|
Community Comment on PHS Research Instruction Policy
September 21, 2000
Mr. Chris B. Pascal, J.D. This letter presents comments of the Association of American Universities (AAU), the Council of Graduate Schools (CGS), the Council on Governmental Relations (COGR) and the National Association of State Universities and Land-Grant Colleges (NASULGC), on the proposed PHS Policy on Instruction in the Responsible Conduct of Research published by the Office of Research Integrity on July 17, 2000. The AAU is an organization of research universities devoted to maintaining a strong system of academic research and education, and consists of 59 U.S. universities and 2 Canadian universities. COGR is an association of 143 research-intensive universities that concerns itself with the influence of government regulations, policies and practices on the performance of research conducted at colleges and universities. NASULGC, with roots back to 1887, is the nation's oldest nonprofit higher education association with 210 members from all 50 states, the District of Columbia and the U.S. territories. NASULGC's mission is to support high-quality public education and to enhance the ability of its members to carry out their land-grant heritage in learning, discovery and engagement with society at large. CGS is an organization founded in 1960 to promote the improvement and advancement of graduate education, including best practices and procedures. The present membership consists of 450 graduate schools at colleges and universities in the U.S. and Canada. These associations state unequivocally that the integrity of research and teaching is a core value of their university membership. Responsible conduct of research and the integrity of the research record are the sine qua non of scholars and those who train future scientists and scholars. It should be recognized that much valuable work has been done by universities over the past years in providing education in research ethics to graduate students. Without the principles of honesty and integrity in all aspects of research, neither scientists as members of the academic community, nor the university as a governance structure could survive. As recipients of public funds, our member institutions and our researchers must be accountable for the responsible and ethical conduct of research. We share PHS's strong belief in promoting the responsible conduct of research and preventing research misconduct through education and awareness. For that reason we have reviewed the proposed policy with great care and in the spirit of positive cooperation. PHS has published its call for instruction in the responsible conduct of research at a time when the convergence of a number of technical and scientific advances in the biomedical, electronic and materials areas, while holding out the promise of a real revolution in scientific discovery, also raise new concerns about ethical issues in research. Ensuring continued integrity is an ongoing obligation. In this changing environment the academic community may well benefit from a renewed commitment to the responsible conduct of research and to the integrity of the research record. Our comments on the PHS/ORI draft policy on Instruction in the Responsible Conduct of Research should not be construed as suggesting that universities are unwilling to comply with the goals the PHS policy sets forth. On the contrary, we believe that these same goals already exist in our institutions and align our mutual interests with those of PHS/ORI. We believe, however, that ORI should modify the overly prescriptive tone of the document, which resembles rulemaking more than policy. Policy vs. Rulemaking AAU/CGS/COGR/NASULGC members believe that the public interest and the public trust would be best served through a policy statement that identifies principles and expectations for broad education in the responsible conduct of research. If the PHS/ORI document is intended to be policy, it must be revised to remove prescriptive language. We have made revisions to the document to reflect a policy approach, with the emphasis on principles and goals. We believe that policy is the preferable option, because due to historic differences in governing structure and academic culture, universities will elect different paths to realize generally agreed upon principles. As written, the tone of the document has been read by our membership as imposing requirements that usually result only after regulatory review. PHS should determine whether it intends to work with universities as a partner or whether it has decided to impose rulemaking. If PHS/ORI believes rulemaking is called for, the stipulated regulatory process should be followed. Some of our members endorse the rule-based approach, which binds both parties and obligates a federal agency to limit the extent to which it may act in an unexpected manner. However, we believe that the PHS agencies and the university community can best accomplish our shared goal of promoting responsible research by working together on a policy basis. Comment on the Proposed General Policy and Core Instructional Areas One might infer from the draft language that universities and other research entities are not currently conducting research responsibly, that doctoral and post-doctoral training at academic institutions is inadequate, and consequently that PHS should and needs to tell universities, whom, when and how to educate. While universities support the need for educating students and trainees and are protective of existing unique programs in ethics and in the individual conventions of their professional disciplines, they object to an automatic extension of such training as proposed by ORI. There is neither quantitative evidence nor a persuasive logical correlation that argues the need for training with such a broad scope. Over the course of their careers, established investigators obtain the knowledge and skills necessary to conduct research responsibly. Effective continuing educational opportunities offered by an institution should be pertinent to the background, roles and responsibilities of the individuals. Any PHS/ORI policy should not override institutional flexibility to determine who receives education and in what core subject areas. Following the introductory paragraph, the language of the draft PHS/ORI policy proceeds in a heavy-handed form, by prescribing core instructional areas irrespective of the nature of the research being conducted. A number of these core areas are quite discipline-specific in their application. Some are based in regulation; other core areas represent institutional policy and academic governance; others are and should