The protection of the rights and privacy of human subjects involved in research activities is mandated by federal law. The National Research Act Public Law 99-158, The Health Research Extension Act of 1985, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provide guidelines for research with human subjects to ensure their protection in the design and conduct of research. These federal regulations require that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that such research is reviewed and approved by the institution's institutional review board (IRB).
In keeping with the federal requirements the NSU IRB process is designed to protect the rights of human subjects involved in any and all research conducted by Nova Southeastern University faculty, staff, and students. The NSU IRB is responsible for determining and assuring that:
While federally financed research must be reviewed by an IRB, NSU has determined that all research conducted at the University which involves human subjects, whether funded or unfunded, must be reviewed through the IRB process. The review process begins with an initial review at the school level and may also include a review by IRB representatives from across the University. A research proposal may be reviewed by the University-level IRB board if it contains potential risk to human subjects that includes, but is not limited to, the following:
While the University-level IRB Board has review authority of all NSU research most research in the College of Computing and Engineering is ultimately determined by the College of Computing and Engineering IRB representative to be exempt from further review by the University, but are nonetheless logged and reported to the NSU Office of Grants and Contracts on a monthly basis. This occurs in cases where the research is regarded as not having potential risk to subjects due to one of the following circumstances:
While the IRB process may appear to be an unnecessary administrative burden, the process is critical to the future of research at NSU and it can be completed quickly by following a brief number of specific steps.
The IRB process is relatively simple, but there are a few required steps that must be completed precisely by the student to facilitate the efficient processing of their IRB approval request. It is recommended that students begin the IRB process immediately after the approval of their dissertation idea paper. At this point the proposed research has reached a point that it will probably encounter minimal changes and it is still early enough in the dissertation process to avoid unnecessary delays in the initiation of their research.
The following steps must be followed by the College of Engineering and Computing doctoral students seeking IRB approval for their research:
The student must complete an IRB Submission Form, and an Informed Consent Form (the request for waiver of consent will be reviewed on a case-by-case basis). The forms can be copied from the NSU IRB web site using the "save as" utility in most commercial web browsers. The saved HTML pages can then be opened with Word and modified as necessary. Additional forms and documentation, such as copies of surveys and questionnaires, may also be required.
Confidentiality of Information - The confidentiality of the human subjects is typically the most important factor in determining whether a College of Engineering and Computing research proposal is exempt from further review. As stated in the NSU IRB Policy:
"…an investigator must not maintain any form of linkage in order to go back and review the record at a later time. If linkage between the data and the subject must be maintained, the protocol should be submitted for review."
Due to the nature of almost all College of Engineering and Computing research the possibility of physical harm to human subjects is typically minimal or non-existent. However, human subjects of the College of Engineering and Computing research could suffer financial or emotional harm in some circumstances if their individual responses to sensitive questions became public knowledge. As an example, if a subject describes various faults in the management practices of their organization as part of a College of Engineering and Computing research survey and if their identifying information is later associated with their responses then they may face retribution by their managers. To avoid any possibility of this type of problem the confidentiality of the subject's responses must be maintained and the measures taken by the College of Engineering and Computing researcher to protect this confidentiality must be fully delineated in the IRB Research Protocol. The following are examples of text from IRB Research Protocols that have been approved in the past:
These descriptions are provided as a guide for students in addressing the confidentiality of their research process. The specific description should reflect the unique characteristics of the particular research effort. However, the measures that will be taken in protecting the identity of human subjects must be clearly described in the Research Protocol.
The participation by human subjects in any College of Engineering and Computing research project must be consensual. As stated in the NSU policy:
"…no investigator may involve a human being as a subject in research, as defined in this policy and procedure manual, unless the investigator has obtained the subject's informed consent. The process of informed consent is constituted by two essential elements: (1) the subject has the information he or she requires to make an effective decision, and (2) the subject's participation is not coerced, i.e. his or her consent is voluntary."
While this requirement usually results in the use of an Informed Consent Form in the proposed research, the NSU requirement for human subjects to provide their informed consent does not necessarily require the subject to execute a document as proof of their consent. As noted in the NSU policy the requirement the IRB may approve a consent procedure which does not include, or which alters, some or all or the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents:
While most of the research proposed by the College of Engineering and Computing students may fall under one or more of these situations, the use of an Informed Consent Form must be used unless the use of the form may adversely effect the research (e.g., having a subject sign the form may reduce the spontaneity of their responses to the researchers questions, etc.). If an Informed Consent Form will not be used in the research then the reason for this omission should be described briefly in the Research Protocol.
All the College of Engineering and Computing research proposals that are submitted for IRB approval are initially reviewed by Dr. Wang. Most of the proposals are approved at the College of Engineering and Computing level and are exempt from additional IRB reviews. In unusual cases an additional review of the research may be conducted by the University-level IRB Board. Due to the possibility that required revisions of IRB documentation may necessitate additional College of Engineering and Computing reviews, and due to the possibility that subsequent University-level reviews may be required, it is recommended that students submit their IRB documentation to Dr. Wang 60 days prior to the anticipated start date for their research.
Ling Wang, Ph.D.
College of Engineering and Computing
Nova Southeastern University
3301 College Avenue
Fort Lauderdale, FL 33314
800 986-2247, ext. 22020