 During this module, we will be looking into research ethics and regulations. Research regulations are derived from all the ethical concerns and provide three basic protections to the participants involved in the research. The first one is institutional assurances. Institution could be any place where the research is primarily investigating and taking sample from that place. Institutional assurances are a mechanism to apply research regulations to all research participants. Now, institution could be any hospital, institution could be any university, any school or any such organization from where we are going to see the sampling frame. Now, when we consult that institution, our prime objective is to discuss it with a regulation that we are your participants could approach and how we are going to take data from them. When institutions sign the institutional assurances, they may also elect to apply health and human services regulation in terms of assurance to all research. This is very important for all the organizations and institutions to ensure that their participants should remain safe and they will not get any harm out of that. Now, let's say we go to a school institution of a special child and we want to collect data from those children. If we ask their parents about their children's health, their aspirations, their daily routine and self-care, then we need to see if we are asking them any such questions that are causing harm to the institution's stake or to the individuals we collect data from. So, the question here should be given to the institution beforehand so that they can wet it through their authorities and see if there is any kind of bias or any kind of 13 questions or any kind of psychologically distressed question or any kind of interview protocols that will be a problem or a safety hazard bias for them. Then review by institutional review board. Now, we have to see institutional assurances from where they come from. How an institution is going to ensure that we allow this research and we don't allow this research. For that purpose, every big institution, every big university, every big hospital has an institutional review board, which is called IRP. Review by the institutional board is the glue that holds the evaluation process together. Now, the institution can't do that. One researcher can independently see all the protocols and allow them. So, we have to see that there should be some regulations, there should be some process, which has some hard and fast rules on the basis of which the institution will allow any research and no permission will be given. So, institutional review board is something which is being established in all good institutions to keep that process aligned. IRP review is guided by ethical principles described in Belmont report, which we initially talked about in the beginning of our course, that the principles that Belmont report has made are still applicable and takes the following points into consideration. So, remembering that Belmont report has specific points which are still being used in ethical practices, especially in medical sciences and biomedical sciences. The first one is respect for person. So, this point IRP board has to first look at whether the research that they are going to allow, the institutional assurance they are going to give, would that carry that element or not? That is, no disrespect is being made to that research. They should take care of the vulnerable population and autonomy of the participants. What can vulnerable populations be? Some can be minors, some can be patient populations. Autonomy of the participants means like if the patient is at some crucial stage, like the stage 3 or 4 of cancer patients, they do not get data collection information in hospitals because their IRP board suggests that it is unethical to ask these patients questions because they are not fit to give response to anyone about their health conditions. So, you know, vulnerable populations can deal with IRP board which gives selective permission. Then, beneficence. Research design should be adequate with minimizing harm. For instance, if you are going to do an experiment and you are doing it with a drug, with a patient population, the side effects or harms that have already been established on clinical practice on different animal populations so that we know that there is no major harm or risk involved. Then, justice. Participants should benefit from research and inclusion and exclusion criteria should be fair. So, you know that IRP also looks into that very matter that you are taking participants on what basis and on what basis you are excluding participants from the research protocol. So, you know that all these basic principles of Belmont report that is respect, that is beneficence and that is justice is still practiced and even is being reviewed by institutional review board before giving permission to any researcher to carry out their research in their institutions.