IRB Protocol Development

The below information will assist investigators in the planning, development and submission of human use protocols for review and approval by the IRB.

Investigator Responsibilities
Schedule of Meetings
How to submit a Protocol
Types of Approval
Consent and Assent Guidelines
Does my project require IRB review?

Investigator Responsibilities 

The IRB requires that all investigators (faculty members, staff members, graduate students or undergraduate students) comply with both internal and federal regulations regarding the protection of human subjects and the appropriate administration of protocol activities. Additionally, investigators have the responsibility of staying abreast of policies to remain within compliance.  Failure to do so will result in the investigator losing their capability to perform as the individual responsible the administration of the research protocol. The Researcher’s Guide, the UMBC investigator’s manual for conducting human research, provides complete information about these responsibilites.

Schedule of Meetings               

The UMBC Institutional Review Board meets in MP 322 every sixty (60) days to review human subjects protocols. Full committee reviews of protocols are performed at each of the scheduled meetings; exempt and expedited review applications may be submitted at any time. Please pay attention to the exempt and expedited application guidelines below in order for timely review and approval of research.

The meeting schedule for the 2009-10 academic year is as follows:

October 05, 2009; Full Board Review applications due by September 07, 2009

December 07, 2009; Full Board Review applications due by November 02, 2009

February 01, 2010; Full Board Review applications due by January 04, 2010

April 05, 2010; Full Board Review applications due by March 02, 2010

June 07, 2010; Full Board Review applications due by May 03, 2010

How to submit a Protocol 

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.

Exempt | Expedited Review | Full Board Review

Types of Approval

Initial Approval

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.

Modifications

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.

Consent and Assent Guidelines

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.

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, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference. 

Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review.  Contact the Human and Animal Research Protections Office at 5-2737 or HARPO@umbc.edu 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: 

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. Course-related activities designed specifically for educational or teaching purposes, where data is collected from human participants as part of a class exercise or assignment. The individual data that will be collected and the project product must not be disseminated outside the institution. The course instructor is responsible for ensuring that ethical guidelines are followed and that such projects involve minimal risk and could have otherwise qualified for exempt or expedited review. In these cases, consent forms must clearly state that the data are collected solely for pedagogical reasons and not for actual research purposes. See the Research Class Methodology section for additional guidance.

6. Searches of existing literature.

7. Research involving a living individual, such as a biography, that is not generalizable beyond that individual.

8. 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.

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