2010-21591. Proposed Scientific Integrity Policy of the Department of the Interior

AGENCY:

Office of the Secretary, Interior.

ACTION:

Notice and request for comments.

SUMMARY:

We, the Department of the Interior, are proposing and seeking comment on a Department-wide policy to ensure the integrity of scientific activities in the Department.

DATES:

Submit comments by September 20, 2010.

ADDRESSES:

Send comments to: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Alan D. Thornhill, 1849 C Street, NW., MS 5428, Washington, DC 20240-0002, 202-208-6249.

SUPPLEMENTARY INFORMATION:

In his March 9, 2009, memorandum on Scientific Integrity, the President states that, “Each agency should adopt * * * procedures * * * to ensure the integrity of scientific and technological information and processes on which the agency relies in its decision making or otherwise uses or prepares.” Interior has developed draft policies and standards for ensuring accuracy and integrity in all scientific activities conducted in the Department. After public comment, revision, and approval, we plan to incorporate these procedures into the Department Manual.

You may submit comments on any part of these proposed procedures by e-mail, letter, or in person at the address in the ADDRESSES section of this notice. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Department of the Interior proposes the following procedures for ensuring scientific integrity as a new chapter in the Department Manual:

3.1 Purpose

A. This chapter establishes:

(1) A Departmental policy on integrity of scientific activities and a code of scientific conduct;

(2) Ethical standards for Department of the Interior (DOI) employees who conduct or supervise scientific activities for the Department, or who compile and translate scientific information into formats used by the Departmental management; and

(3) A process for initial handling of violations of the scientific conduct code.

B. Administrative rules and laws pertaining to activities such as falsification of government formats, sexual harassment, civil rights, acceptance of gifts, nepotism, disclosure of financial interest, conflict of interest or outside employment are neither altered nor superseded by the existence of this chapter.

3.2 Scope

This chapter applies to:

A. All employees and contractors who engage in scientific activities; and

B. All volunteers who assist with scientific activities. (Volunteers are required to provide unbiased and objective information to their supervisors. All information collected by a volunteer is considered provisional until verified by the supervisor or other designee.)

3.3 Policy on Integrity of Scientific Activities

The Department:

A. Is dedicated to preserving the integrity of scientific activities conducted on its behalf and will not tolerate misconduct in the performance of scientific activities;

B. Will take appropriate action to protect the public from the effects of inaccurate information produced through scientific activities;

C. Will investigate, to the maximum extent of the law, each allegation of misconduct while ensuring the rights and privacy of any party against whom the allegation is made.

D. Will take appropriate disciplinary action, which may include termination of employment, in accordance with DOI personnel policies for non-compliance with the Code of Scientific Conduct in section 3.4.

3.4 Code of Scientific Conduct

Each person covered by section 3.2 must adhere to the following code of scientific conduct:

To the best of my ability I will do all of the following:

• I will act in the interest of the advancement of science and contribute the best, highest quality scientific information for the Department of the Interior.
• I will conduct, process data from, and communicate the results of scientific activities honestly, objectively, thoroughly, and expeditiously.
• I will be responsible for the resources entrusted to me, including equipment, funds, my time, and my employees' time. I will promptly and accurately collect, use, and report all financial resources under my control; and promptly, thoroughly, and accurately report all scientific work.
• I will fully disclose all research methods used, available data, and final reports and publications consistent with applicable laws and policy.
• I will respect, to the fullest extent permitted by law, confidential and proprietary information provided by communities, Indian Tribes, and individuals whose interests and resources are studied or affected by scientific activities or the resulting information.
• I will neither hinder the scientific activities of others nor engage in dishonesty, fraud, deceit, misrepresentation, coercive manipulation, or other scientific or research misconduct.
• I will welcome constructive criticism of my scientific activities, will welcome and participate in appropriate peer reviews, and will critique others' work respectfully and objectively. I will substantiate comments that I make with the same care with which I report my own work.
• I will be diligent in creating, using, preserving, documenting, and maintaining collections and data. I will adhere to established quality assurance and quality control programs. I will follow the Department's records retention policies and comply with Federal law and agreements related to use, security, and release of confidential and proprietary data.
• I will adhere to appropriate standards for reporting the results of scientific activities and will respect the intellectual property rights of others.
• I will, to the extent possible and practical, differentiate among facts, opinions, hypotheses, and professional judgment in reporting the results of scientific activities to others, including scientists, decision makers, and the public.
• I will be responsible for the quality of any data I collect or any interpretations I make, and for the integrity of conclusions I draw in the course of my scientific activities.
• I will place quality and objectivity of scientific activities and reporting of their results ahead of personal gain or allegiance to individuals or organizations.

