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research. It is the foundation of clinical trials that involvehuman subjects. Additional guidance and information sheets are avail- able from the FDA on multiple topicsrelated to clinical research. H2: Preclinical Trials ELO: Summarize the purpose and process of preclinical trials. Prior to the implementation of clinical research, the FDA requires preclinical trials to determine a drug’s toxic and pharmacologic effects through in vitro and in vivo animal testing in the laboratory. Through these trials, drug developers are able to determine genotoxicity, the ability of a compound to damage genetic information in a cell, in addition to drug absorption, distribution, metabolism, and excretion. H2: Human Clinical Experimentation ELO: Explain the process and objectives of human clinical experiments. Historically, drug research was done only with Caucasian males, causing uncertainty as to the validity of research results for people of other ethnicities and for women and children. In 1993, Congress passed the National Institutes of Health (NIH) Revitalization • A statement that the study involves research • An explanation of the purposes of the research • The expected duration of the subject’s participation • A description of the procedures to be followed • Identification of any experimental procedures • A description of any reasonably foreseeable risks or discomforts to the subject • A description of any benefits to the subject or to others that may reasonably be expected from the research • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained • For research that involves more than minimal risk, an explanation as to whether any compensation will be paid and whether any medical treatments are available if injury occurs, and if so, what the treatments consist of or where further information may be obtained • Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research-related injury to the subject • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled From Office for Human Research Protections (OHRP). (2014). U.S. Department of Health & Human Services. Retrieved from http://www. hhs.gov/ohrp/policy/consentckls.html Commented [SL14]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL15]: The third-level (H3) head “RiskBenefit Ratio” was deleted to avoid there being only one H3 under the H2 “Beneficence.” (p. 8) Commented [SL16]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL17]: A TLO has been created and aligned with this H1. (p. 6) Commented [SL18]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL19]: An ELO has been created and aligned with this H2. (p. 6) 6 Act, which helped to establish guidelines to include women and minorities in clinical research. Additionally, the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003 encourage pharmaceutical companies to study their drugs in children. Clinical experimentation in drug research and development encompasses four phases, each with its own objectives (see Fig. 1.1). A multidisciplinary team approach that includes nurses, physicians, pharmacologists, statisticians, and research associates is required to ensure safety and quality in all phases of clinical research. A brief description of each phase follows: • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. • Phase III: The drug or treatment is
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