A) Visit the Web sites or sign up to join the various email groups and listservs listed below:

Web sites:

• Medical School Department of Public Relations and Communications – This site leads to many news links including a place to join the media list for information on basic science research, clinical/medical studies, embargoed research news, etc.
• Medical School’s Office of Research News & Communications Web site – This webpage includes links to the Biomedical News, E-News, UMHS Daily Bulletin, etc.

Email Groups and Listservs:

• Email Alert Groups – DRDA (Division of Research Development and Administration) maintains several electronic mail groups designed to disseminate information to University of Michigan faculty, staff, and students with specific areas of interest or responsibilities. Those seeking opportunities for funding should consider adding themselves to two lists in particular: DRDA-net and NIH-GROUP.
• Research Listservs
• Basic Science Seminar Calendar

A) Click here (you may need to login) to find a list of active training grants and their PI name. We recommend you contact the PI of the training grant that you wish to participate in and they can discuss their process further with you.

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A) Visit the Medical School’s Office of Research Funding Web site – This webpage contains a link to M-Quest (a database of opportunities for grants, honors, prizes and fellowships created and maintained by the Office of Research) as well as information on email alert groups, internal grant programs, upcoming limited submissions, and links to extramural funding search engines.

A) Start by reviewing your bridging needs with your department Chair. Determine and consider the following:

• What is needed to cover your lab and personnel funded by your lab (minimum needed to cover during the bridging period) (animal cost, salaries, supplies to gather data to apply for next grant in bridge?
• Define how long of a bridge is needed.
• Consider cost sharing required by funding programs / resources of the department available.
• Work with Chair to select programs to apply for and timing of when to apply

Specific Programs in the Medical School:

• Biomedical Research Council (BMRC) Bridging Program – $40,000 up to one year. Must support a federal grant bridge. PI’s grants must reside in the Medical School.
• Medical School Extended Research Bridging Program for Instructional Track Faculty

Specific Programs in the Office of the Vice President for Research (OVPR):
The OVPR offers two programs for Interim Support for Sponsored Projects:

• Bridging Support for Research Faculty
• Research Maintenance for Sponsored Projects

A) At the University, applicants to external sponsors are required to receive review and approval from their home unit, school/college, and institution before sending an application to the sponsor. The review includes all resource commitments (effort, space, budget) as well as information about the project that may need compliance review. The best way to start the process is to contact your department grants administrator – click here for a list by department. Additionally, the school's Grant Review & Analysis office is always happy to field questions. You can contact them by phone (734-763-4272) or email, or visit their Web site.

A) Effective July 1, 2009, internal grants (e.g.: OVPR, pilot grants from various units) that require a Medical School Dean's signature will no longer be handled by the office staff of the Senior Associate Dean for Research (Steve Kunkel, Ph.D.). Instead, the Medical School Grant Review & Analysis Office will be serving as the Office of Research signature on internal applications.

Please submit the administrative shell directly to the Grant Review & Analysis Office. Applications may be submitted electronically to (msgrants@umich.edu), or you may hand-carry hard copies to the office at 3112 Med Sci I. In either case, please include clear instruction on what the Grants Office should do when signature is obtained.

As before, there is currently no hard deadline for these to be received, but please use good judgment on reasonable lead times in order to give staff time to complete. Please contact Heather Offhaus for questions at (hmills@umich.edu) or 734-763-4272.

A) Use the new project application in eResearch for both standard applications and exemption requests. When the IRB meets to review applications, its questions and decisions are recorded in eResearch and study teams are notified via e-mail. Investigators should allow 8-10 weeks for review of standard applications and 4 weeks for review of exemption requests.

Reduce turn-around time with well-crafted protocols and submissions. Once approved, don’t deviate from IRB-approved versions advertisements, informed consent, or protocols – submit any changes made (for example, to the protocol or consent) as an amendment or adverse events, and obtain IRB approval prior to initiating changes.  For more information, visit the IRBMED Web site.

