NURS 222 Chapter 13 Notes Chapter 13: The Role of the Nurse in Drug Research I.

. All prescription drugs must be approved by the FDA prior to availability on the market. Basic Ethical Principles Includes respect for persons, beneficence, justice, and truth telling: 1. Respect for person o Clients should be made aware of alternatives, as well as consequences stemming from those alternatives; choices should be honored whenever possible. o Autonomy- the right of self-determination. (decisions must be respected; clients can refuse any and all treatment except when this decision poses a threat to others). 2. Beneficence o Beneficence- the duty to not harm others, to maximize possible benefits, and to minimize possible harm that might occur in research. 3. Justice o Requires that all people be treated fairly. o Expansion includes equal access to health care for all. o Social benefits and burdens can be allocated objectively and that those with equivalent circumstances should be treated equally. o Truth telling is a principle that requires health care personnel to tell the truth and the whole truth. 4. Informed Consent o Participants right to be informed and that participation is voluntary, without coercion. o Includes: promotion of individual autonomy, protection of clients/subjects from harm, avoidance of fraud and duress in health care, encouragement for professionals to be thorough and clear in communicating info, promoting educated decision making, and promoting self-determination of the client. 5. Risk-to-Benefit Ratio o All consequences must be analyzed and balanced with the inherent risks and the anticipated benefits. Objectives and Phases of Human Clinical Experimentation Good Clinical Practice (GCP): Consolidated Guideline- an international ethical and scientific standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting is the foundation of clinical trials. World Medical Association Declaration of Helsinki has crafted ethical principles for medical research involving human subjects. 1. Preclinical Testing o Includes in vitro and in vivo systems; in vitro is generally in a test tube and in vivo is conducted with living organisms.

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o Followed by toxicity screening to identify abnormal changes in animal organs related to the drug administration and the parameters of the safe therapeutic dose. o Experimental group- receive the experimental intervention or treatment. o Control group- do not receive the experimental intervention or treatment and provide a baseline against which to measure the effects of the treatment. 2. Human Clinical Experimentation o Encompasses four phases: a) Phase I: primarily designed to assess safety Objectives are to determine the human dosage range based on response in healthy human subjects. Identify the pharmacokinetics of the drug. Progression to phase II occurs if no serious adverse effects are demonstrated, drug eliminated in a reasonable amount of time, and the dose range is below that known to induce pathology in animals. b) Phase II: demonstrates the safety and efficacy of the drug in subjects who have the disease the drug is designed to treat. Phase III initiated only when acceptable efficacy and safety data are generated and clearly documented in phase II. c) Phase III: involves large numbers of subjects with the disease intended for treatment; demonstrate safety and efficacy of the drug for a wide client population and to include long-term data if a chronic regimen is under consideration. d) Phase IV: same as Phase III. Assesses long-term use of the drug after phase iii.

3. Study Designs o Different types of studies, but the experimental and control groups do not differ in terms of baseline characteristics or demographics a) Quasi-experimental: comparison of IV device patency of those hospitalized clients who received heparin flushes and those who received saline. Controlled groups get no drug, a different drug, a placebo- pharmacologically inert substance, or the same drug with a different dose, route, or frequency of administration. Active control- control group receiving a different drug. b) Crossover: uses each subject in several different situations. Experimental gets the drug, control group gets alternate; both

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do not receive therapy; the experimental group gets control form of therapy and the control group gets the drug. The subject serves as his or her own control. c) Matched-pair: the researcher identifies several variables that may influence the outcome and then the subjects are matched for these variables (age, weight, history, etc.) and one of the pair is randomly assigned to the experimental group and the other to the control group. o Probability sampling is when subjects are randomly selected from the entire population and is typically used to provide relative confidence in the generalization of findings. o Double blind- neither the health care provider nor the subject knows whether the subject is receiving the experimental or control form of therapy. o Triple blind- a researcher other than the prescribing health care provider collects data and is also unaware of the subjects treatment group. o Single blind- only the subjects are unaware of which group to which they are assigned. o Open label study- indicates that all parties know the treatment group assignment. 4. Nurses Role o Nurse is both client and family advocate and the liaison between the client, health care provider, and research nurse responsible for the protocol. o Ask questions about informed consent and risk-to-benefit ratio. o Comprehensive screening of subjects and monitoring parameters, documentation, etc. Recent Developments and What Is on the Horizon Many new drugs are in development, yet it is very costly to introduce a new drug to the market.