Institutional Initiatives in Regulating Research

by Allen Alvarez
 

Cover of two key documents issued by NAS in 1992 and 2002
Photo credit: National Academy Press. http://www.nap.edu

In my previous post, "Principles in Research Ethics Documents", I compared four responses to the need for promoting ethical research. These include: identifying ethical principles, legislation, promotion of responsible research from within scientific practice, and institutional initiatives. I also reviewed the debate between those skeptical about the role of principles and those who advocate its importance.

The four responses are not mutually exclusive and skepticism about the usefulness of ethical principles does not mean that these should be banished altogether.

For today's post, we will examine one example of institutional initiative to foster ethical practice in research, to explore what role principles play in promoting good research from within research communities.  

Incidentally, several institutions have adopted "overarching set of general principles for their members to provide a common frame of reference" (NAS 1992, p.138). This is in line with the NAS Panel recommendation that the development of research ethics guidelines "should be left to the discretion and initiative of individual faculty and research institutions" (NAS 1992, p.138).

It is likely that institutional initiatives are motivated by the need to comply with legal requirements of funding agencies (e.g. if U.S. law require government-funded projects to comply). Nevertheless, responsible research, in the sense of fulfilling the ethical obligation to protect research subjects (or the moral constraint to avoid harming research subjects), is promoted at the same time. After all, even legally enforced protection of research subjects have their foundation in ethical principles, e.g. the three principles identified by the Belmont Report. Thus, both legal and moral motivations serve the same ethical purpose of protecting research subjects.

Institutional initiatives: the case of the University of British Columbia

One accessible example of institutional initiatives to provide a common frame of reference to promote responsible research among members is the University of British Columbia's (UBC) institutional policies and procedures. The UBC Office of Research Ethics information page presents a comprehensive list of policies, standard operation procedures, regulation and guidance for affiliated researchers (UBC Office of Research Ethics 2011). If we go back to the recommendations from NAS  (1992, 2002), we will see that the initiatives UBC published on that information site include: (1) establishment of explicit procedures, systems and codes of conduct (NAS 2002, pp. 49-71), (2) establishment of institutional performance-based assessment and benchmarking (NAS 2002, pp. 72-83), (3) integration of educational program into the training curricula (NAS 2002, pp. 84-111, cf. NAS 1992, pp. 130ff) and (4) establishment of evaluation systems by self-assessment (NAS 2002, pp. 112-123).

Four UBC research policies provide a common frame of reference for affiliated researchers:

1. Policy #97 (September 1992, revised February 2, 2012): Conflict of Interest. This is 12-page policy document is related to policies 85, 87, 89 and in addition, policies 88 (Patents and Licensing, June 2013) and 105 (Acceptance, Management and Sale of Technology Licensing Equity, November 2000). The policy aims to "(a) identify conflicts of commitment, actual and potential conflicts of interest, and situations that may give rise to the perception of a conflict of interest; and (b) to provide procedures whereby such situations are disclosed and either avoided or appropriately managed". Doing so supports efforts to preserve scholarly integrity and ensures compliance with the requirements of funding agencies. This is in line with the requirements of TCPS2 and U.S. government funding agencies on implementing "policies and systems to identify and manage conflicts of interest in specific ways". This policy is essential because non-compliance leads to loss of research funding. The policy highlights the responsibility of UBC researchers to secure relevant information about the requirements of institutions they receive funding from and comply with such requirements.
2. Policy #87 (July 1993, revised March 1995, February 2014): Research. This 11-page document establishes the authority structure and, lists responsibilities and procedures for research in the University, including signing authority and procedures for funding application and contracts.
3. Policy #85 (January 1995, revised April 2013): Scholarly Integrity. Integrity is clearly an ethical principle or a virtue that is valued by the scientific community (NAS 1992, 2002). UBC Policy #85 is a 9-page document that aims to fulfill the requirements of the Canadian Tri-Council Policy Statement (TCPS 1998, which has been superseded by TCPS2 2014) and foster integrity by formalizing its expectations about the highest ethical standards of conduct in scholarly activities and listing responsibilities, defining which action counts as misconduct, and listing procedures for addressing allegations of misconduct. 
4. Policy #89 (March 2002, revised June 2012): Research and Other Studies Involving Human Subjects. This 10-page policy document aims to establish a research environment where the highest ethical standards for research on human subjects are promoted among UBC researchers by clearly articulating the 3 Core Ethical Principles of the TCPS2 2010 (i.e. Respect for Persons, Concern for Welfare, and Justice) in the June 2012 version, consistent with the current version of TCPS at that time (i.e. TCPS2 (2010) and TCPS2 (2014) which superseded it), consistent with international best practices, and to establish independent research ethics review process. It goes without saying that the application of the TCPS core ethical principles rests on the shoulders of members of research ethics boards (REBs) when they evaluate the ethical issues related to protocols they review.

The implementation of policies #85, #87, #89 and #97 are facilitated by a comprehensive 37-item Standard Operating Procedures (SOPs) that specify details of how the general principles the policies embody are to be fulfilled. The SOPs are categorized into 9 sections with the corresponding sub-sections where the 37 items are distributed:

Section 100: General Administration
101: Authority and Purpose
102: Activities Requiring REB Review
103: Policies and Procedures Maintenance
104: Training and Management of REB Members and Staff
105: Management of REB Personnel
106: Disclosure and Documentation of Conflicts of Interest
107: Signatory Authority
108: Uses and Disclosures of Personal Information (PI)

Section 200: REB Organization
201: Composition of the Board
202: Management of the Board
203: Duties of REB Members

Section 300: Functions and Operations
301: Research Submission Requirements
302: REB Meeting Administration
303: Administrative Review and Distribution of Materials
304: Documentation and Document Management

Section 400: Review of Research
401: Review of Research
402: Delegated Review
403: Initial Review – Criteria For REB Approval
404: The Review Process
405: Ongoing Review and Reporting
406: Annual Renewals
406a: Annual Renewal Processes
407: Study Completion
408: Non-Compliance
409: Administrative Holds, Terminations and Suspensions of Approval
410: Reporting
411: Reconsideration of REB Decisions and Appeal Process

Section 500: Reviews Requiring Special Consideration
501: Vulnerable Populations
502: Special Categories of Research
503: Research Involving Human Genetic Research and Research Concerning Human Reproduction

Section 600: Communications
601: Investigative Staff
602: Other Entities

Section 700:Informed Consent
701: General Requirements of Informed Consent
702: Waiver of Informed Consent
703: Documentation of Informed Consent

Section 800: Responsibilities of Investigators
801: REB Required Investigator Actions

Section 900: Quality Assurance
901: ORE Compliance Audit
902: Audits by Regulatory Agencies

The place of ethical principles in institutional policies and procedures 

The policies and procedures reviewed above aim to foster good research and compliance with commitments to legal contracts (i.e. binding agreements with funding agencies and the relevant laws that apply).

The policy on research on human subjects (UBC Policy#89), refers explicitly to ethical principles, i.e. the core ethical principles of TCPS. Despite the earlier skepticism of NAS (1992) about the usefulness of principles, it seems that even initiatives in line with the second NAS document (2002) recommendations to promote integrity through institutional initiatives will refer to principles. Although the actual application of those principles depend on how effective the responsible actors understand those principles, still, the explicit mention of principles in policy and administrative documents signal their importance, perhaps, as framework to relate the various requirements under those general headings. Evaluating how these general principles are actually and effectively applied will require concrete indicators, unless the implementing guidelines are considered sufficient, i.e. if the corresponding guidelines are implemented, then the principles they specify are applied.

It is possible that the skepticism about principles (e.g., Clouser & Gert 1990 cf. NAS 1992, pp.136-137) have a point and that when ethical principles are mentioned explicitly in institutional policy and administrative documents they are done so nominally. However, these institutional policy documents are created by members of institutions and not by external actors imposing principles on them. Even the TCPS core principles are created by local institutions (in the case of Canada) which are deemed relevant by the very institutions and scientific communities adopting them as their own. Nevertheless, since the adoption of core principles (e.g. that of TCPS) is required of researchers that receive funding from the relevant institutions, it is hard to tell if  researchers are merely doing it to comply or they voluntarily do so because they are convinced it is the right thing to do, regardless of policy requirements.

Even so, the promotion of core ethical principles, e.g. those of TCPS, is the responsibility of leaders of national and local research institutions and regulating agencies. Those principles are identical to the ones identified in earlier documents, e.g. the Belmont Report's (1978) three principles of Respect for Persons, Beneficence and Justice. These principles are widely recognized around the world as universal and are valued by many societies, including scientific communities in many different places. It is therefore not surprising if principles will maintain a prominent place in institutional initiatives to promote scholarly integrity and ethical research in places like the University of British Columbia.

References:

Clouser, K. D., & Gert, B. (1990). A critique of principlism. Journal of Medicine and Philosophy, 15(2), 219-236. http://http://dx.doi.org/10.1093/jmp/15.2.219

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (1998). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS). Available at: http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/Default/. Date modified: December 18, 2014. 