A) No. Deceased persons are not considered human subjects by the regulatory definition. However, you still need to request approval from the Privacy Review Board by completing the request form.

A) Yes, you need approval for the purpose of the extraction of data from the IRB approved database. The IRB needs to approve a data registry and then any subsequent extractions of data will need additional/separate IRB approval.

Click here to access frequently asked questions for clinical research billing.

A) Click here to access forms and instructions to order animals from the Unit for Laboratory Animal Medicine (ULAM).

A) Every proposal to use vertebrate animals in research or an instructional project receives a rigorous review by the University Committee on Use and Care of Animals (UCUCA) before it is allowed to begin. To obtain UCUCA approval, applicants must submit detailed information about the project and provide satisfactory responses to UCUCA reviewer questions. Applicants must also document their qualifications to use animals in terms of relevant experience and training, and seek any additional training required to ensure that the proposed animal use procedures are conducted in an appropriate and humane manner. This review process can often take up to eight weeks to complete. For more information, visit the UCUCA Web site.

A) Gaining access to eSirius (UCUCA's online application submission program) to fill out an animal use application is the first step to working with animals. Click here for the access request form.

Once the form is submitted, and access information is received, you can log into eSirius and start your application by selecting "Submit an Application for a New Protocol." Visit the UCUCA Web site for additional information about obtaining access and getting started.

A) If your application was originally submitted in eSirius, you can start a modification in eSirius as well. To begin, click the option on the Home Page titled, "Submit an Amendment to an Existing Protocol." You will then edit the pages that need to be updated in the approved protocol in order to include the changes you are requesting. For animal use applications that were submitted and approved on the paper Form 8225, a memo to the UCUCA Office which explains the changes is all that is needed. Please remember that new/deleted personnel and changes in housing/use locations need to be modifications to the protocol and should be updated as often as necessary. For additional questions, please visit the UCUCA Web site or contact the UCUCA Office at 734-763-8028.

A) M-CORES is a web resource that provides a central directory of shared biomedical research resources at the University of Michigan. There are links to many institutional core facilities and services that support basic biomedical and clinical research including such areas as biostatistics, clinical research grant writing, and a broad range of sophisticated laboratory technologies. The web resource provides core locations, contact information, and detailed information about available services, instrumentation, and resident expertise.

A) You are permitted to review the records of your minor children (assuming you are the parent or guardian) until they turn 11. After that time, you have to access their records the same way any parent would: either through their PCP or through the Health Information Management Release of Information unit (2901 Hubbard Road, Room 2722, Ann Arbor, MI 48109-2435, fax 734-936-8571). (The reason for this is that, in Michigan, there are certain types of medical services a minor can receive without parental consent. Where those services are concerned, the parent does not have the right to act as the minor’s personal representative – though the minor’s physician can decide that it is appropriate to release information to the parent.)

For adult family members, you need to have the family member fill out a UMHS Release of Information form, specifying that you are allowed to access their records in CareWeb. That form must then be sent to the HIM Release of Information Unit (contact information above) before you access the record. Verbal permission, or letters, is not valid – it needs to be the specified form, and it needs to be on file before you make the access.

If you have any questions on this topic, please call the UMHS Compliance Office at 734-615-4759. Access to records is audited, and disciplinary actions for inappropriate access do occur.

A) The PEERRS requirement is set by the UM Office of the Vice President for Research (OVPR). Upon request, OVPR will consider a waiver of equivalency for investigators from other institutions who have completed human subjects courses like the UM PEERRS modules. E-mail (PEERRS@umich.edu) to request a waiver and include:

1. Name of investigator and their institution/university
2. Role on UM study
3. Description of course completed and a link to it if available on the web
4. Electronic copy of the completion certificate (if available)

E-mail (PEERRS@umich.edu) or Lee Katterman if you have additional questions.

