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Academic year 2004-2005 in Review

In an effort to keep faculty, students, and staff aware of the ever changing and generally increasing world of regulations governing how research at universities is conducted, the Office of Research Compliance is initiating a newsletter that will come out once each semester. The newsletter will cover a number of areas:

  • new university policies
  • an in-depth description of an existing university policy to update and inform the academic community
  • current governmental activity in the compliance area that may affect researchers
  • announcements of workshop and educational opportunities

New Policies:

Issues of who has access to our laboratories that contain hazardous materials and concerns for safety of individuals working in laboratories or other hazardous work areas spurred adoption of two policies in 2004-2005: a Policy on Minors in Hazardous Work Areas and an Interim Policy on Access to Laboratories with Hazardous Materials or Laboratory Animals by Visitors .

The Minors in Hazardous Work Areas

[http://www.indiana.edu/~riskmgmt/minors_hazardous.htm] This policy sets specific guidelines for when persons who are under 18 may be in areas containing hazardous chemicals, BL-2 biological agents and toxins or radioactive materials. In general, the policy requires that the minors be either IU students, employees or visitors for a specific educational purpose. It requires that minors have the requisite safety training for handling the hazardous materials and be supervised. Persons under 16 may not enter certain types of laboratories, regardless of whether they had training or supervision, such as places with significant radioactive materials.

The Interim Policy on Access to Laboratories

[http://www.indiana.edu/~rschinfo/rschcomp/pdf/access_to_labs.doc ] serves dual purposes: first, it assures that persons allowed unsupervised access to our laboratories that contain hazardous chemicals, biological agents and toxins (known as “Select Agents”) and radioactive materials are legally entitled to have access to those areas. Recent federal legislation and regulations, such as the USA PATRIOT Act and Department of Commerce's Export Administration Regulations [ http://www.access.gpo.gov/bis/ear/ear_data.html ] prohibit certain persons from access to materials and technology that could be used for terrorism or military weaponry. The policy's second, but equally important, purpose is to ensure that visitors have the required safety training and command of English to deal with accidents or other emergencies that may arise. Short-term (up to five hours) supervised visits are permitted under the policy. IU deans are responsible for assuring compliance and notifying the Office of Risk Management of any visitors subject to the policy.

The only other policy changes this year were to the University's Policy on Research Integrity and the Bloomington Procedures for Responding to Allegations of Research Misconduct. The Interim Policy and Procedures are at: [ http://www.research.indiana.edu/rschcomp/misprocb.html ]. These changes will be discussed below.

Each of these policies is in effect. Those denoted “interim” are still being reviewed by the faculty governance and may be revised as a result of that process.

Research Integrity Policy

This policy, initially adopted in 1997, represents both university policy and those federal regulations governing research misconduct when public health funding, e.g., NIH, or NSF funds, are involved. The policy defines what constitutes research misconduct, who are covered by the policy and outlines the procedures and standards for reporting allegations of research misconduct and determining if research misconduct, in fact, has occurred.

In the last few months, the New York Times , the Washington Post and the Economist all had articles on “research misconduct.” Both the Post article and the Economist article focused on the published results of a survey of NIH funded scientists about professional ethical practices. Nearly one-third of 3,247 respondents reported some form of unethical practice, some minor - some not so minor.

In addition, the Times article, nicely headed “Allegations of Fake Research Hit New High,” picked up on the significant increase in 2004 in allegations of research misconduct reported to the Office of Research Integrity within the Department of Health and Human Services - up 50% from 2003. Similarly, in its December 17, 2004 edition, the Chronicle of Education had a lengthy story on the incidence of plagiarism in academia, replete with some horrifying tales of careers made and maintained on the basis of plagiarized work.

Research misconduct is, of course, not the norm, but the incidents that make the newspapers do damage to the public's trust concerning our scholarship. It is important as mentors that faculty discuss proper research ethics and that they practice the high standards that they teach others.

? Who is covered by IU's Policy on Research Integrity ?

The policy covers: faculty and graduate students, other IU employees engaged in research (whether or not externally funded) and any other persons affiliated with the University who are engaged in Sponsored Research (i.e. externally research funded activities).

? What acts or behavior constitute research misconduct ?

- falsification of data

- fabrication of data

- plagiarism

- misappropriation of another's work, data, ideas etc. (e.g. authorship disputes; rights to use data collected collaboratively)

- serious violations of research regulations (e.g. regulations regarding human subjects, animal and laboratory safety regulations)

- failure to report research misconduct

- retaliation against persons who have made allegations of research misconduct

? What office administers the Research Integrity Policy ?