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (2010). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS2). Available at: http://www.pre.ethics.gc.ca/eng/archives/tcps2-eptc2-2010/Default/

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (2014). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS2 2014). Available at: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/. Date modified: February 13, 2015.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Bethesda, MD. Available at: http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf.

NAS (1992). Institute of Medicine, National Academy of Sciences, and National Academy of Engineering. Responsible Science, Volume I: Ensuring the Integrity of the Research Process. Washington, DC: The National Academies Press, 199 pages. Published online: March 1, 2003. Last accessed: December 15, 2014.

NAS (2002). Committee on Assessing Integrity in Research Environments. Integrity In Scientific Research: Creating An Environment That Promotes Responsible Conduct. Washington, DC: The National Academies Press, 202 pages. Available at: http://www.nap.edu/read/10430/ Published online: October 1, 2002. Last accessed: December 15, 2014.

UBC Office of Research Ethics (2011). Policies, Procedures & Guidelines. Available online: http://ethics.research.ubc.ca/ore/policies-procedures-guidelines. Published online: February 10, 2011. Last accessed: December 14, 2015

Ethics Principles that Provide Guidance to Researchers

by Allen Alvarez

Principles maintain a prominent place in legal instruments and guidelines used to regulate research around the world. We can see this prominence in the drafting of codes, declarations and reports in response to abuse of research subjects in the years between 1932 and 1964.

A running history of events that influenced the development of research ethics during and after that period is presented by David Resnik (June 2014).

Examples of ethical violations in history

1947
The Tuskegee Syphilis Study that studied the effects of untreated syphilis in 400 African American men, a study the U.S. Department of Health sponsored between 1932 and 1972, may not be in violation of any research regulation during its first 14 years (1932-1946). In 1947, however, it was clear that it violated key ethical principles after the Nuremberg Code. Even after the Code was issued, the sponsor and researchers continued to run an unethical experiment for the next 25 years (1947-1972).

Based on the 10 requirements of the Code, the Tuskegee Syphilis Study is in clear violation of the following:

1. voluntary informed consent to participate is absolutely essential (1, 9) - the 400 subjects were not told that they were in an experiment and they even believed they were getting treatment
2. the requirement to "avoid all unnecessary physical and mental suffering and injury" (4, 5, 7, 8, 10) - the subjects were withheld treatment even when penicillin became widely available in the 1940s (American Chemical Society 1999);
3. "risk to be taken should never exceed" the expected benefits of the study (6, 2, 3) - the subjects took risks without getting any benefits

1946-1948
Unethical human experiments were conducted by the US government in Guatemala that involved intentionally infecting over 1300 subjects with venereal diseases to test the effectiveness of penicillin (Reverby 2011). 83 participants died in the study. 700 participants were treated with penicillin. All participants were not informed that it was an experiment.

1964
Aside from the Nuremberg Code, the Tuskegee Syphilis Study physicians violated ethical standards of medical research when the Declaration of Helsinki was issued in 1964. The Study violated the Declaration for 8 years (1964-1972). As a non-therapeutic study, the physicians who conducted the study contravened key articles under section III, namely:

• 1.  "...the duty of the doctor to remain the protector of the life and health of that person on whom clinical research is being carried out."
• 2. The nature, the purpose, and the risk of clinical research must be explained to the subject by the doctor.
• 3a. "Clinical research on a human being cannot be undertaken without his free consent..."
• 3c. "Consent should as a rule be obtained in writing."
• 4a. The investigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator.
• 4b. At any time during the course of clinical research the subject or his guardian should be free to withdraw permission for research to be continued. The investigator or the investigating team should discontinue the research if in his or their judgment it may, if continued, be harmful to the individual. 

1966
It was on this year that Henry Beecher (1966) published an article that revealed 22 studies that were in violation of known ethical standards at that time.

Responses to unethical research

1974-1979     Identification of basic ethical principles
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was convened in 1974 with a two-part mandate:

1. "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects" and 
2. "to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles" (from the summary of The Belmont Report).

Four years later, the Commission issued the Belmont Report (1978) that:

1. identified the 3 basic ethical principles of (a) Respect for persons, (b) Beneficence and (c) Justice;
2. consideration of 3 requirements that apply those 3 principles. The 3 requirements are (a) Informed Consent, (b) Assessment of Risks and Benefits and (c) the requirement that there be fair procedures and outcomes in the selection of research subjects.

