Ethically Responsible Research

As food is the largest industry in most Western nations, the lack of clearly articulated ethical guidelines for all types of food research—not only research related to food safety—is of particular concern. Information for food researchers to ensure appropriate forethought into the systems and control of ethical assurance is needed to assure quality and validity of research, as well as avoid legal difficulties stemming from unethical procedures or results. Although the public opinion of these needs may focus only on specific issues, such as genetically modified foods or nutraceuticals, a broad set of guidelines is necessary.

This article will explain and define parameters within which ethically responsible food-related research can be conducted with human beings in industrial, academic, and other settings. Many of these guidelines come from general sources and are adjusted to fit the general parameters of food-related research.

Food-related research is not limited to one specific area, but includes all psychological and physiological effects of the foods on humans and human society. The overall purpose of this article is to create a set of guidelines for the best practices within all branches of food-related scientific endeavor. Factors taken into consideration when creating these ethical guidelines include levels of risk, the voluntary consent of the participant, and confidentiality.

Risk
The most obvious and immediate consideration of ethical research is the level of risk involved. Risk refers to the possibility that some harm, loss, or damage may occur. There are various kinds of risk in research including mere inconvenience, physical risk, psychological risk, social risk, economic risk, and legal risk.

Inconvenience might include issues of time taken or feeling too full or hungry; however, it is still a consideration.

Physical risk includes issues of food safety, food allergies, or other injury or illness brought on by foods. With older, very young, and ill populations, fatigue is a serious consideration for the comfort of the participants as well as for the integrity of the data. Research methods must be used that minimize fatigue and discomfort. In food research, this can include the effort required for mastication, particulate size and shape (including sharpness that can cause gum discomfort), temperature, as well as issues of immediate and long-term safety of the foods administered. It should be remembered, however, that physical risk also includes issues of transportation of participants, falls, spills, and other accidental injury during the course of the experimental regime.

Psychological risk can include all of these other risks, and include fear, loss of trust, etc. Many of these other risks might carry resultant aversions to specific foods.

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Social risk in foods, although rare, is still a consideration, whether from concerns of being a “guinea pig” to having eaten specific foods or products.

Economic risk is typically only an issue in food research when it involves the issues of cost-benefit ratios of participation, including lost time or productivity during testing. It may also coincide with other risks, such as illness.

Legal risk is primarily involved in food research as the experimenter’s risk (e.g., food safety), but also includes disclosure of any criminal activity by participants, some of which could include food products, alcohol, or drugs. Perhaps the most ethically important legal risks are misrepresentation of the study and results, including data falsification.

To minimize or avoid risk and to maximize the benefit that may result from research, one must first identify the kinds of risk and the kinds of benefit that are possible within a study. Sieber (1992) put forward one of the most comprehensive models of risk. This 3-dimensional model categorizes circumstances likely to produce risk. The dimensions consist of four aspects of scientific activity, eight risk-related issues, and seven kinds of vulnerable entities. The 4 x 8 x 7 matrix yields 224 cells, each containing the elements of a distinctly different case scenario. Although it is not necessary for every industrial researcher to explore the extensive lengths of this model, is it worth briefly discussing here.

The first of the model’s dimensions, scientific activity, regards how and in what context research is undertaken. The theory or research idea must be considered from an ethics standpoint, as a new idea may change cultural values in fundamental ways. The research process is then examined, referring to steps involved in the actual conduct or empirical study.

Sieber’s final component is the institutional setting of the research. This is an important consideration in that an institution or organization may have specific views or motives that influence the research agenda. The risk is associated with the potential that needs or desires of the organization or organizational representatives either overtly or covertly bias the findings. Such uses of the research findings present the most likely area of abuse for many food-related studies. 

Selection of Participants
One of the most difficult, clouded issues of research is the recruitment and selection of participants. Selection of participants must be equitable, and take into account the purposes of the research, the setting in which it will be conducted, and the population from which the participants will be recruited (National Commission, 1978). Food research often relies on paid participants and volunteers recruited through advertising, telephone recruitment, and in-store interviews, as well as classroom-based recruitment on college campuses, even though these venues are often exclusionary of large portions of the population. Although target markets for some products may justify such recruitment, it is not inherently the case and should be carefully considered. 

Participants should not be selected for potentially beneficial research on the basis of favoritism, and conversely risky research must not be directed at participants for non-scientific reasons. Certain groups may continually be sought as research participants owing to their ready availability in settings where research is conducted or for financial reasons. Such groups as racial minorities, the economically disadvantaged, the cognitively impaired, prisoners, the very sick, and the institutionalized should be protected against the danger of being involved in research solely for administrative convenience. Of special concern within all groups are people with dependent status or compromised capacity for informed consent. 

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Voluntary Informed Consent
Central to ethical research is the voluntary nature of participation. There are specific issues that must be considered in assessing the voluntary and informed consent of participants. According to the Nuremberg Code (1949), informed consent means that the person involved should have legal capacity to give consent for participation. Respect for persons requires that participants be given the opportunity to choose what shall or shall not happen to them to the degree that they are capable. Informed consent can therefore be defined as ensuring that the participant understands what they are being asked to do, why they are asked to do it, and reminded that they do not have to participate or continue participation in any experiment or project. 

