Federal and state agencies have strict policies to ensure compliance with research, safety, health and environment management regulations, including withdrawal of research funding and other harsh civil penalties to institutions and potential individual civil prosecution leading to possible imprisonment and substantial fines.

What Is Compliance? - Watch Video

22 Online Traning Videos are Linked at UMBI's RCS "Required training" Webpage

"Starting a Research Group in 1978: Are the Lessons Still Relevant?" - Watch Video
2002 Course keynote by HHMI President and Nobel laureate, Thomas R. Cech.
Advice on obtaining a faculty position and achieving tenure, leading a research team, mentoring students, balancing research and teaching, and more

NIH Pre-Award Collection of Just in Time (JIT) Compliance
From a legal, regulatory, and public perspective, UMBI is one corporate entity and is held accountable as such by federal and state authorities. The actions of the University's individual constituents are those of the entire university.

The ladder rank faculty, the leader of the laboratory, the Center Director, and the Center's administrative supervisors should work together to ensure that all principal investigators (PIs) and administrative personnel know how to comply with pre-award just-in-time approvals that are detailed on the UMBI ROUTING FORM - University of Maryland Biotechnology Institute (UMBI) - Office of Sponsored Programs (OSP). This routing form is to be submitted with all grant and contract applications, and other requests for extramural support of sponsored programs 6 days prior to date required. For additional information http://www.umbi.umd.edu/research-development/sponsored-programs/index.php

Under question 5. Regulatory Issues: Does this proposal require or involve any of the following:

a) Yes Openness in Research: Do you answer "Yes" or "Unknown" to any of the questions on the Openness in Research Checklist? http://www.umbi.umd.edu/research-development/compliance/images/resopenscklst_1.doc?
If yes attach completed Openness in Research Checklist;

b) Yes Use of radioactive materials or radiation producing devices?
If Yes, provide Authorization Number: ;

c) Yes Use of pathogens, microorganisms, human blood or internal body fluids, or recombinant or synthetic nucleic acid? If you have any questions concerning these materials, go to http://www.umbi.umd.edu/research-development/compliance/path-human-tissue-rdna.php
If Yes, provide UMBI IBC Registration Number: ;

d) Yes Use of select biological agents or toxins, if you have questions concerning these materials, go to http://www.selectagents.gov/
If yes, contact Compliance Officer. Office of Research, Innovation and Commercialization;

e) Yes Use of human subjects via contact and/or survey or use of human specimens? If you have any questions concerning human subjects, go to http://www.umbi.umd.edu/research-development/compliance/human-subjects.php
If Yes, submit this proposal to the UMBI Institutional Review Board (IRB).
Y/N Is the proposal exempt from IRB review?
If exemption is approved, attach the UMBI IRB exemption approval letter and enter approval date:
If non-exempt proposal is approved, attach the UMBI IRB approval letter and enter UMBI IRB Number: ; and

f) Yes Use of laboratory animals? If you have any questions concerning research with animals, go to http://www.umbi.umd.edu/research-development/compliance/vertebrate-animal-iacuc.php
If Yes, provide UMBI IACUC Approval Number:

Specific PI Compliance Responsibilities
NIH uses just-in-time procedures for certain programs and award mechanisms. These procedures call for limited information (e.g., a budget justification and a biographical sketch) to be submitted with investigator-initiated applications and allow for a possible NIH request for additional information, including information concerning other support, when the application is under consideration for funding.

Just-in-time procedures also allow an applicant to defer certification of IRB approval of the project's proposed use of human subjects, verification of IACUC approval of the project's proposed use of live vertebrate animals, and evidence of compliance with the education in the protection of human research participants requirement and IBC approval of the project's proposed use of recombinant nucleic acids until after completion of the peer review and just prior to funding. (Applications in response to RFAs also may be subject to these procedures. The RFA will specify the timing and nature of required submissions.)

After the priority scores are released, NIH sends an e-mail requesting Just-in-Time (JIT) information for grants within the competitive range for possible funding. This notification, sent to the PD/PI, is NOT a Notice of Award, nor should it be construed as an indicator of possible award.

If a decision is made to fund an application, the assigned Institute or Center (IC) will need the following information PRIOR to making an award:

• Certifications If Human Subjects are involved, please provide the assurance type and number (if changed from the initial submission) and the Certification date of IRB Review and Approval. Pending or out of date approvals are not acceptable. Note that IRB approvals are contingent on IBC approval, if applicable.

• If Vertebrate Animals are involved, the assurance number must be provided (if changed from the initial submission), verification of IACUC approval with date, and any IACUC imposed changes. Pending or out of date approvals are not acceptable. Note that IACUC approvals are contingent on IBC approval, if applicable.

