RESEARCH ETHICS By Dr. Anant R. Kukreti Director for Engineering Outreach Professor Department of Biomedical, Chemical and Environmental Engineering (Presentation prepared using one created By Dr. Richard Miller)

Research ethics are simple, right? Don’t fudge your data. Don’t mislead people. Don’t take money to get the “right” answer. Don’t try to profit from your research.

WHY THE EMPHASIS ON ETHICS? Many previous abuses. Unethical and reprehensible experiments on human subjects. Acceptance of gifts or research support in return for “good” results. Burying “bad” results. Disclosure of unverified results for Publicity To obtain additional funding Purposeful attempts to mislead for political reasons.

MISCONDUCT Knowingly falsifying data, results, conflict of interest statements or other things related to your research for personal gain. Honest errors are not misconduct. The key here is intent to deceive. Misconduct is usually a punishable offense. Legal punishment Job discipline

UNETHICAL BEHAVIOR Not necessarily misconduct. Some violation of usual norms of fairness and integrity. May or may not be a punishable offense. Errors are not unethical behavior but not reporting them is (unless the error is clearly harmless)

Respect for Intellectual Property Confidentiality Resnik (http://www.niehs.nih.gov/research/resources/bioethics/whatis.cfm) offers these guiding principals: Honesty Objectivity Integrity Carefulness Openness Respect for Intellectual Property Confidentiality Responsible Publication Responsible Mentoring Respect for Colleagues Social Responsibility Non-Discrimination Competence Legality Animal Care

HONESTY Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, granting agencies, or the public. (Resnik)

HONESTY (Cont.’d) The important part here is DISCLOSURE. For example, sometimes you have to manipulate data by eliminating obviously incorrect data (e.g. sensor malfunction). What is important is that you retain records of the original data AND clearly disclose that you have eliminated “ratty” data.

OBJECTIVITY Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research. (Resnik)

OBJECTIVITY (Cont.’d) No human being is EVER 100% objective. We all have biases, prejudices and preconceived notions. Objectivity is about trying to minimize these bias and, more importantly, admit they exist and be willing to take a hard look at one’s own objectivity.

INTEGRITY Keep your promises and agreements; act with sincerity; strive for consistency of thought and action. (Resnik)

INTEGRITY (Cont.’d) CONFLICT OF INTEREST Bias Conflict of interest is when you have some direct personal interest in the outcome of a project OR it could be perceived that your personal interest would bias your results. Bias Bias is when there is something other than a direct personal interest which may affect your objectivity.

INTEGRITY (Cont.’d) EXAMPLES OF CONFLICT OF INTEREST You own stock in a company sponsoring your research. You do other work, especially personal service work, for a research sponsor. You hire a subcontracting company owned by a family member or friend. You are judging proposals when you are one of the proposers.

INTEGRITY (Cont.’d) EXAMPLES OF BIAS You are reviewing the work of a friend (or enemy). You are reviewing proposals and a friend has submitted a proposal. You are reviewing work that confirms or refutes previous work you have done.

INTEGRITY (Cont.’d) You do not necessarily have to disqualify yourself for conflict of interest or bias. You MUST disclose conflict of interest or bias and let the appropriate people decide your eligibility. For conflict of interest, you can sometimes have a conflicting management plan.

CAREFULNESS Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals. (Resnik)

OPENNESS Share data, results, ideas, tools, resources. Be open to criticism and new ideas. (Resnik) However, be careful of confidentiality agreements. Also, some agencies do not allow release of data until it has been checked by a review panel for accuracy.

RESPECT INTELLECTUAL PROPERTY Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give credit where credit is due. Give proper acknowledgement or credit for all contributions to research. Never plagiarize. (Resnik)

RESPECT INTELLECTUAL PROPERTY (Cont.’d) Most people would not shoplift or rob someone’s house. Intellectual property is the product of academics. If someone “steals” it, it is no different than stealing a car. Unfortunately, the internet makes plagiarism easy. Even if something is an “open source”, not crediting a source is unethical.