A) In some cases it might. Investigators sharing laboratory space also share registration and training obligations. Recombinant DNA work may be registered either under the investigator in whose lab the work is occurring or under the principal investigator of a project. For example, investigators in charge of labs where recombinant DNA work occurs are responsible for ensuring that there is a registration in place with the IBC covering all the recombinant DNA work occurring in their lab space. In addition, they must maintain documentation of the training status for all the individuals working in the lab with recombinant DNA at BL2 or BL2+ containment. Stated another way, principal investigators who are not themselves registered for recombinant DNA work, and who are having this work performed in another investigator's lab, are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing. In addition, everyone working in the shared space must be made aware of ALL rDNA work occurring in that space.

A) The IBC has a new registration form in eResearch. The new form is designed to be a comprehensive registration of all your recombinant DNA work in a single form, across vector types and containment levels. All investigators registered with the IBC under the old system will eventually be required to convert their registrations to the new system.

A) For questions about recombinant DNA, contact the IBC office at 734-936-3934 (jhoats@umich.edu), or the IBC Chair, Philip Hanna (734-615-3706 or pchanna@umich.edu). Answers to many questions may be found on the IBC Web site. For questions about work with infectious agents (non-recombinant) or Select Agents, contact Michael Hanna, Biological Safety Officer (734-647-2318 or mhanna@umich.edu).

A) OSEH has developed a number of occupational safety and environmental health programs for the continued safety of all UM employees, to encourage safe practices and strong environmental stewardship, and to remain in compliance with State and federal regulations. For more information, visit the OSEH training Web site.

A) Occupational Safety and Environmental Health (OSEH) provides full service support in the areas of health, safety, environmental, and emergency management. These programs provide the following specialized services to units across the university:

• Biological and Laboratory Safety (B&LS)
• Environmental and Hazardous Material Management (E&HMM)
• Environmental Stewardship and Emergency Planning (ES&EP)
• Industrial Hygiene and Safety (IH&S)
• Operational Safety and Community Health (OS&CH)
• Radiation Safety Service (RSS)
• Fire Safety Services (FSS)
• Scientific Diving Safety (SDS)

A) The Work~Connections team will assist you in a caring and supportive way when you experience an illness or injury, either work-related or not-work-related.  Work~Connections assistance continues through your recovery and safe return to work. For more information, visit the Work~Connections Web site.

A) First, faculty and management staff will need to disclose their outside activity or interest in M-Inform. M-Inform is the electronic disclosure system that will route your disclosure to your department chair or supervisor for approval.  For visiting faculty, adjunct faculty, and all other staff, their potential conflicts of interest should be disclosed to their supervisor.  For the disclosure form, click here.

In addition, potential conflicts of interest need to be disclosed on Page 2 of the Proposal Approval Form or Material Transfer Form used by DRDA.  eResearch also includes conflict of interest questions that will route potential conflicts to the appropriate committee for review.

Finally, if you are involved in a UMHS committee, you should advise your committee chair of any potential conflict related to your role on the committee.

A) More information can be found at the UMHS conflict of interest Web site.

A) No, you will only need RDRC/SHUR approval if the administration of radionuclides will be involved in your research study.

A) Contact Radiation Safety Service/OSEH for assistance at 734-764-6200.

A) Contact the Radiation Safety Service/OSEH secretary or Radiation Safety Officer at 734-764-6200 for guidance.

A) Contact Radiation Safety Service/OSEH for assistance at 734-764-6200.

A) The Investigational Drug Service (IDS) is a service within the Department of Pharmacy Services and mandated by the University of Michigan Hospitals and Health Centers (UMHHC) and Medical School. The goal of the IDS is to ensure that investigational drug studies and other drug-related research at the UMHHC are conducted in compliance with the requirements of the FDA, study sponsors, Michigan State Board of Pharmacy Regulations, and the Joint Commission (formerly known as JCAHO). The role of this service includes, but is not limited to the following: ensuring acceptable drug storage conditions, drug dispensing, inventory accountability, and providing drug information for investigational drugs being used in human subject research at the UMHHC.

