Disclosures – Paper forms. Spreadsheets. Documents. Disparate systems and data exchange formats with no standard process to manage, prepare and mitigate risks. The task of managing disclosures and conflicts of interest they bring forth is about to get tougher – with workforces evolving, going global and shifting cultural expectations. Your COI management needs to evolve...
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The US Federal Government provides financial support in the form of grants to individuals and institutions for research in the areas of public interest or wellbeing of common citizens. The projects are funded out of the general federal revenue. The federal government has a website ‘grants.gov’ as a single access point for all types of...
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The US Federal Government provides financial support in the form of grants to individuals and institutions for research in the areas of public interest or wellbeing of common citizens. The projects are funded out of the general federal revenue. The federal government has a website ‘grants.gov’ as a single access point for all types of...
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Comprehensive and Integrated Post Approval Monitoring Research is the cornerstone of advancement in science. Medical researchers spend time and money in search of cures for many ailments. For this, they need to expose animals and humans to a variety of untested, unknown elements. It is important to ensure that these studies are conducted as per...
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Human Subjects Research: Individuals who are the subjects of research will be asked to contribute their time and assume risk to advance the research enterprise, which benefits society at large. U.S. federal regulations governing the protection of human subjects in research have been in existence for more than three decades. The Department of Health, Education,...
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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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