Human subjects protection in research ethics and regulations

Ethics and Morality: Human Subjects' Protection

From a Yelp to a Roar

Challenges to Changes

Either you be

From a Yelp to a Roar

You convert the whole medical system into a giant jaws and the individual's only possible response is a yelp of protest." (May 1988)

To quell criticism that protections are slim for the thousands of patients in clinical trials of new drugs and medical treatments," (Whitelaw 2000) reportedly stimulated the idea to create the Office for Human Research Protections, introduced during President Clinton's administration in 2000. Previously, a small office within the National Institutes of Health held this responsibility, which was expanded to increase the oversight of not only federally funded tests, but all human-subject research. In turn, protests for individuals used in research projects became more of a roar than a yelp.

Challenges to Changes

As the reported role of an Institutional Review Board (IRB) or Ethics Committee in an academic medical center is to approve, require changes, or disapprove medical research studies, problem areas encountered by prestigious universities across the United States over the last several years from government audits done by the Office of Human Subjects Protections or the Office for the Protection of Research Risks include:

Protecting research subjects fostering a robust research program monitoring and regulating the activities that constitute this program...." (Wynes, Martin, and Skorton)

Wynes, Martin, and Skorton additionally note, along with these pertinent problems/challenges, another current crisis universities face is the challenge to comply with agency interpretations of regulations as many universities basically,.".. constitute new rules imposed without the normal rulemaking process."

Institutional Review Boards (IRBs), created by universities and academic medical centers, establish committees called to review experimental protocols involving humans. Traditionally, as federal regulations were regarded as performance-based guidelines, IRBs discretionally acted on a protocol-by-protocol basis. Temporary shutdown of several academic IRBs during the past few years, along with the ensuing cessation of clinical research, encouraged administrators and researchers to begin to better protect subjects enrolled in trials, in order to move forward with their research projects. (Wynes, Martin, and Skorton)

In order to continue to move forward with its research projects, Eastern Virginia Medical School requires "Researchers must obtain human subjects protections training annually. This requirement may be satisfied by attending a training session offered by a professional association or training organization." ("IRB Policy Highlights" 2006) in addition:

Regardless of severity, Unanticipated Problems/Adverse Events must be promptly reported.

Audits of IRB approved studies are periodically conducted

EVMS faculty engaging in human subject research must have the research reviewed by the EVMS IRB. "Community faculty using their EVMS credentials or referencing EVMS in publications related to the research must also submit the research through the EVMS IRB." (Ibid)

The University of Medicine and Dentistry of New Jersey instituted their Human Subjects Protections Program during the fall of 2000 to insure they could continue completing research projects. "Mandatory education in the ethics and the practical application of the principles of human subjects' protection is monitored via the IRB approval process. IRB approvals are not issued until an investigator and his research staff can demonstrate that they have completed the web-based training program." ("UNIVERSITY POLICY" 2006)

Along with mandatory education, regular and "for-cause audits of on-going studies," are also currently in place.

If/when human subjects become ill or sustain physical injury as an express result or research participation, along with other actions to be taken:

1. The injured subject which shall be admitted to the hospital and/or outpatient treatment facility, if practicable, for treatment at a University-owned or University-affiliated patient care unit.

2. The Research Dean, the Dean, the Vice President of the patient care unit, and the IRB Chair will be immediately notified.

Either you be...

Should a faculty colleague oppose local IRB mandated training, this researcher would present words from Golda Meir, former Prime Minister of Israel, would be presented:

To be or not to be is not a question of compromise. Either you be or you don't be."

The colleague would be reminded of potential budgeting cuts for noncompliance, and/or that if funds were discontinued for adhering to mandated training, his/her job would also be in danger of being "cut."

The reminder of Herman Weinkrantz that "... court will not deny the equal protection of the law to the unwashed, unshod, unkempt and uninhibited," would also be cited as the colleague would also be reminded that he/she could be tomorrow's newspaper's headlines. This researcher would also review the report by Shamoo, and Resnik (vii) that: "In the last decades of the twentieth century, media headlines featuring research misconduct in American universities focused public attention on the dramatic ethical problems that can arise in research. In some instances, investigators have been accused and occasionally found guilty of falsifying, fabricating, or plagiarizing data. Other cases have involved such allegations as the theft of ideas from grant applications and the abuse of human subjects in research protocols."

Non-compliance with training could trigger more investigations that could that may or may not implicate other "mistakes."

This researcher would retrieve a copy of the November 15, 2001 Washington Times news article for the colleague to show him/her that even Johns Hopkins University's school of arts and sciences was hesitant to require researchers to be trained. Training programs, however, it has been confirmed.".. ensure researchers understand their roles and duties - such as obtaining valid informed consent - and how to use guidelines and regulations to protect human subjects." (Hyslop 1)

The reluctant colleague would be reminded of the highly publicized deaths in 1999 and 2001 of two volunteers participating in clinical research trials brought attention to what some consider weaknesses in the federal oversight of biomedical research using human subjects," ("House Bill Would Bolster") and that as the need for human participants increases, so does the need for universities to comply with IRBs training requirement. Although the federal government currently deems responsibility for research conduct to sites where research is completed, and agencies only step in when cause arises and/or when policy implementation mandates additional action, this could change, the colleague would be reminded.