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 Procedures
Schedule of Meetings
How to submit a Protocol
Types of Approval
Consent and Assent Guidelines
Does my project require IRB review?
"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 research” and
- proposes or intends to explore a particular topic that is "about" a living person who then
- interacts with that living person and
- plans to “generalize “ the information by either publishing (e.g., in a journal) or presenting at a conference
How do you identify human subejct research? Use this handy list to determine if IRB review is required.
The University of Maryland, Baltimore County has a Federalwide Assurance ( FWA00000069, approved through 09/13/2016) from the Office for Human Research Protections. This page contains guidance from the UMBC IRB on its procedures.
The UMBC Institutional Review Board meets during the academic year to review human subjects protocols. Reviews of full committee protocol submissions are performed at each of the scheduled meetings; exempt and expedited review applications may be submitted at any time. The review of all human use research takes place at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
The meeting schedule for the 2013-14 academic year is as follows:October 7, 2013; Full Board Review applications due by September 9, 2013
December 2, 2013; Full Board Review applications due by November 4, 2013
February 3, 2014; Full Board Review applications due by January 6, 2014
April 7, 2014; Full Board Review applications due by March 10, 2014
June 2, 2014; Full Board Review applications due by May 5, 2014
Applications for exempt review may be submitted at any time, preferably two (2) weeks before a project begins; expedited review may be submitted preferably four (4) weeks before.
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 ito discuss all aspects of IRB review, from preparing the submission to completion of the study. We're also available to make presentations about the IRB for groups of any size, including graduate or undergraduate classes, faculty meetings or other meetings.
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. The certificate of training completion must be submitted to the ORPC.
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. Click on the below review categories for more information about the application and review process.
Outside investigators who want to recruit on the UMBC campus
Researchers who are unaffiliated with UMBC but wish to recruit participants on the UMBC campus must request permission from the IRB before recruiting participants via posters, flyers, email announcements or newspaper ads). Outside researchers must submit to the Office for Research Protections and Compliance a letter describing the recruitment activity as well as a complete copy of the materials they submitted to the IRB of their own institution, including the letter of IRB approval for the project. The packet should include, but may not be limited to, the IRB protocol application, consent form or information sheet, recruitment flyer or ad, instruments or measures to be used, and any supporting documentation. The IRB Chair will review the request and issue a letter of permission to recruit on campus. The IRB reserves the right to have requests for permission to recruit on campus go to the full board for review and approval, should the Chair decide that the nature of the study requires the independent scrutiny of the IRB to protect its students and employees.
Investigators from institutions with a Federalwide Assurance
If a study is being conducted at multiple sites, IRB approval is needed from all of the institutions “engaged” in research, one institution may act as the “IRB of record”. An IRB Authorization Agreement may be used when UMBC engages in research with a collaborating institution with whom UMBC does not have a cooperative IRB review arrangement or UMBC or the collaborating institution provides IRB review to 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. The cooperative site must have an approved Federal Wide Assurance (FWA) on file with the office for Human Research Protections (OHRP).
To complete the form, please use the following:
Institution A: In most cases, Institution A (the institution conducting the IRB review) is the site where participant recruiting, screening, and enrolling takes place.
Institution B: The institution who relies on Institution A's IRB review
IRB Registration #: IRB00000334
Federalwide Assurance (FWA) #: FWA00000069
2) List the names,roles and responsibilities of the investigator(s)
3) Obtaining the institution's signatory official on the authorization agreement
Investigators from institutions that do not have a Federalwide Assurance
Investigators, who are not faculty, staff, students, or employees of the University of Maryland, Baltimore County may be covered under the UMBC’s Federalwide Assurance (FWA) only in accordance with the submission of a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. (source: Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement)
The Individual Investigator Agreement is a commitment statement that an unaffiliated investigator will comply with UMBC's human subject protection policies and IRB oversight. This agreement is used when researchers at UMBC engage in research with a collaborating investigator who is not affiliated with UMBC or a collaborating investigator who is affiliated with another institution that may not have its own IRB to review a study. Application guidelines and forms may be downloaded from the IRB Forms page.