• Human Subjects Education For grants involving Human Subjects, certification that each person identified under Key Personnel involved in human subjects research has completed an educational program in the protection of human subjects must be provided. The Other Support and Human Subjects Education information may be submitted within two weeks of receipt of the award notice; but the IC should be contacted for specific guidance. NIH understands that obtaining IRB and/or IACUC and/or IBC approval may take more than two weeks. Therefore, the approvals may be submitted at the earliest date they are available.

NIH Pre-Award Collection of Just in Time (JIT) Information
JIT information requested includes other support, certification of Institutional Review Board (IRB) approval, certification of IACUC approval, and human subjects training certification for all key personnel. JIT information must be submitted for review and evaluation PRIOR to making an award. This information may be submitted via the Just-In-Time function within the eRA Commons. http://grants.nih.gov/grants/managing_awards.htm

NIH Additional Health and Safety Regulations and Guidelines
Grantees are responsible for meeting Federal, State, and local health and safety standards and for establishing and implementing necessary measures to minimize their employees' risk of injury or illness in activities related to NIH grants.

In addition to applicable Federal, State, and local laws and regulations, the following regulations must be followed when developing and implementing health and safety operating procedures and practices for both personnel and facilities:

• 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by the Occupational Health and Safety Administration (OSHA) and included in 29 CFR Part 1910. These regulations are available at http://www.osha.gov/comp-links.html

• Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). Copies may be obtained from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

The following guidelines are recommended for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities:

• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, CDC and NIH, HHS. This publication is available at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm

• Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication can be obtained by telephoning 800-624-8373. It also is available at http://www.nap.edu/catalog/4911.html

• As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines. Information concerning noncompliance with the NIH Guidelines may be brought forward by any person. It should be delivered to both NIH/OBA and the relevant institution. The institution, generally through the Institutional Biosafety Committee, shall take appropriate action. The institution shall forward a complete report of the incident recommending any further action to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985, 301-496-9838/301-496-9839 (fax) (for non-USPS mail, use zip code 20817). In cases where NIH proposes to suspend, limit, or terminate financial assistance because of noncompliance with the NIH Guidelines, applicable DHHS and Public Health Service procedures shall govern. The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) September 2009 are available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

Grantee organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines. However, if requested by the awarding office, grantees should be able to provide evidence that applicable Federal, State, and local health and safety standards have been considered and have been put into practice http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm#_Toc54600068

VERTEBRATE ANIMAL RESEARCH - Registration Forms

UMBI Animal Welfare Assurance Number: A4181-01

What Investigators Need to Know About the Use of Animals - Document

In an effort to improve communications (and reduce frustration) among PIs submitting to the UMBI IACUC, we have developed a flowchart to help users with the various forms required for animal use. Please refer to the below flowchart as needed. Thank you, Robert Belas, Professor and Chairman UMBI IACUC.

UMBI IACUC Forms Processing Flowchart

- The IACUC Coordinator will send PIs a notice 60 days before the month that their protocol expires.

- If a protocol expires, the PI will receive a notice that research funding will be terminated if the protocol is not submitted to the IACUC within two weeks after receipt of the funding termination notice.

IACUC New Protocol Submission Requirements
- 1 original, 12 copies of protocol and 1 original of 2 database searches MUST be submitted
- All sections, including PHS 398 Section "F", MUST be fully completed otherwise this may delay review of your protocol. A completed Section "F" must accompany all submissions. If there is a section which does not apply, please indicate so by "NA"
- All forms and supplemental attachments must be typed
- For attached additional sheets, please type in the appropriate section(s) of the research form "see additional sheet(s)"
- Specify the appropriate Animal Research Facility to be used for your animal research (COMB, Shady Grove, UMB or Other)
- Cutting and pasting the body of your grant for the experimental design will NOT be accepted in the protocol

• All instructions MUST be followed; otherwise this will delay review of your protocol and it may be returned to you
• UMBI IACUC meetings, when scheduled, are held the third Tuesday of the month
• All submissions are required to be submitted to the IACUC Coordinator no later than the 1st Friday of every month at 4 p.m. Renewal forms should be submitted 30 days before the protocol expiration date
• If you would like to collaborate with an institution that does not have an Animal Welfare Assurance number; make sure that the institution obtains an Animal Welfare Assurance number from OLAW. Without an an Animal Welfare Assurance number, the institution cannot participate in our animal research

Procedure for Funding Approval Associated with an Existing Animal Protocol

When Sponsored Programs becomes aware that an award will be funded, Sponsored Programs will notify the IACUC Coordinator. The IACUC Coordinator will request a copy of the final grant proposal experimental design from the Center grant/contract administrator. An existing approved animal protocol number is permissible for use with multiple grants. The IACUC approval memo must include all related award numbers and descriptive titles.The IACUC Chair will delegate an IACUC member to compare the final grant/contract experimental design to the stated animal use as described in the accepted IACUC protocol.

