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Responsible Conduct in Research HUMAN SUBJECT PROTECTION.

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1 Responsible Conduct in Research HUMAN SUBJECT PROTECTION

2 Responsible Conduct of Research The Office of Research Integrity (ORI) supports several programs designed to promote education and training in the responsible conduct of research (RCR) that covers the following nine instructional areas: – Data Acquisition, Management, Sharing and Ownership – Conflict of Interest and Commitment – Human Subjects – Animal Welfare – Research Misconduct – Publication Practices and Responsible Authorship – Mentor / Trainee Responsibilities – Peer Review – Collaborative Science Education in the responsible conduct is essential because unethical or compromised behaviors on the part of researchers lead the public to lose trust in the research community. When trust is lost, credibility is lost. When credibility is lost, the opportunity to improve human well-being and protect the environmental is lost. When belief that science can make a difference is lost, funding for research is lost. The America Competes Act states that any graduate student, undergraduate student or postdoctoral associate who receives support from a federal award MUST have instruction in the Responsible Conduct of Research.

3 Human Subject Research All research on human subjects is reviewed – Regardless of design type – Regardless of source of funding – Including educational, class-based research projects Research is defined as "scholarly inquiry utilizing scientific methodology to systematically gather, record, and analyze data for the purposes of developing or contributing to knowledge. " (OPRR, 1993, p. 14). Human subject is defined as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction, or (2) identifiable private information.”

4 Ethical Foundations of Human Subject Protections The Nuremberg Code developed in response to experiments conducted on concentration camp prisoners by German doctors during World War II. The Nuremberg Code established the right and the importance of voluntary participation and informed consent. The Declaration of Helsinki is a statement of recommendations from the World Medical Association in 1964 (amended in 1975, 1983, 1989, and 1996). The declaration established the following principles: human research should be based on successful laboratory and animal experimentation and should have importance that outweighs the risk; the investigators must be competent for the intended task; participants should provide informed consent; protocols should be reviewed by an external body to avoid investigator bias.

5 Ethical Foundations of Human Subject Protections The National Research Act (1974) was passed in response to the Tuskegee Syphilis Study. The 40 year study monitored, but did not treat, 600 African- American men who were infected with syphilis. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research with the charge of developing ethical guidelines for human research. The Belmont Report was published in 1979 and establishes boundaries between medical practice and biomedical research. It also identified respect, beneficence and justice as the ethical principles that should guide human research, and it established guidelines for the selection and consent process of human participants. Three principles that are under the Belmont Report are discussed in this link below. The three principles are: Respect (for Person): Treat each person as a free individual with dignity Beneficence: Do good and avoid harm Justice: Treat people fairly

6 Ethical Foundations of Human Subject Protections The Public Health Services Act (1985) established and explained the role of Institutional Review Boards (IRBs) in protecting human participation in research. The Common Rule (1991) provides uniform regulations used by all federal agencies funding research on humans. Media attention and increased public awareness of individual rights and societal dependency on high quality, ethical research have resulted in broad public discussion and a need for accountability on the part of researchers and institutions and funders that support them.

7 Important Points in Human Subject Protection From these important documents and statements, the scientific community has developed/continues to develop how we view and evaluate research on humans. The following are some important foundational beliefs: – Minimization of Risks: What are the risks? Are they necessary for the research question to be addressed? Does the risk outweigh the benefits (both to the subject and to society at large)? – Informed Consent: The subject must understand the all the risks, benefits, research procedures and must be of the state of mind that they can knowingly give consent. Additionally, no coercion or pressure may be apply to participate and the subject may leave the study at any time, for any reason. – Equitable Selection of Research Subjects: Does the population of your study cohort match the population of your target group? Are certain persons of different gender, socio-economic status, race being excluded? If they are, a justification must be provided.

8 Important Points in Human Subject Protection Additionally, there are other important concepts--e.g. privacy of personal data, special populations--that need to be explored as you think about how to ensure protection of persons participating as a subject in your research or educational protocols. These ideas and concepts are much more detailed than presented here. These concepts are explained further in the more comprehensive human subject training that is required before you are allowed to perform research with/on human subjects. The websites provided at the end of this presentation provide more information.

9 INSTITUTIONAL REVIEW BOARD (IRB) Reviews all Institute research and educational protocols involving human subjects. Approval of the IRB is required for any human subject related activity to proceed. Functions to assure that: o Risks to human subjects are minimized, and are reasonable in relation to anticipated benefits, and o Privacy and confidentiality of the subjects are maintained. Helps the Institution ensure compliance with federal regulations concerning research activities performed with/on human subjects. IRB Membership The IRB must be comprised of at least five individuals, including: o a scientist experienced in human subject research o a non-scientist, and o a non-affiliate (a person who has no other affiliation with the organization). The Cary Institute IRB, in accordance with state and federal regulations and professional standards of ethical conduct, strives to protect the rights and welfare of all human subjects of research conducted under its auspices.

10 Compliance The Department of Health and Human Services, Office for Human Research Protections (OHRP) oversees human subject protection compliance at the federal level. An institution must have a Federal-wide Assurance (FWA) on file with DHHS (renewed every three years) to perform federally funded research with a human subject component. An institution must establish training and oversight mechanisms. See the following site for the Cary Institute’s Human Subject Protection and IRB information:

11 PROPOSAL REVIEW The IRB reviews proposals in two ways : o Expedited Review o No more than minimal risk to subjects, and o Fits into a specific type of procedure; e.g. collection of data from video or voice recording, continuing that was previously approved by the IRB o Full Review o Involves more than minimal risk, or o Research conducted on Special Populations, i.e. children, pregnant women, prisoners, or mentally-impaired persons Minimal Risk = the probability and magnitude of harm or discomfort anticipated in the research are not greater than would be ordinarily encountered in daily life or during the performance of routine physical/psychological tests.

12 Required Training for Work with Human Subjects All researchers involved in any human subject research at the Cary Institute must complete the following NIH training: The training ensures a basic level of knowledge on relevant issues, such as: o The history of unethical HS research and the reasoning behind the ethical regulations used today o The issues of Special Populations, Informed Consent, Justice, and Fairness o The purpose of an IRB and it’s important functions At the end of the training (~2 to 3 hrs), you must print out the certificate of completion and turn it in to the Cary Grants Management Office.

13 Resources The Cary Institute’s link to Compliance with Institutional Review Board (IRB) information: The Website of the Office for Human Research Protections (OHRP). This site has a lot of information, from IRB regulations to international standards. The website below was funded by the Office of Research Integrity. The official title of the project is Educating Staff in Community Agencies about Human Subjects Protection in Research. ori.dhhs.gov/education/products/mass_cphs/training_staff/RCReng/RCRHome.htm

14 I certify that I have completed the RCR Training Module on Human Subject Protection Date Print Name Signature Certificate of Completion Please print out sign and return to Grants and Compliance Office Click to Print


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