The Individual Investigator is required to submit a copy of Human Subjects Protection Training from either their own institution or complete the CITI training at UMBC. The instructions for completing CITI training are at http://www.umbc.edu/research/ORPC/human_subjects_use_training.html.
Please allow sufficent time prior to initiating a research study with collaborators as institutional review and approval is required.
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.
In sum, PIs who have the responsibiliy for the conduct of the study must obtain UMBC IRB approval of all phases and changes prior to conducting the research, regardless of where the research takes place. PIs should contact the ORPC in a timely manner whenever collaborative research is planned. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.
Federal regulations require that grant applications or proposals that support human subjects research be reviewed and approved by an IRB. As part of this 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.
In these cases, the principal investigator may ask the IRB to specifically and separately review and approve activities in this planning phase. This guidance is created to address this topic.
Description of planning and development activities
The PI will describe 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 description to the ORPC at firstname.lastname@example.org. 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.
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.
Please continue to this page to learn more.
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. Contact the ORPC at 5-2737 or email@example.com with questions of clarification. Remember, the IRB has the final say in what research must be reviewed.
Examples of research that may not require IRB review include:
1. Activities with no hypothesis-driven methodologies and no research protocol, where the anticipated result or product is the publication of an article in a newspaper or magazine
2. Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, “customer service” surveys.
3. Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University (i.e. quality improvement/quality assurance) or for developing new services or programs for students, employees, or alumni, as long as the privacy of the participants is protected, the confidentiality of individual responses is maintained, and survey participation is voluntary. If, at a future date, an opportunity will arise to contribute previously collected survey data to a new project producing generalizable knowledge, an application for IRB review would be required before the data could be released to the new project. See the QI/QA algorithm for additional guidance.
4. Fact-collecting interviews of individuals where questions focus on things, products, or policies, rather than on people or their opinions. Example: canvassing librarians about inter-library loan policies or rising journal costs
5. Searches of existing literature
6. Procedures carried out under independent contract for an external agency. Generally, program evaluations not requiring human subjects review involve data internally collected and analyzed for the normal course of business. The evaluation goals range from simple descriptive statistics to qualitative information, and examples include program enrollment data, constituent demographics, and outcome analyses. Therefore, irrespective of human subject involvement, these program evaluations remain internal and thus do not contribute to generalizable knowledge.
7. Class Projects. The IRB recognizes that graduate and undergraduate research methodology courses are designed by instructors to teach students research skills through a combination of readings, lectures and research activities or projects. Such research projects allow the student to apply what is taught in the classroom rather than to contribute to existing research literature in a field. Other activities do present the opportunity to apply skills learned in the class setting with the public in general. It is these activities that may place the proposed activity under the regulatory definition of “research” (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102).
Instructors do have the responsibility of ensuring that the student is educated on the general principles of research ethics, human subject protection, and that the students receive human subjects training. Please use the below definitions to determine if a project requires IRB review.
Participants enrolled in a class setting
In general, classroom educational activities that instruct students in research methodologies and techniques usually do not fall within the federal definition of research as described in 45 CFR 46.102(d). As such, activities that involve data gathered (surveys/ questionnaires/ interviews/ observations of public behavior) solely as part of a classroom project that will not go outside the classroom setting will not require review by the IRB. Presentations of class research results at the end of a semester are acceptable.
Participants not enrolled in a class setting
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 special guidelines (http://www.umbc.edu/research/ORPC/IRB_researchmethods.html) 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. Students may use data collected in these projects to support their own independent projects (URCAD, masters, and dissertation). They must, however, submit a separate application ( http://www.umbc.edu/research/ORPC/IRBprotdevelop.html) to the IRB for review.