and Game Theory
|"Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies. " The Belmont Report|
The methodology of economics experimentation has been developed by economists over the last 40 years and is now used in political science, anthropology, sociology, management science, and other social sciences. Economics experiments typically have no risk in the sense that the experiences are similar to day to day decisions. In a typical economics experiment, participants are brought together in a laboratory, classroom or through the internet. They make a series of decisions and are rewarded based on their decisions and the decisions of other participants. They are instructed on how they will interact, and how the pattern of decisions will affect their own rewards and in some cases the rewards of others. Instruction is designed to assure that understanding is successful - participants are usually given opportunity to ask questions and may be required to pass a test of understanding. Participants understand that they can leave at any time. After they make their decisions, their decisions are recorded, and they are rewarded depending on the decisions they made and that others made. Different participants may earn different rewards, usually money, paid anonymously and in private after the experiment. Monetary rewards based on outcomes are used to ensure that participants are well motivated. They are considered important to maintaining experimental control over subjects' motivations, which exert a strong influence on the predictions of the theories being tested. Subjects are sometimes paid a small additional fee for showing up on time and listening to instructions.
When interactions take place using a computer network, the environment is typically no different from sitting in front of a computer screen, making decisions in response to the information that is displayed there. Face to face interactions are typically in the form of negotiations over a price or are similar to discussing a proposal in a committee setting. Participants are not exposed to any sort of harm nor can the decisions they make lead to harm to others. Subjects are volunteers and may leave at any time. Data that might identify particular individuals are not made public. Social science experiment that follow the methodology of experimental economics have been conducted with thousands of students over several decades and there are no instances of harm nor has any form of risk been discovered or reported. These methods are often used as part of classroom exercises to make clear how theories apply to daily experiences in economics and in social environments.
Experimentation fitting this general description is minimal risk and exempt under categories (1) and (2) of the CFR because it involves research conducted in esablished or commonly accepted educational setting involving normal educational practices and constitutes observation of public behavior. Subjects are protected by alerting them in advance that they are volunteers and may withdraw their participation at any time, and by clear explanations of the tasks and rewards prior to performance of the tasks.
Because it is exempt informed consent is not required for this research. Consent is ongoing through continued participation. The relevant informational aspects of informed consent are satisfied by a properly implemented experimental protocol. Here is an analysis of the elements of medical informed consent as applied to economics experiments:
(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
Documenting Informed Consent and Preservation of Data
Because this type of research is exempt, no written signed consent is required. Written signed consent is also undesirable because it is not ordinarily used outside the research setting, and may raise unfounded fears on the part of partipants that the research is not minimal risk, or that they are being deceived. With the exception of the description of the procedures, the information above can be effectively provided through a web-based signup system, or if such a system is not available, by blackboard, or by providing participants with an information sheet giving the relevant information. It is not a good idea to inform participants of non-existent risks: for example, statements of the sort "There are no known risks" or "There are no alternative treatments" will at best be confusing to participants, and at worst will raise unfounded suspicions.
Except in web-based experiments, the detailed procedures are generally given orally.
Publication generally requires both that the data in anonymous form and written versions of the oral scripts be available to other researchers in perpetuity.
Information Provided to the IRB
Because this type of research is exempt, it is usually subject only to administrative review. However, few institutions allow researchers to self exempt, so it may be necessary to provide information that enables the reviewers to determine that the proposed research is of the type described above. This would not ordinarily include a discussion of the purpose of the research unless it is relevant to subject recruitment: because the research is minimal risk, the benefits and purpose are not relevant to the protection of subjects. In cases where the purpose of the research is discussed, it should be adequate to provide a paragraph indicating the general types of issues that will be studied. Detailed discussions of theories, technical hypotheses and literature review are not relevant nor does the human subjects protection community generally have the expertise needed to understand them.
To determine that the research is exempt, some description of the procedures are generally needed. A sample script, together with the general range of cases that will implemented can usually accomplish this purpose. Detailed information about the amount of money paid to participants and particular sessions are not ordinarily needed to determine whether the research is exempt.
One issue of concern to IRBs is the nature of the subject pool. Exempt research cannot involve vulnerable subject populations. Recruiting subjects based on past participation or non-participation in particular sessions or classes ought not be problematic, and the particular way in which this is done is not generally relevant. Recruiting subjects based on ethnicity or gender ought not be problematic as long as it is related to the purpose of the study; however, in this case it may be necessary to make an explicit statement of the criteria for inclusion/exclusion and how it is related to the purpose of the study.
Multiple Project Assurances and Federal Wide Assurances
In addition to the CFR title 45 part 46 most human subject research is also bound by Multiple Project Assurances negotiated between institutions and the Department of Health and Human Services. Frequently these agreements include an assurance that all human subject research, exempt or not, and regardless of funding source, will adhere to the Belmont Report. This need not be of concern for economics experiments: The Belmont Report explicitly recognizes that rules for medical research are not likely to be appropriate for the social sciences. The relevant portion of the Belmont report reads:
"Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies."
In addition the Belmont Report assigns no special status to written and signed consent.
MPAs are being phased out and replaced by Federal Wide Assurances. This involves further restrictions on exempt research: under FWAs exempt research is explicitly subject to the requirements of written informed consent. It does not, however, require signed informed consent, so no waiver is needed in this respect. The two elements of informed consent that do require explicit waiver are the purposes of the research, and a written description of the procedures to be followed. The impractibility of conducting this type of research with those elements of informed consent is explained above.