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Chapter 7
Chapter 7

Research & Innovation

Physicians who are involved in clinical research have special responsibilities as investigators to protect the rights, safety and welfare of research participants that include matters of study design, informed consent and selection of participants.

Physician involvement in research

Research involving human participants should be conducted in a manner that minimizes risks and avoids unnecessary suffering. Participants must be able to make informed decisions about whether to participate or continue in a given protocol.
Opinion 7.1.1

Physician Involvement in Research

Physicians who are involved in any role in research with human participants have an ethical obligation to ensure that participants’ interests are protected and to safeguard participants’ welfare, safety, and comfort.
Opinion 7.1.2

Informed Consent in Research

Physicians must ensure that the participant (or legally authorized representative) has given voluntary, informed consent before enrolling a prospective participant in a research protocol. The obligation to obtain informed consent arises out of respect for persons and a desire to respect the autonomy of the individual.
Opinion 7.1.3

Study Design & Sampling

Well-designed, ethically sound research aligns with the goals of medicine, addresses questions relevant to the population among whom the study will be carried out, balances the potential for benefit against the potential for harm, employs study designs that will yield scientifically valid and significant data, and generates useful knowledge.
Opinion 7.1.4

Conflicts of Interest in Research

Minimizing and mitigating conflicts of interest in clinical research is required in order to justify and maintain trust in the medical research community.
Opinion 7.1.5

Misconduct in Research

Physicians with oversight responsibilities in biomedical or health research have a responsibility to ensure that allegations of scientific misconduct are addressed promptly and fairly.

Disseminating research results

Physicians have obligations as scientists, which include disseminating research findings. Prompt presentation to scientific peers and publication of research findings are the foundation of good medical care.
Opinion 7.2.1

Principles for Disseminating Research Results

Physicians have an ethical responsibility to learn from and contribute to the total store of scientific knowledge. When they engage in biomedical or health research, physicians have obligations as scientists, which include disseminating research findings.
Opinion 7.2.2

Release of Data from Unethical Experiments

Data obtained from cruel and inhumane experiments should virtually never be published. In the rare instances when ethically tainted data have been validated by rigorous scientific analysis and are the only data of such nature available, and human lives would certainly be lost without the knowledge obtained from the data, it may be permissible to use or publish findings from unethical experiments.
Opinion 7.2.3

Patents & Dissemination of Research Products

Physicians who develop medical innovations may ethically patent their discoveries or products but should not allow patents to languish or use patents to limit the availability of medical innovations.

Special issues in research

To ensure that the interests of human participants are protected, physician-researchers and those who serve on oversight bodies should give careful attention to issues of methodological rigor, informed consent, characteristics of the medical condition under study, as well as safety and monitoring.
Opinion 7.3.1

Ethical Use of Placebo Controls in Research

Use of placebo in the control arm of a study deprives these patients of the accepted therapy for a period of time. As such, the use of a placebo control will more easily be justified as the severity and number of negative side effects of standard therapy increase.
Opinion 7.3.2

Research on Emergency Medical Interventions

In certain situations and with special safeguards, it can be appropriate to provide experimental treatment without a participant’s informed consent. To protect the rights and welfare of participants in research on emergency medical interventions, physician-researchers must ensure that the experimental intervention has a realistic probability of providing benefit equal to or greater than standard care and that the risks associated with the research are reasonable in light of the critical nature of the medical condition and the risks associated with standard treatment.
Opinion 7.3.3

International Research

Physicians engaged in international research may encounter differing cultural traditions, economic conditions, health care systems, and ethical or regulatory standards and traditions than in the US. While fundamental requirements to ensure scientifically sound research and to protect the welfare, safety, and comfort of human participants apply in any research setting, physicians who are involved in international research may need to address special concerns about selection of research topic, study design, informed consent, and the impact of the research on the participating community
Opinion 7.3.4

Maternal-Fetal Research

Maternal-fetal research must balance the health and safety of the woman who participates and the well-being of the fetus with the desire to develop new and innovative therapies. Physicians engaged in maternal-fetal research should demonstrate the same care and concern for the pregnant woman and fetus that they would in providing clinical care.
Opinion 7.3.5

Research Using Human Fetal Tissue

The use of fetal tissue for research purposes raises a number of ethical considerations, including the degree to which a woman’s decision to have an abortion might be influenced by the opportunity to donate fetal tissue. Physicians who are involved in research that uses human fetal tissue have a responsibility to protect the interests of pregnant women as well as the integrity of science.
Opinion 7.3.6

Research in Gene Therapy & Genetic Engineering

In general, genetic manipulation should be reserved for therapeutic purposes. Efforts to enhance “desirable” traits are contrary to the ethical tradition of medicine. In addition to fundamental ethical requirements for the appropriate conduct of research with human participants, research in gene therapy or genetic engineering must put in place additional safeguards to vigorously protect the safety and well-being of participants and future generations.
Opinion 7.3.7

Safeguards in the Use of DNA Databanks

Human participants who contribute to research involving DNA databanks have a right to be informed about the nature and scope of the research and must give consent for how their information may be used.
Opinion 7.3.8

Research with Stem Cells

Physicians who conduct research using stem cells obtained from any source must, at a minimum, adhere to institutional review board requirements, ensure that the research is carried out with appropriate oversight and monitoring, and ensure that the research is carried out with appropriate informed consent.
Opinion 7.3.9

Commercial Use of Human Biological Materials

Physicians involved in research with human biological materials should disclose potential commercial applications to the tissue donor, obtain informed consent to use biological materials in research from the tissue donor, and share profits from the commercial use of human biological materials with the tissue donor.
Opinion 7.3.10

Expanded Access to Investigational Therapies

Physicians who care for patients with serious, life-threatening illness for whom standard therapies have failed, are unlikely to be effective, or do not exist, should familiarize themselves with access to investigational therapies through the U.S. Food and Drug Administration’s “expanded access” program to be better able to engage in shared decision making with patients.