3.5 Employee Responsibilities

A. All employees must comply with:

(1) The Federal Policy for the Protection of Human Subjects, published at 56 FR 28012-28018 (June 18, 1991);

(2) The Standards of Ethical Conduct for Employees of the Executive Branch in 5 CFR 2635; and

(3) All Federal statutes, Executive Orders, Presidential Memoranda, Office of Government Ethics and Office of Personnel Management regulations, and Departmental regulations and policies (as required by 43 CFR 20.501 and 20.502).

B. All employees must immediately report through official channels or directly to the Office of Inspector General (OIG):

(1) Any known, suspected, or alleged fraud, waste, abuse, or mismanagement affecting the Department; and

(2) Any serious integrity matter that affects the integrity of the Department.

C. Employees who engage in scientific activities must comply with the Code contained in section 3.4.

D. Employees who are involved in the conduct and reporting of scientific activities must comply with the Federal Policy on Research Misconduct, published at 65 FR 76260-76264 (December 6, 2000).

3.6 Bureau and Office Responsibilities

Each bureau and office must:

A. Establish procedures to ensure adherence to the requirements of this chapter; and

B. When investigating allegations of misconduct under this chapter, ensure that investigators have adequate scientific expertise, provide for due process, and be consistent with the Federal Policy on Research Misconduct.

3.7 Legal Effects of This Chapter

This chapter:

A. Is intended to improve the internal management of the Department of the Interior;

B. Does not create any right or benefit, substantive or procedural, enforceable by law by any person against the United States, its agencies, its officers or employees, or any other person; and

C. Does not replace the Standards of Ethical Conduct at 5 CFR 2635 and other relevant ethical obligations of Department of the Interior scientists.

3.8 Allegations of Misconduct

A. Establishing a Finding of Scientific Misconduct

Before taking disciplinary action under this section, a supervisor must establish a finding of scientific misconduct. A finding of scientific misconduct requires that:

(1) There is a notable departure from accepted practices of the scientific community for maintaining the integrity of the scientific or research record;

(2) The misconduct is committed intentionally, knowingly, or in reckless disregard of accepted practices; and

(3) The allegation is established by a preponderance of evidence.

B. Disciplinary Action

(1) Once a supervisor has verified an employee's misconduct under section 3.8A, the supervisor will administer disciplinary action in accordance with DOI personnel policies and using for guidance the Departmental Manual chapter on “Discipline and Adverse Actions” 370 DM 752. Supervisors should:

(i) Select the penalty they believe necessary to correct the misconduct and to discourage repetition; and

(ii) Evaluate each situation to ensure that the actions proposed and taken are reasonable.

(2) When there is a significant unauthorized departure from accepted practices, or repeated violations of a less serious nature, supervisors may propose and decide on appropriate penalties, including termination of employment.

(i) If a supervisor is considering a formal disciplinary action, the supervisor must immediately consult the Human Resources office.

(ii) The Human Resources office may consult with the Office of the Solicitor (SOL) on proposed disciplinary actions and must consult with SOL on all proposed disciplinary actions that are appealable to the Merit Systems Protection Board.

(3) All responses to allegations of misconduct, from inquiry to confirmation to adjudication and appeal, must be consistent with the guidelines and principles in the Federal Policy on Research Misconduct, Departmental policy, and 370 DM 752.

C. Appeal Rights

For disciplinary actions up to and including a 14-day suspension, employees not covered by a collective bargaining agreement have the right to appeal through the Administrative Grievance Procedure. Employees covered by a collective bargaining agreement have the right to appeal through a Negotiated Grievance Procedure (NGP). For suspensions of more than 14 days, up to removal from Federal service, employees have the right to appeal to the Merit Systems Protection Board or through an applicable NGP (5 CFR 752). Neither temporary employees, probationary employees, contractors, nor volunteers have any appeal rights.

3.9 Authorities

A. Statutes and Regulations

(1) 5 U.S.C. 301 allows the head of an executive department to prescribe regulations for the conduct of its employees.

(2) 43 CFR 20.501 requires employees of the Department to comply with all Federal statutes, Executive Orders, Office of Government Ethics and Office of Personnel Management regulations, and Departmental regulations.

(3) 43 CFR 20.502 states that employees are required to carry out the announced policies and programs of the Department.

(4) 43 CFR 20.502(a) states that an employee is subject to appropriate disciplinary action if he or she fails to comply with any lawful regulations, orders, or policies.

