# Research Approvals and Material Transfer Agreements ## expand\_more ![Student looking at animal over the view of a city](/sites/g/files/omnuum7191/files/styles/hwp_1_1__720x720_scale/public/division-of-science/files/img_0104.jpg?itok=oVSyHlXm) Research proposals may need approval before applying for permits to conduct research and collect specimens. Ensure your research project is reviewed and approved by the designated office within Harvard and in the country where you plan to conduct research. Due to the complexities associated with international projects, you should always consult with your local research administrator as early as possible. **Approvals for Research Involving Animals** The use of live animals in research and teaching is a societal and individual privilege that is taken seriously at Harvard and is a highly regulated activity. University policies and government regulations require advance review and approval of all vertebrate animal and cephalopod research prior to its commencement. The Faculty of Arts and Sciences’ federally mandated Institutional Animal Care and Use Committee (IACUC) is responsible for reviewing and approving proposed studies which include on-campus studies, field/wildlife studies (foreign and domestic), and any use of animals in teaching labs. IACUC policies, procedures, and guidelines are available on [the IACUC](https://hu.sharepoint.com/sites/FAS/IACUC/SitePages/Home.aspx) website; access is via HarvardKey with permission from IACUC Administration (). All individuals planning to use using vertebrate animals or cephalopods in research and/or teaching must: - establish, or be listed on, an IACUC-approved protocol, - participate in the institution’s occupational health program, - be appropriately trained to perform procedures, and - complete assigned Harvard Training Portal modules that acquaint the participants with Harvard policies as well as federal, state, and City of Cambridge regulations regarding the use of animals. These processes may be started or verified by contacting IACUC Administration (). If you have a sponsored award that requires an IACUC approval letter, please send an email to with the PI name, GMAS project number, and protocols numbers that are relevant to the research proposal. **Approvals for Research Involving Human Subjects** Human subjects research at Harvard University is guided by the ethical principles set forth in the [Belmont Report](https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html) (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The Committee on the Use of Human Subjects (CUHS) serves as the Institutional Review Board (IRB) for the University area which includes the Cambridge and Allston campuses at Harvard. CUHS offices are in the [Office of the Vice Provost for Research](https://vpr.harvard.edu/). The Institutional Review Board (IRB) is responsible for ensuring that research with methods performed on people is done in an ethical and legal manner. This includes doing interviews or surveys. Research with human subjects requires approval from the IRB at the institution the PI is from. You will need to have most of the details of your research protocol ready before submitting it to the IRB, to answer the required IRB questions. The IRB office also requires completing ethics training. More information about the process of research involving human subjects can be found on their [website](https://research.fas.harvard.edu/human-subjects-irb). **Collecting and Sharing Research Materials** Collecting and sharing research materials may require Prior Informed Consent (PIC), the establishment of Mutually Agreed Terms (MAT) or Material Transfer Agreements (MTAs) that specify the rights, obligations, and restrictions of both the providing and receiving parties concerning issues such as ownership, publication, intellectual property and permitted use and liability. Consult the office of Technology Development ) if you need assistance in developing or negotiating a research consent or any sort of research agreement. The office provides high-quality, expedited service while keeping Harvard investigators’ interests protected. Log in with your Harvard credentials to submit an: [Incoming MTA form](https://otd.harvard.edu/materialtransfer/mta.php) [Outgoing MTA form](https://otd.harvard.edu/outgoing-submittal-form/form.php) Collecting or transferring genetic materials from abroad may be subject to Nagoya protocol. [The Nagoya Protocol (NP)](https://www.cbd.int/abs/) applies to genetic resources that are covered by the [Convention on Biological Diversity](https://www.cbd.int/convention/), and to the benefits arising from their utilization. The protocol established the Access and Benefit-sharing Clearing-House (ABS Clearing-House) , a platform that helps users access genetic resources and associated traditional knowledge, and providers fairly and equitably share in the benefits arising from their utilization. The protocol outlines obligations for genetic resources (i.e., specimens/samples) and associated traditional knowledge-related regulations around accessing, benefits sharing, and required compliance measures. Prior Informed Consent (PIC) is required before access to anything that contains DNA (living or dead) Mutually Agreed Terms (MAT) must be established (if required), including benefit-sharing. Benefits could be monetary or non-monetary. **Even non-signatory countries (e.g., the U.S.) must comply with ABS legislation of the country where there are conducting research or collecting materials.** Collection of research materials from protected areas such as federally protected lands (e.g., National Forests, National Parks), State-protected lands (e.g., Nature Preserves, State Parks), privately-owned land trusts and preserves, and protected species may require specific permits, so it is important to know better where your research will be conducted and to apply for appropriate permits. Endangered Species are protected by The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Visit the following sites to determine if your research species require additional permits for collection, transportation, or importation: CITES checklist: Endangered Species: ; or Centers for Disease Control (CDC): U.S. Dept. of Agriculture (USDA), Animal and Plant Health Inspection (APHIS): US Fish & Wildlife Service: