Laws impact on many different research areas, and exactly what compliance obligations arise in each scenario will depend on the nature of your project. As well as reading this overview, you should talk to someone who is experienced in your research field, and/or someone in the Office of Research and Sponsored Projects (ORSP), the Office of the Vice President for Research and/or the Office of the General Counsel (OGC) for guidance around the specific requirements and approval processes that may attach to your research – and talk to them in the earliest stages of your project planning.
Before you can work out which regulatory requirements may impact on your research project, you need to be able to answer these preliminary questions:
- What is the nature of the research?
- Where is the research happening?
- Who is funding the research?
- Who is doing it / who is involved in the actual research?
- Do the people involved need any particular qualifications, skills or experience – and do they have them? Do the people involved need any particular training?
- When is it occurring – are there any deadlines? Can you meet them?
IMPORTANT NOTE: This list is intended as a starting point for identifying research compliance issues – but is NOT exhaustive of all requirements that might apply to all projects. You should speak to someone experienced in your research field, or a legal or compliance expert, about the specifics of your project.
The most common triggers of compliance in research are interaction with human subjects (people, patients or personal information), the use of animals, the use of any kind of substances, devices or chemicals, engaging in activities that could prompt safety concerns, and external funding (through grants or sponsorship). This checklist goes into each of these areas in more detail, as well as flagging other miscellaneous compliance issues to watch for.
- Does your research involve any interaction with people, or the use of personal information? If so, you may need approval from the Institutional Review Board (IRB)before you begin your research or even recruiting subjects – and you will need to be certified as having taken the relevant training through PEERRS, before approval can be granted. There may also be other approvals depending on the research: read more on our Human subjects compliance page, and also the U-M Human Research Protection Program (HRPP) website.
- Is your research clinical or health related? If so, set up a consultation with the Michigan Institute for Clinical and Health Research (MICHR). They can help you work out what regulatory compliance, planning and procedural issues you need to deal with in your specific research project (which are too many and varied to list here) – and help you manage those issues moving forward.
- Will you be using vertebrate animals in your research? If so, you will require prior approval from the University Committee on Use and Care of Animals (UCUCA). If you are using transgenic animals, you will also need approval from the Institutional Biosafety Committee (IBC). Read more on our Animal subjects page.
- Is your research funded by a federal grant or some other external sponsorship? You will need to work with the Office of Research and Sponsored Projects (ORSP) (pre-award) and the Office of Sponsored Programs (post-award) to ensure compliance at all stages of your research. See our pages on the financial and non-financial aspects of grant administration, including information about the OMB Circular A-21″Cost Principles for Educational Institutions”, that applies to all federally sponsored research agreements.
- Will you be conducting any of your research on patients who might otherwise be billed for the clinical services? There are specific rules for dealing with clinical billing in a human subjects research setting: see our page on Billing & Grant Funding compliance for an overview, and consult with the Clinical Research Calendar Review & Analysis Office (CRAO) before engaging in any clinical research billing.
- Will you be using radioactive materials? You need to be authorized to use radioactive materials for your research, which is granted by U-M’s Radiation Policy Committee (RPC). Note that the specific rules that apply may vary depending on whether you are using the radioactive materials on humans or not. See the Radiation Safety pages on the Occupational Safety and Environmental Health (OSEH) site for more in-depth information.
- Will you be using any materials that are dangerous to handle, store or use? This includes hazardous substances or waste, toxic substances, explosives, carcinogens or pollutants. You may need a permit for some materials, and you should always have safe management protocols in place before you commence using such materials. Review OSEH’s resources on hazardous materials and waste and talk to someone in OSEH about your specific needs.
- Will you be transporting any research materials that could be considered hazardous, including dry ice? See OSEH’s page on Hazardous Materials and Dry Ice Shipping for information about the special rules and procedures that you must comply with.
