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Answers to frequently asked questions by selected research administration units.

• What ACUC form should I use for a new project and how do I know it is the latest version?
  
  The latest version of the ACUC forms are posted for down-loading on the Office for the Protection of Research Subjects-ACUC website: http://www.research.northwestern.edu/oprs/acuc/forms.html
  
  
• How do I comply with the requirement that the OPRS/ACUC office needs an original signed protocol submission?
  
  All forms need to be submitted to the ACUC electronically at: acuc@northwestern.edu. An original, signed copy of your documents is not required until such time that the submission has been approved and prior to the release of your approval letter.
  
  
• What is the Institutional Assurance Number required for all PHS submissions?
  
  Northwestern's assurance number is A3283-01
  
  
• How can I voice concerns I might have about animal care and use issues or perceptions of violations of federal law/policy regarding the well being of animals?
  
  The ACUC has established a confidential report line - 847.467.2282 or "7-ACUC". This number is connected to a mailbox and callers may remain anonymous if they desire. All reports will be investigated by the ACUC and appropriate follow-up actions will be taken, as well as any necessary notifications to the NU leadership.
  
  Additionally, Northwestern has selected EthicsPoint to provide you with a simple way to report activities that may involve misconduct or violations of University policy. You may file a report or dial 866-294-3545. This service is not a substitute for, nor does it supercede, any existing reporting methods or protocols already in place at Northwestern for reporting suspected problems or complaints. Instead, the EthicsPoint system provides an additional means of reporting such issues. Any suspected problems or complaints reported via EthicsPoint will be reviewed in accordance with current University procedures, including those described in the Faculty, Staff, and Student Handbooks.
  
  
• Is occupational health service program a requirement for everyone exposed to live animals or animal tissue/cells?
  
  Occupational Health Service Program enrollment is a requirement. The level of involvement is determined by activity, species and the medical survey questionnaire.

• What does Accounting Services for Research and Sponsored Programs do?
  
  Accounting Services for Research and Sponsored Programs (ASRSP) provides financial status reports to government and private sponsors, generates invoices, deposits revenue, and collects outstanding receivables for sponsored projects. ASRSP also provides CUFS level 4 and 5 approvals for transactions, administers the Effort Reporting System, inventories government titled equipment, and coordinates the annual A-133 audit along with other audit activity.
  
  
• What is a sponsored project?
  
  A sponsored project may be thought of as a transaction in which there is a specified statement of work with a related, reciprocal transfer of something of value. A sponsored project may support University activities including but not limited to research, training, instruction, public service and construction. Any funding provided by U.S. government agencies, at the federal, state, or local level is treated as sponsored project funding. Funding from voluntary health organizations or associations, such as the American Heart Association or the American Cancer Society, is usually treated as a sponsored project. For additional information regarding the criteria in determining a sponsored project, please see http://www.research.northwestern.edu/osr/criteria.html.
  
  
• Who opens object codes of expense on sponsored projects?
  
  The Office of Sponsored Research (OSR) is the appropriate office to contact regarding the opening of object codes on sponsored accounts.
  
  
• Can you explain more about posting costs within 90 days?
  
  Ninety (90) days has emerged as the standard used by government and business auditors to determine whether costs are reasonably assigned to their proper account and function. It is not a standard established by regulation or law. Rather, it is based upon a practical standard that it is reasonable to expect that costs can be properly assigned within 3 months of their occurrence. Additional information can be found at: http://www.northwestern.edu/finsys/polcydoc/faq90.htm
  
  
• Who handles my project in ASRSP?
  
  In our efforts to provide outstanding service to the research community, ASRSP Grant & Contract Financial Administrators are assigned responsibilities according to sponsor. Please see the Financial Administrator Directory to locate the Grant and Contract Financial Administrator assigned to your project.
  
  
  
• Click here for answers to Effort Reporting FAQs.

 

• How do I get key card access to the animal research facility?
  
  First, you must:
  1. Have completed all required ACUC training,
  2. Be listed as a contact on an approved protocol,
  3. Be enrolled in the institution's occupational health program for animal care and use,
  4. Have completed any CCM training if required for barrier access or non-human primate use.
  
