IRB or the Institutional Review Board is a committee established to review and approve research involving human subjects. Federal laws that the security of the privacy and rights of population involved in examination activities is of extreme importance have mandated it. The Health Research Extension Act of 1985, the National Research Act Public Law 99-158 and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provides guiding principles for human subject research to guarantee their wellbeing and lay down the regulations of the research process. Such regulations demand that any establishment receiving and requesting funds from agency or a federal department involving human subjects must be reviewed and validated by the Institutional Review Board. (King, 2006)
In the initial process of reviewing all research, studies comprising of human subjects are analyzed in three ways – Central Level Review, Expedited Review and Full Review. All research protocol is initiated with a complete submission of data and facts to the principal investigator’s Center Representative. The Center Investigator has to review the submission and ascertain that all necessary documents, such as a research protocol and an IRB submission form are included.
The primary investigators are to work with the Center Representatives. This helps in preparation of the required IRB documents in accordance with Nova Southeastern University (NSU) policies and procedures. NSU IRB is designed to safeguard human subjects and responsible for determining that the welfare and human rights of the subjects is sufficiently provided for. It ensures that the human subjects should never be exposed to unreasonable physical, mental or mental risk to propagate research, nor should the risks to the subject be overlooked due to the magnitude of the research. It is also the duty of the IRB to make sure that the researchers or scientists are qualified to conduct experiments on human subjects.
Documents, which are essential to IRB, are informed consent forms from the subjects, evidence of approval by other IRB’s at other sites, data collection instruments and brochure and recruitment material. The IRB at the level of university must review the research proposal with importance if it indicates potential risk to human candidates as is to be evinced in cases. This involve administration of drugs or narcotics to the subject, research involving pregnant women or the fetus, life threatening physical conditions, physically intrusive procedures, research which has previously exposed subjects to potential risks or which invades a subject’s privacy and renders him a victim of legal or civil liability. (Lamb, 2004)
Once the documents are duly filled up, the IRB process starts when the completed document is presented to the Center Representative. In case the documents are found satisfying, the Center Representative exempts it from further review. Otherwise, it would require a Full Review or Expedited protocol. If Full Review is required in accordance to the protocol the Center Representative forwards the submitted form to the Office of Grants and Contract. It is also the duty of the Center Representative to ask the principal investigator to provide 23 copies and the original IRB submission form; it would then reach the OGC (Office of Grants and Contracts). Besides this, one copy of all research techniques, such as questionnaires, interviews and surveys should be submitted. After the submission of all required paperwork, the OGC assigns a protocol number to the IRB submission, reviews it for completeness, forwards it to other IRB members, where the protocol would be placed on a specified agenda and would be evaluated on the forthcoming IRB meeting.
If needed, revision requests are sent to the principal investigator through the United States postal mail. Once the IRB approval is granted, OGC notifies the principal investigator. Even in cases with low potential risks, it is necessary to inform the OGC. While, in some cases the IRB may appear to be an unnecessary burden, such as in routine procedures of education, psychology and medicine, the process is nonetheless crucial to the future of research.
IRB conducts the continuing research of all funded and unfounded projects approved by the Full Review procedure as specified by the research procedure appropriate to the degree of risk involved. Federal Regulation maintains that the IRB approved research should be reviewed by IRB. This date would not be fixed beyond the period of 365 days from the approval date or at lesser intervals if it is deemed necessary or the research belongs to the high-risk category. (Kar, 2006)
A few efficient steps are required to expedite the IRB process that have to be answered precisely by the researchers to facilitate the efficient processing of the IRB approval request. Once the preliminary dissertation proposal is approved, the student should start immediately with the IRB process as, at this point, it will probably encounter the minimum changes and unnecessary delays can be avoided. These steps include the completion of SCIS set of training modules as per the requirements of the CITI program, which ensures that the students qualify a course in the protection of human subjects. Certain sets of modules are mandatory for CITI; every college and center at NSU selects modules, which their respective inspectors have to complete. Non-affiliated NSU Members of the research team must go through the process of completion of the modules that falls within the parameter of the identical learner groups as the primary investigator of the research. However, program of the CITI needs a completion before the submission to the board of the IRB for the preliminary assessment of a procedure or revision or review in a continued manner.