B. Federal Policy on Research Misconduct, 65 FR 76260-76264, December 6, 2000

C. Standards of Ethical Conduct for Employees of the Executive Branch, 5 CFR 2635

3.10 Definitions

A. Conflict of Interest

Any financial or other interest which conflicts with the actions or judgments of an employee when conducting scientific activities because it:

(1) Could significantly impair the employee's objectivity; or

(2) Could create an unfair competitive advantage for any person or organization.

Department of the Interior scientists are also subject to conflict of interest and appearance of a lack of impartiality requirements at 18 U.S.C. 208 and 5 CFR 2635 Subparts D and E.

B. Decision Makers

Departmental employees who:

(1) Are not engaged in scientific activities;

(2) Communicate, recommend, or decide policy or management;

(3) Communicate, recommend, or decide expenditure of Departmental funds; and

(4) Rely in part on scientific products, or on documents compiled and translated from scientific products, to ensure that agency actions are supported by evidence and have a rational basis, and are not arbitrary or capricious.

During the conduct of Departmental business, decision makers may be involved in editing of documents for clarification of major points to aid decision making. Such editing is beyond the scope of this chapter.

C. Employees Who Engage in Scientific Activities Are

(1) Individuals who conduct or directly supervise scientific activities, including but not limited to proposing, performing, or reviewing research, or in reporting research results; and

(2) Individuals who directly supervise or personally perform work involving the compilation and translation of scientific information into formats used by the Department's decision makers.

D. Fabrication

Making up data or results and recording or reporting them.

E. Falsification

Manipulating research materials, equipment, or processes; or changing or omitting data or results such that the research is not accurately represented in the research record.

F. Plagiarism

The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

G. Reporting

Dissemination or disclosure of the results of scientific activities. Dissemination and disclosure may be oral or in any media, including print and digital media.

H. Research

All basic, applied, and demonstration research in all fields of science, engineering, and mathematics, including social, behavioral and economic research.

I. Research Misconduct

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion. (This definition is quoted from The Federal Policy on Research Misconduct (65 FR 76260-76264).)

J. Science

Knowledge obtained and tested through use of the scientific method. Science may also include the observation and classification of facts with the goal of establishing verifiable knowledge derived through induction and hypothesis.

K. Scientific Activities

Activities involving inventorying, monitoring, experimentation, study, research, modeling, and scientific assessment. Scientific activities are conducted in a manner specified by standard protocols and procedures and include any of the physical, biological, or social sciences as well as engineering and mathematics that employ the scientific method. Inspections for regulatory compliance and resulting records are not included because they are covered by separate requirements.

L. Scientific Assessment

Evaluation of a body of scientific or technical knowledge which typically synthesizes multiple factual inputs, data, models, assumptions, and/or implies best professional judgment to bridge uncertainties in the available information.

M. Scientific Method

A method of research in which a problem is identified, relevant data are gathered, a hypothesis is formulated from these data, and the hypothesis is empirically tested.

N. Scientific Misconduct

Fabrication, falsification, or plagiarism in proposing, performing or reviewing scientific activities and their products.

O. Scientific Product presents the results of scientific activities including the synthesis, compilation, or translation of scientific information into formats used in the Department's decision-making process.

Appendix

Commentary to Explain and Clarify the Intent of the Basic Elements of the Code

A. Scientific Excellence, Integrity, and Conflict of Interest. Honesty and integrity of Department employees subject to the Code are vital to the public interest and critical to conducting the Department's mission. Scientific activities provide data to inform many of the Department's decision-makers regarding the stewardship of our Nation's land, energy, mineral, water, air, biological, and cultural resources. Employees subject to the Code must avoid conflicts of interest that occur when personal interest or gain interferes with or could be construed to interfere with the objectivity of their actions or judgments. They are obligated to be thorough in documenting their work to ensure that the details of their methods are described adequately enough to allow other scientists to critically evaluate or reproduce their results. They will use the best available and practicable practices, protocols, methodologies and technologies available to them when conducting scientific activities as well as in the review, use and dissemination of scientific information. This Code does not suggest that it is unethical to use novel investigative approaches, employ unusual methods of analysis, exclude data known to be faulty for identifiable material reasons, or interpret data in a new or unique way. However, novel methods and data modifications should be fully documented in the research record to avoid misinterpretation of any such departure from standard protocols or methodology.

