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

• 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

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  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
Click to see WIRB Submission Requirements and Submission Forms

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/pdf/clinterm.pdf

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 DNA 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 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 DNA Registration - Recombinant DNA to be registered with the UMBI IBC includes all research involving the use or manipulation of recombinant DNA. Recombinant DNA research is defined by the NIH Guidelines [Section IB] as either molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or DNA molecules that result from the replication of molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell. Recombinant DNA experiments considered "exempt" as defined within the NIH Guidelines must also be registered

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