Faculty Training Resources
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.
From a legal, regulatory, and public perspective, a university 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 faculty, the leader of a laboratory, the director or chair, and the HR staff should work together to ensure that all scientific and administrative personnel have received appropriate training
It is the responsibility of each individual to conduct his or her activities 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 training on safe practices using a 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
Faculty who use administrative/faculty review committees such as an 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. Grants management offices often develop 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 a grants management 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:
-Radioactive materials or radiation producing devices from the Institutional Radiation Safety Committee (IRSC);
-Pathogens, microorganisms, human blood or internal body fluids, recombinant or synthetic nucleic acid from the Institutional Biosafety Committee (IBC);
- Select agents or select toxins from the Responsible Official;
- Human subjects from the Institutional Review Board (IRB); and
- Vertebrate animals from the Institutional Animal Care and Use Committee (IACUC)
- Take the NIH online tutorial on financial conflict of interest requirements.
VERTEBRATE ANIMAL RESEARCH
What Investigators Need to Know About the Use of Animals - Document
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
Cutting and pasting the body of your grant for the experimental design will NOT be accepted in the protocol.
When the grants office becomes aware that an award will be funded, they will notify the IACUC Coordinator. The IACUC Coordinator will request a copy of the final grant proposal experimental design from the department 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 the grant office 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 the grants office 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 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
Your IRB submissions should contain a proposal title and a university grants office proposal number or award number so the submission can be tracked by the research office.
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).
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.
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.
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.
If you believe your research may be exempt:
Contact the gtants office 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.
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
The 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). 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 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 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 IBC include all prions, 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 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 IBC at many universities.
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 IBC as well as the CDC or APHIS through the Responsible Official.
SHIPPING BIOLOGICAL & HAZARDOUS MATERIALS
Research Compliance and Safety provides certification training for personnel involved in any aspect of shipping dangerous goods (hazardous materials). Re-certification is needed at least every 2 years
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 a university, other than the exceptions specifically allowed in a university policy.
Grants management offices often require PIs to complete an Openness in Research Checklist and attach it their routing sheet when a 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 appropriate individual.
GTS Legionella Laboratory
P.O. Box 7555
Gaithersburg MD 20898
(888) 948-4811 (Toll Free)
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(301) 948-6972 (Fax)