  Second, you need to contact the CCM Training Office to request a key card and present an ACUC approval letter and a picture ID card.
  
  
• Can my current access card - i.e. Hogan-Evanston or Ward/Searle-Chicago - be used for the new research buildings - i.e. Pancoe or Lurie?
  
  No. The Pancoe and Lurie Buildings use a proximity reader and also require a fingerprint for verification as to card user.
  
  
• Will my CCM key card provide me unlimited access?
  
  No. Access is limited to those areas required. If you find you need access to an area where access was denied, please contact the CCM Training Office.
  
  
• Why is a fingerprint required?
  
  This is an additional level of security that is required to protect all researchers and for regulatory purposes. Failure to provide this additional level of security allows unauthorized individuals access to facility with no control. Only CCM management personnel have access to the security system files.
  
  
• If I lost my CCM access card, what do I do?
  
  Notify the CCM training office to tell them that you have lost the card so it can be inactivated and request an appointment to get a new one. One card is provided in the beginning for free, but all other cards are an additional fee that may be paid by cash or credit card.
  
  
• Why are there cameras located throughout the animal research facility?
  
  This is for increased surveillance and to allow the NU police to determine if there are intruders or dangerous individuals in the facility when responding to security alarms prior to entering the facility.
  
  
• If I need to talk to someone about using animals in research that can I call?
  
  You can either call the main numbers - 312.908.8257 or 847.491.5748 - or go to the CCM website at www.research.northwestern.edu/ccm/.

• How can I find out about the status of my project?
  
  Submit your question to irb@northwestern.edu including PI name, IRB project number - if known - project title, and a description of the information for which you are looking. Status requests are usually processed within 24 hours.
  
  
• What procedures must I follow if I want to make changes to my study?
  
  All changes to an approved study must be submitted for review and receive IRB approval before the changes can be implemented. A revision form found at:
  
  http://www.research.northwestern.edu/oprs/irb/forms/revisions.doc should be completed and signed by the principal investigator.
  
  If you are revising your consent form(s), attach the new form(s) and answer 'yes' to the revised consent form question. Also attach any other revised documents - i.e., new questionnaires, recruitment materials - for IRB review.
  
  The protocol may be changed without prior IRB approval only when there is an apparent immediate hazard to a patient. However, the IRB must be notified by letter as soon as possible of such a change and review is required immediately. (Note: The submission of a revision does not change the expiration date of a project. The expiration date is always one year from the time of the initial review or periodic review.)
  
  
• What is Periodic Review?
  
  A Periodic Review is a re-evaluation of an approved project conducted at least once a year, as mandated by federal regulations. This review allows the IRB to monitor the progress of the project. If you plan to continue conducting research beyond your current expiration date, you must complete a Periodic Review Form and submit it to OPRS at least 45 days prior to the expiration date of last years approval.
  
  If you are still carrying out data analysis, the study should remain open. Research protocols must have continuing approval until all data analysis has been completed and termination reports are submitted. After the project has expired, no further research can be done. Your project will be closed if you do not submit your application. If your project is not reviewed and approved prior to the expiration date, no further research can be conducted. Because federal regulations make no provisions for grace periods or extensions after the expiration date, investigators will be asked to prepare a new project submission form to reopen the project. If you are uncertain about the expiration date of your project, consult the initial approval letter. The expiration date does not change despite other submissions about the project during the year.
  
  
• What is the required training and who is required to take it?
  
  Effective June 20, 2003, human subjects protection training is required for NU researchers engaged in human subject research. Anyone listed on an IRB project must complete this training as well as the HIPAA and research training. Information on these requirements as well as a list of individuals that have completed the training can be found at the following link: http://www.northwestern.edu/oprs/irb/education/

• Why does Northwestern have an ORI and what does ORI do?
  
  ORI was established to help Northwestern's research community understand and uphold the laws, regulations and policies to which we are subject; to support our commitment to innovative research and intellectual growth; and to emphasize a culture that focuses on ethics and integrity.
  
  ORI supports and safeguards Northwestern University's research community by:
  • Identifying compliance risks in the University's research practices and communicating those risk to the research community;
  • Partnering with the research community in innovative and effective ways to minimize and manage research risks;
  • Educating the research community with respect to appropriate business practices related to the conduct of research at Northwestern University; and
  • Monitoring and correcting non-compliance in accordance with University and federal guidelines.
  
