VT Human Subject Protections Tutorial

(downloadable version)

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1 About this Tutorial

The content of this tutorial is split into two main sections:

  • Section 1: Compliance
  • Section 2: Ethics (Note: the formal title of this section is Threats to Ethical Decision Making During Research)

Both sections (Section 1 and Section 2) are required reading. The required quiz following Section 1 and Section 2 must be completed to receive credit for the completion of the VT Human Subjects Protection Tutorial.

Each section contains a table of contents drop down menu for your convenience; however, you do not need to use the table of contents drop down menu to get through the tutorial. Instead, simply click the "next" button after you have read each page and you will be directed through the entire tutorial and to the required quiz. If you'd like a downloadable version of this tutorial's content (in PDF form), click the "downloadable version" link above (top-right corner of screen).

The first section called "Section 1: Compliance" will help you and your research team to learn more about the development of codes and principles of research ethics, the informed consent process, selection and recruitment of research participants, protection of confidentiality of subjects, and regulation of research. You will also learn the basics of submitting VT IRB protocols and what will be expected of you, as a researcher, after you have obtained initial VT IRB approval.

The second section called "Section 2: Ethics" (Threats to Ethical Decision Making During Research) will help you and your research team to learn about a variety of factors that can undermine researchers' ability to make ethical decisions when conducting research with human subjects.

This tutorial is certainly not exhaustive, and the VT IRB promotes further education of researchers regarding the principles of research ethics.

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Introduction | « Page 2 of 3 »

2 Reason for Training

In October 2000, the National Institutes of Health (NIH) established a policy requiring education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects.

To further demonstrate Virginia Tech’s commitment to the protection of human subjects, the VT IRB’s policies state that it will hold all research conducted at the institution to the same standards as federally funded research.

In conclusion, the VT IRB requires completion of human subjects protection training for all investigators (internal or external) of a project. This tutorial is only one of several options available that are accepted by the VT IRB. Visit our website at http://www.irb.vt.edu/pages/training.htm for additional training options.

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3 Importance of 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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