Assurances Required for Research at Lipscomb
The charge to the Lipscomb IRB is broader than the charge to most IRB’s around the country. Items A through E below list our charge. Your proposal to IRB must ensure that the safety, liability and other concerns listed in A through E below are fully addressed in your research plan, or you must demonstrate that none of these concerns apply to your research.
A. To ensure that the safety, privacy and anonymity of livinghuman research subjects are fully protected as required by U.S. Code of Federal Regulations, Title 45, Part 46.
B. To ensure that safe practices and policies appropriate to the research project are in place as specified by the Lipscomb academic departments in which the research will take place.
C. To minimize the likelihood that the University is exposed to unusual liability.
D. To minimize the likelihood that the reputation of the University will be damaged.
E. To ensure that non-human vertebrate research subjects are treated humanely as required by the Animal Welfare Act of 1966 and its several amendments.
In addition to the common concerns of IRBs with safety of human research subjects, the Lipscomb IRB is charged with protecting the safety of research workers, animals used in research and other obligations. What follows is a list of assurances that the University requires. This document is closely linked to the document “Determining if IRB review is Required”. Signatures are required for as many of the items below as apply to your work.
1.Will your research involve obtaining or working with human tissue or body fluid samples? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in safely working with these materials and properly disposing of them.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
2.Will your research involve live samples of pathogenic organisms? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in safely working with these materials and properly disposing of them.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
3.Will your research involve chemicals that are regulated by EPA or OSHA or any type of high energy radiation? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in safely working with these materials and properly disposing of them
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
4.Will your research involve any invasive medical procedure, on humans or non-human vertebrates? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have adequate training for performing the procedure and that you have appropriate professional liability insurance.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
5.Will your research involve any non-invasive high stress medical or exercise procedure, on human or non-human subjects? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have adequate training for performing the procedure and that you have appropriate professional liability insurance.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
6.Will your research involve the use of any controlled substances? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in safely working with these materials and properly disposing of them.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
7.Will your research involve providing or administering any medication to human or non-human subjects? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have adequate training for this processincluding any necessary licensing and that you have appropriate professional liability insurance.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
8.Research involving animals is federally regulated under the Animal Welfare Act (AWA) (7 U.S.C. 2131, seq.) and the Health Research Extension Act of 1985 (Public Law 99-158). Your IRB proposal must show that your research fully complies with these regulations.
Will your research involve close contact with non-human vertebrate species? The contact could involve tagging, weighing and other such procedures that could be stressful to the research subjects. If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in safely working with the specific species and that you have training in, and a commitment to, the humane care and use of the particular species.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
9.Will your research involve neonates, minors (anyone under 18 years of age), prisoners or those with diminished mental capacity? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in working with these special populations.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
10.Will your research involve producing photographic or video images of human research subjects? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have training in maintaining the anonymity and privacy of research subjects when working with these kinds of materials.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
11.Will your research involve a focus on specific persons, corporations or other entities with an emphasis on evaluating decisions, practices or policies they have put in place? If Yes, your faculty research supervisor, or immediate supervisor must certify that you have appropriate training in research methods and an appropriate knowledge of libel law.
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
12. Will your research involve administering a survey (verbally, in writing, online or in any other way) to research subjects?
Yes _____No _____
Date ______
Your Name (printed)Your Signature
Supervisor’s Signature
13. If the answer to question 12 is Yes, have you submitted a copy of the survey to the Provost’s Office?
Yes ___No ___
If your answer to Question 13 is No, STOP THE IRB APPLICATION PROCESS NOW. You must submit a copy of the survey to the Provost’s office before submitting your research proposal to the IRB. Carry a copy of the survey to the Provost’s office, then complete the IRB submission process.