CONFIDENTIALIATY Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records. (Resnik) There are those who WILL steal the work of others. Don’t help them by disclosing information before owner is ready.

RESPONSIBLE PUBLICATION Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication. (Resnik)

RESPONSIBLE PUBLICATION (Cont.’d) Academia has always been about “publish or perish.” There is a lot of pressure to “get the numbers up.” Number of publications is often used as a factor in ranking. However, irresponsible publication practices (like publishing the same paper multiple times) often come back to haunt the dishonest.

RESPECT FOR COLLEAGUES AND RESPONSIBLE MENTORING Respect your colleagues and treat them fairly. Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions. (Resnik) It is easy to treat student and junior colleagues as indentured servants. Never threaten withholding graduation or tenure except for reasons of incompetence or poor quality work.

SOCIAL RESPONSIBILITY Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy. (Resnik) This can be a balancing act. Often, researchers want to please a sponsor, but if the results show social harm, the researcher is honor bound to disclose it. Researchers should not be doing research just for the sake of doing research, getting a grant or publishing a paper. There should be some advancement of science or humanity.

COMPETENCE Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole. (Resnik)

NONDISCRIMATION AND LEGALITY Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors that are not related to their scientific competence and integrity. Know and obey relevant laws and institutional and governmental policies. (Resnik)

HUMAN SUBJECT AND ANIMAL CARE/PROTECTION When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly. Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments. (Resnik)

HUMAN SUBJECT PROTECTION REMEMBER: Human subject research MUST be approved by the Institutional Review Board (IRB). A human subject protocol MUST be approved, filed and followed!

ESSENTIALS OF HUMAN SUBJECT PROTECTION Human subjects must be fully informed That they are in an experiment What is the objective/how is data used They can opt out at any time If this information would affect the experiment, additional protection is needed. Additional protection is needed for minors.

ESSENTIALS OF HUMAN SUBJECT PROTECTION (Cont.’d) Data and confidentiality MUST be protected. Data can only be reported in aggregate or anonymous ways. Care must be taken that no individual can be identified unless that person gives permission. There must be PHYSICAL protection of data (locked cabinets, passwords, etc.)

ESSENTIALS OF HUMAN SUBJECT PROTECTION (Cont.’d) Surveys for internal use as QC/QA are NOT human subject research Research which asks humans for facts or information obtainable from public sources is not human subject research BUT anything that asks for opinion or estimate is!

Resnik offers these concrete examples of unethical behavior: Publishing the same paper in two different journals without telling the editors Submitting the same paper to different journals without telling the editors Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper Discussing with your colleagues confidential data from a paper that you are reviewing for a journal Trimming outliers from a data set without discussing your reasons in paper or using an inappropriate statistical technique in order to enhance the significance of your research Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work

Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field Stretching the truth on a job application or curriculum vita Giving the same research project to two graduate students in order to see who can do it the fastest Overworking, neglecting, or exploiting graduate or post-doctoral students Failing to keep good research records Failing to maintain research data for a reasonable period of time Making derogatory comments and personal attacks in your review of author's submission

Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board Not reporting an adverse event in a human research experiment Wasting animals in research Exposing students and staff to biological risks in violation of your institution's biosafety rules

Rejecting a manuscript for publication without even reading it Sabotaging someone's work Rigging an experiment so you know how it will turn out Making unauthorized copies of data, papers, or computer programs Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

DUH! Ethics I call the things on the previous slides: Any reasonable person should KNOW or at least suspect these things are wrong!

The truly difficult cases are the gray areas of ethics. Sometimes, there is no clear rule or clear solution.

GRAY AREAS Disclose – You are always better off if people KNOW what you did. Fairness – Chose what you think is the fair solution. Know the rules or ASK! Keep good records.

SUMMARY Research ethics are largely common sense. Disclosure is key. As long as people are aware of data analysis/manipulation, bias, and conflict of interest you are probably OK. Special protection is needed for human subjects (IRB Approval).