10. Addressing Compliance Issues

When preparing a grant application for a research project that involves the use of any of the following, the applicant will need to address compliance issues.

When preparing a grant application for a research project that involves the use of any of the following, the applicant will need to address compliance issues on at least some level in the application:

• Human subjects
• Animals
• Hazardous materials, select agents, or recombinant DNA

At a minimum, the applicant will need to justify the use of human subjects, animals, and/or hazardous materials, select agents, or recombinant DNA;  describe the experimental design; and explain laboratory and safety procedures.  After all, if a reviewer has a concern about how an applicant has addressed a compliance issue, that compliance issue then becomes a science issue, calling into question a critical component of the project’s approach.

Describe the Use of Human Subjects

When research involves the use of human subjects, the applicant should include information to justify use of those subjects, to demonstrate that the potential benefits of the proposed research outweigh the potential risks to the human subjects, and to explain exactly how the human subjects will be safeguarded from any potential risks. The applicant should also demonstrate appropriate inclusion of women, minorities, and children in the proposed research project.

Describe the Use of Animal Subjects

Similarly, when research involves the use of animals, the applicant should include information to justify use of those animals;  to delineate the species, strains, ages, sex, and number of animals to be used;  and to describe the veterinary care that will be provided to the animals. The applicant should also describe the procedures that will be used to ensure that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research.  To this end, the applicant should describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.  If the research results in more than momentary pain or distress to animals, the applicant should conduct a search for alternatives to replace the use of live animals, to reduce the number of animals required, and to refine techniques to decrease pain and distress. The applicant should also describe his or her search for alternatives and summarize the results. If the research requires that any animals be euthanized, the applicant should describe which method of euthanasia will be used and justify the reasons for its selection.

Describe the Use of Hazardous Materials, Select Agents, or Recombinant DNA

If a project involves the use of hazardous materials or select agents, the applicant should justify the use of those materials;  describe the appropriate training for all personnel who will work with the materials or agents;  and explain laboratory safety, security, and biological containment requirements and practices.  The applicant should also delineate emergency contingency plans, including those for containment and cleanup of spills.  If the project involves the use of recombinant DNA, the applicant should demonstrate that he or she will adhere to NIH requirements for recombinant DNA research.

Prepare Research Protocols

Some sponsors require that applicants submit and obtain approvals of any required human subjects, animal subjects, and/or biosafety protocols before the grant application is submitted to the sponsor;  others, such as NIH, allow “just-in-time” approvals.  If the targeted funding agency allows “just-in-time” approvals, the investigator may submit the application to the sponsor before obtaining institutional approvals.  Then, when the applicant is notified that an award is likely, he or she must submit and obtain institutional approvals of the approproiate protocol(s) before the research project can proceed.  The sponsor’s solicitation should indicate when institutional approvals for compliance issues should be submitted. Applicants are encouraged to contact the Office of Research Compliance with questions or for assistance.

Institutional Review Board

Home page:                               http://researchcompliance.tamu.edu/irb/

E-mail:                                      irb@tamu.edu

Phone:                                      979-458-4067

Assurance number (TAMU):        FWA00000092

Assurance number (BCD):          M-1453

The primary purpose of the Institutional Review Board (IRB) is to safeguard the rights and welfare of human subjects at risk in any research activity, whether that activity is financially supported or not.  To this end, the IRB requires that any investigator conducting research involving the use of human subjects submit a human subject protocol for review.

A human subject protocol is a document that delineates the formal design for research involving human subjects;  it includes a statement on the purpose of the research, the selection of subjects, research procedures, and data analysis methods, as well as a description of the risks and benefits of the proposed research to the subjects.

The IRB reviews human subject protocols to determine whether the risks of the proposed research outweigh the benefits of that research for the subjects involved in the study. If the IRB determines that risks will be involved, they will verify that those risks will be minimized, and that participants will be made fully aware of the risks and of their right to withdraw from the study at any time without any form of penalty.

When the proposed research carries no or only very minimal risk to the subjects, the IRB may elect to conduct an administrative review of the protocol. However, if the proposed research is not exempt or appropriate for an expedited review – for instance, if it involves a sensitive topic and/or involves the use of children, pregnant women, or prisoners – the IRB will conduct a full review of the protocol during one of its monthly meetings.   

Submit a Protocol to the IRB

1.   Go to http://researchcompliance.tamu.edu/irb/irbrevapp, then click on the link to the “IRB Protocol Checklist and Application” to obtain a pdf fillable human subjects protocol form.

2.   Save the form to a computer file.

3.   Complete the form.

4.   Schedule a pre-submission review of the protocol.

      Note:  To schedule the review, call 979-458-4067 or e-mail irb@tamu.edu.

