The below information will assist investigators in the planning, development and submission of human participant use protocols for review and approval by the IRB.What is “research”? Human Participant Use Federal Assurance
Does my project require IRB review?
How to submit a Protocol for IRB review
Schedule of Meetings Types of Approval
Consent and Assent Guidelines
“Research” is defined in the Code of Federal Regulations as “a systematic investigation that contributes to generalizable knowledge”.
In other words, for the most part, an investigator will:
- be engaged in a research project that is
- designed to test a hypothesis or assess a theory by
- proposing or intending to explore a particular topic that is “about” a living person and interacting with that living person (collecting “identifiable private information” from that person) which then will
- develop or contribute to generalizable knowledge by drawing general conclusions (e.g., knowledge gained from a study may be applied to populations outside of the specific study population), or inform policy and then
- either publish (e.g., in a journal) or present at a professional conference beyond UMBC. Note that presentations do not include oral presentations to classmates and the course instructor in a research methods course.
When preparing proposal application materials for submission the National Institutes of Health (NIH), investigators should take the time to review the NIH’s guidance and human research use definitions to complete the forms required in grant application packages. Please contact your OSP representative or the ORPC if you have questions.
The University of Maryland, Baltimore County has a Federalwide Assurance ( FWA00000069, approved through 07/26/2021) from the Office for Human Research Protections.
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. Look at the above definition or contact the ORPC at 5-2737 or firstname.lastname@example.org with questions of clarification. Click this link for what the IRB does not consider human research. Remember, the IRB has the final say in what research must be reviewed. Use this handy guide to make an initial determination for IRB review.
Please review the requirement for human subjects use training. The IRB requires that all research personnel, including faculty, graduate students and undergraduate students complete the on-line education module. Training must be completed before submitting an application.
Principal investigators may make the initial determination about the type of review appropriate to the project. However, final determination on the type of review rests with the IRB. If another type of review is more appropriate, the project will be reviewed under that review procedure and the PI notified.
The IRB Chair screens studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will not need to go through expedited or full-committee review. If the study is not found exempt, it will need to go through expedited or full-committee review. This link describes the exempt application and review process. Exempt projects will take approximately one week for initial review. If there are no changes required, the project will be approved at that time.
These projects are pre-reviewed by the ORPC within one week and researchers are notified if there are changes needed. Studies are then forwarded to a member of the IRB committee. Expedited reviewers have three weeks to complete their review. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research. This link describes the expedited application and review process. Expedited reviews average about four weeks.
Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects. The meeting schedule for the 2017-18 academic year is below; submissions must be received in the OPRC office no later than thirty (30) days before the scheduled meeting. This link describes the full board application and review process.October 1, 2018 December 3, 2018 February 4, 2019 April 1, 2019 June 3, 2019
IRB Authorization Agreements (IAA) or reliance agreements
An investigator may request UMBC’s IRB to rely on another, external IRB to provide review and approval of a research project. Or, another institution may wish to rely upon UMBC for IRB review and oversight for a research project.This cooperative IRB review arrangement helps avoid dual review. The agreement describes the role and authority of the IRB(s) involved in the study, the responsibilities of the investigator’s regarding human subjects protection education, training, policies, and reporting, the term of the agreement and the number of protocols to be reviewed. This link describes the IRB reliance process.
Classroom projects (i.e. research methodology courses) are designed to teach students research. As above, such activities involve gathering data via surveys, questionnaires, interviews and/or observations of public behavior. The design of these projects will involve some type of interaction with individuals outside of the classroom setting. The IRB has developed guidelines to advise course instructors on what are acceptable topics, the use of the consent process and their responsibilities for student IRB education training and application forms.
Student Researcher Notification
Student researchers may wish to carry out research projects or studies that involve using data collected on a faculty advisor’s IRB approved protocol. The IRB has created a process to allow students to conduct their own lines of inquiry under a previously approved IRB protocol without obtaining independent IRB approval.