remain under the purview of academic journals and editorial boards. We believe specific curriculum requirements should remain the responsibility of the academic leadership of the institution. Comments on Specific Sections of the Policy Our comments review, in sequence, each section of the proposed PHS/ORI policy. Attached to this letter is the draft PHS/ORI policy with the actual language and format of our recommended revisions. I. Introduction The applicability of the instructional requirement is ambiguously stated. PHS has the authority to establish policies affecting researchers funded by PHS. However, an extension of this policy beyond PHS-funded researchers should be left to the discretion of the institution. To avoid any ambiguity in the scope of the PHS requirement, the affected community should be clearly defined. II. General Policy In light of our above comments on the Introduction, which also apply to this section, we suggest that the last sentence be deleted. An exhortation from PHS that institutions mandate instruction to all researchers is intrusive of institutional policy. III. Definitions "Institution". The second sentence, which points out the legal and financial accountability of universities, though important, is irrelevant to the topic of the policy and should be deleted. The definition of "staff" should be moved from Section IV. Scope, into the Definitions section and be revised to include only those staff with substantive roles in the design, conduct, and reporting of research. The inclusion of consultants and subcontractors is particularly problematic for institutions and PHS/ORI should limit the institution's obligation to those researchers present in the institution. We urge PHS/ORI to recognize institutional flexibility in the determination of who is covered under the PHS policy. IV. Scope This section defines a global constituency for the mandated instructional program. The resulting scope of coverage would be enormous. Reemphasizing our comments on "staff" above, we strongly recommend that PHS/ORI narrow the applicability of any program of instruction to those who have direct and substantive involvement in the design, conduct and reporting of PHS-funded research. Effective instructional opportunities offered by the institution should be pertinent to the roles and responsibilities of the individuals. V. Instructional Program Goals Section A. We recommend that PHS move this entire section to the Introduction. Most of these goals would be relevant to the conduct of research, rather than merely to an instructional process. Statement A.3 is very troubling and should be deleted. New approaches and techniques may well challenge what is normative scientific practice - this has nothing to do with responsible conduct of research. An appreciation for the variety of accepted scientific practices should be encouraged. VI. Core Instructional Areas The draft mandates that any instructional program cover all stated core areas. We reiterate our request that PHS/ORI make the content areas relevant to the nature and scope of the research. One could well imagine that physical scientists, who have no animal or human subjects in their research programs, would find such instruction wasteful of their time and without context. PHS should make allowances for variances in the disciplines and research areas. Further, a number of the core areas are quite discipline specific in their application. What is appropriate mentoring in the basic biomedical sciences may be well outside the boundaries of responsible and appropriate mentorship in the behavioral sciences. The same disciplinary cultural nuances are well known in authorship practices. Specific curriculum requirements should be left to the discretion of principal investigators and the academic leadership of the institution. The core areas are an incongruous mix. Some are law/regulation based with local oversight by IRBs, IACUCS, and Biosafety committees. Other topics verge on academic governance and institutional policy - relationships between dissertation advisor and student, collaborative science, and data management, acquisition, ownership and sharing. Some instructional areas include subjects that are legitimately under the purview of journals, or peer review that takes place in federal agency study sections or in editorial boards prior to journal publications. It would seem that these subjects are less the responsibility of the institution and more the responsibility of PHS, journals, and professional societies. Finally, some areas are truly grounded in critical thinking and decision-making processes whereby one learns skills that affirm ethical conduct and treatment of others. A "one size fits all" approach will not serve the research community well. Any list of topics should be presented as an illustration of the range of areas germane to responsible research, but should be neither all inclusive or exclusive of other quite relevant issues that may not be included in PHS's core areas. We ask that, as a first step to reflect necessary institutional and disciplinary flexibility, ORI replace the words "shall contain" with less prescriptive language. Item 10,"Compliance with existing PHS and Institutional Policies", should be targeted specifically to the scope of the policy. It might be rephrased as "Existing PHS and Institutional Policies Relevant to the Responsible Conduct of Research". Section B. The second sentence, which addresses evaluative components to reinforce learning and information transfer, should be deleted. It is sufficient to indicate instead that PHS recognizes the institutions' obligation to demonstrate competence. VII. Description of Core Instructional Areas The draft document not only defined a list of mandated core areas but also further extended the subtopics to be addressed within these areas. This appears to our institutions as micromanagement of the education program by PHS/ORI. Given the variances within disciplines and the nature of the specific research these are arguably only the rudimentary elements on which to build a much richer instructional experience. Such descriptions may be useful as a resource to the community in planning educational programs but should not be stipulated in the PHS/ORI policy statement. Institutions and principal investigators should tailor the content of instructional opportunities to reflect applicable laws/ regulations/rules, institutional policies, and ethical considerations in the particular research domain. VIII. Instructional Models and RCR Resources This section should be dropped from the policy. It suggests that PHS is dictating what are "acceptable" instructional approaches, and