Defining an Institutional Review Board:
An institutional review board can be defined in simple terms as a committee which has been formally designated for the purpose of approving, monitoring and reviewing the clinical trials that are involving human participants. This committee can be called in some other names like:
- Independent ethics committee
- Ethical review board
- Research ethics board (1)
As such, the primary objective of this committee is the protection of rights, safety as well as the well being of the human participants of the particular research project. The review of the clinical trial protocol would assess the ethics of research along with its methods thereby seeking to maximize the safety of the included human subjects. In several countries, this committee is serving as an independent representative and competent body. (1), (2)
What are the Responsibilities of an Institutional Review Board (IRB)?
It can be said that the basic responsibility of an institutional review board is to ensure the competent review of each and every ethical aspect of the proposals received and to ensure that the research proposals are free from bias and influence of any kind that is potential to affect the research objectives. The institutional review board has to confirm the scientific soundness of the research proposals through suitable Scientific Review Committees. IRB should also be able to provide guidance to the researchers on all the aspects of safety and well being of the including participants.
In the case of smaller institutions, the IRB would take up a dual role of Ethical and Scientific reviews. And, it is to be noted that the scientific evaluation should ensure the technical excellence of the proposed research study. Thus, the responsibilities of an institutional review board can be put as following points:
- Protecting the dignity, rights as well as the well being of the participants of the proposed research.
- Ensuring that the ethical values as well as the international scientific standards are expressed as local community values and customs.
- Assisting in the development as well as the education of a research community that is responsive to local health care requirements. (2), (3)
What will be The Composition of an IRB?
In general, an IRB must be multi-disciplinary. This committee must comprise of members from various sectors of the society. As mentioned earlier, independency and competency are the hallmarks an IRB in India. An IRB should be kept fairly small with the total number of 8 to 12 members. However, it is generally accepted that minimum of five members will be required to form a quorum without which the decisions regarding any research cannot be taken. As such, the members of an IRB should be mix of:
- Medical persons
- Non-medical persons
- Scientific persons
- Non-Scientific persons
- Lay persons
This mixture is required for an IRB in order to represent the differed view points. Thus, an IRB may include the following people:
- 1 to 2 basic medical scientists
- 1 to 2 clinicians
- A legal expert/judge
- A social scientist (or representative of non-government voluntary agency)
- An ethicist (or can be a philosopher or theologian)
- A lay person from the particular community
- Member Secretary
It is to be noted that, at any cost, an ethics committee should include a member who is independent of the trial site and also a member whose area of interest or specialization is non-scientific in nature. (2), (3)
How will be the Training?
The members of an ethics committee must be encouraged to keep updated about all the national and international developments in ethics. This will be done through various orientation courses on the related topics or through the regular training, so that the members become aware of their roles and responsibilities. With regards to the clinical trial review, it is always preferable to train the members in Good Clinical Practice. In addition to these trainings, any change in the regulatory needs should be brought to the attention of the committee and thus, each and every member should be aware of the local, social as well as the cultural norms. (2), (3)
What are the Review Processes?
The methods of review must be stated in the SOP. Here are the review processes for your reference:
- Periodic Review: An ongoing research study might be reviewed at regular intervals as specified in the SOP of the particular ethics committee. The intervals may range from six months to one year.
- Continuing Review: An IRB has the responsibility to continue the reviewing of the approved projects if needed.
Interim Review: An interim review can be conducted by a sub-committee. However, the IRB should decide the circumstances as well as the mechanism under which an interim review is permitted. Moreover, the decisions that are being taken during the interim review must be notified to the main committee. (2), (3)
Monitoring of Studies:
Once the research project is approved, it is the responsibility of IRB to monitor the study. The investigators of the particular study must be asked to submit the status reports at regular intervals of time and these intervals must be specified in the SOP of IRB. The committee will review the 'Serious Adverse Events' reports that are got from the trial site and will take the necessary actions. (2), (3)
Regulation of an IRB:
Currently, Ministry of Health is actively considering setting up of the legislation of guidelines. Once this occurs, a Biomedical Research Authority will be set up which would require all the institutional review boards to register with the authority. This authority would also evaluate and monitor the functioning of IRBs. In addition, the authority would develop various mechanisms to enforce the accountability and transparency of the institutions. (3)
In addition to the above requirements, there are certain other special concerns that are applicable to specific areas of the clinical study which would require some additional protection. Hence, the IRBs should take note of those concerns for an effective performance of the institutional review board. (2)