Human subject research
Human subjects research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subjects research can be either medical research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subjects research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subjects research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
Human subjects research is used in various fields, including research into advanced biology, clinical medicine, nursing, psychology, sociology, political science, and anthropology. As research has become formalized, the academic community has developed formal definitions of "human subjects research", largely in response to abuses of human subjects.
Human subjects
The United States Department of Health and Human Services defines a human research subject as a living individual about whom a research investigator intervention or interaction with the individual, or 2) identifiable private information.As defined by HHS regulations :
- Intervention – physical procedures by which data is gathered and the manipulation of the subject or their environment for research purposes.
- Interaction – communication or interpersonal contact between investigator and subject.
- Private Information – information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
- Identifiable information – specific information that can be used to identify an individual.
Human subject rights
- Voluntary, informed consent
- Respect for persons: treated as autonomous agents
- The right to end participation in research at any time
- Right to safeguard integrity
- Protection from physical, mental and emotional harm
- Access to information regarding research
- Protection of privacy and well-being
From Subject to Participant
Ethical guidelines
In general, it can be said that experimental infections in humans are tightly linked to a history of scandals in medical research, with scandals being followed by stricter regulatory rules. Ethical guidelines that govern the use of human subjects in research are a fairly new construct. In 1906 some regulations were put in place in the United States to protect subjects from abuses. After the passage of the Pure Food and Drug Act in 1906, regulatory bodies such as the Food and Drug Administration and institutional review boards were gradually introduced. The policies that these institutions implemented served to minimize harm to the participant's mental or physical well-being.The Common Rule
The Common Rule, first published in 1991, also known as the Federal Policy for the Protection of Human Subjects, is dictated by the Office of Human Research Protections under the United States Department of Health and Human Services and serves as a set of guidelines for institutional review boards, obtaining informed consent, and Assurances of Compliance for human subject participants in research studies. On January 19, 2017, a final rule was added to the Federal Register with an official effective date of July 19, 2018.Nuremberg Code
In 1947, German physicians who conducted deadly or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Trials. A portion of the verdict handed down in the doctors' trial became commonly known as the Nuremberg Code, the first international document to clearly articulate the concept that "the voluntary consent of the human subject is absolutely essential". Individual consent was emphasized in the Nuremberg Code in order to prevent prisoners of war, patients, prisoners, and soldiers from being coerced into becoming human subjects. In addition, it was emphasized in order to inform participants of the risk-benefit outcomes of experiments.Declaration of Helsinki
The Declaration of Helsinki was established in 1964 to regulate international research involving human subjects. Established by the World Medical Association, the declaration recommended guidelines for medical doctors conducting biomedical research that involves human subjects. Some of these guidelines included the principles that "research protocols should be reviewed by an independent committee prior to initiation" and that "research with humans should be based on results from laboratory animals and experimentation".The Declaration of Helsinki is widely regarded as the cornerstone document on human research ethics.
The Belmont Report
The Belmont Report was created in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to describe the ethical behaviors that involve researching human subjects. It is most heavily used by the current United States system for protecting human subjects in research trials. By looking primarily at biomedical and behavioral research that involve human subjects, the report was generated to promise that ethical standards are followed during research of human subjects. There are three standards that serve as the baseline for the report and how human subjects are to be researched. The three guidelines are beneficence, justice and respect for persons. Beneficence is described as protecting the well-being of the persons and respecting their decisions by being ethical and protecting the subjects from harm. The two rules of beneficence are maximizing the benefits of research and minimizing any possible risks. It is the job of the researcher to inform the persons of the benefits as well as the risks of human subjects research. Justice is important because it causes the researchers to be fair in their research findings and share what they have found, whether the information is good or bad. The selection process of the subject is supposed to be fair and not separate due to race, sexual orientation or ethnic group. Lastly, respect for persons explains that at any point a person who is involved in a study can decide whether they want to participate, not to participate or withdraw themselves from the study altogether. Two rules of respect for persons involve the person being autonomous and persons with diminished autonomy and entitled to protection. The sole purpose of these guidelines is to ensure autonomy and to protect against those with a lesser chance to remain autonomous because of something out of their control.Ethical concerns
As science and medicine evolve, the field of bioethics struggles to keep up with updating guidelines and rules to follow. There has been an interest in revisiting the ethics behind human subject trials. Members of the health field have commented that it may be useful to have ethics classes available to students studying to be health care professionals as well as have more discussions surrounding the issues and importance of informed consent. There have also been a bigger push to protect participants in clinical trials. Rules and regulations of clinical trials can vary by country. Suggestions to remedy this include installing a committee to keep better track of this information and ensure that everything is properly documented. Research coordinators and physicians involved in clinical studies have their own concerns, particularly that an implementation of ethics rules could potentially disrupt the logistics of preparing a research study, specifically when it comes to enrolling patients. Another concern that research teams may have is that even if the rules are ethically sound, they may not be logical or helpful for conducting their studies.Of note currently in the research field is the manner in which researchers direct their conversations with potential human subjects for a research study.
Research in rural communities
Recently there has been a shift from conducting research studies at research institution facilities or academic centers to rural communities. There is concern surrounding the topics addressed during the discussions with this specific demographic of participants, particularly having to do with funding, overall efficacy of the treatment being studied, and if conducting such studies is done to the highest ethical standard.Ann Cook and Freeman Hoas from the University of Montana's Department of Psychology conducted a study to gain more understanding about what influences potential candidates to consent to participation in any given clinical trial. They published their findings in February 2015. Cook and Hoas asked for the perspectives of the researchers and whether they would consent to being a subject in a clinical trial. To assess the shift to rural communities, they surveyed 34 physicians or researchers and 46 research coordinators from states that have "large rural populations and have historically demonstrated limited participation in clinical research." Proper consent forms were provided and signed at the start of the study. Of the physicians and research coordinators that participated in this study, 90% were from hospital centers or worked in a hospital-clinic setting. Of all the participants, only 66% of research coordinators and 53% of physicians received training in research methods, while 59% of the coordinators received any ethics training. Only 17% of the physicians had ethics research training prior to this study.