Who can be a principal investigator
UMBC personnel who carry out activities involving human research subjects fall under the auspices of UMBC’s Federalwide Assurance with the Office for Human Research Protections (OHRP). The individual who has the primary responsibility for a project that includes the design and implementation of research involving human subjects is known as the Principal Investigator (PI). The PI ensures that all research staff, including students, be made aware and understand their individual and collective responsibilities for research related tasks including obtaining informed consent, creating and following procedures for safeguards and protections of human research participant well being, personnel training, etc. In terms of an IRB application, at PI is a full time faculty member in a department where human subjects research activities are conducted and may also be defined by UMBC’s Policy on Principal Investigator Eligibility.
Qualified graduate or undergraduate students (as evaluated by the IRB) may also serve as a PI, but a faculty member must co-sign an application and serve as a “research advisor” for the protocol. The IRB expects the faculty member to be knowledgeable about human research regulations and UMBC IRB procedures and complete the required CITI training courses. Advisors should also be familiar with the student’s proposed project in order to supervise the student in the conduct of the research, assist the student in solving issues and be the resource to the student in promptly reporting incidents to the IRB.
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. Please contact the office staff for more information.
When will I hear from the IRB about my study?
The length of time a study will take to be approved and an approval letter received depends on the type or level of review required. . The ORPC staff, working in concert with the IRB, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load.
IRB approval is granted when all requirements are met based on the federal regulations and UMBC IRB policies. Upon approval, the PI is sent written notification with the IRB approval number and annual review date. The written notification of approval will be provided directly to the faculty advisor if the principal investigator is a student. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
Continuing Review (Annual Renewal)
Federal policy requires all studies approved in an expedited category or by full board review be renewed at minimum annually. Annual renewal is required until all the data has been analyzed and all activity, including participant contact, related to the project has ceased.
Once a protocol has received approval by the IRB, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. Per federal regulations, any desired modification in an approved research protocol must receive approval from the IRB.
Federal regulations require that grant applications or proposals that support human subjects research be reviewed and approved by an IRB. Sponsors, including NIH and NSF, will accept new grant proposals with the understanding that the researcher will proceed with the IRB review process upon receiving notification of a score in the fundable range. This is called the Just-in-Time procedure.
The NIH may issue awards with restrictions; the NSF may follow the same process, with the caveat that institutions provide documentation to make an award when proposals involve human subjects. In these cases, the principal investigator may ask the IRB to specifically and separately review and approve “planning phase” activities.
As part of its review, IRBs are required to ensure that the activities described in the grant are consistent with the proposed or IRB-approved protocol. At times principal investigators will plan research projects that will eventually lead to the submission of grant applications where human subjects use are:
- planned in future but have not been finalized, or
- when a PI received a “just-in-time” notice from a granting agency and is requesting documentation of IRB approval.
Description of planning and development activities
The PI will submit a request, in a paragraph or two, the objectives of the planning and development activities including:
- the planned participants
- the planned design of the study, and
- the potential benefits and/or risks participants may experience from participating in the research.
Please submit this request at least twenty-four (24) hours before a determination is required to the ORPC at email@example.com. The ORPC staff will review the request, in conjunction with the IRB Chair, to make sure that there are no activities described in the planning and development involves human subjects. If this is the case, the ORPC will assign an IRB protocol number and administratively approve the planning and development project activities for up to 12 months. To satisfy the NSF’s “planning phase” documentation process, PIs must submit a NSF-approved request along with the Planning Phase Administrative Approval request. The Office of Sponsored Programs will attach both documents to submit to the NSF.
Investigators must understand this is request for a planning only and that a submission of an IRB application for the complete study is required prior to initiating the research. Planning and development project activities do not substitute for the IRB’s review and approval of pilot studies. These must still be reviewed by the IRB using the protocol submission process before they are initiated.
When the PI submits a protocol application to begin the actual human subjects research, he or she will inform the ORPC that an active (i.e., existing and approved) planning and development approval is associated with this new submission, and will provide the IRB protocol number and title in the new protocol application.
Length of approval
The planning phase application will remain active until the application for research involving human subjects is approved by the IRB, at which time the planning phase protocol will be automatically inactivated. The PI is responsible for notifying the Office of Sponsored Program of the of planning and development activities approval if such approval is associated with submission of a grant application.
According to Federal Regulations ( 45 CFR 46.116), no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. The written presentation of information in the consent form is used to document the basis for consent and for the subject’s future reference. Remember that obtaining participant consent is a process. The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent. The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Consent must be given without coercion or undue influence.
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