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:
1) the welfare and rights of human subjects are adequately protected and informed consent given, if necessary;
2) human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of the research;
3) the necessity and importance of the research outweighs the risks to the subjects; and
4) the researcher(s) is/are qualified to conduct research involving human subjects.
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 GSCIS is ultimately determined by the GSCIS 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 preliminary proposal. 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 GSCIS doctoral students seeking IRB approval for their research:
1. The student must complete the "SCIS" set of training modules in the CITI Training Program.
2. The student must complete an IRB Submission Form and a Research Protocol. 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 an Informed Consent Form and copies of surveys and questionnaires, may also be required.
3. After completing the required forms the student should notify their advisor and request that they indicate in DTS that the student requires an IRB review. This will open a separate section in DTS for the student to upload their IRB documents.
4. The student will then upload the IRB documentation to DTS. The IRB Submission Form, the Informed Consent Form which will be used, and the Research Protocol must be uploaded to the designated folders. Any additional forms should be uploaded into the “Additional IRB Documentation” folder.
5. The status of the IRB review, including the final IRB approval, will be emailed to the student and their advisor by Dr. Cannady.
Confidentiality of Information - The confidentiality of the human subjects is typically the most important factor in determining whether a GSCIS 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 GSCIS research the possibility of physical harm to human subjects is typically minimal or non-existent. However, human subjects of GSCIS 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 GSCIS 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 GSCIS 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:
“Strict confidentiality will be maintained at all times. New employees and their project managers will be given numbers for tracking purposes. Contact records used for linking the names of the new employees and their project managers to their tracking numbers will be deleted at the conclusion of the study. During the study, the contact records will be maintained in one computer location protected by password and one disk backup stored in a government-classified safe. All reporting will be in the aggregate; names or colleges will not be used to identify individuals.”
“The participant name is entered into the application database only if the participant consents to participate. The userID is then used at login to enter a new project or to update a project. The application will verify that each userID is unique. Confidentiality will be maintained by the use of the distinct userID in the application. After the data collection time period has expired, the researcher will assign and refer to the participants by numerical coding and all personal identifying data will be deleted. The list linking participants with userID and numerical coding will be maintained by the researcher in locked files. The researcher anticipates reporting to be in aggregate format. All demographic data collected will be accessible only to the researcher. The user table has permissions of ‘write-only’ through the application.”
“Information obtained in this study will be strictly confidential unless disclosure is required by law. Participants will be assigned a study number, and this number, rather than the participants’ names, will be recorded at the time of interviews. Only the study investigator will have a record of which person has been assigned what number and this information will be secured in a locked filing cabinet. Participant names will not be used in the reporting of information in publications or conference presentations. The results of the study will be reported in terms of the various treatment groups, not in terms of individuals. Thus anonymity and confidentiality will be protected.”
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 GSCIS 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:
· The research involves no more than minimal risks
· The rights and welfare of subjects will not be adversely affected
· The research could not practicably be carried out without the waiver or alteration
· Whenever appropriate, the subjects will be provided with additional pertinent information after participation
· The research is to be conducted for the purpose of demonstrating or evaluating federal, state, or local service programs that are not research programs, etc.
While most of the research proposed by GSCIS 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 GSCIS research proposals that are submitted for IRB approval are initially reviewed by Dr. Cannady. Most of the proposals are approved at the GSCIS 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. To facilitate the management and processing of IRB submissions all initial reviews will be conducted by Dr. Cannady on the 15th of each month. An IRB report is forwarded from GSCIS to the NSU Office of Grants and Contracts that lists all of the proposals that were reviewed during the month. Due to the possibility that required revisions of IRB documentation may necessitate additional GSCIS 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. Cannady 60 days prior to the anticipated start date for their research. Most GSCIS proposals are approved during the mid-month reviews, but due to the potential for additional administrative reviews students are encouraged to submit their IRB documentation to Dr. Cannady at the earliest possible date.