The Commission used the expression "basic ethical principles" to mean "general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions" (p. 4). The source of these basic principles is the cultural tradition of the members of the Commission and these are only 3 of those other principles "generally accepted" in the said cultural tradition that "are particularly relevant to the ethics of research involving human subjects" (p. 4).

Albert Jonsen, who was a member of the Commission, recounts that an original list of 8 principles were identified (Jonsen 2005: 4). Because the commissioners felt that the list should not include too many principles and that whichever included should be universal, they reduced them to three which were suggested by H. Tristram Engelhardt (respect for persons as free agents and concern to support the best interests of human subjects in research) and Tom Beauchamp (distributive justice) (Jonsen 2005: 4).

Ethical principles are social and relational. These refer to what we, as members of society, value as important in relation to other members of society. Ethical principles are different from personal values although we sometimes call these values 'our principles'. Personal values of specific individuals may or may not be social but they are personal in the sense that these are valued regardless of its implications to others. Ethical principles, on the other hand, are valued on the basis of our relation to others and because we relate to others. 

1991     Legislation
The U.S. government published the Federal Policy for the Protection of Human Subjects (45 CFR part 46, subpart A), a.k.a.  the “Common Rule” in 1991. The Common Rule is codified in separate regulations by 15 Federal departments and agencies. Subpart B of 45 CFR 46 requires additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. The Common Rule outlines the basic provisions for Institutional Review Boards (IRBs), informed consent, and Assurances of Compliance. Since 1991, all researchers of government funded studies, including those conducted in foreign countries, and researchers in government institutions are legally required to comply with the requirements of the Common Rule. The current version (2009) of 45 CFR 46 with all its subparts are available here and here. It is continuously being updated to meet the changing demands of protecting research subjects.

21 CFR, especially 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (IRBs), and 58 (Good Laboratory Practice for nonclinical laboratory studies), are issued to govern Food and Drug Administration (FDA) regulated research activities and clinical trials. Other related FDA regulations are listed here.

1992    Promotion of responsible research from within scientific practice
The National Academy of Sciences (NAS) published Responsible Science: Ensuring the Integrity of the Research Process (NAS 1992). The book referred to misconducts in research that goes beyond the requirements of earlier regulations intended to govern research involving human subjects (NAS 1992, pp. 135-136). It is noteworthy to quote what the NAS thought about the role of guidelines it is contemplating to develop to promote responsible conduct:

Guidelines for the conduct of research differ from institutional policies [emphasis added] that are designed to address misconduct in science or conflict of interest or that, in response to regulatory requirements, govern research involving human subjects [emphasis added], hazardous materials, or recombinant DNA.¹¹ Research conduct guidelines are intended to promote responsible conduct of research and, to the extent that questionable practices and misconduct in science are linked, to reduce the amount of misconduct in science. However, although there are positive advantages associated with the adoption of such guidelines, this approach, by itself, may not be effective in fostering responsible research conduct. The imposition of guidelines also carries certain risks and limitations in the collegial academic environment. 

Responsible Science also estimated the incidence of misconduct, discussed some of the causes of misconduct, proposed a definition of misconduct, and recommended ways to prevent misconduct in research. Bernard Gert, who was critical of the principle-based approach to bioethics, is listed on the Panel on Scientific Responsibility and the Conduct of Research (or the Panel).

Ten years later, NAS followed up with another book Integrity In Scientific Research: Creating An Environment That Promotes Responsible Conduct (2002). This was prepared by its Committee on Assessing Integrity in Research Environments. It defines integrity from an individual and institutional point of view:

For individuals, it is an aspect of moral character and experience.¹ For institutions, it is a matter of creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness that inform institutional practices. (NAS 2002, p.34)

The document highlights a combination of making the institutional environment conducive to promotion of integrity through the establishment of explicit procedures, systems and codes of conduct (NAS 2002, pp. 49-71), establishing an institutional performance-based assessment and benchmarking (NAS 2002, pp. 72-83),  integrating an educational program into the training curricula (NAS 2002, pp.84-111, cf. NAS 1992, pp. 130ff) and evaluation by self-assessment approach (NAS 2002, pp. 112-123).

While I frame the four approaches identified by NAS (2002) as attempts to respond to previous unethical conduct in research, I do not mean to imply that these responses are mutually exclusive.