If they match, the IACUC Chair will sign an IACUC funding approval memo with the grant/contract award number and title listed. The IACUC Coordinator will notify Sponsored Programs that funding may proceed. This review should take no longer than five business days if the language matches.

If they do not match, the IACUC Coordinator will notify Sponsored Programs that the IACUC has requested submission of a new or amended animal research protocol for the next IACUC review cycle. In this case, funding will not commence until the protocol is approved

Use of Contractor/Supplier Antibodies or Other Materials Produced by Animals
If you use biologicals in your research that you obtain from an outside animal research company, contractor or supplier, you must obtain from that organization their:
- Animal protocol with IACUC number used to produce the material
- NIH OLAW Assurance Number (foreign companies must also have a number)
- Animal protocol approval letter from the organization's IACUC

HUMAN SUBJECTS RESEARCH
Each UMBI application or proposal that involves human subject research or human material, regardless of the level of risk foreseen, requires IRB review prior to the initiation of the activity
WIRB Online Submission Feature
The online submission feature will let you upload documents to WIRB through a safe and secure process. Go to www.wirb.com and click on the yellow "Online Submission" button.
The general steps are:
1) Select the type of submission you wish to make
2) Upload your individual documents to the site
3) Complete the 'Submitter Information" page
4) Click on the "Finalize Submission" button
5) Receive your confirmation page (and email) that includes your Submission Number
The confirmation means that WIRB has received and can begin processing your submission.

Your IRB submissions should contain a proposal title and a UMBI sponsored programs proposal number or award number of FRS number so we can track your submission in the Office of Research, Innovation& Commercialization

Belmont Report:
The purpose of the IRB is to inform and protect human subjects used in research (Belmont Report). The IRB acts as an advocate for the research subject. This means that the IRB, during its review of a research application/proposal and the informed consent, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks and alternative treatments that are available if participation in the study is refused (Code of Federal Regulations Title 45 Part 46 DHHS Protection of Human Subjects, Rev23Jun05).

OHRP:
The Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted. The Compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable law. The Compilation can be accessed on the OHRP website: http://www.hhs.gov/ohrp/international/index.html#NatlPol To use the Compilation, go to page 3 and then click on the country of interest.

OHRP also has a frequently asked questions website:
http://www.hhs.gov/ohrp/faq.html

NIAID Clinical Terms of Award:
NIAID's Clinical Terms of Award include submission of documentation for all NIAID-supported clinical research involving human subjects, including the development of new technologies using human subjects or materials derived from patients or volunteers; studies into the mechanisms of human disease using patient or volunteer samples; therapeutic interventions, clinical trials, and any studies that require institutional review board (IRB) or independent ethics committee (IEC) approval to collect samples from patients or volunteers; epidemiologic and behavioral studies; and outcomes and health services research. The NIAID Clinical Terms of Award and Checklist are at the NIAID website: http://www.niaid.nih.gov/ncn/clinical/clinterm.htm

IRB & PI Responsibilities:
The IRB has the responsibility for reviewing all applications or proposals for human subject research. HHS regulations at 45 CFR 46.103(f) require that the IRB review the actual application or proposal; not just protocols defined as the formal design or plan of an experiment or research activity.

An application/proposal is defined as a request for the funding ofasponsored program that usually includes all the information necessary to fully describe research plans, including staff capabilities, resources, and a budget.

A protocol is defined as a plan attached to an application/proposal that includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

The IRB determines whether a submitted research application/proposal is exempt or non-exempt from IRB review. If the research is found to be non-exempt, the IRB then determines whether the application/proposal is eligible for expedited or full IRB review. (See the diagram below.)

If you believe your research may be exempt:
Contact the Office of Research Compliance and Safety for an exemption. If an application/proposal must be submitted to the IRB, the IRB administration will decide if the application/proposal fits the exempt category. An exempt approval notice will be forwarded to the principal investigator (contact). Click to see the categories of research that fall into categories exempt from further review by the full IRB.

Research Involving Private Information or Biological Specimens
NIH OEP/OER has put together an excellent flow chart for determining whether research protocols using private information or biological specimens already collected from individuals is or is not human subjects research.
http://grants2.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf

Expedited Review
Certain types of research are eligible for an expedited review. The IRB may use an expedited review procedure when the research involves no more than minimal risk to the subjects and where the only involvement of human subjects will be in one or more of the Expedited Review Categories. In an expedited review, the application/proposal is forwarded to the IRB for review. The response is returned to the principal investigator or designated contact person. The principal investigator may need to revise the application/proposal to address specific concerns raised by the expedited review. When these changes are made, the IRB can grant final approval.

