ethics: the responsible conduct of research the university of texas at el paso

Ethics: The Responsible Conduct of Research

The University of Texas at El Paso

Institutional Review Board (IRB) & Human Subjects Research

What are the basic ethical principles of the Belmont Report?

What is an Institutional Review Board (IRB)?

What authority does the IRB have?

What is a good definition for “research” and “human subject”?

IRB & Human Subjects ResearchWhat are the basic ethical principles

of the Belmont Report?

The Belmont Report, which was issued April 18, 1979 after a conference held in February 1976 at the Smithsonian Institution’s Belmont Conference Center in Maryland, identified three basic ethical principles that should govern human subject research. These three principles are:

• respect for persons, • beneficence and • justice.



Respect for Persons

Each research subject is an individual capable of making up his or her own mind about whether to participate in a research study.

Research subjects that have a diminished capability (whether they are immature, incarcerated or incapacitated) are vulnerable.

They receive special protection under federal law (45 Code of Federal Regulations Part 46.



Beneficence

Comes from the Hippocratic maxim “do not harm”.

Subjects in a research study should be protected from research risks, have their decisions respected and their well-being assured.

Researchers need to maximize possible benefits and minimize possible risks to subjects.

An informed consent document is usually required to communicate the risk/benefit ratio and other relevant information to subjects.



Justice

Implies that subjects should be selected equitably.

No one group of subjects, such as the economically disadvantaged, or the institutionalized, should continually bear the burden of research.

IRB & Human Subjects ResearchWhat is the IRB?

An Institutional Review Board (IRB) usually has approximately 13 committee members.

It was established by federal law (45 Code of Federal Regulations Part 46)

Monitored by federal officials at the Office for Human Research Protections (OHRP).


An IRB oversees all research involving human subjects conducted by faculty, students, or staff, or using any university or school district property or non-public information to contact human research subjects.


IRB members are of varied professions and genders. Some members are scientists, nonscientists, and some members may have no affiliation with the institution or school district.

IRB & Human Subjects ResearchWhat authority does the IRB have?

The IRB has the authority to approve, disapprove or modify research protocols. The committee can also suspend or terminate its approval of a research activity.

The committee uses a deliberative process to review protocols. Protocols can either be exempted from IRB review, or reviewed by expedited (review by 2 members) or full committee review (review by a quorum of the 13 members).

IRB & Human Subjects ResearchWhat is a good definition for “research” and “human subject”?

45 Code of Federal Regulations Part 46.102 (d) defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

45 CFR 46.102 (f) lists “human subject” as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Institutional Review Board (IRB) & Human Subjects Research

Will identifiable private data be taken for research that can be linked to the subjects?

How do I know if I need to submit a protocol form for IRB approval?

What are the elements needed in an informed consent document?

IRB & Human Subjects ResearchWill identifiable private data be taken for research that can be linked to the subjects?

It is important to determine:

•whether the research involves the collection of data, documents, records, pathological specimens or diagnostic specimens that are publicly available or non-public

•whether the information collected can be linked either directly or indirectly back to the research subjects or whether it is entirely anonymous.

•Research protocols may be exempted if the data you are collecting 1) existed before your research begins, 2) is publicly available and 3) is anonymous.

IRB & Human Subjects ResearchHow do I know if I need to submit a protocol form for IRB approval?

If you are engaged in a research project where there is an intervention or interaction with a living person from whom data/information/specimens (identifiable or unidentifiable) will be collected using public or non public sources, •you are required to submit a protocol form, informed consent, questionnaires, and any approval letter (from school districts, clinics, hospitals, etc.) needed in your particular project. This policy applies to all research involving human subjects, regardless of funding.

IRB & Human Subjects ResearchWhat are the elements needed in an informed consent document?