- Will your activities prompt any other safety or environmental concerns? Some of the common triggers (including lasers, nanomaterials, hazardous equipment) are listed in this short OSEH Survey for new researchers. You should always have safe management protocols in place before you commence research that could raise safety or environmental issues. Review the wealth of information on OSEH’s website, especially the Research Safety pages, and talk to someone in OSEH about your specific project – they will help you work out what issues and requirements you need to be aware of and manage.
- Will you be using select agents (biological agents or toxins)? Select agents are microorganisms or related toxins identified by the government as presenting a potential public health risk as agents of bioterrorism. Special rules apply to their use: read this introduction for faculty members wishing to use select agents in their research maintained on the Institutional Biosafety Committee (IBC) website.
- Does your research involve the use of recombinant DNA or gene transfer? If so, you will need approval from the Institutional Biosafety Committee (IBC). See the PI responsibilities for projects involving r-DNA and contact the IBC Coordinator to talk about your project. See also the OSEH page on biological safety.
- Does your research involve the use or derivation of human pluripotent stem cells? If so, approval is required from the Human Pluripotent Stem Cell Research Oversight Committee (hPSCRO) before you obtain human embryonic stem cell (hES) cell lines or perform any research involving hES cell lines. You also need a materials transfer agreement for the cell lines. See this hPSCRO overview and FAQs for more information.
- Will you be using controlled substances? If so, you need to be properly licensed by the State of Michigan and registered with the Drug Enforcement Administration (DEA). For use of controlled substances in animals, see this U-M Policy for Licensing and Registration Qualifications, and the UCUCA page on controlled substance use in research. Note also that there are special record keeping requirements for controlled substances.
- Will you be using human tissue? The Tissue Procurement Service (TPS) is the designated mechanism through which you can receive human tissue, and a signed letter from TPS is required before you can obtain Institutional Review Board (IRB) approval for your human subjects research. You can find FAQs, fact sheets and service request forms on the TPS website.
- Will you be using biomedical devices? The Biomedical Engineering Unit (BEU) provides support for all patient care equipment, including consultation (device selection, installation, etc), periodic inspections, training, and corrective maintenance. Contact Joseph Hazelton on (734) 763-3231 to learn more.
- Will you be using investigational new drugs or devices? You will need to ensure compliance with various requirements, including those imposed by the Food and Drug Administration (FDA): consult with Michigan Institute for Clinical and Health Research (MICHR) for further guidance, and see the FDA regulations summarized on the OVPR Policies page. For clinical drug trials, you must contact the Investigational Drug Service (within the U-M College of Pharmacy) to discuss coordination of your study.
- Are you considering being an FDA “sponsor investigator” (that is, holding an FDA contract relationship personally) or will you be investigating new drugs or devices under another company’s sponsorship (such as a pharmaceutical company)? If you are considering being a sponsor investigator, U-M can help you develop your submission to the FDA, and help acquaint you with the complex, additional FDA requirements you will need to meet as a sponsor investigator. Contact Michigan Institute for Clinical and Health Research (MICHR) early in this process to learn more and get support.
- Do you have a plan in place to manage your research data? Data should be preserved in accordance with any specific regulatory requirements for your area of research and for a long enough time (and in a suitable manner) that allows you to defend your research and published results in the future. In addition, it’s important to remember that research data created in the course of your U-M employment using U-M controlled resources is a University asset; so you should ensure such data is accessible to the University and is managed appropriately (per SPG 601.11 and SPG 601.12). For further advice, see the Office of the General Counsel’s Guidelines for Access to and Use of Research Data, and the Data Sharing Resource Center maintained by the ORSP.
- Is your research classified (e.g. military or government research)? If so, make sure you understand the obligations that attach to this: see the ORSP page on classified research.
- Does your research involve any technology or equipment that has military application, or is intended for use in outer space? If so, your research may well be controlled by the International Traffic in Arms Regulations (ITAR), which means you cannot have foreign nationals working on your projectand you must be careful not to exportany of your research outside the U.S. (including by taking your research overseas with you on a laptop) without first seeking advice. Talk early with the ORSP (through your project representative or the Export Compliance Officer) to learn more about whether your project is subject to these requirements, and how to manage them if it is.
