counselors as researchers

Running head: COUNSELOR RESEARCH 1

Counselors as Researchers

Myrna Davis-Washington

University of the Rockies


Counselors as Researchers

Instead of identifying themselves as researchers, most

counselors and psychologists perceive research as an activity for

professionals in academia or in specialized settings. Since most

schools and community agencies are experiencing increased

pressures for accountability and third party financial supporters

(i.e., pharmaceutical companies) are seeking more effective

evidence-based treatments that produce the outcomes that

practitioners expect, practicing professionals can no longer

relinquish involvement in research and evaluation. Instead, they

must view themselves as ‘counselor/researchers,’ refresh their

clinical research skills, and reacquaint themselves with the

ethical issues in research in clinical and educational settings.

Because conducting research can be expensive, securing adequate

funding can provide ethical challenges for counselor/researchers,

especially in an era in which pharmaceutical companies, insurers,

and other for-profit entities (some of the few sources with the

resources to fund studies) are often interested in supporting


research on therapeutic interventions. In addition, clinical

studies have become so expensive to conduct that multiple sources

of funding often support a single study and pharmaceutical

companies often hire counselors as researchers to conduct studies

on potential psychopharmacological agents for treating mental

illnesses. (Welfel, 2010; Schwartz, Curfman, Morrissey, and

Drazen, 2008)

While some say that the funding of research by

pharmaceutical compromises the objectivity of the researchers and

their ability to present results contradictory to the interests

of the companies, others say that this funding is not necessarily

problematic and that pharmaceutical companies have a right to

conduct research in their areas of interest. This paper discusses

the credibility of research funded by pharmaceutical companies,

the ethical implications of accepting funding from a for-profit

company, whether it should be discouraged, and how professionals

should handle such circumstances.

In this author’s opinion, pharmaceutical companies have a

right to and should conduct research in their areas of interest;

how else can they strengthen the credibility and effectiveness of


their products? This concurs with the basic fiduciary

responsibility of the counselor/researcher to regard the client’s

welfare above all else. In active research, the client derives

the ancillary benefits of rigorous standards of investigation and

care, the recruitment of outstanding counselors and students,

early availability of the most effective proven therapies, and

early recognition of unsafe or ineffective therapies and

diagnostics. Clinical research combines the discoveries from

basic sociobehavioral research with the observations and insights

of the counselor/researcher to: (2) test potential therapeutic as

well as diagnostic and preventive measures in preclinical

settings where appropriate; (2) proceed to rigorous evaluation in

humans; (3) make formal comparisons between current agents and

practices; (4) develop new ones, and (5) determine optimal

efficacy and safety. Strengthening clinical research will enable

counselor/researchers to bridge the research translation gap

between the discoveries and insights gained from basic

sociobehavioral research and the careful evaluation of new

agents and approaches for diagnosis, prevention, and therapy in

patients and healthy individuals at risk. Strong clinical


research ensures that the flow of energy from bench to therapy to

community is bidirectional; as discoveries flow from the

laboratory to the client, clinical observations and questions

flow back to provide new directions for basic directions.

Moreover, funding from pharmaceutical companies helps to ensure

that discoveries made in the U.S. can be further developed and

evaluated in the U.S. These benefits then flow to the clients

because of new economic activity and an improved and more

efficient mental health care system. (Claims, 2004).

In addition to reacquainting and familiarizing themselves

with the ethical issues in research in clinical and educational

settings espoused by the American Psychological Association (APA,

2002, Standard 8) and the American Counseling Association (ACA,

2005, Section H); giving priority to their fiduciary

responsibility to honor the dignity of their clients and the

fundamental principles of ethics (i.e., respect for human

autonomy, nonmaleficence, beneficence, justice, and fidelity);

and acting as advocates for their clients; the essential ethical

responsibilities of the counselor/researcher include a number of

responsibilities. These include: (1) developing scientifically-


acceptable research protocols that are worth participants’ time,

having a reasonable chance of yielding meaningful findings, and

contributing to the body of knowledge; (2) protecting the rights

of human and animal participants in the research process; (3)

reporting results fairly and accurately, avoiding fraudulent or

misleading publication results; and (4) cooperating with

colleagues, sharing research data, and claiming authorship only

when justified. In situations in which for-profit companies are

offering funding for research, counselor/researchers should

disclose this support, design the research as objectively and

rigorously as possible, be free to publish results even if they

contradict the interest of the funding sources, and be alert to

possible misuses of the results (APA, 2002; ACA, 2005; Welfel,

2010).

