Environmental Health and Safety

Office of Research and Project Administration

SPONSORED PROGRAMS COMPLIANCE

1. Responsible Conduct of Research

Administrative Responsibilities/Issues:

Science is systematic, exact and built on a foundation of trust and honesty. It is knowledge gleaned from study, experimentation and observation. For science to provide an understanding of nature, the utmost integrity must be woven into this experimentation and the interpretation of its results. Assurance of the responsible conduct of research lies not only with the investigator but with all involved in the conduct and administration of sponsored research activities. While administrative staff may not have significant control over some components of research, a basic knowledge of what constitutes "responsible research" can lay the groundwork for overall compliance.

Environmental health and safety: In these days of uncertainty, everyone involved in research should be aware of the policies and procedures for day-to-day laboratory safety, and in the event of a large scale emergency. Often, both faculty and staff turn to their administrative staff for direction in these situations. Administrators need to be aware of the policies and procedures for emergency response, fire, industrial accidents, biosafety hazards and pest control. Information to assist administrators on any of these issues can be found on the Environmental Health and Safety website (http://www.safety.rochester.edu) and in Section 2. Administrators should strive to act proactively with regard to environmental health and safety as opposed to reactively.
Use and protection of human subjects: Protecting human subjects is not usually a task found in the job description of a research administrator. However, a knowledgeable administrator can be of considerable assistance to an investigator proposing the use of human subjects, and to a study coordinator. Helpful information on how to submit a proposal to the University of Rochester’s Office for the Human Subject Protection, RSRB forms and guidelines, HSPP educational information and regulations and references can be found on their website (http://www.urmc.rochester.edu/rsrb). Administrators should become familiar with the information found on this site and encourage their investigators to review this information before drafting their protocol and consent forms.

Maintaining compliance is difficult given the volume of regulations, guidelines, policies and ever increasing demands on the investigator’s time. It is important to remember that subjects cannot be enrolled without an active RSRB approval. Administrators may find it helpful to create a database of approval numbers and expiration dates for their investigators. Every investigator would appreciate a helpful reminder to keep their RSRB approvals active. Additional information on the regulations that govern the use of human subjects in research can be found on the website of the Office for Human Research Protections (OHRP) at the following url: http://www.hhs.gov/ohrp .

Use and protection of animals: Scientists conduct research on animals because the risk to humans is too high. Although some members of society question whether this decision is an ethical one, the majority accept the necessity of animal research but insist that it be conducted in a humane manner. Administrators should stress the importance of the humane treatment of animals to all of their investigators. An approval by the University Committee on Animal Resources is required before research using animals can commence. Information on how to submit studies to UCAR for approval can be found on their website (http://www.urmc.rochester.edu/ucar). Annual reports to UCAR are required to continue research using animals. Administrators may want to consider developing a data base to track the UCAR approval numbers and their expiration date for their investigators. Every investigator would appreciate a helpful reminder to keep their UCAR approvals active. Administrators should ensure that anyone working with animals have successfully completed the training required by the University Committee on Animal Resources.
Conflicts of interest: Conflict of interest is a term that encompasses a wide spectrum of behaviors or actions involving personal gain or financial interest. A conflict of interest exists when an individual exploits, or appears to exploit their position for personal gain or for the profit of a family member. The University of Rochester conflict of interest policy (http://www.rochester.edu/ORPA/policies/) prohibits activities that create even the appearance of a conflict of interest. Full disclosure is the only means to address conflict of interest, whether real or perceived. Administrators must ensure that all investigators (please see the definition in the Faculty Policy on Conflict of Commitment and Interest) complete and sign an annual conflict of interest disclosure form (http://www.rochester.edu/ORPA/policies/), that their departmental chair or center director reviews all completed forms and that disclosures of conflict are disclosed to the Dean’s office. Administrators should be prepared to assist in the development of a plan to manage the disclosed conflict.
Publication: The publication of experimental work accomplishes several things. It reports new scientific findings; allows for the evaluation of results; credits other scientists and enables others to extend or repeat work; attributes credit for the work to the authors and even more importantly, establishes who accepts responsibility for the work. Publishing helps scientists win grants, promotions, tenure, higher compensation and professional prestige. A common saying in science, “publish or perish” can be all too true. Scientists often feel pressured to publish. Science benefits society only insofar as its findings are made public.

The duties and responsibilities of authorship are not to be taken lightly. Determination of authorship is an important issue. In general, authors must contribute to the published work in some way. Defining the responsibilities of authorship can present a problem. If a published work contains an honest mistake the result of which is a significant impact on the paper’s scientific message and the mistake is attributed to one author, are all authors responsible for the mistake as well? Administrators should encourage authors to read and understand the “instructions to authors” provided by scientific journals to ensure that those applicable sponsors are acknowledged on published works, including posters and abstracts. Proper identification of authorship is particularly important because authorship can play a critical role in identifying scientific participants on projects, invention disclosures and subsequent royalty payments, and scientific and fiscal accountability during the life of the project and for audit issues.
Data and Intellectual property: The determination of ownership of research data begins with one question: Who collected the data? However, equally important is a second question: Under whose intellectual direction and guidance were the data collected? A third question that must be asked is: Is there a valid obligation to assign the rights of the data to another? When PHS awards a grant to the University, all data collected as part of that grant belongs to the University. Grants may be transferred from one institution to another in the event that the Principal Investigator relocates, but this transfer must be approved by the original grantee institution as well as the sponsor. Laboratory personnel, including trainees should never be allowed to take their original data notebooks with them when they leave the institution to begin a new career. The removal of copies may be permitted to allow the trainee to prepare papers or manuscripts but always only with the permission of the principal investigator. The University of Rochester has specific policies regarding access to and retention of research data and the freedom of information act. (http://www.rochester.edu/ORPA/policies/recgrid.html)