1994-1998     Institutional initiatives
In Canada, the three major public research funding bodies (the Social Sciences and Humanities Research Council (SSHRC), the Medical Research Council (MRC which was replaced in 2000 by the Canadian Institutes of Health Research, CIHR), and the Natural Sciences and Engineering Research Council (NSERC)) consulted to develop a common ethics policy statement (Greene 2002).  The process produced the Tri-Council Policy Statement (TCPS): Ethical Conduct for Research Involving Humans in 1998. TCPS required researchers and their institutions to follow the policy's ethical principles when their project is funded by any of the three agencies.

Here is Ian Greene's summary of seven of the 8 guiding ethical principles in TCPS (1998):
1.  Respect for Human Dignity
2.  Respect for Free and Informed Consent
3.  Respect for Vulnerable Persons
4.  Respect for Privacy and Confidentiality
5.  Respect for Justice and Inclusiveness
6.  Balancing Harms and Benefits
7.  Minimizing Harm

It is understandable if Greene may have left out principle 8, i.e. Maximizing Benefit, since that principle is closely related to TCPS principle 7. In fact, both can be considered specifications of the Belmont Report's principle of Beneficence.

2009     Adoption of institutional initiatives
The  Health Canada Research Ethics Board published its Administrative Policy and Procedures Manual (Ethics Review of Research Involving Humans) in January 2009. The Manual lists all 8 of the TCPS (1998) Guiding Ethical Principles in its Appendix A including principle 8-Maximizing Benefit.

2010
The TCPS, 1st edition (1998), was revised in 2010 as TCPS2. The changes are listed here. It is noteworthy to mention that TCPS 1998's "8 Guiding Ethical Principles" (Context of an Ethics Framework. C.) was replaced by TCPS2 2010's "3 Core Principles" (Chapter 1.B) which are essentially the same as the 3 principles in the Belmont Report (1978).

2014
The TCPS2 (2010) was revised once again in 2014 as TCSP2 (2014). The changes are listed here. The 3 Core Principles are retained and are the same as in TCPS2 (2010).

Declaration of Helsinki (2013) 

After the year 2000, the Declaration of Helsinki was amended again in 2002, 2004, 2008 and 2013. The 2013 version lists 12 general principles (articles 3 - 15) and several others specific to risks, burdens and benefits, vulnerable groups and individuals, scientific requirements and research protocols, research ethics committees, privacy and confidentiality, informed consent, use of placebo, post-trial provisions, research registration and publication and dissemination of results and
unproven interventions in clinical practice.

Part of the process that influenced revisions since 2002 onward is the 1997 publication of Peter Lurie and Sidney Wolfe's (1997) claim that the NIH, WHO, UN and CDC designed unethical clinical trials on the prevention of mother-child transmission of HIV in developing countries.

The Lurie & Wolfe (1997) New England Journal of Medicine Sounding Board paper has been widely cited, raising the awareness about the need to develop regulation and ethics review capacity across international borders, especially when clinical trials are done through multi-country collaboration between scientists in different countries, including low income countries where the risk of research injustice is high.

All the institutions called out responded with initiatives that would address the ethical violations Lurie & Wolfe (1997) identified. NIH funded capacity building projects to train researchers and members of ethics review committees in low income countries in reviewing and regulating research to assure compliance to high ethical standards. NIH's Fogarty International Center launched the International Research Ethics Education and Curriculum Development Award which helped train local bioethicists in different countries and enhanced their capacity to develop local research ethics review guidelines. One example is the Philippines' National Ethical Guidelines for Health and Health Related Research (pages 13-267).

WHO and UN collaborated to launch initiatives in ethics review capacity building through TDR and SIDCER's Strategic Initiative for Developing Capacity in Ethical Review which supported researchers in different countries in Asia-Pacific to organize their respective Forums for Ethics Review Committees in Asian and Western Pacific countries (FERCAP).

The European Commission (EC) also contributed to to the global response to research injustice following Lurie & Wolfe's (1997) exposé by funding capacity building initiatives including the multi-country project CTC-ETHICS - Ethical issues in clinical trial collaborations with developing countries from 2000 to 2002. CTC Ethics organized capacity building events to train researchers in ethics review of multi-country research and conducted studies in research ethics leading to publications in peer-reviewed journals. Reidar Lie, the Principal Investigator of that project, hired a research assistant, Allen Alvarez, to interview members of ethics review committees in the Philippines (including FERCAP members) about the use of placebo in clinical trials when an effective treatment already exists. The interview study results got published in the journal Bioethics (2005). Lie and Alvarez's collaboration later led to Alvarez completing his PhD (University of Bergen, 2009) under Lie's supervision. 