Should accepting funding from self-interested pharmaceutical

companies be discouraged? Of course not; without the financial

support of wealthy pharmaceutical companies, there would be few

advances in modern medicine. Not only are pharmaceutical

companies the most logical source of funding for research

available, their interest in strengthening the credibility of


their products is genuine, and they are some of the only sources

of funding expensive research projects. Without their support,

science, medicine, and psychotherapy would remain in the “dark

ages” that existed before the accelerating pace of discovery in

basic biomedical research produced an avalanche of new knowledge

about the human body and its functions, from the human genome,

the basic molecular and cellular processes, to the mechanisms of

health and disease (Claims, 2004). And because pharmaceutical

companies are desperately seeking the credibility and

effectiveness of their products, there are now a myriad of

discoveries of potential human benefit awaiting evaluation for

efficacy and safety (Claims, 2004).

During the past several years, oversight of relations

between the pharmaceutical industry and physicians has increased

dramatically. Although many medical organizations (i.e., the

American Medical Association [AMA] and the American College of

Physicians [ACP]), have promulgated guidelines addressing

pharmaceutical company gifts, consulting fees, conference and

travel grants, free samples, and dinners; the drug industry

itself (specifically, the Pharmaceutical Research and


Manufacturers of America [PhRMA]) has issued its own guidelines

in the “PhRMA Code on Interactions with Healthcare Professionals”

(modeled on the AMA’s 1998 “Ethical Guidelines for Gifts to

Physicians from Industry”). In addition, physician and

counselor/researcher interactions have become the focus of

intense regulatory oversight by federal and state agencies such

as the Office of Inspector General (OIG) in the U.S. Department

of Health and Human Services (HHS) (an agency whose mandate is to

investigate and prosecute fraud and abuse in Medicare and

Medicaid, including drug company kickbacks to physicians and

therapists to influence their choice of drugs and drug companies’

submission of false pricing data to increase levels of

reimbursement). In April 2003, the OIG issued a “Compliance

Program Guidance for Pharmaceutical Manuracturers” that addressed

not only patently illegal practices, but also the “gray areas” of

physician/therapist–industry relations, including consultancies,

conference grants, and gifts. Although these exchanges were not

illegal, they carried “significant potential for abuse” under the

antikickback statute. Perhaps the APA and the ACA should follow

the example of PhRMA and amend their existing ethical guidelines


to model those of the AMA and the OIG by including guidelines

that are more specific in addressing

industry-counselor/researcher interrelations. (Chimonas and

Rothman, 2005)

What might be confusing for most counselor/researchers is

that the other APA (the American Psychiatric Association) has

developed, endorsed, and disseminated specific clinical practice

guidelines (CPG’s) that act as the standards of care for health

care providers in situations where for-profit companies are

funding research. Because of their influence, it is imperative

that these guidelines are based upon objective data, unprejudiced

by stakeholder groups, and that they mandate that any financial

associations between authors of CPG and the pharmaceutical

industry are made transparent. One study (Cosgrove, Bursztajn,

Krimsky, Anaya, and Walker, 2009) investigated the financial

relationships to the pharmaceutical companies of twenty work

group members who authored the guidelines for the treatment of

schizophrenia, bipolar disorder, and major depressive disorder;

to examine the degree and type of financial ties to the

pharmaceutical industry held by authors of three major CPG’s.


Findings showed that: (1) eighteen CPG authors (90%) had at least

one financial tie to the pharmaceutical industry; (2) all CPG

authors who had industry relationships had financial

relationships with companies whose products were specifically

considered or included in the guideline they authored; and (3)

the leading categories of financial interest held by CPG authors

were research funding (77%), consultancies (72.2%), members of

corporate boards (44.4%), and collaborators in industry-funded

studies (44.4%). The conclusions: ninety percent of authors of

three major CPG’s in psychiatry had financial ties to companies

that manufacture drugs which were explicitly or implicitly

identified in the guidelines as recommended therapies for the

respective mental illnesses. (Cosgrove, Bursztajn, Krimsky,

Anaya, and Walker, 2009)

Another study (Shah and Finucane, 2007) conducted a non-

industry funded, double-blind, placebo-controlled, head-to-head

trial of the three top-selling atypical antipsychotic drugs

widely used off-label for the treatment of agitation, aggression

or psychosis in Alzheimer’s dementia patients and concluded that

there was no significant difference from placebo in the primary


study endpoints, and a greater incidence of adverse effects

(sedation, confusion, extra-pyramidal signs, and weight gain).