Full Board Review
An application/proposal that involves more than minimal risk to human subjects is reviewed by the members of the IRB at a convened meeting. After the full IRB review, the principal investigator may need to revise the application/proposal to address concerns raised by the IRB. These changes will then need to be reviewed again by the full board of the IRB.

PATHOGEN, HUMAN MATERIAL & RECOMBINANT OR SYNTHETIC NA RESEARCH - forms
The UMBI Institutional Biosafety Committee (IBC) reviews research protocols for the purpose of ensuring safe biomedical research and development in compliance with local, state and federal requirements (The NIH Guidelines - Effective September 22, 2009). The IBC performs risk assessments and sets containment levels that ensure the safety of UMBI's employees and the surrounding community. The IBC periodically reviews previously approved research projects. Once a project has been approved, an approval letter is sent to the principal investigator listing the project's IBC approval number(s), containment levels set by the IBC, project title(s), and any additional requirements

Human Materials Registration - Human material to be registered with the UMBI IBC include human tissue samples, blood, serum, plasma, internal body fluids (semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid) and any body fluid that is visibly contaminated with blood) from patients, volunteers, or cadavers as well as human-derived tissue culture cells. Common laboratory cell lines including HEK293 and HeLa are not exempt and must be registered. Also included are any unfixed tissue or organ from a human (living or dead), HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV- or HCV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV or HCV

Pathogens or Potential Pathogens Registration - Human or animal pathogens or potential pathogens to be registered with the UMBI IBC include all bacterial, viral, fungal, parasitic microorganisms with a potential for vertical or horizontal transmission. Host-specific viruses and viral vectors commonly used for gene transfer must also be registered. This includes, but is not limited to E. coli, adenovirus, MuLV, and other commercially available or investigator-generated or modifiedvectors

Recombinant or Synthetic Nucleic Acid Registration - Recombinant or Synthetic NA to be registered with the UMBI IBC includes all research involving the use or manipulation of recombinant or synthetic nucleic acid. Recombinant or synthetic NA research is defined by the NIH Guidelines. Recombinant or synthetic NA experiments considered "exempt" as defined within the NIH Guidelines must also be registered with the UMBI IBC.

Select Agent Registration - Select agent(s) are listed by the HHS Centers for Disease Control and Prevention (CDC) and the USDA Animal Plant Health Inspection Service (APHIS). These materials are considered: Non-overlap select agents and toxins; High consequence livestock pathogens and toxins (overlap agents); or USDA high consequence livestock pathogens and toxins (non-overlap agents and toxins). Laboratories intending to obtain select agents must be registered with the UMBI IBC as well as the CDC or APHIS through the UMBI Responsible Official

TRAINING - forms
Information about safety and compliance training, training topics and the employee training checklist form

OPENNESS IN RESEARCH (EXPORT CONTROL)
The principle of openness in research is one ofoverriding importance to this university. Accordingly, no program of research that requires secrecy may be conducted at UMBI, other than the exceptions specifically allowed in University policy (IV-2.20-Policy on Classified and Proprietary Work).

You must complete the UMBI Openness in Research Checklist and attach it to your routing sheet when the project, proposal or agreement:
- Contains language referring to or mandating compliance with export laws, or
- Restricts researcher participation (faculty, student, others) based on country of origin or citizenship, or
- Requires researcher participation in US-citizen-only meetings, or
- Prohibits the hiring of non-US citizens to be involved in the proposed research, or
- Grants the sponsor a right of prepublication review for matters other than the inclusion of patent and/or proprietary sponsor information, or
- Limits access to confidential data so centrally related to the research that a member of the research group who was not privy to the confidential data would be unable to participate fully in all of the intellectually significant portions of the research.

If the answer to any of these questions is "Yes" or "Unknown," or you have other questions related to openness of research according to University policy, please contact the Compliance Officer (410) 385-6329 gilpin@umbi.umd.edu

POLICIES RELATED TO RESEARCH COMPLIANCE & SAFETY

• UMBI Policy on Research Compliance, Safety, Health and Environmental Management (IV-2.4(A) in progress
• UMBI Policy on Health and Safety Training (IV-2.30(A)
• UMBI Policy on Classified and Proprietary Work (IV-2.20)
• UMBI Policy Concerning HIV Infection and AIDS (VI-11.00(A)
• UMBI Policy on Occupational Exposure to Bloodborne Pathogens (VI-11.00(B)
• UMBI Procedure on Bloodborne Pathogens Exposure Control Plan (VI-11.00(C)
• UMBI Policy on Infectious Disease Response (VI-13.00(A)
• UMBI Policy on Security of Select Biological Agents and Toxins (VI-15.10(A)