Remuneration for participation in research should be fair and equitable. However, the specifics of each protocol affect how these decisions are made. Researchers and IRBs need to be familiar with the study population and the research context in order to make reasonable judgments about how compensation might affect participation. Wherever compensation is set, it will influence the decisions of some more than others. In particular, it will be more important for those for whom it will make a significant financial difference. Therefore, IRBs should ensure that payments are not so high that they create “undue influence” or provide an undue incentive that could impact a potential subject`s risk assessment or the voluntary nature of their decisions. Personnel issues as research subjects are essentially the same as those affecting students as research subjects, i.e. investigators and IRBs must be wary of the risk of undue coercion or influence and the need to protect confidentiality. The FDA disagrees with these comments and the assertions that the cited cases constitute constitutional obstacles to the publication of this rule.
The FDA strongly supports the concept of informed consent. However, it is not always possible to obtain informed consent, as recognized by Congress when passing amendments to the law. Congress has explicitly allowed exceptions to the informed consent requirement in research in limited situations. (See the preamble to the proposed provision for a more detailed discussion of the powers conferred by the Act on Permitted Exceptions to Informed Consent (60 FR 49086)). For most investigations, informed consent is documented using a written document containing important information about the research. Part of the purpose of the informed consent form is to provide information for the current and future reference of the potential subject and to document the interaction between the subject and the investigator. However, while a signed declaration of consent is required, this alone is not an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, the use of question and answer sessions, community meetings and videotaped presentations. In all cases, however, individuals should have the opportunity to respond individually to their questions and concerns. For example, if potential subjects include individuals whose primary language is not English or populations with low literacy levels, the IRB should pay particular attention to ensuring that oral presentations and consent or approval forms are understandable to all subjects or parents of subjects who are children. Subjects who do not speak English must receive a consent or authorization document in a language they understand.
The Bureau strongly recommends the use of such a document whenever possible. (See Office of Human Resources Protection guidelines on this subject, see www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html; For more information on children`s consent requirements, see the FAQ on Research with Children.) An ARL is required to conduct research on human beings in the Commonwealth of Virginia with a person who, as an adult, is incapable of making an informed decision as defined in the Virginia Code ยง 54.1-2982 when consent is required. The legally authorized representative of the person gives consent/authorization and the signature must be attested. 7. Other comments sought clarification on whether the requirement in paragraph 50.24(d) would apply to studies aimed at clarifying a pathophysiological explanation (e.g., blood sampling studies); Studies using interventions of different techniques (e.g., two different methods of spectator CPR); research on basic pathophysiological mechanisms in emergency situations; studies comparing the timing of standard fluid administration for shock and surgical techniques; etc. If FDA regulations were not applicable, these comments asked whether the DHHS “harmonized” regulations would apply to these studies and require prior review by DHHS, or whether another agency would be responsible for screening the proposed research. 21. Another comment questioned the validity of the proposal`s claim that “the proposed rule gives double weight to the legal test of necessity” because “(1) the intervention is necessary because of the health condition and (2) the collection of valid data [*51505] is necessary due to the lack of a demonstrably satisfactory available treatment for the disease”. This commentary indicates that the context of the “necessity clause” makes it clear that the use of a device is necessary to sustain the subject`s life – that the relationship of necessity exists between the intervention and the subject`s condition. This commentary indicates that it is a perversion of legal language to claim that the term “necessary” is used to refer to the relationship between data collection and proven processing.