A) A study involving an investigational drug or biologic that is conducted by Medical School faculty and/or using UMHHC facilities must be reviewed by the Investigational Drug Service (UMHS IDS). Per Pharmacy Policy, investigational drugs used in humans in the UMHHC must be stored and dispensed by IDS pharmacy. Exceptions (waiver of IDS involvement) may be allowed in situations where it can be shown that storage or dispensing of the drug by IDS presents a hardship to the investigator, to study subjects, or to the conduct of the study. In these cases, IDS shall assure that storage, dispensing, and inventory control criteria are met by auditing these processes.

Investigational drugs are defined as (1) chemicals or drugs that are not FDA-approved for use in humans; (2) a commercial product or an FDA-approved drug, provided at no charge by the study sponsor for use in a comparative trial with other drugs or placebo; or (3) an FDA-approved drug, supplied at no charge to the subject, to be used for a non-FDA-approved indication for the purpose of a study.

A) IDS receives and reviews new protocols in eResearch. Answering “yes” in Section 7-1.7 in eResearch indicating that drugs or biologics are involved in the study, will prompt completion of Section 15. Selecting “UMHS Investigational Drug Service (IDS) - Fee will apply“ in section 15.2 will prompt completion of Section 15-1, which is the Investigational Drug Service (IDS) Information. IDS will automatically receive email notification that a new study requires IDS review in eResearch.

A) The Investigational Drug Service (IDS) charges grant accounts for the services provided. The IDS fees are compensation for services; the IDS does not profit from its activities. Typically, an estimate of the IDS budget is prepared by an IDS pharmacist after the protocol is submitted for review through eResearch. The pharmacist attaches the estimated budget to the IDS approval notice in eResearch. However, if necessary, an investigator can request a budget prior to the eResearch submission. To prepare the estimate, the IDS pharmacist will need to review a copy of the protocol and information on subject accrual and treatment.

A) The best way to determine if an IND is required for a study is to contact the FDA (http://www.fda.gov/cder/). Please call the CDER (Center for Drug Evaluation and Research) Drug Information main phone number at 301-827-4570.

A) The treating physician must contact the Investigational Drug Service (IDS) pharmacy (734-936-7469 or page 2944) to notify them of the potential use of a compassionate/emergency use drug and the potential patient (including registration number and hospital location). IDS will determine the appropriate address for drug shipment.

A) Check with your Department or Division Administrator, as some departments have a centralized ordering process, and others ask each laboratory to do their own ordering of supplies.

A) All laboratory equipment used in conjunction with hazardous materials must be decontaminated before being sent out for service, sale or disposal. Hazardous materials include all potential chemical, radioactive, and biological contaminants. UM policy requires that a “Laboratory Equipment Decontamination Form” be completed by the equipment owner and attached to the outgoing equipment. Plant Operations, Property Disposition, Moving and Trucking, Zone Maintenance, and some outside contractors require that this form be completed before servicing or moving the equipment. The form requires a signature from the laboratory personnel certifying that the equipment has been decontaminated. The service provider will also be required to certify that the equipment appears to have been decontaminated. OSEH Radiation Safety Services (RSS) requires that the laboratory notify RSS before equipment used for radioactive work can be removed from the radiation use area. RSS will survey the equipment and determine if the equipment is free of radioactive contamination and safe for removal. RSS can be contacted at 734-764-4420. Click here to obtain the form from the OSEH website.

A) See “How do I close down my lab?” on how to close a laboratory. Remember that EACH piece of equipment must be labeled as to its destination and safety to move.

A) After you identify the faculty member to receive or purchase the equipment, you must contact the Property Control Office and follow the procedure.

A) The FDA defines a medical device as any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body, with the exception of drugs.

A) Biomedical Engineering Services – also known as Biomedical Engineering Unit (BEU) – provide critical services 24/7. They provide support for all patient care equipment including consultation (i.e., device selection, installation, applications and optimum service modes), periodic equipment inspections, in-service training, and corrective maintenance. They also provide preventative and corrective maintenance for clinical support equipment. For more information, contact Jahan Azizi or Salim Kai, Clinical Engineers, at 734-936-2284.

