Institutional Review Board,Human Subjects Research, and

Ethics: The ResponsibleConduct of Research

The University of Texas at El PasoIRB and Responsible Conduct of Research Training

Institutional Review Board (IRB)and Human Subjects Research

The following topics will be covered in this section:

• What are the basic ethical principles of the Belmont Report?

• What is the Institutional Review Board?

• What authority does the IRB have?

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

• Can identifiable private data be taken from 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?

• When can I begin data collection from human subjects?

• Who is responsible for reporting any problems/injuries with research subjects?

• Where can I find out more information?

Institutional Review Board (IRB)

and Human Subjects Research (continued)

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.

What are the Basic Ethical Principles

of the Belmont Report?

What are the Basic Ethical Principles

of the Belmont Report? (continued) 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).

What are the Basic Ethical Principles

of the Belmont Report? (continued)

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.

What are the Basic Ethical Principles

of the Belmont Report? (continued) 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.

• The Institutional Review Board (IRB) at The University of Texas at El Paso (UTEP) is a committee representing various research disciplines.

• It was established by federal law (45 Code of Federal Regulations Part 46) and the Multiple Project Assurance document signed by UTEP and federal officials at the Office for Human Research Protections (OHRP).

• The IRB oversees all research involving human subjects conducted by faculty, students, or staff, or using any University property or non-public information to contact human research subjects.

What is the IRB?

• IRB members are of varied professions and genders. Some members are scientists, nonscientists, and some members have no affiliation with UTEP.

What is the IRB? (continued)

• 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 members), or full committee review (review by a quorum of members).

What Authority Does the IRB Have?

• 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 a “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.”

What is a Good Definition for “Research” and “Human Subject”?

Could Private Data be Taken from Research that Can be Linked to the

Subjects? It is important for you to determine whether your research involves

the collection of data, documents, records, pathological specimens or diagnostic specimens that are publicly available or non-public and whether the information that you collect 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 begins2. Is publicly available, and 3. Is anonymous.

How 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.

What Happens Once I Submit the Form?

• Principal Investigators (PIs) submit the protocol form and all other documents to the Office of Research and Sponsored Projects (ORSP) Institutional Review Board (IRB) via IRBNet (www.irbnet.org).

• The ORSP reviews the protocol for completeness and makes a preliminary determination of the review status as exempt, expedited or requiring full committee review.

• PIs are generally required to have an IRB protocol in “pending status” before submission of a grant application.

What Happens Once I Submit the Form? (continued)

• IRB approval can take two weeks to complete, depending upon the research project involved.

• The protocol must be approved by the IRB before any research data collection can begin.

• You will receive an email notification from ORSP when the protocol has been approved.

• In your study documents at www.irbnet.org, your memo of determination will be available to you and your

collaborators to be used as needed.

• Protocols are usually approved for a one year period.

• PIs must submit their protocols for review at least two weeks before the expiration date, and is reviewed until the research has concluded.

• ORSP will send a notice of renewal to the PI prior to the protocol’s expiration.

• All changes to the protocols, as approved, must be submitted for subsequent review prior to implementing any changes.

What Happens Once I Submit the Form? (continued)

What 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.5. Procedures for safeguarding confidentiality of records.6. Compensation or medical treatment available for injury, if

applicable.

7. Contact the ORSP for any questions, injuries or for the names and phone numbers of PIs and Institutional Coordinator for Research Review.

8. Participation is voluntary, and the subject may end his/her participation at any time without any penalty

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’ languages) 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.

What Are the Elements Needed in an Informed Consent Document? (continued)

When Can I Begin Data Collectionfrom Human Subjects?

The involvement of human subjects in research, including faculty or staff projects, surveys, theses, dissertations and all student human subject research projects, may not begin until the IRB has reviewed and approved the research protocol, informed consent, and testing instruments. Approval letters for off campus research performance sites (such as school districts, clinics, hospitals, etc.) must be on file with this office before the study data collection may begin.

The PI will receive an email notification confirming approval of the protocol. In the study documents at www.irbnet.org, your memo of determination will be available to you and your collaborators to be used as needed. Once IRB approval has been obtained, the PI must obtain appropriate informed consent from each subject prior to collecting research information.