B. Abuse of Resources. Department employees subject to the Code will ensure appropriate use of resources in the conduct of scientific activities, including equipment, funding, staff time, information resources, and any privately owned or Federal property through the awareness of the requirements of applicable laws and regulations. Most importantly, employees will use resources wisely, efficiently, respectfully, and prevent abuse of cultural and natural resources during the conduct of scientific activities. Employees must strive to select methods and materials that, to the best of current knowledge, minimize or eliminate adverse impacts to cultural or natural resources or their future examination, scientific investigation, treatment or function. Professional standards for non-invasive or non-destructive testing/sampling will be followed when studying cultural materials. Animals used for research purposes are public resources, and employees will obey public laws concerning treatment of laboratory animals. Public Law (Pub. L. 99-198), The Food Security Act of 1985, and Federal regulation (9 CFR Part 3) primarily apply to treatment of laboratory animals. Scientists should follow public laws (including Pub. L. 99-108, as applicable) and regulations for activities involving animals in the wild and should consider, where appropriate, guidelines regarding treatment of wild animals published by professional wildlife or scientific societies.

C. Research Involving Human Subjects.

(1) Department employees subject to the Code conduct scientific activities among groups, including but not limited to hikers, campers, hunters and anglers, present-day ethnic or occupational communities, and Indian Tribes. These consultations must meet compliance requirements for planning, the Native American Graves Protection and Repatriation Act of 1990 (Pub. L. 101-601), historic preservation, and subsistence uses. Such persons involved in scientific activities must be treated with professionalism and respect. To this end, the Department adopted the common rule published as Federal Policy for the Protection of Human Subjects (56 FR 28012-28018, June 18, 1991). Exempted from this rule is human subjects research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior unless the information obtained is recorded in such a manner that human subjects can be identified, and/or disclosure could place subjects at risk of criminal or civil liability. Many information collections are regulated under the Paperwork Reduction Act of 1995 (5 CFR 1320), and applicable Departmental procedures should be followed (381 DM 11, 12). Exempted from this rule is observation of human public behavior that involves no data collection from subjects.

(2) Before initiating new scientific activities with any group, Department employees subject to the Code should be familiar with the laws, regulations, and policies (including those that are bureau-specific) governing privacy and freedom of information, ethnographic research guidelines, and types of release and consent forms, as provided information might not be protected from release. Department employees will ensure that the research methods are made clear to participants, that permission is obtained to use interview materials, tapes, photographs, maps and any other materials, and that participants know the legal limits of confidentiality.

D. Hindering scientific and information gathering activities; failing to protect proprietary and confidential information; engaging in dishonesty, fraud, deceit, misrepresentation; or engaging in or knowingly permitting other scientific, research, or professional misconduct.

(1) Inappropriately hindering scientific activities by Departmental employees subject to the Code is not tolerated by the Department. This includes actions such as biased review of scientific proposals or manuscripts; physical disruption of another scientist's experiments, field surveys, or database; denial of reasonable access to resources or data needed by other scientists to perform their work; or failure to provide information that other Departmental employees need to duplicate scientific activities or verify their accuracy. Scientific staff will allow management and others appropriate access to resources entrusted to them, unless doing so would violate legal, regulatory or policy restrictions, compromise the scientific validity of their activities or substantially interfere with their performance. Employees are expected to understand existing rules and guidelines regarding the need to make data gathered with Federal dollars accessible. Reasonable judgments to delay public access depend upon individual circumstances when premature release would compromise validity or decision-making ability. Specifically, this applies to work in progress where data have not gone through a planned quality control/quality assurance protocol that is part of the research design. Therefore, this Code does not attempt to provide universal guidelines for making such case-by-case determinations.

(2) Requirements related to use, security and release of proprietary data are sometimes covered by law, regulation or policy and may be established through an agreement with the originator of the data. These agreements are usually established on a case by case basis. Employees will adhere to these agreements to the extent permitted by law, or policy. The Code prohibits denying other scientists reasonable access to published scientific information for the purpose of enhancing one's interests.

(3) Falsification and fabrication of data and results by Departmental employees are not tolerated by the Department and would be a violation of the Code by employees subject to it.

E. Participating in Review Processes and Offering Fair and Objective Opinions.

(1) Peer review is an important element in the creation and use of scientific information. In all cases, external (to the Department) scientific review of scientific activities, information, inventory or monitoring data to be published or used in decision-making is beneficial and, in some cases, it is essential. All employees subject to the Code must know, understand and adhere to Departmental and bureau specific guidelines related to peer review of scientific activities. Open and honest debate is essential for the advancement of science, and peer review is an important part of that debate. The peer-review process should be free of personal and professional jealousies, competitions, non-scientific disagreements, and conflicts of interest.