Optimism and skepticism toward the role of principles in fostering compliance to non-legal requirements and guidelines

Beyond legally enforceable regulatory instruments, the issue of compliance to ethical standards for research in non-legally binding guidelines, is important to address. Parallel to corporate efforts (Trevino, et al. 1999) in managing ethics in relation to legal compliance, regulation of research according to ethical aspirations embodied by principles require that we identify the core principles contained in legal instruments and guidelines.

However, there are doubts whether imposition of guidelines that enforce these principles can be effective in "fostering responsible research conduct" since the "imposition of guidelines also carries certain risks and limitations in the collegial academic environment" (NAS 1992, pp.135-136). In particular, the Panel (1992, pp.136-137) listed 10 disadvantages of institutional guidelines, namely:

1. "Many scientists believe that research conduct guidelines are unnecessary and ineffective research practices are often too complex and too varied to be governed by a few general principles (emphasis added)"
2. "adopting such principles is a time-consuming process that requires the efforts of active researchers who are already burdened by other obligations"
3. "focusing on guidelines diverts attention from the consideration of complex ethical issues and genuine dilemmas in the research environment"
4. "research guidelines cuts against faculty autonomy and other values associated with academic freedom as ideals of the academic environment"
5. "guidelines may encourage implementation of rules and rigid regulations, as well as “cookbook” approaches to scientific endeavors" 
6. "guidelines that describe appropriate research conduct will expose them to additional litigation and administrative vexations (Nobel, 1990)"
7. "Many scientists believe that explicit guidelines can add little of substance to the material already included in publications such as On Being A Scientist and Honor in Science"
8. "guidelines may not be necessary because the norms of science are self-evident and because existing policies provide abundant advice to determine how to conduct research responsibly"
9. "the effort needed to bring to the attention of faculty and students any research conduct guidelines that have been adopted" is a drawback" 
10. "If research conduct policies are not appropriately implemented, they can be viewed as empty gestures or “window dressing” that will serve little purpose." 

The Panel concluded that "Written guidelines are unlikely to influence academic research behavior if they are imposed from above or from outside (emphasis added)" (NAS 1992, p.137).

The effective strategy they endorse is an integrated bottom-up (rather than top-down) approach to developing guidelines, i.e.

To be effective, guidelines must be incorporated into the process of research and education and become an operational part of day-to-day activities. If faculty desire to develop guidelines for the conduct of research, such policies should be formulated by those who will be directly affected and should be adapted to specific research fields and protocols.

Institutional guidelines are likely to be less effective than ones formulated at the group or laboratory level. However, research institutions may wish to adopt an overarching set of general principles for their members to provide a common frame of reference. (NAS 1992, p.138)

The Panel noted that academic or scientific freedom is too important that any imposition to restrict it must be justified. Thus, guidelines or regulatory interventions that restrict such freedom are only needed when misconduct is likely to persist: "steps that might restrict scholarly or scientific independence were taken only when there was clear evidence that inappropriate behaviors or hazardous situations might persist in the absence of institutional policies" (NAS 1992, pp.136-137). They caution that "care should be taken to avoid adopting constraints that could be damaging to the research process" (NAS 1992, p.138).

Furthermore, "development of such guidelines should be left to the discretion and initiative of individual faculty and research institutions" (NAS 1992, p.138).

What do you think should be our approach to fostering ethical research? Approach A. others review research protocol to regulate and reduce misconduct? Approach B. researchers take initiative in self-regulating their research practice so that they can avoid misconduct? or Approach C. combine review and self-regulation?

References:

Beecher, H. K. (1966). Ethics and Clinical Research. New England Journal of Medicine, 274(24), 1354-1360. http://dx.doi.org/10.1056/NEJM196606162742405

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (1998). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS). Available at: http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/Default/. Date modified: December 18, 2014. 

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (2010). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS2). Available at: http://www.pre.ethics.gc.ca/eng/archives/tcps2-eptc2-2010/Default/

CIHR, NSERC, SSHRC (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) (2014). Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans. Tri-Council policy statement: Ethical conduct for research involving humans (TCPS2 2014). Available at: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/. Date modified: February 13, 2015.

Greene, I. (2002). Summary of the Guiding Ethical Principles for Research Ethics. Available at: http://www.yorku.ca/igreene/tricoun.htm. Published: February 1, 2002. Last accessed: December 15, 2015

Health Canada (2009). Available at: http://www.hc-sc.gc.ca/sr-sr/pubs/advice-avis/reb-cer/index-eng.php#t12_a. Last accessed: December 15, 2015.