An analysis of the exhibition hall at the 2002 APA (American

Psychiatric Association) Annual Meeting revealed that 79% of the

space was occupied by pharmaceutical companies (89,800 square

feet) and 54% of all companies with booths were in violation of

APA and FDA rules about marketing to physicians. With findings

like these, how can the guidelines be objective and unprejudiced

by the for-profit stakeholder groups? And how does this comply

with the APA’s (2002) and the ACA’s (2005) primary responsibility

to respect the dignity and to promote the welfare of the clients?

And how should professionals handle such circumstances in the

absence of definitive guidelines to address relationships with

third party pharmaceutical guidelines? (Shah and Finucane, 2007)

According to James C. Coyne (Department of Psychiatry,

University of Pennsylvania) and Alexander C. Tsai (Case Western

Reserve University School of Medicine), “the power of gift-

giving, both large and small, must be acknowledged if appropriate

regulatory policies are to be created and enforced” Coyne and

Tsai, 2005). In other words, counselor/researchers should use


the same informed consent that they use with their clients to

emphasize the transparency and disclosure of industry sources of

funding. In addition, the authors suggested that “an independent

research institute, funded neither by a pharmaceutical industry

motivated to peddle pills nor by health insurance industry

motivated to restrict their use, would certainly be useful when

doing head-to-head trials of new patent-protected agents versus

older generic agents versus placebo, weighing their risks and

benefits as well as their costs” (para. 10). The authors also

concluded that a pharmaceutical industry truly interested in

showing value might even go so far as to sponsor such studies on

its own. (Coyne and Tsai, 2005)

Recent years have also seen the creation of nonprofit

foundations housed at academic institutions, but organized for

the benefit of individual investigators and funded by

pharmaceutical industry sponsors. Although academic institutions

and pharmaceutical companies have traditionally occupied very

distinct positions with regard to public trust, they have become

collaborators in research with a common goal. On the one hand,

these collaborations may be helpful in providing needed research


funds at a time when there are constraints on funding from the

National Institutes of Health. On the other hand, they may not

be required to publicly disclose the details of their own funding

sources and expenditures, leaving editors, reviewers, readers,

and clients in the dark about the actual sources of support for a

research project. As collaborations among researchers and for-

profit companies expand, worries about the aggressive pursuit of

profit that has tarnished the reputation of the pharmaceutical

industry may be transferred to medical institutions and clinical

investigators, suggesting to some that biomedical research is

more about increasing profit than promoting public health.

(Schwartz, Curfman, Morrissey, and Drazen, 2008; Sharp and

Yarborough, 2006)

In late 2006, four editors of The New England Journal of Medicine

(Robert S. Schwartz, Gregory D. Curfman, Stephen Morrissey, and

Jeffrey M. Drazen) published an article by the Lung Cancer

Screening Group in which computed tomographic (CT) scanning was

used to screen a high risk population for evidence of early-stage

cancer. From the data they gathered, the authors concluded that

the majority of stage 1 lung cancers treated after their


detection by CT screening had a favorable prognosis. An ethical

dilemma arose when the editors discovered that the Lung Cancer

Screening Group’s research was funded by thirty-two different

entities, one of which was the Foundation for Lung Cancer: Early

Detection, Prevention and treatment, a foundation headed by the

principal investigator of the 2006 study that was housed at her

academic institution. To make matters worse, the only other

contributor during most of the study’s existence was a major

tobacco company. (Schwartz, Curfman, Morrissey, and Drazen, 2008)

The editors (Schwartz, Curfman, Morrissey, and Drazen,

2008) posited that this situation raised two concerns: (1) the

importance of ultimate sources of funding being made clear to the

journal’s readers; and (2) the appropriateness of asking whether

a study on clinical outcomes in lung cancer should be directly

underwritten in part by a tobacco industry. They further noted

that, given the enormous burden of smoking-related illness and

the ongoing sale of cigarettes and other forms of tobacco, one

might question the advisability of research entities accepting

funding from tobacco companies except through the American Legacy

Foundation, which distributes funds received through the Master


Settlement Agreement with U.S. tobacco companies. To these

editors it is extremely important that although the science in a

submitted manuscript should be judged on its merits, one cannot

fully appreciate a study’s meaning without acknowledging the

subtle biases in design and interpretation that may arise when a

sponsor stands to gain from a report. Because of these

subtleties, it is important that readers be fully informed about

funding sources for research so that they can judge their

relevance for themselves. Therefore, for their contributors,

Schwartz, Curfman, Morrissey, and Drazen (2008) expect that

authors will be particularly attentive to transparency in

reporting if a funding entity has a vested interest in the

outcome; the public’s trust in biomedical research depends upon

it. (Schwartz, Curfman, Morrissey, and Drazen, 2008)

This same fidelity is at risk when counselor/researchers do

not fully disclose the sources of their research funding to

determine if the funding is self-serving for the pharmaceutical

company and if it places the client’s interests and welfare ahead

of their own. As one of the fundamental principles of ethics,

fidelity means making the clients’ welfare the top priority, even


when such loyalty is inconvenient and uncomfortable. Truthfulness

is an essential aspect of fidelity in counseling and

psychotherapy because the primary medium of the service is verbal

communication and because it underlies the statements in the

codes regarding the structure of the counseling relationship and

relationships with colleagues, employers, and professional

associations (i.e., those with third-party payers like

pharmaceutical companies). Fidelity is also the foundation for

the caution about the use of deception in research design.