There is no circumstance in which explicit or implicit coercion should be used to obtain or maintain cooperation. When the investigator has a specific relationship (i.e., teacher-student, professional-client, employer-employee) with a potential participant, special care must be taken to ensure that the consent is truly voluntary and that the participant feels free to decline to participate. Although much research is conducted with undergraduate students in university settings, it is not inherent that students must participate, and alternatives to required participation, such as research papers, must not constitute coercion in terms of relative difficulty. 

Although they are a convenient, often cost-effective sample who typically fit purchaser profiles, the power that professors and instructors hold over their students must not be exercised to force a hesitant or unwilling student to comply with a research regimen. Such coercion may be subtle due to the power disparity between the professorate and the student population. Similarly, employees in food companies are often asked or compelled to participate in panels. Care must be exercised in assurance of protection for those individuals who do not wish to participate, but perceive covert threats to their job security for failure to participate. 

Most codes of research establish specific items for disclosure intended to assure that participants are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (if applicable), and a statement offering the participant the opportunity to ask questions and to withdraw at any time from the research. 

In developing consent statements, researchers usually try to address the concerns they think their participants ought to have. It is important for the researcher to determine what the concerns of the participant population actually are. 

A special problem of consent arises where informing participants of some pertinent aspect of the research is likely to impair the validity of the research. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that incomplete disclosure is truly necessary to accomplish the goals of the research, there are no undisclosed risks to participants that are more than minimal, and there is an adequate plan for debriefing participants, when appropriate, and for dissemination of research results to them. This may be as simple as telling them what parameters were manipulated to telling them how their choice was manipulated through social or emotional means.

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• Communication and Comprehension. Voluntary informed consent is an ongoing, two-way communication process between participants and the investigator, as well as a specific agreement about the conditions of the research participation. There are many aspects of the investigator’s speech and behavior that communicate information to participants. Body language, friendliness, a respectful attitude, and genuine empathy for the role of the participant are among the factors that may speak louder than words. Because the participant’s ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the participant’s capacities. 

Investigators are responsible for ascertaining that the participant has comprehended the information. To assess comprehension, participants in pilot or exploratory trials should be asked to read the consent statement and explain it in their own words. It should be revised until it is correctly understood. Special provisions may need to be made when comprehension is severely limited (e.g., mental disability, immaturity, sensory loss) without risk of condescension in the instructions and attitudes of the researchers. For all participants, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these participants must be honored.

• Voluntariness. Consent to participate in research is valid only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt or covert threat is presented in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance (National Commission, 1978). Those weakened or institutionalized are especially vulnerable for a variety of reasons, including the potential loneliness experienced by some institutionalized older adults who may participate for fear of losing social interaction or an expressive outlet. Those who cannot speak for themselves, whether for reasons of maturity, disability, or illness are inherently at risk from a variety of perspectives regarding consent and comprehension. 

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence—especially where possible sanctions are involved—urge a course of action for a participant. Undue influence would include actions such as manipulating a person’s choice through the controlling influence of a close relative and threatening to with-draw health services to which an individual would otherwise be entitled.

• Consent of Special Populations. Children, retarded adults, the poorly educated, frail older adults, and prisoners may fail to fully understand the right to refuse to participate due to context or ability, or may fail to grasp the details relevant to their decision. Food researchers should avoid using these populations unless clear information and consent is available from legal guardians. Although research with children is vital to food research, special care must be exercised, especially in the areas of safety and trust. 

As mentioned previously, there are instances where prior knowledge of an experiment by a participant can bias the results. With these populations, some level of deception may at times be necessary, but can only be used if followed by a full debriefing. 

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Debriefing
Debriefing is an important process of providing an opportunity for interaction with participants and relevant others immediately following research participation in order to clarify issues arising from participation. Depending on the nature of the research, it may also be appropriate to provide an immediate opportunity for discussion of the findings of that particular study with participants and relevant others. Researchers in specific food-related areas, such as nutrition or functional foods, state that one benefit of their research is its educational or therapeutic value for participants. 

The debriefing process provides an appropriate time to consolidate the educational and therapeutic value to participants through appropriate conversation and handouts. It is a two-way process, and participants deserve an opportunity to ask questions and express reactions that may be useful to the researcher. The debriefing period should be planned as an integral part of the study. The timing and nature of debriefing should be appropriate to the circumstances. If the research deals with private or sensitive matters, the debriefing should take place privately with each participant. 

Privacy
It is essential that researchers protect the privacy of research participants and the confidentiality of data to the extent possible and communicate to the participant how this will be done. Privacy refers to persons and to their interest in controlling the access of others to themselves and their data. Privacy affects the participants’ willingness to participate in research and to give honest responses. 

