks of the study.

Assent: Assent is the 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.

Compensation: A payment or reimbursement of the participant’s time or expense. This can even be class credit.

Benefits: Something that can be related to or resulting from research efforts. This could be a benefit to the subject or to society.

Anonymous: 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.

Confidential: 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.

See Anonymous vs. Confidential for more information on the differences between these two terms.

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.

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 umric@maine.edu and the IRB will let you know if an application is required.

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.

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 45 CFR 46.102(e) defines a human subject as a living individual about whom an investigator conducting research obtains:

information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or
uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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 your start date. For Full Board review, your proposal should be submitted by the submission deadline listed on the IRB website.

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.

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

See Forms, Instructions, and Samples for sample recruitment materials.

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.

Yes, you must obtain IRB approval from the University of Maine regardless of funding.

No, you need IRB approval before recruitment or study enrollment begins.

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.

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.

Email a brief summary of the activity to umric@maine.edu and the IRB will respond with a determination.

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.

The PI should close out the applications or notify the Office of Research Compliance at 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.

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).

The main expectation is that the faculty sponsor assists students during the IRB process. The faculty sponsor must review the application before submission to ensure that the application is thorough and accurate. The faculty sponsor must also monitor the student 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.

If you simply need to update personnel on an approved study, you do not need to edit the approved application. An email to umric@maine.edu referencing the study title and number along with name of person to be added, years of human subjects research experience, role on the project, and email address is sufficient. If the Collaborative Institutional Training Initiative (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.

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 study staff must also have completed all the required IRB training.

No. The PI must be listed on the consent form. Beyond that, we suggest listing no more than 3 people that 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.

You will need to submit the continuing review form that was emailed to you along with the status report and consent forms to umric@maine.edu. 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.

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.

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.

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.

Yes. See Reactivating a Closed Study for guidance.

We will not rely on an IRB that is outside of the United States.

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).

All staff, students and faculty who submit an application for IRB review must complete the online CITI training.

That is okay. You can submit the application with just those people that have already completed the training and get approved to start your research. Once additional personnel complete the training, you can submit an email to umric@maine.edu requesting to add those individuals, following the instructions to request a modification to a previously approved study.

No. All personnel must complete the Social/Behavioral or Biomedical IRB course. See instructions for selecting the correct IRB training.

Office of Research Compliance

Definitions

Initial Submissions

IRB Approvals

Principal Investigator (PI) and Study Team Management

Ongoing Study Management

Working with Outside IRBs

IRB Required Training

Questions?