Frequently Asked Questions (and Answers!) About Our Human Research Protection Program Starting September 1, 2020
- What activities require submission to the HRPP/IRB Office prior to beginning a proposed activity?
- What is the review process for classroom activities?
- What is the review process for Quality Improvement/Program Evaluations?
- What is the review process for Undergraduate honors theses, master’s theses, or doctoral theses?
- What is ‘Research’ according to the Federal Policy for the Protection of Human Subjects (“Common Rule”; 45 CFR 46)?
- What is a ‘human subject’ (human participant) according to the Federal Policy for the Protection of Human Subjects (“Common Rule”)?
- Who can be the Principal Investigator on submissions to the HRPP/IRB Office?
- Can a student be the Principal Investigator (PI) on submissions to the HRPP/IRB Office?
- What needs to be submitted to the HRPP/IRB Office for approval?
- How do I submit my application package to the HRPP/IRB Office?
- What happens after my application is received by the HRPP/IRB Office?
- What are the different levels of review my research may undergo?
- What are the possible outcomes of review?
- Do I need to complete any training before the IRB can approve my submission?
- What are my responsibilities after I receive IRB approval?
- Who can I contact for more information?
What activities require submission to the HRPP/IRB Office prior to beginning a proposed activity?
All Monmouth University faculty, administrators, and students who are planning to conduct any of the following activities, (regardless of location of the activity), must submit the activity to email@example.com using the MU IRB Application (current as of 9.2020):
- Classroom activities that will involve obtaining information from people (or about people)
- Quality Improvement/Program Evaluations that involve obtaining information from people (or about people)
- Undergraduate honors theses, masters thesis, or doctoral theses
- Activities that meet the specific definitions of “research” with “human participants”, according to the Federal Policy for the Protection of Human Subjects (“Common Rule”; 45 CFR 46), see below FAQ’s for definitions.
What is the review process for classroom activities?
- Complete the MU IRB Initial Application (Sections A, B, C, D).
- Ask your Class Instructor to sign Section O.
- Submit your CITI Training Completion Report with the Application to the IRB Office for review.
If the proposed activity meets all of the following criteria, the submitted project will simply be registered with the HRPP/IRB Office, and a confirmation letter will be sent to the course instructor:
- Involve minimal risk (i.e., the level of risk encountered in daily life) to the participants.
- Not involve vulnerable populations (e.g., children, adults who cannot consent form themselves, prisoners)
- Involve obtaining voluntary, prospective agreement from participants with whom the student interacts
- Not involve sensitive topics (e.g., illegal activities, child abuse, sexual assault, drug use etc.)
- Not involve associating the participants’ identities with their information in any way.
If all of the above criteria are not met, the submitted project will be reviewed by the HRPP/IRB Office, on behalf of the Institution, to confirm that the rights and welfare of participants are protected.
What is the review process for Quality Improvement/Program Evaluations?
POSTPONED. To be introduced into electronic submission system, Axiom
The submission will be reviewed by the HRPP/IRB Office, on behalf of the Institution, to confirmed that the proposed activity constitutes quality improvement/program evaluation. If it does, it will simply be registered with the HRPP/IRB Office. If not (e.g., if the activity actually constitutes research involving human subjects, the submitting individual will be notified regarding need to submit additional information for appropriate review by either the HRPP/IRB Office, or the IRB.
What is the review process for Undergraduate honors theses, master’s theses, or doctoral theses?
Monmouth University views these activities as necessarily meeting the definitions of ‘research’ involving ‘human subjects’, and they will be reviewed accordingly. The process is described below in the FAQ: “What are the different levels of review my research may undergo?”
What is ‘Research’ according to the Federal Policy for the Protection of Human Subjects (“Common Rule”; 45 CFR)?
Research is a systematic investigation (an activity that involves a prospective plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a question) including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (i.e., designed to obtain new information that would be applicable beyond the system (e.g., Monmouth) in which it will be conducted/implemented and beyond the target population who will participate in the activity.
- the activity must meet both bolded ‘parts’ of the definition in order to be considered ‘research’.
- There are activities that are specifically deemed not to be research. One example:
- 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.
What is a ‘human subject’ (human participant) according to the Federal Policy for the Protection of Human Subjects (“Common Rule”)?
A human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Who can be the Principal Investigator (PI’s) on submissions to the HRPP/IRB Office?
Only faculty and administrators can be PI’s on submissions. Adjuncts or visiting faculty may serve as a Co-Investigator (Co-I) only if the Department Chair and School Dean agree, and there is a full-time faculty member serving as a PI. Individuals who are not affiliated with MU may serve as a Co-I with a full-time faculty member or administrator serving as a PI.
Can a student be the Principal Investigator (PI) on submissions to the HRPP/IRB Office?
No. Undergraduate and graduate students can serve as Co-Investigators with a full-time faculty member as PI.
What needs to be submitted to the HRPP/IRB Office for approval?
The following should be submitted, as applicable:
- A completed MU IRB Initial Application (Current 9.2020) – instructions are contained within the form to complete relevant supplemental forms
- The study protocol;
- Any subject materials such as recruitment materials, information sheets, consents, scripts, and questionnaires, diaries, or surveys;
- Letter(s) of permission from any non-MU sites; or, when applicable, documentation of IRB approval or exemption from the external site;
- The grant application, when applicable;
- If researchers on the application are currently trained via the NIH human research training program, proof of current training (those trained on the CITI program do not have to submit proof)
How do I submit my application package to the HRPP/IRB Office?