  
• How does ORI support the University's mission?
  
  ORI is dedicated to encouraging responsible and ethical research throughout Northwestern's research community. As part of the Office for Research, ORI's commitment to supporting innovative research is founded on the principles of integrity and honesty. ORI values:
  • Service - partnering to help and support the research community
  • Ethics - establishing and interpreting standards and principles for research misconduct
  • Responsibility - promoting trust and accountability
  • Vigilance - identifying and mitigating research risks throughout the research community
  • Integrity - serving the research community with honesty and respect
  • Community - promoting cooperation and coordination to manage research risks
  • Excellence - improving research at Northwestern through innovation and participation
  
  
• How does the University define scientific misconduct?
  
  Scientific or research misconduct is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those commonly accepted within the academic community for proposing, conducting and reporting on research. Research misconduct is to be distinguished from honest error and differences of interpretation. It includes, but is not limited to:
  • Falsification or misrepresentation of data, including:
    1. Reporting experiments, measurements or other statistical analysis never performed;
    2. Manipulating or altering data or other manifestations of the research to achieve a desired result;
    3. Falsifying or misrepresenting background information, including biographical data, citation of publications, or status of manuscripts;
    4. Selective reporting, including deliberate suppressions of conflicting or unwanted data.
  • Plagiarism, being a representation of another's work as one's own.
  • Abuse of confidentiality, including use of ideas and preliminary data gained from:
    1. Access to privileged information through the opportunity for editorial review of manuscripts submitted to journals, and
    2. The opportunity for peer review of proposals being considered for funding by agency panels or by internal committees, such as the Institutional Review Board (IRB) and the Animal Care and Use Committee (ACUC).
  
  
• If I suspect that research misconduct has occurred, what do I do?
  
  Members of the academic community are responsible for reporting what they believe to be misconduct, as described above, on the part of research personnel. If you believe an instance of misconduct has occurred, you should contact the Dean of the appropriate school. Complaints relating to University research centers, involve more than one school, require special consideration, and/or involve federally sponsored projects can be made directly to the Office for Research at 847.491.3485, ORI at 312.503.0054 or to the appropriate Dean. The identity of confidential sources will be protected to the extent consistent with the needs of an inquiry or investigation. Those individuals who provide information in good faith about questionable conduct will be protected against reprisals.
  
  Additionally, Northwestern has selected EthicsPoint to provide you with a simple way to report activities that may involve misconduct or violations of University policy. You may file a report here or by dialing 866-294-3545. This service is not a substitute for, nor does it supercede, any existing reporting methods or protocols already in place at Northwestern for reporting suspected problems or complaints. Instead, the EthicsPoint system provides an additional means of reporting such issues. Any suspected problems or complaints reported via EthicsPoint will be reviewed in accordance with current University procedures, including those described in the Faculty, Staff, and Student Handbooks.
  
  
• What is involved in the research misconduct investigation process?
  
  Once a misconduct complaint is received, a preliminary assessment will be performed to determine whether the complaint falls under the University's definition of research misconduct. If the preliminary assessment determines that the complaint warrants further review, an inquiry committee will be appointed to determine if the allegation warrants a full investigation. If an investigation is recommended by the inquiry committee, an investigation committee will be appointed to thoroughly examine the allegation and determine whether misconduct has taken place, by whom and to what extent. The investigative committee will create and submit a report to the Vice President of Research (VPR) and Provost for review and disposition.
  
  ORI provides support to the committees and communicates the actions and committee recommendations to the VPR and Provost. ORI ensures adherence to University policies and guidelines for reviewing misconduct. The University's guidelines for reviewing misconduct can be found here. The updated policy will be available on the ORI website.
  
  
• Where can I go to learn more about University and Agency rules and regulations?
  
  The Office for Research maintains the University's policies and guidelines for investigators in scientific research online. The Office of Sponsored Research (OSR) has links to University, federal and external agencies' guidelines for research here.

How often is the Guide reviewed and updated?

The Guide is reviewed and updated on a monthly basis to ensure that information included is current and accurate. Additional updates and supplemental content are also added as frequently as requested.