What is the Institutional Review Board?
Misericordia University (MU) established an Institutional Review Board (IRB) to review all research involving human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the IRB and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB is meant to aid both the subjects and the researchers by bring scrutiny to research protocols by a group of peers who can objectively assess the potential risk and accommodations made to minimize them. The IRB function to support community researchers.
What are the IRB's major responsibilities?
The IRB’s major responsibly is to assure that the rights of individuals involved in research are protected. The IRB is guided by three ethical principles: respect for persons, beneficence, and justice. These three principals are found in the Belmont Report. A copy of the Belmont Report can be found here. Additionally, the Nuremburg Code and Declaration of Helsinki specifically emphasize that a study is designed so that risks to subjects are minimized and potential benefits justify potential risks giving the IRB an obligation to review study design and scientific quality.1
How does an investigator assure that the rights of individuals in his/her study are protected?
Investigators should do all that they can to achieve the ethical principles outlined in the Belmont Report. Generally, investigators are to protect the subjects from harm by identifying and minimizing the risks involved in the research; assuring that subjects participation is voluntary; be certain that research subjects are properly informed of what their participation will entail – this is usually conveyed in an informed consent document; selecting subjects fairly – selection should be based on fair procedures so that one group is not overburdened, overused or unfairly favored or discriminated against; and assuring that subjects identities and responses to research procedures are protected.
When is IRB approval needed?
All research involving the use of human subjects conducted by Misericordia University’s faculty, staff or students or sponsored by the university must be reviewed and approved prior to the start of the research. Once initiated, the research must be conducted in full compliance with IRB policies and procedures.
According to 45 CFR 46, research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, and a human subject means a living individual about whom an investigator (whether professional or student) conducting research:
1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
What is a systematic investigation?
A systematic investigation involves a logical and organized approach to data collection and analysis, developed in advance of project initiation. Qualities of a project involving systematic investigation include:
- one or more specific questions of interest, often framed as hypotheses, that the project will seek to answer
- data collection methods appropriate to address the question(s)
- data analysis plans appropriate for the type(s) of data collected
- an ability to use the analyzed data to answer the question(s)
What constitutes a study designed to develop or contribute to generalizable knowledge?
A study designed to develop or contribute to generalizable knowledge intentionally links to, applies, and/or expands upon existing knowledge. The methods allow for replication and for comparisons with data collected from different samples of the same population, and the results apply to people beyond those directly studied. Qualities of a project designed to develop or contribute to generalizable knowledge include:
- basis in a theoretical framework of established knowledge
- identification of a gap in knowledge that the project plans to address
- identification and description of one or more specific populations of interest
- unbiased sampling methods (i.e. random or probability sampling), when feasible, that allow for the recruitment of samples representative of the population(s)
- operationalization of variables and constructs
- data collection plans employing measurement tools and techniques with established and satisfactory reliability and validity
- data analysis plans using techniques consistent with those employed in the literature of the theoretical framework and considered appropriate for the type(s) of data collected
- an ability and plan to use the collected and analyzed data to draw meaningful conclusions about the result and link these back to the theoretical framework and identified gap in knowledge.
What is institutional research?
Internal institutional research is the gathering of data from employees and students which will be used solely for internal program improvement, informational or required data-collection purposes. For example: course evaluations; surveys to improve institutional services or processes; data collection to establish opinions, experiences or preferences of the University community or information used to characterize the institution. IRB approval is not required for institutional research EXCEPT when one of the two conditions exists:
1. the information deals with sensitive subject matter and disclosure of the responses outside of the research could place the subject at criminal or civil liability or be damaging to the subject's reputation, employ-ability or financial standing; or
2. it is anticipated that the data generated will be used for research, the results of which will be disseminated outside of the University.
What if I get a survey from an outside agency which collects data on the College which might very well end up in a publication?
The question to be considered is whether the information is reported anonymously - no student, staff or faculty names will be attached AND whether the information would in any way be damaging to an individual as described above. Again, the information has to have an INSTITUTIONAL purpose. A researcher who sends you surveys to distribute to your class/employees which asks their opinion about something is not necessarily of value to the institution. Therefore if you receive a survey like this and you are unsure of whether it has an institutional purpose, you should contact the IRB Office for an opinion.
What training/education is required for the researcher(s)?
All Misericordia University faculty, staff, students, individuals obtaining consent, or key research personnel are required to complete training in the protection of human research participants, specifically Collaborative Institute Training Initiative (CITI) courses, prior to obtaining IRB approval. Information on this training can be found under the "Preparing an Application" section. All MU affiliates have free access. Please note, all students must have a faculty advisor to conduct research at Misericordia University.
How do I submit an application?
All researchers need to submit applications using a new online system, iMedRIS. Please see iMedRIS tab on the IRB website for details.
Who do I contact if I have questions?
You may contact the IRB Office at email@example.com or by filling out the form below.
1 Bankert, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function (3rd ed.). Boston, MA: Jones & Bartlett.
2 Information reproduced from Viterbo University, Institutional Review Board, with permission.