Your completed HRPP Initial Application and supporting materials (as above, and as prompted within the application) should be emailed as a single pdf attachment to the IRB at IRB@monmouth.edu .
What happens after my application is received by the HRPP/IRB Office?
You will receive an email acknowledging your submission. A completeness check will then be conducted and you will be notified if any materials are missing. Once it is confirmed that your submission is complete, an assessment will be made regarding the type of review your research requires. See below.
What are the different levels of review my research may undergo?
If your research meets the definitions of ‘research’ and ‘human subject’ above, it will either qualify for exemption, expedited, or convened/full board review.
Exemption Review: If all proposed activities fall within 1 or more exemption categories defined in the Common Rule (see 45 CFR 46.104(d)), the review will be conducted by the IRB/IACUC Coordinator, or the IRB Chair or designee. There are restrictions when the activity involves children and prisoners, so contact the IRB Office (firstname.lastname@example.org) if these populations are proposed for use. Also note that Monmouth University has not adopted exemptions #7, #8 (“Broad Consent”). Exempt research is exempt from the requirements of the Common Rule, but not exempt from the ethical requirements (See The Belmont Report) and will be reviewed to ensure that appropriate protections are in place.
Expedited Review: If all proposed activities involve minimal risk, and fall within the federally-defined expedited review categories, the activity is subject to all requirements of the Common Rule, including IRB review. However, since the activity is ‘minimal risk’, the IRB review can be conducted by 1 IRB member (as opposed to the full committee). All federally-mandated approval criteria for nonexempt research must be met in order for the study to be approved.
Convened/Full Board Review: If the proposed activity does not qualify for exemption or expedited review, the study will be placed on the agenda for the next scheduled IRB meeting. Generally, the board meets on the second Tuesday of each month (with the exception of July and August). Studies determined to require full board review that are received by the first Tuesday of the month will be placed on the agenda. All federally-mandated approval criteria for nonexempt research must be met in order for the study to be approved.
What are the possible outcomes of review?
Approval. No further action is needed. You may begin your study.
Modifications Required for Approval/Conditional Approval: Conditions must be satisfied before the approval becomes effective.
Defer/Additional Information Required: This action is taken by the IRB when modifications are required of the nature or amount that the full IRB cannot make or specify exact changes or parameters, or additional information or clarification is needed. If this outcome is a result of a full/convened IRB review, your response will need to be reviewed by the convened IRB at a subsequent meeting.
Disapprove (Full Board only). This action is taken when the convened IRB determines that the proposed research activity does not satisfy the criteria for approval and that it cannot be modified to render it approvable.
Tabled (Full Board only). This action is taken when the convened IRB cannot review a study on the meeting agenda. For example, quorum for the meeting is lost, or the primary and/or secondary reviewer are not present, or a study document is missing and review cannot be conducted without it (e.g., consent form, protocol etc.).
Do I need to complete any training before the IRB can approve my submission?
Yes. All study team members must complete training in human research protections before the IRB can approve the submission.
Please follow the Steps to Register for CITI Program Training and complete required MU training content. Training is valid for a period of three years from the date of completion.
What are my responsibilities after I receive IRB approval?
You have several reporting responsibilities after you obtain IRB approval (besides requests for continued approval, where applicable)
- Since you must conduct your study as it was approved by the IRB, any changes you want to make to it must first receive approval from the IRB before you implement that change. This is accomplished by submitting a Modification Form (located in the Forms and Templates area). The only exception to this requirement is if you must deviate from the protocol to eliminate apparent immediate hazards to the subject. If this occurs, you must report this event to the IRB as soon as possible.
- If an incident, experience, or outcome occurs, or new information comes to light during the conduct of the research that meets all of these three criteria:
- Is unexpected (incident, experience or outcome is not expected (in terms of nature, severity, or frequency);
- Is related or possibly related to participation in the research (“reasonable possibility”);
- Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
…then the event constitutes an unanticipated problem involving risks to subjects or others (UP), and it is reportable to the IRB as soon as possible. These UPs can be very important signals regarding promised protections and safety of research subjects. Remember, it may not just be that a previously unknown event has happened; It could be that the event was expected, but it is occurring more severely, and/or at a higher rate, than previously expected. Also note that UPs do not just encompass physical issues; a stolen laptop that has study data on it may constitute a UP in that there is an unexpected risk of a breach of confidentiality.If you are unsure if an event constitutes a UP, please feel free to email email@example.com and we will set up a time to discuss the event.
- Finally, if you deviate in any way from the study as it was approved by the IRB (e.g., use of the wrong consent form, not conducting all screening procedures before enrollment, skipping or adding study procedures etc.), you need to submit the details to the IRB as soon as possible.
When you submit any of the reportable events above, the IRB will conduct a review to ensure that the rights and safety of subjects remain protected, and the integrity of the study remains intact. You will be notified of the outcome of the review, and any actions that need to be taken as a result.
Who can I contact for more information?
If you have any questions, please email firstname.lastname@example.org and we will respond as quickly as possible.