A copyright exists the instant the author’s words/actions are rendered into some tangible form. The owner of a copyright (the author) has exclusive rights over reproduction, distribution, sale and public performance of the work. Co-authors own the copyright on their portion of the work. Current copyright law states that “fair use” of copyrighted material will not constitute an act of infringement. The definition of “fair use” states that the copying and use of copyrighted material must be of a personal, nonprofit nature ( ie: criticism, news reporting, teaching, research or scholarship). Any questions regarding “fair use” should be directed to the University’s Office of Counsel.

A patent is a grant to an applicant for a specific and limited period of time during which the grantee has a legal right to exclude others from making, using or selling his or her claimed invention in exchange for the grantee’s provision of a full disclosure as to how the invention may be made, used or functions. In short, it is a reward for disclosing something of social value to the public. A patent is governed by explicit law. The point in time to file a patent is as soon as the inventor is able to provide the full and complete disclosure. The University of Rochester’s Office(s) for Technology Transfer
(medical center - http://www.urmc.rochester.edu/techtransfer/
or campus http://www.rochester.edu/ott/) are responsible for the management of intellectual property resources at the University of Rochester. Principal Investigators should be encouraged to contact the Office of Technology Transfer as early as possible if they believe they have intellectual property that could be patented and/or commercialized.
Error, negligence or misconduct: Even the most responsible scientist can make an honest mistake. When such errors are discovered, they should be acknowledged in the same journal in which the mistaken information was originally published. Mistakes made through negligent work are a different story. If scientists cut corners for whatever reason, they are placing their reputation and the public’s confidence in science at risk. Beyond honest errors and errors caused through negligence are another category of errors, those that involve deception. These acts of scientific misconduct undermine progress and the entire set of values on which science rests.
Response to violations of ethical standards: Encountering or witnessing a violation of the ethical standards of the research community can be one of the most difficult situations one can face. In this situation it is easy to find an excuse to do nothing, but someone who has witnessed this type of misconduct has an unmistakable responsibility to act. The federal government requires that all research institutions that receive public funds for research have a policy in place to deal with allegations of unethical research (http://www.rochester.edu/ORPA/policies/). In addition, these same funding agencies enforce their own laws and regulations that deal with misconduct in science (http://www.rochester.edu/ORPA/Regulations/debarmen.htm).
Collaborative research: Collaborative research presents several advantages. By combining unique expertise, resources and technology, investigators are empowered to tackle problems that are not conducive to a singular experimental approach. Collaborative research can occur between researchers in different departments at the same institution, between researchers located at different institutions, and between industry and the University. While almost always a positive approach, collaborative research also comes with its share of challenges. The rules of engagement involving collaborative arrangements must always be clearly stated and understood. Departmental research administrators can assist their investigators by stressing the importance of formalizing research collaborations in writing whenever possible.

Much of what is called collaborative research is interdisciplinary and often interdepartmental. Unfortunately, collaborations may be viewed and misconstrued as undermining the traditional departmental infrastructure. This perception can be somewhat alleviated by insuring that University signoff procedures are followed for grant submissions. These signoff procedures insure that all departments have reviewed and agreed to the collaborative research as well as the financial considerations.

Collaborative research between different institutions must begin with an understanding, on the part of both the researchers and the institutions, of the responsibilities on each side of the collaboration. This understanding should be documented by a formal letter acknowledging the collaboration and providing assurance that the subcontractor will follow all appropriate policies and regulations. The Office of Research and Project Administration will provide such a letter during the required proposal signoff process.

When collaborative research occurs between industry and the University, concerns arise regarding the sharing of research resources, restrictions on public disclosure and publication of the research. For these types of collaborations, a formal collaborative agreement should be utilized. The types of issues that should be addressed in this type of agreement include: the goals of the research, the responsibilities of the collaborating parties, a timeline for completion of the stated goals, statements regarding accountability and authorship as well as ownership of data. The Office of Research and Project Administration can assist in the development of these agreements and is responsible for the negotiation of these agreements.
Mentoring: The word mentor means a loyal and trusted friend, enlightened advisor and teacher. In the research environment, a mentor is someone who is responsible for the guidance and academic, technical and ethical development of a trainee. Mentoring is more than just advising. Mentors inform, instruct and provide an example for their trainees. The actions and activities of mentors affect the attitude of their trainees to such degree that trainees often assume the traits and values of their mentors.

The mentor is responsible for providing trainees with all relevant rules, regulations and guidelines that may apply to the conduct of research. Administrators can assist mentors by helping them keep abreast of changes in these rules, regulations and guidelines as they occur. Students, post-docs and even laboratory technical staff can be mentored. Administrators should introduce themselves to those being mentored to allow the mentee to understand there is someone other than their mentor they can go for guidance and information.
Training in the Ethical Conduct of Research: The University of Rochester requires that graduate students and postdoctoral fellows attend the “Ethics in Research” course offered each fall. This class is offered at no cost. Administrative and technical staff are invited to attend these classes as well. Information on the course can be found at the following url: http://www.urmc.rochester.edu/neuroscigrad/courses.html#1501