thereby reinforces the regulatory tone rather than a policy approach. Illustration of best practices or effective approaches used in the academic community might be collected and communicated by PHS/ORI separately from this policy. IX. Phase-in Period and Implementation Given the scope of the proposed training, institutions should be granted time to develop an institution-specific phase-in plan. The effectiveness of the instructional opportunities could be compromised in the long run by rushed actions subject to rigid timetables. Instead PHS might anchor individual institutions' phase-in schedules on an institutional assurance, which affirms the institution's intent to comply with the policy, and makes the plan and its compliance milestones available to PHS for review at certain intervals. Section C. Wording such as "strongly recommended" reinforces the rule-making tone. We urge PHS to refer to institutions providing opportunities for periodic, continuing educational opportunities in changing rules, regulations, and emerging ethical considerations in research. Section D. The tone of this section moves well beyond policy and reads more like statutory mandate. If PHS believes that it needs to publish a "Material Change" notice in the Federal Register, we suggest that the draft document be treated by the PHS and the affected community as rule making. In that case, PHS should take these requirements through the full rule-making process including assessment of the Regulatory Flexibility Act, the Unfunded Mandates Act, the Paperwork Reduction Act, Waiver of Procurement Rulemaking, Small Business Regulatory Enforcement Fairness Act and the Executive Order on Federalism. We would prefer that this section be deleted. X. Accountability and Reporting Section A. Consistent with the above recommendations for revising the policy as drafted, this section would essentially be eliminated and replaced by a statement indicating PHS/ORI reliance on institutional responsibility and performance outcomes. Institutions should not be required to explain or certify to PHS/ORI whether their instructional programs are expanded to faculty not supported by PHS funds. Section B. We urge ORI to distinguish between the institutional and PI roles in the assurance of the responsible conduct of research. The institution should be required to certify that it has developed a program of instructional opportunities in the responsible conduct of research. ORI should place responsibility with the PI for assurance that project-specific instruction has been completed for appropriate project personnel. A description of the education program would be available to PHS, comparable to other institutional policy compliance assurances. As currently written, this section is inappropriate and should be deleted or revised. Financial Considerations For many years, institutions have been conducting programs in the responsible conduct of research for graduate students and trainees and, in some cases, for principal investigators and others directly involved in the conduct of research. When this policy statement is published in final form, the universities will extend such programs to routinely include principal investigators and other key personnel. However, it is important to note that these requirements levy another financial burden on institutions that is over and above the normal "infrastructure" that has been required in the conduct of research. It is time to reexamine these requirements and address ways in which institutions may be reimbursed for the appropriate costs of carrying out such federal requirements. This is even more critical if the requirements for inclusion of individuals are as broad and all encompassing as it is in the current draft. Compliance requirements for federal programs are rapidly increasing, but the funds to carry out and support these new requirements have not always kept pace. Instructional costs are usually contained in facilities and administrative rates as part of the administrative component, but the administrative component is capped for many universities. As part of this initiative on the responsible conduct of research, PHS/ORI must also consider the question of reimbursement for the required training activities. We believe that the policy (or rulemaking) on this subject should be narrowed and that the discussion of costs should be broadened to consider options for dealing with reimbursement, focused on recovery through negotiated facilities and administrative rates. Our member institutions are devoting significant energy and resources to the development of NIH's recently mandated training for human subjects protection. We understand that NIH, as part of its congressionally mandated effort to reduce regulatory burdens, is considering options for recovery of costs resulting from this training requirement. It would seem prudent for ORI/PHS to use the experience gained from these efforts on human subjects training to gauge the cost and reasonableness of implementation before additional training requirements are imposed. In Conclusion The colleges and universities that comprise the membership of our four associations concur with PHS/ORI that all researchers should be afforded educational opportunities that contribute to their development as scientists and encourage proliferation of life-long attitudes toward conducting research responsibly. The review of this proposed PHS policy has not only illustrated the complexity of the core areas to be considered for inclusion, but also the increasing number of entities (e.g., NIH, FDA, OHRP and ORI) within HHS that require coordination to meet the goals this policy sets. We recognize that ORI has particular expertise in the field of misconduct in science, but this proposed PHS policy goes far beyond its regulatory mandates and detailed expertise - and into the regulatory and policy purview of others within HHS. We, therefore, believe that the Secretary needs to vest authority for development of this training policy in an administrative apparatus that more appropriately takes into account the regulatory responsibility and expertise among the many affected PHS agencies. This will help prevent a proliferation of conflicting or redundant regulatory requirements, and assure the coordination necessary to achieve the goals of the proposed training policy. Thank you for the opportunity to provide comments. Sincerely,
Nils Hasselmo
Debra Stewart
Katharina Phillips
C. Peter Magrath Enclosure Cc: David Satcher, Assistant Secretary for Health and Surgeon General, DHHS Ruth Kirschstein, Principal Deputy Director, NIH Jane Henney, Commissioner of Food and Drugs, FDA Greg Koski, Director, OHRP
|