Clinical trials and research completely depend on the consent of people who volunteer to participate in such studies. These people are termed as human subjects. Health and Human Services plays a significant role in protecting and safeguarding the interests and well-being of these subjects. It deals with rules for Drug Safety, Pharmacovigilance and more.
Protection of Human Subjects
Federal Regulations for the Protection of Human Subjects have been there since 1991 to govern federally supported research that invlove humans as subjects. On January 19, 2017, the U.S. Department of Health and Human Services commonly known as HHS released the final revisions to Federal Regulations for the Protection of Human Subjects, also known as the Common Rule.
These have been issued by the U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies. The Final Rule was published in the Federal Register on January 19, 2017. It will update regulations protecting individuals participating research. The provisions included in the new rule will go into effect by 2018.
It employs new steps to protect human subjects involved in research, assisting useful reasearch, reducing delay, burden, and ambiguity for those engaged in investigation.
Some Features of the New Rule
There are many salient features of the New Rule. First, a single Institutional Review Board (IRB) will have to review and approve all multi-site research and the extension of the Common Rule to all clinical trials conducted at a U.S. institution that gets federal funding regardless of funding source. The new rule further strengthens protections for people who volunteer to participate in research. It also ensures no additional inappropriate administrative burdens, due to oversight especially in low-risk research. It also allows flexibility in the dynamic research environment of the present times.
The regulations followed currently referred to as the ‘Common Rule’ has been in place since 1991. These rules were framed when the research was mostly conducted at universities and medical institutions. At that time studies generally took place at a single site. Today the field of research with human participation is extensive, complex and dynamic. It has up scaled and become diverse. Research also has become digital creating both advantages and disadvantages.
Consent forms will be required to provide potential research subjects understand the scope of the project that including clarity about risks and benefits to help them take an informed decision about participation.
Researches for studies on stored identifiable data or identifiable bio-specimens will have an option of relying on broad consent obtained for future research as an alternative to getting IRB approval to waive the consent requirement.
Categories of research based on the level of risk posed to the participants are exempted If the research is regulated by and participants are protected by HIPAA rules there is a new exemption for secondary research involving identifiable private information.
Consent forms for certain federally funded clinical trials would be required to be posted on a public website. These revisions are done with the purpose of modernizing and strengthening the Federal Policy for the Protection of Human Subjects and making it more effective.
It acknowledges the significant contribution of individuals who volunteer to participate in research without which medical advances would have been impossible.
Protection of Research Participants
Protection of research participants is essential, safeguarding them is crucial for medical research for effective health solutions. This action of the federal government underlines the commitment to the well-being of all those who volunteer to participate in research studies.