Jonsen, A. R. (2005). On the origins and future of the Belmont Report. In Childress, J. F., Meslin, E. M., & Shapiro, H. T. (Eds.). Belmont revisited: Ethical principles for research with human subjects. Georgetown University Press. pp. 3-11. https://books.google.ca/books?id=4U6iStmnQlYC&lpg=PP1&pg=PA3#v=onepage&q&f=false

Lurie, P., & Wolfe, S. M. (1997). Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. New England Journal of Medicine, 337(12), 853-856. http://dx.doi.org/doi:10.1056/NEJM199709183371212

Reverby, S. M. (2011). “Normal Exposure” and Inoculation Syphilis: A PHS “Tuskegee” Doctor in Guatemala, 1946–1948. Journal of Policy History, 23(01), 6-28. http://dx.doi.org/doi:10.1017/S0898030610000291

NAS (1992). Institute of Medicine, National Academy of Sciences, and National Academy of Engineering. Responsible Science, Volume I: Ensuring the Integrity of the Research Process.   Washington, DC: The National Academies Press, 199 pages. Available at: http://www.nap.edu/read/1864/. Published online: March 1, 2003. Last accessed: December 15, 2014.

NAS (2002). Committee on Assessing Integrity in Research Environments. Integrity In Scientific Research: Creating An Environment That Promotes Responsible Conduct. Washington, DC: The National Academies Press, 202 pages. Available at: http://www.nap.edu/read/10430/ Published online: October 1, 2002. Last accessed: December 15, 2015.

Nobel, J. J. (1990). Comparison of research quality guidelines in academic and nonacademic environments. JAMA, 263(10), 1435-1437. http://dx.doi.org/10.1001/jama.1990.03440100159023

Resnik, D. (2014). Research Ethics Timeline (1932-Present). Available at: http://www.niehs.nih.gov/research/resources/bioethics/timeline/. Published online: November 17, 2004. Revised: June 2, 2014. Last accessed: December 15, 2015.

Trevino, L. K., Weaver, G. R., Gibson, D. G., & Toffler, B. L. (1999). Managing ethics and legal compliance: What works and what hurts. California Management Review, 41(2), 131.

The Need for Principles in Research Ethics

by Allen Alvarez

View of the defendants in the dock at the International Military Tribunal trial of war criminals at Nuremberg. Thursday, November 1, 1945, Nuremberg, Germany. Credit: National Archives and Records Administration, College Park. Copyright: Public Domain. Available at: http://digitalassets.ushmm.org/photoarchives/detail.aspx?id=7388

Nuremberg Code (1947)

The history of research ethics is usually told beginning from the principles identified in the Nuremberg Code of 1947. Ten requirements for conducting medical experiments on human subjects were laid down in that code from the judgment of the war crimes tribunal after World War II. The code refer to these requirements as "basic principles" that "must be observed in order to satisfy moral, ethical and legal concepts" in conducting human experimentation.

Although the 10 requirements may not be the same as recent understanding of what ethical principles are, they do identify similar socially valued rules for conducting morally acceptable medical experiments on humans, namely:
1. voluntary informed consent to participate is absolutely essential (1, 9);
2. "avoid all unnecessary physical and mental suffering and injury" (4, 5, 7, 8, 10);
3. "risk to be taken should never exceed" the expected benefits of the study (6, 2, 3)

 

Declaration of Helsinki (1964 - 2000)

The World Medical Association codified the principles they value in the Helsinki Declaration of 1964. The 1964 original document lists 5 basic principles (section I), 2 principles for clinical research (section II) and 4 principles for non-clinical biomedical research (section III). These 11 principles (or standards) updates the ones listed in the Nuremberg Code. The Declaration was further revised four times in 1975, 1983, 1989 and 1996. The fifth revision in 2000 was the most controversial due to disagreements on international standards for the use of placebo (article 29) and the issue of assurance of access to best proven intervention arising from the study (article 30).    

The requirements or standards referred to in the Nuremberg Code and the Declaration of Helsinki as principles are understood today as rules (or guidelines). This distinction between ethical standards/requirements/rules and principles became clearer in the Belmont Report of 1979.

Based on Rachels (2009: 15-23)

Rules and principles

One way to make sense of the distinction between 'requirements/rules/standards' and 'principles' is to distinguish between moral rules, ethical principles, moral theory and judgments about a specific actions.

In simple terms, judgments are based on rules, rules on principles, and principles on moral theory (e.g. utility-based, duty-based, or virtue-based theories of moral obligations). Moral reasoning can be understood as proceeding in this hierarchical order of abstraction.
 