Investigators should be also encouraged to consult with their center representatives if they have any queries regarding the CITI training. It is mandatory for the students to fill up and submit the IRB forms and a research protocol. To facilitate the completion of a new submission form or the protocol it is important to make sure that the title submitted matches the title of the study provided on all the other forms.
Complete contact information should be provided for the principal and co-investigators; if the research is employing research assistants, their contact information should be provided as per norms. The IRB also demands provision of references to literature to support the study and the proposed experiment. If professional terminology is used, it should be adequately explained. The location of the study or the site information has to be specific and include physical addresses. Forms can easily be downloaded from NSU IRB website and the saved HTML pages can be accessed with Word and modified as necessary. Questionnaires, copies of surveys and informed consent forms may also be called forth.
After the due completion of the required forms, it is the duty of the students to notify their advisor to let the DTS be informed and open a separate section that would enable the students to upload their documents related to IRB. The IRB submission form, the consent form and research protocol must be uploaded to designated folders, while additional forms are to be uploaded in the Additional IRB Documentation folder.
The status of the IRB review will then be e mailed to the students and their advisor. In order to seek review and continuation request the principal investigator should notify the IRB chair immediately. It is the duty of the principal investigator to submit in writing any changes incorporated in the study to the IRB office through the submission form or amendment. No changes can be implemented until the IRB chair approves of the alterations. Failure to report changes may well result in the termination of the protocol. Typically, the requests for review amendments should include one original of all the documents originally approved by the review board along with the 23 copies. (King, 2006)
The IRB is guided by a set of considerations. Transparency is maintained in the matter of funding and money grants by the regulations of the advance pricing agreement program or APA. The APA also provides technical guidance for conducting an analysis. There are no specific site requirements for the APA other than a secure site, site access and standard support facilities. The APA also focuses on the requirements of the research program and demands full documentation of analysis. Compliance of rulemaking requirements with the APA is mandatory to the IRB process.
All regulations are subject to the APA unless expressly stated otherwise by the statute. Any doubts as to the applicability of the APA should be resolved in favor of the APA. APA regulation means every rule, every order and standard of general application or regulation or the amendment, regulation or revision or supplement of any rule or by any state agency to interpret, implement, or make precise the law enacted or to govern its method or administered by it.
The APA lays down the rule that no state agency can issue, utilize, enforce or attempt to implement any standard of general application, criterion, manual, order, instruction, bulletin, guideline, or other general rule unless it is granted as a change or regulation that has been operated by APA pursuant Secretary of State. A three-step analysis should be used to determine whether the procedure must be regulated as per the APA rules.
1. Is the policy or procedure a rule or standard of general application or a modification or supplement to such a rule?
2. Has the policy or procedure been adopted by the agency to implement and interpret the law enforced or to govern the agency’s procedure?
3. Has the policy or procedure been expressly exempted by statute that it be adopted as a regulation compliant with the APA? (Lamb, 2004)
Confidentiality of information is of extreme importance…the confidentiality of the human subject and possibility of physical harm should be minimal or non-existent. Strict confidentiality is to be maintained during the study period, employees and their project manager records are to be erased at the termination of the research. However, during the study period it is essential that all contact records should kept sage and classified. Such reporting must be conveyed in aggregate terms and names of collages or institutes should not reveal the identity of the individuals. The application database should enter the names of the participants only after they have consented to be a part of the study.
It is only then that the used ID is in operation in order to gain access to a new study. It is the mission of the application to verify that each ID is unique and there is no fear of duplication. After the completion of the data collection period the researchers are to assign and refer to the human subjects by coding that are numerical and ID data are to be deleted forever. The list of the participants in the research process is to be numerically coded and maintained in high security lockers.
All demographic data will be accessible only to the researcher; however, the user table is provided with the permission to write only through the application. The disclosure of such confidential information can happen only if the law demands it; otherwise, a study number would be given to the participants and it is the number and not the name that will be recorded during interviews. Participant names should be utilized in case of public information, seminars or scientific conferences. Anonymity and confidentiality are to be maintained at all costs. (Kar, 2006)
In any GSCIS research project, the participation of human subjects should always be consensual. The investigator has no right to involve human subjects in the study without obtaining the subject’s informed consent. It is important to bear in mind the two essential norms, which comprise the process of the informed consent: – the subject should be provided with all the relevant data, which helps him to take decision; no methods of coercion should be involved, the decision of the subject to participate in the research process should be voluntary.
