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

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 HR staff should work together to ensure that all scientific and administrative personnel have received the appropriate training

It is the responsibility of each individual to conduct his or her activities at UMBI in compliance with all applicable government, University, and administrative unit policies, procedures and regulations. Supervisors at every level are responsible for hazard control, safety and research compliance. They are responsible for documenting employee trainingon safe practices using the UMBI Employee Health and Safety Training Plan, for correcting errors and defective conditions which could result in personal injury and/or property damage, and for developing a positive attitude among employees toward safety and accident prevention

Specific PI research compliance responsibilities
UMBI Faculty who use UMBI administrative/faculty review committees such as the Institutional Biosafety Committee (IBC), Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB) must comply with just in time compliance for NIH grants and contracts. Sponsored Programs has developed a method to satisfy this requirement without putting major additional burdens on the investigators or administrative committee personnel.

Grants and contract proposals can be submitted and reviewed by an external funding orgainization with a "Protocol Pending" designation on the UMBI Routing form, but the grant or contract will not be funded until there is an IACUC, IBC, or IRB-approved protocol (whichever is appropriate) whose language matches the language in the award or contract. It is permissible for an investigator to use a single protocol number for multiple grants. The requirement is that the protocol be active and that the language in the active protocol matches the work described in each of the grants or contracts.

Obtain appropriate approvals of protocols prior to the initiation of research with:
-Openness in Research (Export Controls) -routing form 5.a;
-Radioactive materials or radiation producing devices from the Institutional Radiation Safety Committee (IRSC)- routing form 5.b;
-Pathogens, microorganisms, human blood or internal body fluids, recombinant or synthetic nucleic acid from the Institutional Biosafety Committee (IBC) - routing form 5.c;
- Select agents or select toxins from the UMBI Responsible Official - routing form 5.d;
- Human subjects from the Institutional Review Board (IRB) - routing form 5.e; and
- Vertebrate animals from the Institutional Animal Care and Use Committee (IACUC) -routing form 5.f
- Take the NIH online tutorial on financial conflict of interest requirements

Just-in-Time Procedures

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 at UMBI, 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.)

Information on other support will be requested as part of the just-in-time procedures. IC scientific program and grants management staff will review this information before award to ensure the following:
l Sufficient levels of effort are committed to the project.
l There is no scientific, budgetary, or commitment overlap.
Ø Scientific overlap occurs when (1) substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
Ø Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.
Ø Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application.
Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the IC with the applicant and the PI at the time of award.
l Only funds necessary to the approved project are included in the award.|
For modular applications, the applicant is not required to submit detailed budget information in the application. In lieu of the standard budget forms, the applicant requests total direct costs for each year of support requested. The request must be accompanied by budget narrative for all personnel (by position, title, and level of effort), including consultants and “to be appointed” positions, and, when applicable, for consortium/contractual costs. NIH will request additional budget information in exceptional circumstances only. Other support information will be requested only for modular applications likely to result in an award. (See Subpart B of this part for more detailed coverage of modular applications and awards.)

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)