VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
3 Importance of Research Ethics & Compliance
Societies and cultures around the world establish for themselves moral standards or rules (personal ethics) which define right or wrong conduct by members within the societies, and which establish punishments for those who violate those standards/rules. Those moral standards seek to ensure that people act in ethical ways in their interactions with others in society. Professional groups and organizations within a society also establish ethical principles which mandate practices and behavior of professionals when they act in an official capacity (e.g., business, legal, medical, and scientific research ethical practices). In contrast to personal ethics, which are generally written into legal codes, adherence to professional ethics is typically self-regulated within the professional organization.
As noted in the “History” section to follow, some individual researchers have valued the acquisition of scientific knowledge more highly than the protection of human subjects’ rights and well-being. Significant harm to and death of subjects has occurred when scientists failed to adhere to basic moral standards/rules such as:
- Concern for the well-being of others
- Respect for the autonomy of others
- Trustworthiness & honesty
- Willing compliance with the law (with the exception of civil disobedience)
- Basic justice; being fair
- Refusing to take unfair advantage
- Benevolence: doing good
- Preventing harm
When professional organizations fail to adequately regulate the conduct of their members (through voluntary regulation), the Government generally steps in to enact involuntary (mandatory) regulations which must be followed, and if violated, the perpetrator risks legal action and criminal punishment or financial sanctions. Because of problems with research conducted in the past in the U.S., Congress has passed a variety of legislation intended to force professionals to adhere to personal and professional ethical principles which they should innately follow.
Virginia Tech expects its faculty and student researchers who use human subjects in research to: (1) adhere to established personal (societal) ethical practices; (2) follow professional ethical principles established by their respective disciplines; (3) ensure full compliance with federal regulations governing protection of human subjects; and, (4) ensure full compliance with Virginia Tech policies and procedures which address protection of human subjects. Failure to comply with those four points may result in loss of privileges to conduct research at the University, and could result in loss of federal funding, or withdrawal of federal permission to conduct research affecting all researchers at the institution.
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