- Are there any restrictions on the openness of your research, or any controls on the publication of your research (such as sponsor approval being required)? Since U-M’s primary mission is to generate and disseminate knowledge in the public interest, including through academic freedom and open scholarly exchange, research should only be restricted in certain limited circumstances – see the Regents’ Policy Concerning Research Grants, Contracts and Agreements for more information. It is also important to realize that if there are any restrictions or approvals associated with publication, then your research will most likely be “controlled” for the purpose of export controls – meaning that you may be limited in your ability to use foreign nationals on your research team, collaborate with others outside the University, or take your research outside the US (even just on laptop): see the ORSP pages on export controls for more information and to seek further advice.
- Do you have a plan in place to manage any potential conflicts of interest? See the ORSP Guide to Understanding Conflict of Interest in Sponsored Research and Technology Transfer or our separate compliance pages on conflict of interest to learn more.
- Will any foreign students or colleagues be working with you on this project? If so, their involvement in the research and their access to its resultant data may be considered an “export” under U.S. law, depending on the type of research you are doing – even where their involvement or access to the data is occurring in the United States. It is important that you flag the foreign national’s involvement with the ORSP and consider whether export control requirements apply, and whether a special license needs to be sought for their involvement (or their involvement reconsidered) – a failure to do so may result in prison sentences for the faculty involved! See the ORSP pages on export controls for more details.
- Will you or any of your research team be travelling overseas as part of your research activity, or travelling overseas with laptops containing your research data? If so, be sure to consider export control issues, including the special considerations around travelling abroad with laptops and other technology, and other travel related compliance issues.
- Are you collaborating with non U-M researchers, or doing any of the work off-site? Both scenarios can raise additional legal, compliance and management issues, so you should discuss it up front with the Office of Research and Sponsored Projects (ORSP) and/or the Office of the General Counsel (OGC). Note also that if you are transporting or shipping materials between sites that could be considered hazardous (including dry ice), you must take special precautions to comply with Federal requirements: see OSEH’s page on Hazardous Materials and Dry Ice Shipping for more information.
If your research is clinical or health related, start by talking to the Michigan Institute for Clinical and Health Research (MICHR) – they provide consultations to help you plan your research, and to better arm you with contacts and information for managing a project, including the compliance aspects.
If you will be conducting your research under a grant or sponsor funds, talk to the Office of Research and Sponsored Projects (ORSP) to learn more about the proposal and approval timelines.
If your questions relate to a specific type of approval process, use the links in the checklist above to find direct contacts within the approval Committees and supporting departments (including the Institutional Review Boards (IRB) for human research issues, the University Committee on Use and Care of Animals (UCUCA) for animal research issues, the Institutional Biosafety Committee (IBC) for r-DNA and select agent issues, the Radiation Policy Committee (RPC) for radiation use, and Occupational Safety and Environmental Health (OSEH) for hazardous substances and other safety and environmental concerns).
For other research compliance questions, or if you are not sure who to talk to about your research issue, contact the Office of the Vice President for Research. Questions can be directed to Lois Brako, Assistant Vice President, Regulatory and Compliance Oversight.
A good introduction to research compliance issues is provided through PEERRS, U-M’s Program for Education and Evaluation in Responsible Research and Scholarship. This system is also used to certify members of your research team for training programs that are pre-requisites to certain research approvals (including the IRB).
The e-Research system guides you through compliance requirements as part of your application process – for human subjects and biosafety committee approval, animal subjects approval, and grant funding. The Regulatory management pre-application checklist gives a guide to what information you will need to have accessible when you apply for IRB or IBC approval.
First published 3/4/11, last updated 3/7/17 – Contact us if you believe any information is incorrect or outdated