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RESPONSIBLE CONDUCT IN RESEARCH (supported in part by a grant from the National Postdoctoral Association). Collaborative Research. Presentation content. Short Pre-test Presentation Objectives NIH Comment increased tendency for collaboration pitfalls of collaboration

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RESPONSIBLE CONDUCT IN RESEARCH(supported in part by a grant from the National Postdoctoral Association)

Collaborative Research

Created January, 2009

presentation content

Presentation content

  • Short Pre-test
  • Presentation Objectives
    • NIH Comment
    • increased tendency for collaboration
    • pitfalls of collaboration
    • ways to enhance collaborative research
    • SIT institutional processes involved in collaborative research
    • ethical considerations
    • available resources
  • Reference Material
  • Faculty Presentation
  • Case Study and Discussion
  • Short Post-test

RCR – Collaborative Research

Created January, 2009

nih comment

NIH Comment

  • “The scale and complexity of today’s ….research problems increasingly demand that scientists move beyond the confines of their own discipline and explore new organizational models for team science…Many scientists will still continue to pursue individual research projects, but they too will be encouraged to make changes in the way they approach the scientific enterprise.”
  • National Institutes of Health Roadmap for Research

RCR – Collaborative Research

Created January, 2009

increased tendency for collaboration

Increased tendency for collaboration

  • Funding sources are under stress
    • --All sponsors seeking ways to maximize their support
  • Investigators increasingly need complementary skills
    • --Research is increasingly complex and inter-related
  • Current technology eases long-distance collaboration
    • -- Internet, eMail, networked systems, web-based technology
  • Bayh-Dole Act encourages tech transfer
    • -- 1980 Federal Act allows universities to keep ownership
  • Collaborations seem to improve the science
    • -- Macrino, F. “Scientific Integrity: An Introductory Text with Cases.” Second Edition. American Society for Microbiology Press 2000

RCR – Collaborative Research

Created January, 2009

pitfalls of collaborative research

Pitfalls of collaborative research

  • Failure to communicate
  • --“Most often, problems arise in scientific collaborations because the scientists failed to explicitly define their expectations of one another.”
    • “Preempting Discord: Prenuptial Agreements for Scientists”
    • -- Howard Gadlin and Kevin Jessar, NIH Ombudsmen
  • Lucrative tech transfer value
    • -- can introduce discord to the research team
  • Different objectives
    • -- for-profit and non-profit collaborations reflect different aims

RCR – Collaborative Research

Created January, 2009

ways to enhance collaborative research

Communicate…….. and then communicate again

    • --Don’t assume anything. This is particularly advisable when dealing with industry
    • Define expectations of who will do what
    • Discuss authorship in advance
    • -- Different disciplines have different standards for determining authors
    • Discuss data and material management
    • -- Don’t assume everyone knows who will be doing what
    • Discuss intellectual property
    • -- Is there any background IP? Is IP likely?
    • Discuss accountability
    • -- All institutions must observe the same federal rules. Find out in advance if there are any conflicts of interest

Ways to enhance collaborative research

RCR – Collaborative Research

Created January, 2009

sit institutional processes in collaborative research

SIT Institutional Processes in collaborative research

  • A proposal, submitted through the Faculty Support Center, will be necessary (OSR/Faculty Support will assist – the earlier the better)
  • Collaborative process may require an initial Non-disclosure Agreement -also called Confidentiality Agreement (OSR or Office of Academic Entrepreneurship will assist)
  • Collaborative process involves a subcontract……either from SIT to the collaborating institution, or to SIT from the collaborating institution (OSR will handle)
  • Awards are made to, and received from, institutions. Awards are not made to individual investigators (OSR will receive & set-up award)
  • Terms of intellectual property must be negotiated between institutions (OSR or the Office of Academic Entrepreneurship will handle)
  • Contact FSC as soon as you suspect you will be preparing a proposal

RCR – Collaborative Research

Created January, 2009

ethical considerations

Ethical considerations

  • Be aware of the need for review and approval from Institutional Review Board ……human subjects
  • -- required for questionnaires, use of patient records (even anonymous), oral histories, etc……..NOT JUST BIOMEDICAL. Also, ‘exempt’ is a category, it does not imply an investigator is ‘exempt’ from the application process
  • Be aware of the need for Institutional Animal Care and Use Committee
  • -- required for use of all vertebrate animals. Again, ‘exempt’ is a category, it does not imply an investigator is ‘exempt’ from the application process

