Relevant Regulatory Background & History: The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects, is the common ethical standard for publicly funded research in the United States. Individuals who are the subjects of research may be asked to contribute their time and assume risk to advance the research enterprise,...
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Existence (or assumption) of a Conflict of Interest (COI) has the potential to jeopardize a research project and tarnish the reputation of the research organization conducting the investigation. An important part of research administration is to eliminate existence of COI before it can have a damaging effect on the study being performed. As a part...
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What are stem cells? Stem cells are undifferentiated (unspecialized) cells that have the capability to proliferate – or divide and renew themselves for long periods. They can be obtained from various sources in the human body: bone marrow, peripheral blood, and embryos. The type and potential of stem cells varies. Totipotent: Obtained from the fertilized...
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Institutional Review Boards (IRBs) are assigned with the critical job of reviewing, approving, and monitoring research involving humans. One of the main responsibilities of an IRB is to protect the rights and welfare of human subjects from harm – be it physical or psychological. With such responsibility resting on their shoulders, it is imperative that...
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Any research project on human subjects requires clinical trial protocols to be maintained. It is the duty of the Institutional Review Board (IRB) to ensure that all types of research conducted on human subjects is in accordance with federal, state, institutional, and ethical guidelines. In short, the IRB plays an important role in protecting the...
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Biosafety can be defined as the application of information, techniques, and equipment to prevent potentially infectious and/or hazardous biological materials from harming people and the environment. Biosafety measures delineate the conditions under which biohazardous materials and agents can be safely handled. Biohazardous materials could be microorganisms, toxins, body fluids, controlled substances, allergens, carcinogens, oncogenic matter,...
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For any research organization, arranging for funds is an important and imperative step that enables it to carry forward research and development. Grants – federal or private – are one way of acquiring the much-needed funds. Starting from applying for grants and securing them, to managing the funds responsibly, the process needs to be transparent,...
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In life science research organizations worldwide, use of laboratory animals such as mice, guinea pigs, hamsters, rats, etc. for experimental purposes is vital and practically indispensable. However, the management of these animals is a complex and time-consuming task. Lab animal care personnel often struggle with the minutiae of ordering animals, caring for them, and maintaining...
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A conflict of interest (COI) is a situation in which personal or financial considerations may cloud the judgment of a professional. The professional could be a doctor, lawyer, accountant, or a researcher. For example, if a researcher is provided with financial grants from a pharmaceutical company to conduct his/her research, the researcher may be inclined...
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