The policy is administered by the Vice President for Research. There are two Research Integrity Officers (“RIOs”); one on the Bloomington campus and one at IUPUI.

? If I believe research misconduct is occurring where can I go?

- Complaints can be made to the appropriate RIO or the chair of the Standing Committee on Research Integrity in Bloomington or the chair of the Ethics Committee at IUPUI. Issues arising on the regional campuses should be directed to the RIO on the Bloomington campus (812-856-1229; Gellis@Indiana.edu) .

? How does the fact that the research in question involves federal funds affect the university's policy?

- In the federal world of research misconduct, there are only three types of research misconduct: falsification of data, fabrication of data and plagiarism (otherwise known as “FFP”.)

- If the allegations involve “FFP” and public health funds, we are required to:

1) notify the governmental agency;

2) conduct a very specific two step investigatory process within predetermined time limits; and

3) report our conclusions and recommendations to the Office of Research Integrity for review

? What are common “pitfalls” faculty and graduate students should pay close attention to?

One of the most common complaints relates to misappropriation of another's work arising out of collaborative research. In essence, who has done what? Has X been given the appropriate recognition for X's contribution to the project? It cannot be emphasized enough that faculty (whether with other faculty or their graduate students) should make clear (preferably in writing), at the outset and continually review, who is responsible for what and who will get credit for what. This includes the decision on who will be listed as an author and in what order.

? What are the new changes to the Policy?

The Interim Policy (1) reflects the new definition of research misconduct under the federal regulations, and (2) authorizes campuses to elect a simpler hearing process for research misconduct allegations not involving forms of federal research misconduct (FFP). The standard applied to find whether research misconduct occurred has also changed. The act(s) must be:

(1) a significant departure from accepted practices of the relevant research community

(2) committed intentionally, or knowingly or recklessly, and

(3) proven by the preponderance of the evidence.

In the time since we redrafted the policy to make these changes, the federal government has amended its regulations once again, and we will be assessing whether further changes are required to conform to the new regulations.

New York Times article, July 10, 2005 [link no longer available]

Washington Post article, [ http://www.washingtonpost.com/wp-dyn/content/article/2005/06/08/AR2005060802385.html]

Economist , June 11, 2005 at 76 (web link only for subscribers)

The Chronicle of Higher Education article [ http://chronicle.com/free/v51/i17/17a00801.htm ]

Office of Research Integrity [ http://ORI.HHS.GOV ]

Current Developments

The regulatory area of most concern to universities is proposed changes in the Export Administration Regulations and Department of Defense regulations, and if either is adopted these changes will significantly alter how research is conducted in university settings. The proposed changes are designed to increase our national security by focusing on the use of “dual purpose” technology by foreign nationals from certain “off-limit” countries. China , Russia , and India are among the countries often on the “off-limit list.” This means that foreign faculty, students, and staff who are not legal residents of the United States and are from a country on the “off limit list” either cannot use certain types of equipment (including software) or will need a license from the federal government. You may link to the Department of Commerce's website at http://www.research.iu.edu . This is a useful tool for understanding how to determine what, if anything, in your laboratory is subject to the Export Control Regulations. It is important to keep in mind three facts:

  • Foreign nationals from countries to whom “covered” technology cannot be “exported” without a license cannot have use of that technology in the United States without a license (the “Deemed Export Rule”), unless there is an exception under the regulations.
  • At present, foreign nationals engaged in fundamental or basic research are exempt from the Deemed Export Rule. Proposed changes to the interpretation of the regulations would eliminate this exemption.
  • The key to what technologies are covered is the extent to which the technology (or software codes) are proprietary or not publicly known. Technologies that are publically available are NOT subject to the regulations.

In addition there are radioactive materials, chemicals and biological agents and toxins that cannot be exported to anyone without a license. The list of agents and toxins that cannot be exported is broader than the select agent list and may include materials you may have in your labs. Please check with the Office of Environmental Health & Safety at 812-855-9333 for Bloomington and the regional campuses, or at 317-274-2830 for IUPUI and all regional medical education centers before shipping any of these materials.

Our office in Bloomington (812-856-1229) is available to assist you in determining if you have equipment or technologies that may be subject to the regulations or to give workshops on the regulations generally.

Announcements and Workshops at IU in the Fall

  • IUPUI has new Interim Guidelines and Procedures on Conflicts of Interests for Academic Appointees. These procedures detail who must disclose financial interests, what financial interests need to be disclosed and the procedures for management of disclosed conflicts. The procedures create a campus Conflicts of Interest Committee. These guidelines and procedures can be found on the web at www.research.iu.edu under research compliance. Click on “policies and procedures.”