Studies involving human subjects, animals, drugs or medical devices, and other sensitive areas of research are subject to regulatory oversight. While regulations might seem to be a nuisance or an impediment at times to the freedom of scientific inquiry, their purpose is to ensure that proper protocols are followed so that established safeguards and protections are maintained. The beneficiaries of this oversight are not just those individuals directly affected by a study—participants in a clinical trial, for instance—but also the investigators and anyone else involved in research who would be affected by setbacks stemming from unregulated practices that result in inhumane or unsafe conditions. For more information, see Research Regulatory Issues. Following are some of the basic considerations:
If you are conducting a study involving human subjects, what kind of study is it—a quality assurance/quality control study, a preparatory to research study, or a research study? (For an explanation of the differences, see Research Regulatory Issues.) If you are engaging in research involving human subjects, have you met all of the requirements of the Institutional Review Board? (For more information, see Human Subjects Research Projects.) Is your research an industry-sponsored study, or is it funded by a federal agency? If industry-sponsored, have you met all of the requirements of the UPMC Clinical Trials Office (which is responsible for facilitating the implementation of industry-initiated and -sponsored clinical trials being conducted within the UPMC environment)? If you are conducting a clinical study on UPMC property, have you complied with UPMC’s research fiscal review procedures? Have you entered the study into a public registry such as www.clinicaltrials.gov? (For more information, see Registration of Clinical Trials.) If you are studying a new drug or medical device, have you filed all of the required documents with the Office of Investigator-Sponsored IND and IDE Support (O3IS)? (For more information, see Drug or Medical Device Development.) If you are working with cadaveric tissue, have you registered the study with the Committee on Research Involving the Dead (CORID)? (For more information, see Cadaveric Studies.) If you are conducting an animal study, has your protocol been approved by the Institutional Animal Care and Use Committee (IACUC)? (For more information, see Animal Studies.) Have you completed the required training modules for the type of research you’ll be conducting? Are you aware of any conflicts of interest that you might have? Have you completed the conflict of interest disclosure form? Do you know what help with any of these issues is available from CTSI and how to access that help?