However, in cases where the risks involved are minimal the process of the informed approval does not essentially require the subject to execute a document as the proof of consent. Such waivers may be issued in cases where the rights and welfare of the subject will not be hampered, in cases where the research cannot function practicably without the waiver.
Here subjects are duly informed about the developments and goals of the study and cases where the research carried out is for the reason of evaluating or demonstrating local service, state or federal programs. However, the omission of an informed consent form should be detailed and described in the research protocol. Conversant approval forms should be put into use unless the utilization of the form may unfavorably affect the responses of the subject and thereby hamper the research. (King, 2006)
Federal regulations stipulate that IRB’s must be comprehensively constituted to enhance and foresee the scope of research activities of the institution, the involvement of the type of population assumed with the context of exposure to risk factors. The IRB may invite personages with capability in particular areas to assess issues, which require expertise such as scientific and scholarly knowledge and experience. There is a very low chance that these individuals would be voting with the IRB.
Thus internal consultant review comprises of the identification and recruitment of an individual who serves as an IRB member with expertise beyond or in addition to the current IRB team. IRB chair or IRB staff may at any time request internal consultant review for studies, which call for, expedite research. Such requests may also be made for studies requiring full committee reviews prior to the convened IRB review of a given study; or the committee may deem it necessary to recruit further internal consultants.
Once the internal consultant is identified, it is the duty of the IRB to provide the consultant with appropriate data and study material as well as comprehensively chart out the requirements of the board. Conflicts of interests of internal consultants are to be identified, evaluated and managed according OPRS IRB Policy 67. Internal consultants may also be asked to provide their expertise regarding a certain issue and provide an overall review and assessment. (Kar, 2006)
On the other hand, the external consultant review comprises of the identification and recruitment of individuals with expertise beyond or in addition to the present team, bit who are not IRB members or even affiliated with UCLA. Such external consultants may be requested by the ORB chair to review studies, which qualify for expedited research. The IRB chair or a convened IRB may also request external consultant review for studies, which call forth, full committee review. In such cases, the consultants may be asked to provide their expertise regarding a specific issue. While obtaining an external consultant review, stringent regulations are to be followed.
1. To respect the investigator’s intellectual property and to avoid professional conflicts the principal investigator should be duly informed through email of the request for the external consultant and thereby provide an opportunity to identify individuals according to protocol.
2. It is the duty of the IRB staff to contact the individual once the potential consultant has been identified and requests his consultation.
3. Upon receiving agreement from the identified individual, the IRB staff will provide the consultant with written request to serve as a consultant and provide relevant study material as well as underline specific issues. (King, 2006)
As mandated by a formal request, the external consultant is asked to disclose any conflicts of interest. The process of determination of conflicting interests is based on the consultant’s self-assessment. In the event of the consultant, expressing financial or other interests in the research process, the IRB chair and staff has to identify an alternate candidate.
A consultant is requested to provide his comments in writing to the board and comments may be delivered to the IRB staff by the prescribed deadline. The consultant may even be requested to present his opinions to the board in person. In cases of research requiring full committee review, consultant comments are to be distributed to the board members along with related study materials approximately one week prior to the scheduled meeting. If ever a consultant is asked to attend a convened IRB meeting, he will be excused prior to the vote. The consultant does not have the right to vote or count towards quorum. The consultant’s written comments are to be retained by OPRS as part of the protocol file. (Kar, 2006)
The Department of Health and Human Services, DHHS, requires that the adequacy of IRB to taker into account the evaluation related to the scope, though assumed, of research activity of the institution. It should consider the nature and variety of the population in the context including the given complexity and size. The IRB’s should be adequately competent through the multiplicity of the constituents, including reflection of cultural, gender and racial backgrounds and understanding to such concerns as community related diversity and attitudes.
Kar, P; (2006); IRB: Reviews and Applications; Kolkata: Dasgupta & Chatterjee
King, H; (2006); Ethical Principals; Auckland: HBT & Brooks Ltd
Lamb, D; (2004); Cult to Culture: The Development of Civilization; Wellington: National Book Trust