When Can I Begin Data Collectionfrom Human Subjects? (continued)

• PIs will promptly report to the IRB any injuries or other unanticipated problems encountered during the course of the research study.

• PIs should call the Office of Research and Sponsored Projects (ORSP) at 915-747-8841 to report research-related injuries or problems.

Who is Responsible for Reporting any Problems/Injuries with Research Subjects?

Ethics: The Responsible Conductof Research

The following topics will be covered in this section:– 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?– How do I renew or make changes to an approved IRB protocol?– When do I cease research on an approved IRB protocol?– How do I file an amendment to my approved protocol?– What do I do if problems/injuries occur with my subjects after

IRB approval of my research?

What 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)

• 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.

What Constitutes Fabricationof Research Data?

• 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.

Describe Falsification in Reportingon Research Findings

Plagiarism: 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.”

How Do I Avoid Conflictof 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.”

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 ORSP as a potential conflict of interest.

How Do I Avoid Conflictof 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.

How Do I Avoid Conflictof Interest Situations? (continued)

How Do I Renew or Make Changes to an Approved IRB Protocol?

Continuing IRB review of an approved IRB protocol must be handled in a substantive and meaningful manner by the IRB before the protocol expiration date (see last approval memo for expiration date). The researcher (PI) will be reminded via email that his/her protocol is expiring. Researchers need to submit a renewal request via www.irbnet.org at least two weeks before protocol’s expiration date. The progress report questions are located in the online document library and this must be included with the request along with current consent documents and any changes they wish to make in their protocol and other documents related to the study. Researchers may elect to terminate their protocol if the studyis no longer active.

When Do I Cease Research on an Approved IRB Protocol?

A protocol is considered expired at the end of its protocol period. All research related to this study must cease

unless a renewal request is approved by the IRB. This renewal request must be submitted via www.irbnet.org at least

twoweeks before the study expiration date. The IRB office will process the renewal through IRB review. You will be

notified by email when the review process is complete. The determination letter will be available with other study documents at www.irbnet.org.

An approved IRB protocol may be modified during its protocol period by submitting a revision package via www.irbnet.org. This package must include informed consents, procedures, research sites, subjects, testing instruments, a change in PI, etc. The PI needs to identify the nature of the changes in the amendment request; i.e., additional questions in a survey instrument, change in data collection method, etc. All amended documents need to be included in the revised package submitted on www.irbnet.org. If a research site is being added, an approval letter from that site is required in order to receive IRB approval.

How do I File an Amendment to My Approved Protocol?

When an amendment is approved by the IRB, the original protocol period (from the date the protocol was first approved or the last renewal approval) will stay in force for the amendment approval. Example: If a protocol was initially approved for a protocol period of January 1, 2007 through December 31, 2007, and an amendment to that protocol is presented in June, 2007, the date of the amendment approval will reflect the date the IRB approved the protocol amendment, but the protocol period listed on the amendment approval will remain January 1, 2007 through December 31, 2007.

How do I File an Amendment to My Approved Protocol? (continued)

What Do I Do if Problems/Injuries Occur With My Subjects after IRB Approval of My

Research?

The PI of a research project has the responsibility to protect

the rights and welfare of human research subjects, including

the requirements to provide each subject with an IRB-approved informed consent document, and to promptly

report to the IRB office via phone or email any injuries, adverse events, unexpected problems or additional risks of harm or discomfort previously unrecognized if encountered during

the course of the study.

Where Can I Find Out More?

• Office of Research and Sponsored Projects (ORSP)Administration Building, Room 209915-747-5680 or irb.orsp@utep.edu

• Institutional Coordinator for Research Review for the Institutional Review BoardAdministration Building, Room 209915-747-5680or irb.orsp@utep.edu

• The University of Texas at El Paso,Office of Research and Sponsored ProjectsInstitutional Review Boardhttp://research.utep.edu/Default.aspx?

tabid=13100

• Office for Human Research Protections (OHRP)http://www.hhs.gov/ohrp/

If you are a UTEP employee, a copy of the completion certificate for this training module needs to be included when submitting a protocol to the ORSP Office, unless you already have one on file in that office.

Where Can I Find Out More? (continued)