Research

Research at Trevecca

Trevecca Nazarene University faculty and students are involved in a number of research projects.  Some research reflects faculty and students' professional research interests and some research is related to class or program requirements.  All research conducted by Trevecca faculty and students, and all research conducted at Trevecca Nazarene University by outside groups, must be approved by Trevecca Nazarene University's Institutional Review Board.

Information about Trevecca Nazarene University's Institutional Review Board (IRB) can be found within the below navigation.

IRB Home Page

Institutional Review Board

Trevecca Nazarene University's Institutional Review Board (IRB) is responsible for ensuring compliance with established federal and university procedural and ethical guidelines for research.
 

Mission

The mission of the Institutional Review Board is to:

1) Guard and protect the rights and well-being of human subjects
2) Promote the integrity of researchers in demonstrating leadership and compassion in dealing with their research subjects
3) Foster community respect for Trevecca's process in carrying out quality research while ensuring the dignity of research participants
4) Ensure compliance with established federal and university procedural and ethical guidelines.

 

Responsibilities

The Institutional Review Board will review all research involving human subjects.  The IRB may approve, modify, or disapprove any research project not meeting the principles and ethical constrains of governmental or the university's guidelines concerning treatment of human subjects.  The board will be responsible to review initial projects, projects continuing past a 12-month time frame, and any project where the methodology changes substantively.

Researchers under the auspices of the Institutional Review Board:
Everyone whose research involves human subjects should submit an application for approval:
1. All Trevecca faculty, staff, and administrators
2. All doctoral candidates
3. All students doing non-class related research (must be under the supervision of a faculty mentor)
4. All non-Trevecca persons applying to use Trevecca's students, faculty, staff, or administrators in their research
5. All faculty members requiring class-related research must submit a general outline of their students' projects to ensure the safety of human subjects and to establish accountability.

Contact Information

For questions about the Institutional Review Board, human subjects research, or other research-related issues, you can contact the Chair in the Institutional Review Board via email at IRB@trevecca.edu or by regular mail at the following address:

Institutional Review Board
Office of Academic Affairs
Trevecca Nazarene University
333 Murfreesboro Rd.
Nashville, TN  37210

 

IRB History

Historical Examples of Exploitation of Human Subjects

Nazi Medical War Crimes

During World War II, Nazi physicians conducted experiments on thousands of concentration camp prisoners which were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected.  "Medical experiments" included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons.  More information about the Nuremberg trials against the physicians is available at the U.S. Holocaust Memorial Museum web site.

In December 1946, 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments.  Despite the arguments from German physicians that the experiments were medically justified, the Nuremberg Military Tribunals condemned the experiments as "crimes against humanity."  In the 1947 verdict, the judges included a section called "Permissible Medical Experiments."  This section became known as the Nuremberg Code and has formed the basis for ethics codes internationally.
 

The Tuskegee Syphillis Study

The most notorious example in the United States of prolonged and knowing violations of the rights of a vulnerable group of research participants was the long-term study of black males conducted at Tuskegee by the United States Public Health Service. This study was initiated in the 1930s as an examination of the natural history of untreated syphilis; it continued until 1972.

More than 400 black men with syphillis participated, and about 200 men without syphilis served as controls.  The men were recruited without informed consent and, in fact, were misinformed that some of the procedures done in the interest of research (e.g., spinal taps) were actually "special free treatment."

By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, a report of the study indicated that the death rate among those with syphilis was about twice as high as it was among the controls.  In the 1940s, penicillin was found to be effective in the treatment of syphilis.  The study continued, however, and the men were neither informed nor treated with the antibiotic.

The first accounts of this study appeared in the national press in 1972.  The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare to review the study and advise on how to ensure that such experiments would never again be conducted.  Among the recommendations was the request that Congress establish a "permanent body with the authority to regulate, at least, all federally supported research involving human subjects."

In acknowledgment of its responsibility, the Government continues to compensate surviving participants and the families of deceased participants. 

Additional information can be found at this web site:
Tuskegee Syphilis Experiment    
 
Information about the changes instituted as a result of the Tuskegee Syphilis Study can be found on the web site of the Centers for Disease Control and Prevention.   It can be found under "T" in the A-Z index or by typing "Tuskegee" in the search box.
 

Jewish Chronic Disease Hospital Study

In 1963, studies were undertaken at New York's Jewish Chronic Disease Hospital to undestand whether the body's inability to reject cancer cells was due to cancer or debilitation.  Previous studies had indicated that healthy persons reject cancer cells promptly, and the researchers allegedly believed that the debilitated patients would also reject the cancers but at a substantially slower rate when compared to healthy participants.

These studies involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases.  Consent had been given orally, but did not include discussion on the injection of cancer cells, and consent was not documented.  The researchers felt that documentation was unnecessary because it was customary to undertake much more dangerous medical procedures without the use of consent forms.

Patients were not told that they would receive cancer cells, because the researchers felt it would unnecessarily frighten them. Researchers defended this view with the assertation that they had good cause to predict that the cancer cells wre going to be rejected.