These 10 basic parts should be included in your statement of informed consent to research subjects:

1) purpose of the research, time or costs the subject will spend to participate, and a full description of all the procedures to be used with the subject (in simple terms)

2) risks to the subject

3) benefits of participating in the research project

4) alternative procedures or treatments

IRB & Human Subjects ResearchWhat are the elements needed in an informed consent document? (continued)

5) procedures for safeguarding confidentiality of records 6) compensation or medical treatment available for

injury, if applicable7) contact names and phone numbers for PIs for any

questions or injuries 8) participation is voluntary, and the subject may end

his/her participation at any time without any penalty

IRB & Human Subjects ResearchWhat are the elements needed in an informed consent document? (continued)

9) space for signature & date by participant (and parent or guardian, if needed) and PI unless a waiver of signed consent has been granted by the IRB.

10) a Spanish (or other subjects’ language) translation of the English version of the informed consent (depending upon the subjects to be included in the research) at the level of language appropriate for those particular subjects

IRB & Human Subjects ResearchWhere can I find out more information?

Additional information is available at the following Web sites:

The University of Texas at El Paso, Office of Research and Sponsored Projects, Institutional Review Board: http://www.utep.edu/orsp/Compliance/com.etc.html

Office for Human Research Protections (OHRP): http://ohrp.osophs.dhhs.gov

Ethics: The Responsible Conduct of Research

What is misconduct in science?

What constitutes fabrication of research data? Describe falsification in reporting on research

findings. Plagiarism: how do I know if I have pirated

someone’s ideas?

How can I avoid conflict of interest situations?

EthicsWhat is misconduct in science?

According to the Office of Research Integrity, DHHS, “Misconduct will be limited to ‘fabrication, falsification, or plagiarism in proposing, performing or reviewing research or in reporting research results.’” (From ORI Annual Report, 1999)

EthicsWhat constitutes fabrication of research data?

Fabrication of data means that a scientist manufactures a fake set of research results, makes up data or distorts the truth of the experiment.

An example would be a researcher who concocts fake data to plot a graph, thus inventing false research conclusions.

EthicsDescribe falsification in reporting on research findings?

Falsification implies an alteration of data, or distortion of experimental results.

For example, a scientist might falsify the scoring of taped interviews with subjects. The data exists, but has been manipulated and misrepresented.

EthicsPlagiarism: how do I know if I have pirated someone’s ideas?

When a researcher lifts another person’s text, pictures, cartoons, quotations, surveys, graphs, or other ideas into his/her own research paper, without clearly stating who is really responsible for the work, this is plagiarism. Edward E. David, Jr. in Ethics and Values in Science, from a presentation at the February 25-26, 1993 Sigma Xi forum on Ethics, Values and the Promise of Science, defines “Plagiarism - appropriating without proper credit not only others’ words, but also their ideas.”

EthicsHow do I avoid conflict of interest situations?

UTEP Policy/Procedures for Management of Conflict of Interest in Sponsored Research states: “A potential conflict of interest occurs when an individual’s private interests compete with his/her professional obligations to the University to a degree that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. Federal regulations address such conflicts when a significant financial interest could affect or may be reasonably expected to bias the design, conduct or reporting of NSF and/or HHS sponsored research.”

EthicsHow do I avoid conflict of interest situations? (continued)

A researcher (including his spouse and dependent children) has a significant financial interest in a company if his/her salary (consulting fees or honoraria), equity interests (stocks), or intellectual property rights (royalties) exceed $10,000 or are more than five percent ownership interest. “Could any of my or my immediate family’s financial interests potentially be affected in any way by my current or proposed grant/contract supported research?” At UTEP, if a researcher answers “yes” to this question, he/she should disclose this financial interest to the Office of Research and Sponsored Projects as a potential conflict of interest.

EthicsHow do I avoid conflict of interest situations? (continued)

An example of a conflict of interest situation would be a physician working at a university laboratory who has a significant financial interest (stock) in a large pharmaceutical company. He also benefits from research dollars coming back to fuel his drug testing from that company. He stands to gain from the increased value of his stock in the pharmaceutical firm, when the drugs do well on the market.

ethics: the responsible conduct of research the university of texas at el paso

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