RCR – Collaborative Research

Created January, 2009

available resources

Faculty Support Center

    • Pre-proposal development
    • Assistance with forms and budget development
    • Assistance with various federal electronic portals
    • Works in concert with the Office of Sponsored Research
  • Office of Sponsored Research
    • Proposal submission
    • Contract negotiation
    • Award set-up and all non-technical reporting
    • Liaison with all sponsors on investigator’s behalf
    • Works in concert with Faculty Support Center, Office of Academic Entrepreneurship and Division of Finance
  • Office of Academic Entrepreneurship
    • Works in concert with the Office of Sponsored Research
    • Negotiates licenses
    • Assists investigator with entrepreneurial issues

Available resources

RCR – Collaborative Research

Created January, 2009

reference material

“Silence is Not Golden: Making Collaborations Work “

      • -- Joan P. Schwartz, Ph.D. , NINDS
  • “Preempting Discord: Prenuptial Agreements for Scientists”
      • __ Howard Gadlin, NIH Ombudsman and Kevin Jessar, NIH Associate Ombudsman
  • “Dynamic Issues in Scientific Integrity: Collaborative Research
      • __ American Academy of Microbiology
  • RCR Training and Education Developed by Columbia University

Reference material

RCR – Collaborative Research

--- http://ori.dhhs.gov/education/products/columbia_wbt/rcr_science/index.html

Created January, 2009

faculty presentation

Faculty presentation

Dr. Christos Christodoulatos – Assoc. Provost for Academic Entrepreneurship

RCR – Collaborative Research

Created January, 2009

case study

After four years of funding from NSF, Dr. Jane Doe in Computer Science at Stevens and Dr. John Smith in Computer Science at NYU and their respective graduate students, have developed a new kind of search-engine algorithm that they feel could directly compete with either Google, Yahoo, or MSN. In fact, technical representatives from Google are visiting that morning to discuss the technology and representatives from MSN are scheduled to visit the next week.

Both scientists are experienced investigators and imminently respected in their field; however they disagree on issues of the intellectual property associated with this major development. Dr. Doe wants to negotiate a license with either Google or MSN and Dr. Smith wants to create a spin-off company. The disagreements have become so heated that the collaboration is threatened.

Consider the following questions:

CASE STUDY

RCR – Collaborative Research

Created January, 2009

case study cont

CASE STUDY (cont.)

Q: With representatives coming from Google and MSN, what is the first thing that both investigators should do immediately?

A: Before engaging in ANY discussion with an outside entity, both respective universities’ offices associated with intellectual property should be contacted as well as their Offices of Sponsored Research. As importantly, Confidentiality Agreements between university personnel and the Google and MSN representatives must be fully executed before any discussion can take place.

RCR – Collaborative Research

Created January, 2009

case study cont1

CASE STUDY (cont.)

Q: Why do the administrative offices have to be involved? They didn’t develop the technology and they will probably just slow down the discussions.

RCR – Collaborative Research

A: Stevens has a policy regarding the ownership splits for intellectual property developed by Stevens employees; however, the intellectual property belongs to the institution. These administrative offices are charged with management and oversight of intellectual property and sponsored research.

Created January, 2009

case study cont2

Q: How could the current discord among the investigators have been prevented?

CASE STUDY (cont.)

  • A: Communicate…….. and then communicate again
    • -- Don’t assume anything. This is particularly advisable when dealing with industry
    • Define expectations of who will do what
    • Discuss authorship in advance
    • -- Different disciplines have different standards for determining authors
    • Discuss data and material management
    • -- Don’t assume everyone knows who will be doing what
    • Discuss intellectual property
    • -- Is there any background IP? Is IP likely?
    • Discuss accountability
    • -- All institutions must observe the same federal rules. Find out in advance if there are any conflicts of interest

RCR – Collaborative Research

Created January, 2009

case study cont3

Q: Are there any laws, regulations, or institutional polices that may apply?

CASE STUDY (cont.)

A: Federal awards (particularly grants and cooperative agreements are subject to the terms and conditions of the Bayh-Dole Act found at 35 USC 200-212 and 37 CFR 401. Among other things, this code and regulation gave universities control of their inventions that resulted from federal funding.

Additionally, all universities have organizational policy regarding ownership of intellectual property developed by university employees.

RCR – Collaborative Research

Created January, 2009

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