CUR 2002 Workshop Report
 
ADMINISTRATIVE SUPPORT OF RESEARCH RESPONSIBILITIES
 
Barbara Byrne, Vice President for Academic Affairs, University of the Sciences in Philadelphia, moderator
Maria Moyer, Director of Laboratory and Field Facilities, Richard Stockton College of New Jersey
Sally Mateja, Co-ordinator of Institutional Review Board, Murray State University, Kentucky

Byrne: Role of the VPAA or Chief Academic Officer

• Assurance of compliance signatory at many institutions; responsible often for animal and human research compliance with chief administrative/finance officer often responsible for other assurances
• Cheerleader and referee walking a fine line between meeting local, state and federal regulations by reinforcing the concept that designated individuals and/or groups have the authority to allow research to proceed or to stop it if the PI is not in compliance while insuring that as few impediments as possible are placed in the way of the faculty members who are doing research

Moyer: Responsibilities, directly or through Associate Director include:

• In several areas such as right-to-know Dr. Moyer has been assigned responsibility for the entire university
• Important components of success include:
  • Be sure you have been given the authority to successfully carry out your responsibilities
  • Work hard to facilitate research, but crack down firmly if you need to
  • Communication to faculty and students of the regulations, policies and procedures
              Face-to-face sessions
              On-line modules developed in-house to address specific issues
              Newsletters
              Posters in laboratory and field facilities
              Individual sessions
  • Repeat training at regular intervals to reinforce information and add new information, including changes in policies and procedures
  • Tailor training to the audience--e.g. chemistry faculty members need different right-to-know training than housekeepers, but both need it
  • Keep careful records of training sessions
              Who attended
              What was covered and how
              Measures of what was learned--test, performance, etc.
  • Get regular training yourself and network to keep up to date

Mateja: Administering the IRB as required for any institution that gets any federal funds and does any human research

• Don't reinvent the wheel but use accessible web sites (NIH and University of Minnesota are two good ones) and adapt their materials--with proper credits, of course
• Brand new OHRP guidelines give good information about what is required of IRBs to meet federal expectations; check them out at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/wirbproc.pdf 
• Check out < www.IRBForum.org > for excellent resources and links to other on-line information
• Attend an IRB 101 program by PRIM&R (Public Responsibility in Medicine and Research) at http://www.primr.org/  and then obtain a CD Rom copy of this program from OHRP 
  ( http://ohrp.osophs.dhhs.gov/references/cdrom.pdf ) for educational use on hour campus. This CD is available, free of charge, to all IRBs that have submitted a Federal Wide Assurance to DHHS.
• Policies and procedures
  • May be developed by a faculty and/or staff working group, perhaps the IRB members
  • Faculty feedback should be sought and will increase buy-in and ease of implementation
  • The faculty does not vote on policies and procedures or methods of implementation as this would be a conflict of interest of major proportions
  • As with the compliance issues above, make it as easy as possible to comply but be sure you have the authority and the willingness to refuse to let research go forward until it is in compliance
  • No one, up to and including the President of your institution, has the authority to overturn IRB decisions; an appeals process is not appropriate; however, the chair of the IRB should work closely with PI's so that they can develop successful proposals in a timely manner with a minimum of hassle

Extensive discussion centered primarily on how to develop policies, how to implement them, and who has the authority to enforce them. The very practical aspects that were addressed were much appreciated.