The Responsible Conduct of Research. Daniel R. Vasgird, PhD, CIP Research Compliance Services Office of Research Responsibility University of Nebraska, Lincoln (402) 472-1837 firstname.lastname@example.org http://research.unl.edu/orr.
Daniel R. Vasgird, PhD, CIP
Research Compliance Services
Office of Research Responsibility
University of Nebraska, Lincoln
-Integrity in Scientific Research, The National Academy of Sciences
Rules are just a small part of the picture. The alpha and the omega has to be integrity from which all else will follow, including compliance.
ORCS Mission:Foster a culture of integrity and compliance within the University directed at ensuring that participants in the University of Nebraska, Lincoln research enterprise internalize and pursue the goal of self-directed responsible conduct of research.
Stated that the disinterested pursuit of
truth is the norm of science, expressed as:
Perseverance and success,
but for some increased:
Risk for unintentional bias
Willingness to cut corners
Willingness to commit serious misconduct
“Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results… Research misconduct does not include honest error or differences of opinion.”
A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.
National Research ActIn July 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researchwhich established IRBs.
Human dignity and social justice in
an economically and politically
The major responsibility for insuring ethical decision making in human research rests with the IRBs in terms of empowerment, flexibility and discretion.
“Research” means a systematic investigation designed to develop or contribute to generalizeable knowledge. 46.102 (d)
“Human subject” means a living individual about whom an investigator…conducting research obtains
(1) data through intervention or interaction with the individual, or (2) identifiable private information. 46.102(f)
To approve research, an IRB should determine that all of the following conditions exist: 1. Risks to subjects are minimized. 2. Risks are reasonable in relation to anticipated benefits, if any, to subjects and to advancement of knowledge.
3. Selection of subjects is equitable.
4. Informed consent will be sought.
5. Informed consent will be documented.
6. Where appropriate, research plan makes adequate provision for monitoring the data collected to insure safety of subjects. 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.
- verbal instructions - questions & answers after reading ICF with subject
- setting/timing (family/friends consultation) - agreement/documentation
ETHICS IN ETHNOGRAPHIC RESEARCHIn a nutshell, researchers must make their research goals clear to the members of the community where they undertake their research and gain the informed consent of their consultants to the research beforehand. It is also important to learn whether the group would prefer to be named in the written report of the research or given a pseudonym and to offer the results of the research if informants would like to read it. Most of all, researchers must be sure that the research does not harm or exploit those among whom the research is done.http://www.aaanet.org/committees/ethics/ethics.htm