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Protecting Research and Research Participants

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  1. Human Subject Research Is Grounded In Trust And Respect
    1. BIO companies' research leads to cures and treatments for disease. Today, there are 168 biotech products and they have helped a quarter billion people worldwide. Another 371 biotech medicines in late stage development are targeting more than 250 diseases.
    2. Innovations that lead to the discovery and development of treatments for unmet clinical needs cannot proceed without three kinds of contributions, each involving its own kind of risk and uncertainty -
      1. The good will of individuals who volunteer to be subjects in testing new products;
      2. The creativity, insight, and hard work of individual scientists who pursue novel hypotheses over many years; and
      3. The long-term commitment of financing by investors, both public and private.
    3. The strong public interest in the improved health and health care made possible by biotechnology research commands us to act in ways that justify the role played by all of the relevant individuals and groups:
      1. Research participants - individuals whose condition or disease is of interest, individuals who possess clinical or genetic attributes of interest to the researcher, and "healthy" volunteers who help in early phases of clinical research;
      2. Investigators -- clinicians, health care providers and scientists who assume responsibility for the care of research participants enrolled in a research protocol, and/or the analysis of research data;
      3. Research institutions -- hospitals and clinics (whether private or government operated) that provide the clinical setting in which investigators tend to the needs of research participants; and
      4. Research sponsors -- persons (whether individuals, institutions or corporations) that assume responsibility for conduct of research and data analysis, including research supporting submission of an application for approval of a new drug, device or biologic, as well as post-market testing of products.
    4. Where relevant to the participant's health care and medically appropriate for use in health care decision-making, sponsors should permit investigators and/or research institutions that have direct treatment relationships with a participant to communicate, at an appropriate time and in an appropriate manner, results of the research with the study participant.
  2. Protecting The Contribution Of Research Participants Transcends National Borders
    1. No matter what country hosts clinical research, data collection or analysis, sponsors and investigators should protect and value the contribution of each research participant.
    2. Clinical trials involving the administration of a new drug to a living human being should be conducted in accord with the Good Clinical Practices developed through the International Conference on Harmonization (ICH-GCP).
    3. Clinical research should be conducted in accord with applicable local laws. In the U.S., the Federal Food and Drug Administration provides Good Clinical Practice Guidelines, and FDA regulations assure that ethics review is provided by Institutional Review Boards operating under the "common rule" codified at 21 CFR parts 50 and 56.
    4. Even where these laws do not apply, investigators and sponsors should seek review of research involving more than minimal risk to a living human being. FDA regulations provide a clear definition of "minimal risk" by referring to the risks faced by a person in every day life.
    5. Where a research participant will be asked to face more than minimal risk, an ethics review board operating in accord with the laws of the host country should review the potential risks to participants, and balance them with possible benefits to participants and mankind.
  3. Disclosure And Oversight By Institutional Review Boards Provides Critical Support For Participant's Informed Consent
    1. No research participant should be involved in research without his or her voluntary consent to a research protocol, after an informed discussion of its risks. FDA regulations provide for rare exceptions, such as research on products used in emergency interventions, or consent by a legal representative.
    2. A research participant should be allowed to withdraw consent at any time for any reason.
    3. A research participant's authorization or specification of limitations on permissible uses of data and biological materials must be respected.
    4. Wherever possible, any payment to research participants, including any changes to such payments, should be reviewed by an IRB to ensure that their structure or amount does not encourage participants to inappropriately disregard research risks.
    5. Investigators should be forthcoming regarding potential physical, social and psychological risks to the research participant that may be associated with a research protocol, including unanticipated risks that become apparent during the conduct of the research.
  4. Conflicts Of Interest Should Be Identified And Appropriately Managed
    1. Investigators and sponsors of a clinical trial should be responsive and cooperative with institutions' efforts to identify financial or other interests that may create a conflict of interest, or the appearance of a conflict in reviewing research risks.
    2. Investigators should disclose to a reviewing IRB or other institutional oversight committee any financial or other interest in the research protocol that could have professional, personal, or material financial implications.
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