(2) Reviewers should focus on the logical and scientific validity of the research findings, rather than personal feelings, or interactions (past or current) between the reviewer and the author/investigator. Authors/investigators should address reviewers' comments in a thorough manner, and should document appropriately how they responded to those comments. It is the responsibility of prospective reviewers to disqualify themselves, if the review cannot be done in an objective manner (5 CFR 2635.502). Reviewers should not instigate changes to any scientific study by its authors through intimidation, either implied or stated. Reviewers should document in writing all changes made to the manuscripts or proposals to conduct scientific studies in writing.

F. Integrity in the Collection and Preservation of Data.

(1) Quality control and assurance, including protocols, standards, and methodologies, should be routinely established for activities pertaining to the conduct of scientific inquiry and the collection of data. Persons engaged in scientific activities and their managers must know and follow established programs, protocols, standards, and methodologies for the activities they conduct to inform Departmental decisions. Preservation of collections and records created during the conduct of scientific activities is controlled by Federal law (44 U.S.C. chaps. 21, 29, 31, and 33) and Departmental regulations and policies (36 CFR 1228.1-1228.282; 381 DM 11, 12; 384 DM 2, 3, and 4) and bureau regulations and policies. This is important for substantiating scientific activities and supporting subsequent decisions that are influenced by the results. Employees subject to this Code must follow these laws, regulations and policies. Collections made for retention include, but are not limited to, cultural objects in archeological collections and non-cultural biological, geological, and paleontological samples.

(2) Documents that should be retained for the scientific record vary according to the nature of the study and include: study plans; methodology; primary data, such as laboratory notebooks, original data, metadata, and quality assurance/quality control information; and formal data sets, analyses and products. These items may be in any medium, including printed and electronic media. Failure to retain data in accordance with law, regulations and policy is not tolerated by the Department.

G. Responsible Authorship and Dissemination of Information.

(1) Authorship of a scientific product must be based on a major intellectual contribution (as part of conception, design, data collection, data analysis, or interpretation) and a significant contribution to its preparation (writing, reviewing, or editing). Authorship includes the responsibility for ensuring that the work reported meets scientific criteria and ethical standards. Conferring authorship to individuals engaged in scientific activities without their knowledge or consent is strictly prohibited by the Code.

(2) Scientific knowledge is cumulative and is built on the contributions of numerous scientists over many years. Recognition of other contributors often takes the form of credits in a publication through an acknowledgment or citation. However, only authors whose substantive comments have been received and incorporated prior to submission should be listed in acknowledgments. Authors will cite or acknowledge any scientific work or the source of any idea that is not regarded as common knowledge among specialists in the particular field and that substantially contributes to a scientific activity and its interpretation and result. The Code prohibits plagiarism or theft of ideas, data or unpublished findings. Departmental employees subject to this Code will acknowledge and, to the extent permitted by law, protect the intellectual efforts of others and the confidentiality of information provided by human subjects. However, when Departmental employees are preparing documents required by the National Environmental Policy Act (NEPA) and the considerations in this paragraph are in conflict with the regulations and guidance of the Council on Environmental Quality regarding the publication of information under NEPA, the regulations and guidance of the Council shall govern.

(3) Duplicative publication is not tolerated by the Department. This does not suggest that it is inappropriate to publish more than one manuscript based on a single scientific activity. In some cases, the same scientific activity may be of interest to separate audiences having different technical specialties or to journals having different readerships. Prior publication of portions of an original idea should always be referenced in later publications. Publishing parts of another paper, or publishing another paper with only minor changes, should only be done to reach different or larger audiences and with the knowledge and consent of the publisher. Employees subject to the Code will accept professional responsibility associated with authorship and know that the interpretation and results of their work are used to inform important decisions in the public interest. Repetitive publication of findings in popular literature does not constitute duplicative publication.

(4) In order to ensure that the Department's decision making is based on the best available science, the Code requires a scientific product to be subject to the required level of review. Public release of a scientific product without the required level of review or without the inclusion of appropriate disclaimers could be considered misconduct.

(5) Additionally, in support of the Department's interest in protecting its decision making, the Code prohibits changing conclusions, deletion of data, or knowingly omitting data from reports and testimony for purposes of misrepresentation or manipulation. At the same time, the Code prohibits suppressing data collection, scientific studies, or publication of results by scientists or their supervisors for the purpose of manipulating Departmental decisions. These actions are not tolerated by the Department. They are violations of the Federal Policy on Research Misconduct because they wrongly characterize results and manipulate results so that research is not accurately represented. Scientific conclusions may only be changed in light of new data or new analyses. Scientists should not succumb to coercion to change data. If an employee subject to the Code believes that he or she has been subjected to coercion, it should be reported immediately to the respective supervisor, bureau, or Departmental ethics program.

Laura Davis,

Associate Deputy Secretary of the Interior.