Counselor/ researchers wrestling with an ethical dilemma should

ask themselves which of the courses of action under consideration

is most faithful to the promises that have been made. (Welfel,

2010)

Consider the implications of the core principles of ethics

on the relationship between the industry and the

counselor/researcher. The principle of nonmaleficence suggests

that the counselor/researcher has an obligation to be as sure as

possible about what the real truth about his or her research is.

This means that the counselor/researcher needs to have more

dialogue with the pharmaceutical company to gain a better sense


of the company’s motivation for the research. The

counselor/researcher should also exercise caution in proceeding

by making a fully-informed judgment. If the research is self-

serving, respect for autonomy, in conjunction with

nonmaleficence, might lead the counselor/researcher to explore

the implications of the research and disclose the pharmaceutical

company’s motivations to his or her employer and/or his or her

colleagues. Additionally, helping pharmaceutical companies take

responsibility for their actions also helps them behave in a more

responsible and ethical manner. (Welfel, 2010)

Finally, Sharp and Yarborough (2006) found three integral

elements of what they call “the received view” regarding the

management of financial conflicts of interest in clinical

research: (1) industry relationships are best managed through

internal institutional policies, such as requiring investigators

to disclose financial relationships to administrative officials,

limiting investigator involvement in patient enrollment and other

research activities, and imposing stiff sanctions on researchers

who fail to reveal industry ties; (2) institutional

administrators or university compliance officials are best able


to assess whether financial relationships may create conflicting

interest that require management; and (3) successfully managing

financial conflicts of interest is essential for preserving

public confidence in the integrity of clinical research.

So, what should counselor/researchers do when confronted

with a situation in which they suspect that a sponsoring

pharmaceutical company may be funding their solely because it has

a vested interest in the outcome of the research? As stated

earlier, in this writer’s opinion, they should operate from the

same informed position that they use in their relationships with

their employers and with their clients; and use transparency in

all of their relationships. This also means disclosing everything

(verbally and in writing) and backing that disclosure up with

documentation. It may be prudent, however, for the

counselor/researcher to disclose such suspicions to his or her

supervisor or employer before doing so to the pharmaceutical

company. It is this author’s opinion that a counselor/researcher

should speak directly to the sponsoring pharmaceutical company

only when called upon to vacate his or her own values and beliefs

and his or her professional code(s) of ethics. This is advocating


for the clients, which (as stated earlier) is one of the main

fiduciary responsibilities of the counselor/researcher.

In the final analysis, when medical institutions and their

counselor/researchers forge research collaborations with the

pharmaceutical industry, they should be mindful of the potential

for these relationships to erode public confidence in the

integrity of clinical research. To foster and sustain a common

vision of the aims of the research partnership, the

pharmaceutical companies, researchers, and volunteers should be

forthright in revealing the multiplicity of interests they may

have in entering into research. Only in fully acknowledging the

breadth and depth of their ties to private industry and

explaining how their involvement furthers the pursuit of

important social goals, can investigators and research

institutions make themselves accountable to their public partners

in research. This requires financial transparency with regard to

individual and institutional interests in conducting research

(Sharp and Yarborough, 2006)

Financial transparency to all parties in research,

especially to those most vulnerable and least knowledgeable, is a


prerequisite of informed trust in the integrity of biomedical

research. In this regard, three contexts are especially critical:

(1) disclosures of industry ties to community partners; (2)

discussions of research financing with potential volunteers, and

(3) descriptions of financial relationships to institutional

review boards. This robust disclosure and financial openness will

help assure that the goals of clinical research are shared by

clinical scientists and the communities they serve and that the

continued use of moral circumspection in reflecting upon what it

means to be a responsible, trustworthy research partner. By

embracing a commitment to financial transparency, research

institutions and counselor/researchers will demonstrate a

willingness to treat their less powerful partners in research

with the full measure of dignity and respect they deserve. This

standard not only complies with federal regulations and mandates

and ethical guidelines, but is central to the preservation of

public trust in biomedical research. (Sharp and Yarborough,

2006),

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counselors as researchers

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