Belmont Report (1979)

After the signing of the U.S. National Research Act of 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was convened and they issued the Belmont Report in 1978 which was published in the Federal Register in 1979. The Report is the first document to list what we understand today as ethical principles for research. The mandate of the Commission is "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles" (from the summary of The Belmont Report).

Three principles were identified in the Belmont Report:

1. Respect for persons - this principle "demands that subjects enter into the research voluntarily and with adequate information"
2. Beneficence - obligation to "(1) do not harm and (2) maximize possible benefits and minimize possible harms"
3. Justice - to distribute burdens and benefits of research in a just way is formulated as "(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit"

The Report mentions historical instances of unethical research that should now be prevented such as

during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

The basic principles identified in the Belmont Report are needed as bases for justifying specific moral rules and guidelines that will be developed later in national and international instruments regulating research. These principles were also used in developing guidelines in clinical ethics and bioethics, popularized in the well-known book by J. Childress and T. Beauchamp (1979). A fifth edition came out in 2001.

CIOMS Guidelines (2002)

The Council for International Organizations of Medical Sciences (CIOMS) issued their International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1982, 1993 and 2002. The latest version adopts the 3 principles contained in the Belmont Report as general ethical principles (2002, p. 17) that ground the 21 guidelines that follow. 

The debate on the importance of principles

Some (e.g., Clouser & Gert 1990) are critical of the use of general principles while others (Beauchamp 1995; Gillon 2003) defend it.  Clouser and Gert argued that principles, e.g. those identified by Beauchamp and Childress (1994), do not adequately determine action nor provide practical guidance because they are so general and vague. Moral rules are more specific. The label "principles" does not make research ethics documents, e.g. the Nuremberg Code or Declaration of Helsinki, susceptible to such criticism because the principles contained there are more like rules. It does apply to principles in post-Belmont Report documents but not to requirements that apply those principles, e.g. the requirement 'to obtain informed consent' that apply the principle of respect for persons.

The debate between proponents of Kohlberg's stages of moral development and Gilligan's ethics of care also asks this question about the importance of principles. Kohlberg's highest stage of moral development is one that is based on universal ethical principles, e.g. justice. Gilligan criticizes the prominence of principles as specific only to men (Gilligan 1977). She argued that women focus on response or "caring" rather than on universal principles of morality. Therefore, we cannot assume that everyone (men and women alike) will rely on universal principles of morality as their most developed state of morality.

Despite empirical studies pointing to the personal motivations for moral actions, some authors (Cropanzano, Goldman & Folger 2003) defend the role of principles or standards of right and wrong. 

Still others (Emanuel, Wendler, Grady 2000) prefer more specific ethical requirements "that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies."

References:

Beauchamp, T. L. (1995). Principlism and its alleged competitors. Kennedy Institute of Ethics Journal, 5(3), 181-198. http://dx.doi.org/10.1353/ken.0.0111

Beauchamp, T. L. and Childress, J. F. (1994). Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press.

Carlson, R. V., Boyd, K. M., & Webb, D. J. (2004). The revision of the Declaration of Helsinki: past, present and future. British Journal of Clinical Pharmacology, 57(6), 695–713. http://doi.org/10.1111/j.1365-2125.2004.02103.x

Clouser, K. D., & Gert, B. (1990). A critique of principlism. Journal of Medicine and Philosophy, 15(2), 219-236. http://dx.doi.org/10.1093/jmp/15.2.219

Cropanzano, R., Goldman, B., & Folger, R. (2003). Deontic justice: the role of moral principles in workplace fairness. Journal of Organizational Behavior, 24(8), 1019-1024. http://dx.doi.org/10.1002/job.228

Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical?. JAMA. 2000;283(20):2701-2711. http://dx.doi.org/10.1001/jama.283.20.2701

Gilligan, C. (1977). In a Different Voice: Women's Conceptions of Self and of Morality. Harvard Educational Review, 47(4), 481-517. http://dx.doi.org/10.17763/haer.47.4.g6167429416hg5l0

Gillon, R. (2003). Ethics needs principles—four can encompass the rest—and respect for autonomy should be “first among equals”. Journal of Medical Ethics, 29(5), 307-312. http://dx.doi.org/10.1136/jme.29.5.307

Rachels, J. (2009). Ethical theory and bioethics. In Kuhse, H., & Singer, P. (Eds.). (2013). A companion to bioethics. John Wiley & Sons. pp. 15-23. http://samples.sainsburysebooks.co.uk/9781444307825_sample_415149.pdf

Also available here.