A) Intellectual property is an invention and/or material that may be protected under the patent, trademark, and/or copyright laws, or by contract. The Office of Technology Transfer is the service unit responsible for protecting intellectual property from all schools and colleges on the Ann Arbor campus, as well as U-M’s Dearborn and Flint campuses. For more information, contact a Tech Transfer representative at the Tech Transfer Web site or 734-763-0614.

A) Observations and experiments during research activities often lead to new discoveries and inventions. We encourage you to contact U-M Tech Transfer during your early research activities to discuss your options and to provide guidance with respect to the disclosure, evaluation, and protection of your technology. Completing and submitting an Invention Disclosure Form will initiate the formal technology transfer process.

The Office of Technology Transfer is the service unit responsible for protecting intellectual property. The Tech Transfer office, along with the Office of the Vice President for Research and General Counsel, contracts with outside patent counsel for intellectual property protection, thus assuring access to patent specialists in diverse technology areas.

A) When you disclose an invention to the Tech Transfer office, it starts a process that could lead to the commercialization of your technology. An Invention Disclosure is a written description of your invention or development that is provided to the U-M Tech Transfer office. Submission of an Invention Disclosure to the Tech Transfer office begins the formal technology transfer process. Click here to download a disclosure form and simple instructions. After you submit the Invention Disclosure Form, a licensing specialist will be assigned to assist you. The licensing specialists will work with you to review the invention disclosure, conduct patent searches (if applicable), and analyze the market and competitive technologies to determine the commercialization potential of the invention.

You should complete an Invention Disclosure whenever you feel you have discovered something unique with possible commercial value. This should be done well before presenting the discovery through publications, poster sessions, conferences, press releases, or other communication. Once publicly disclosed (i.e., published or presented in some format), an invention may have restricted or minimal potential for patent protection. For more information, contact a U-M Tech Transfer representative through the Tech Transfer Web site.

A) Ownership depends upon the employment status of the creators of the invention and their use of University facilities. Consideration include:

• What is the source of the funds or resources used to produce the invention?
• What was the employment status of the creator(s) at the time the intellectual property was made?
• What are the terms of any agreement related to the creation of the intellectual property?

As a general rule, the University owns inventions made by its employees while acting within the scope of their employment or using more than incidental University resources. The university policy on ownership is stated in Regents’ Bylaw 3.10 and the U-M Technology Transfer Policy. Contact the Tech Transfer office for guidance.

A) Yes, but since patent rights are effected by these activities, it is best to submit an Invention Disclosure (see “How do I disclose an invention?”) well before communicating or disclosing your invention to people outside of the University of Michigan. There are significant differences between U.S. and other countries as to how early publication affects a potential patent. Once publicly disclosed (published or presented), an invention may have restricted or minimal potential for patent protection outside of the United States.

A) Patentable subject matter includes processes, machines, compositions of matter, articles, some computer programs, and methods (including methods of making compositions, methods of making articles, and even methods of performing business). A natural substance that has never before been isolated or known may be patentable in some instances, but only in its isolated form (since the isolated form had never been known before). A variation of a naturally occurring substance may be patentable if an inventor is able to demonstrate modifications that offer substantial advantages of using the variant. For more information, contact a U-M Tech Transfer representative through the Tech Transfer Web site.

A) If you wish to obtain materials from outside collaborators, an incoming Material Transfer Agreement (MTA) will need to be completed. Contact your project representative in the Division of Research Development and Administration (DRDA) for more information on incoming MTAs. Click here for details or phone 734-764-5500.

A) It is important to document items that are to be shared with others and the conditions of use. If you wish to send materials to an outside collaborator or investigator, an outgoing Material Transfer Agreement (MTA) should be completed. Contact a U-M Tech Transfer representative (through the Tech Transfer Web site or at 734-763-0614) for assistance in completing outgoing MTAs.