In subsequent review proceedings conducted by the Board of Regents of the State University of New York, it was found that th study had not been presented to the hospital's research committee and that the physicians responsible for the pateints' care had not been consulted.  The researchers were found guilty of fraud, deceit, and unprofessional conduct.  
 

The Willowbrook Study

The vulnerability of children, especially institutionalized children, as participants in research is demonstrated in a series of studies conducted from 1963 to 1966 at the Willowbrook State School, a New York institution for "mentally defective" children.  In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances, newly admitted chidlren were deliberately infected with the hepatitis virus.  Researchers defended the deliberate injection of these children by pointing out that the vast majority of them would acquire the infection anyway while at Willowbrook, given the crowded and unsanitary conditions, and because only children whose parents had given consent were included.

During the course of these studies, Willowbrook closed its doors to new patients, claiming overcrowded conditions.  However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients.  Thus, in some cases, parents found they were unable to admit their children to Willowbrook unless they agreed to their participation in the studies.

This controversial case raised important questions about the adequacy and freedom of consent, inadequate disclosure of the child's risk of later developing chronic liver disease, and the lack of information given to parents about access to doses of gamma globulin for their children.
 

Note: much of this information is derived from the National Institutes of Health Tutorial.  The full tutorial is available at http://phrp.nihtraining.com/users/login.php

 

IRB Training

Training

Why is training in human subjects protection important?

The principles of protection of human participants in research were established in the Belmont Report in 1979.  The Belmont Report, prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, identified three principles essential to the conduct of research with humans: respect for persons, beneficence, and justice.  The links below provide additional information about research studies that violated the rights of vulnerable groups of human subjects, along with federal documents concerning the protection of human subjects.

The Nuremberg Code
The Belmont Report   
45 CFR 46 - Code of Federal Regulations Section regarding the Protection of Human Subjects


Who should take the training on human subject participation?

Any research involving humans or human tissues conducted under the auspices of Trevecca Nazarene University must be reviewed by the Trevecca Nazarene University Institutional Review Board (IRB).  Research with minimal involvement of human participants, such as surveys or questionnaires, require some procedural IRB review. Anyone whose research project requires IRB review must submit a completed certificate indicating that he or she has completed the training.

The following people may require training, depending on their research:

    Doctoral students
    Doctoral advisers
    Management and Human Resources (MHR) students whose thesis research involves human subjects
    MHR thesis advisers
    Students conducting non-class-related research under the guidance of a faculty member
    Researchers applying to use Trevecca Nazarene University's students, faculty, staff or administrators in their research

 
How can I be trained in human subject protection?

This free, web-based course presents information about the rights and welfare of human reserach participants, and describes the responsibilities of the investigator to minimize risk to them.  All researchers must complete the training course.
You will have the option of printing a certificate of completion at the end of the course.  The certificate of completion must be printed out, signed, dated, and attached to the proposal that is submitted to the IRB.  

To access the training course, follow the steps below.  If you have any questions after completing the training, contact our advisor or the IRB chair via email at IRB@trevecca.edu.

STEP 1

Go to the National Institute of Health web site:  http://phrp.nihtraining.com/users/login.php.

STEP 2
Click on the "Registration" button to set up an account.

STEP 3
Once you have set up an account, you can work on the tutorial at your own pace.  You should be able to do a section at a time, if you wish.

STEP 4
Follow the directions on the screen and proceed through the tutorial.  When you complete the tutorial, be sure to print the certificate that shows you have successfully completed the tutorial. 
The certificate of completion must be printed out, signed, dated, and attached to the proposal that is submitted to the IRB.

Mailing address:

Institutional Review Board
Office of Academic Affairs
Trevecca Nazarene University
333 Murfreesboro Rd.
Nashville, TN  37210

Email address:
IRB@trevecca.edu

 

IRB Forms

Forms

The following forms should be used by those conducting research at Trevecca.  If you have questions, please consult with your advisor or contact the IRB Chair.

Application Form

Click on the link below to download the IRB Application form.  Be sure to save it to your computer.  Fill out the form electronically, print it, sign it, and submit it to your faculty adviser for signatures.  Once all required signatures are obtained, the application should be scanned as a single PDF file including:
 
application
completed signature page
certificate of training in human subject protection
a copy of any instruments which will be used in your research
 
and emailed as an attachment to the IRB Chair:  IRB@trevecca.edu
 
Only applications submitted as a single PDF file will be accepted for review.

 IRB Application form


Informed Consent Form

Informed consent is required for most research projects. The researcher should confer with his or her faculty adviser to determine the appropriate consent form to use.  A sample of the consent form(s) should be included with the application.  The links below provide some sample consent forms, which should be edited so that they are specific to your research project.

Class Research 

Certain classes require all students to conduct research projects involving human subjects under the guidance and supervision of the faculty member teaching the class.  For these classes, the following form can be used to secure IRB approval of the research projects of the class.