5.   Attend the pre-submission review and make careful note of any items that may need to be revised.

6.   Incorporate suggested revisions.

7.   Submit one original and one photocopy of the completed human subjects protocol and all required attachments to Sharon Alderete, IRB, Office of Research Compliance, Texas A&M University, Centeq Building, 1500 Research Parkway, Suite B150, College Station, TX  77843-1186.

8.   Attend the IRB meeting to answer any questions that the IRB members may have.

      Note: Call 979-458-4067 oe e-mail irb@tamu.edu to learn the date, time, and location of the IRB meeting.

9.      After all items have been satisfactorily addressed, the IRB will issue an approval notice.

Institutional Animal Care and Use Committee

Home page:                               http://researchcompliance.tamu.edu/iacuc/ 

E-mail:                                       ulacc@vprmail.tamu.edu

Phone:                                      979-845-1828

Assurance number (TAMU):        A-3893-01

Assurance number (BCD):          A-3027-01

Assurance number (HSC):          A-3895-01 (Scott & White only)

Assurance number (IBT):            A-4012-01

The primary purpose of the Institutional Animal Care and Use Committee (IACUC) is to ensure the humane use and care of animals used in any research activity, whether that activity is financially supported or not.  To this end, IACUC requires that any investigator conducing research involving the use of animals submit an animal use protocol for review. An animal use protocol is a document that delineates the formal design for research involving the use of animals;  it includes a justification for the use of animals, as well as for the species and number of animals to be used. It also includes a statement describing how the animals will be obtained, housed, cared for, and, if necessary, euthanized.

IACUC reviews animal use protocols to ensure that animals will be used and cared for in a humane way.  They also review protocols to ensure that the investigator will avoid or minimize discomfort, pain, or injury to the animals;  use no more animals than are necessary to reach sound scientific conclusions or to teach the class;  and, when appropriate, painlessly sacrifice animals.

Submit a Protocol to IACUC

1.   Go to http://researchcompliance.tamu.edu/iacuc/forms, then click on the link to the “Animal Use Protocol” to obtain a pdf fillable animal use protocol form.

2.   Save the form to a computer file. 

3.   Complete the form.

4.   Schedule a pre-submission review of the protocol.

      Note: To schedule the review, call 979-845-1828 or e-mail ulacc@vprmail.tamu.edu.

5.   Attend the pre-submission review and make careful note of any items that may need to be revised.

6.   Incorporate suggested revisions.

7.   Submit one original and one photocopy of the completed animal use protocol – along with a copy of the research proposal – to Olivia Ash, IACUC, Office of Research Compliance, Texas A&M University, Centeq Building, 1500 Research Parkway, Suite B150, College Station, TX  77843-1186.

8.   Attend the IACUC protocol review meeting to answer any questions that the ULACC members may have.

      Note: Call 979-845-1828 or e-mail ulacc@vprmail.tamu.edu to learn the date, time, and location of the ULACC meeting.

9.   After all items have been satisfactorily addressed, IACUC will issue an approval notice.

Institutional Biosafety Committee

Home page:                               http://researchcompliance.tamu.edu/ibc/

E-mail:                                       ibc@tamu.edu 

Phone:                                      979-458-1467

The primary purpose of the Institutional Biosafety Committee (IBC) is to review and oversee the use of hazardous materials (e.g., toxins and pathogens), select agents, or recombinant DNA used in any research activity, whether that activity is financially supported or not.  To this end, the IBC requires that any investigator conducing research involving the use of hazardous materials, select agents, or recombinant DNA submit a registration document.

The registration document requires that the applicant justify the use of hazardous materials, select agents, or recombinant DNA. It also requires that the applicant state the purpose of the research; identify which toxins, pathogens, or recombinant DNA will be used;  describe laboratory procedures; describe potential medical risks; explain how exposure will be controlled;  identify any hazardous materials that will be transported into or out of the laboratory; and explain procedures for disposing of hazardous materials.

The IBC reviews registration documents to ensure that appropriate laboratory practices, biological containment procedures, and emergency plans are in place before research begins.

Submit a Registration Document to the IBC

1.   Go to http://researchcompliance.tamu.edu/ibc/ibcrevapp, then click on the link to the “IBC Application” to obtain a pdf fillable registration form.

2.   Save the registration form to a computer file.

3.   Complete the registration form.

      Note: Only those portions of the registration form that are applicable to the research project need  to be completed.

4.   Forward the completed registration form to the IBC, Office of Research Compliance, Texas A&M University, Centeq Building, 1500 Research Parkway, Suite B150, College Station, TX  77843-1186.

      Note: Original signatures are required. All protocols require a 10-day review process. After the review process is completed, the applicant will be notified if there are any items requiring revision or clarification.

5.   Incorporate suggested revisions and/or clarifications and resubmit the protocol to the IBC for further review.

6.   After all items have been satisfactorily addressed, the IBC will issue an approval notice.