An understanding of the privacy concerns of potential participants enables the researcher to communicate an awareness of, and respect for those concerns, and to protect participants from invasion of their privacy. A research experience regarded by some as a delightful opportunity for self-disclosure could constitute an unbearable invasion of privacy for others. Informed consent is an important way to respect these individual differences. 

The investigator ensures privacy when specifying the kinds of things that will occur in the study, the kinds of information that will be sought and given, and the procedures that will be used to assure anonymity or confidentiality. The participant then decides whether to participate under these conditions. One who considers a particular research procedure an invasion of privacy can simply decline to participate. 

An individual’s right to privacy from research inquiry is protected by the right to refuse to participate in research (Sieber, 1992). Everyone has the right to respect for private life in relation about his or her health (Council of Europe, 1997). Everyone is entitled to know any information collected about his or her health. It is essential, however, that disclosure about an individual’s health must be discussed in light of the researcher’s expertise. For example, participants should not misunderstand certain nutritional assays as diagnostic verification of health problems or a disease state. 

Every precaution should be taken to respect the privacy of the participant and to minimize the impact of the study on the participant’s physical and mental integrity and on the personality of the participant. Limitations must always be considered in population and participant selection. 

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Confidentiality
Confidentiality is another vital aspect of the agreement between a researcher and participant as part of informed consent. Confidentiality refers to agreements with persons about may be done with their data, recognizing the privacy of some of the information likely to be conveyed. Assurance of confidentiality includes what steps will be taken to ensure that others are not privy to the identity of participants or to identifiable details about individuals. Even in noninvasive food preference surveys, it would be an ethical breech for a researcher to ever discuss a participant’s preferences with people who could identify that participant. It would also be an ethical breech to utilize participant lists for marketing of products unless explicitly outlined prior to participation. 

One of the most confusing points to many researchers is the difference between confidentiality and anonymity. Anonymity means that the researchers acquire no unique identifiers such as the participants name, Social Security number, driver’s license number, etc. When designing the research, one should decide whether the data could be gathered anonymously or not. The main reasons for gathering unique identifiers are so that participants can be re-contacted, results can be mailed to the participant (after results are mailed out, no record of the names of participants remains), or so that signatures may be obtained on the consent forms. If a person is coming into a laboratory, signing a consent form, or giving any identifying information, participation is not anonymous, but must be maintained as confidential. All confidential information must be kept secure. This means, for example, that databases must be at least password protected or encrypted and paperwork is kept in a locked cabinet or other secure place. 

One of the key components of risk assurance is that the researcher cannot make personal decisions for a participant of what information is acceptable to release and what is not. In almost all instances, it is unacceptable to release any information at all about any individual participant, regardless of how insignificant the information may seem to the researcher. Any release to unapproved persons is deemed as a breech of the forms of consent. There are several approaches to help eliminate or at least minimize the link between identity and the data gathered. It is important to note, however, that when data are shared via a public archive, all identifiers must be removed, and the researcher must ensure that there is no way to deduce identity (Sieber, 1992). 

General Ethical Principles of Research on Humans
Research is a coherent, well-defined investigation into nature with specific, predetermined goals and objectives. Such investigations that concern food products are inherently based on the fitness for human consumption and the eventual measurement of observations from human research participants. 

According to one of the most significant sources for perspective on ethics in research, the Nuremberg Code (1949), an “experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.” Although this may not seem immediately necessary or practical to industrial food research, this statement is vital to the integrity of the scientific process. Although serendipity plays a role in the process of discovery, the means by which the investigation is structured must meet specific criteria. These criteria can be summarized into three global points: dignity and freedom, beneficence, and justice.

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• Dignity and Freedom. Every research participant’s dignity and freedom must be respected at all times. The respect of the dignity of the human person is at the root of the ethics of science and new technologies as well as of human rights. The interests and welfare of the human being participating in an experiment must prevail over the sole interest of an organization, society, or science. Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection (European Group, 2000; Nuremberg Code, 1949; National Commission, 1978; Sieber, 1992). 

In food-related research, it is vital to ensure that participants are not forced to taste, smell, or ingest such foods or products as would evoke illness or other trauma. Included in this freedom is assuring that the religious or ideological views of the participants are respected. For example, adherents to Islam or Judaism must never be unknowingly fed pork, vegetarians must never unknowingly be fed meat, etc. Terms and conditions of participation must ensure the participant is treated with respect. This includes the terminology used to describe participants. Ageist, racist, sexist, classist, and other language must be excluded from all instruments, personal interaction, and dissemination of the work.

• Beneficence. In research, beneficence is defined as maximizing good outcomes for science, humanity, and the individual research participants while avoiding or minimizing unnecessary risk, harm, or wrong. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. 

Although the term beneficence is often understood as acts of kindness or charity, beneficence here is understood in a stronger sense, as an obligation. Two general rules have been formulated to guide the beneficent nature of research: (1) do not harm, and (2) maximize possible benefits and minimize possible harms (WMA, 2000). Thus, although it may be deemed ethical to provide vitamin supplements to only one experimental group, it would never be ethical to deprive specific nutrients to a group of people. It must be remembered that although a person consents to participate, and may even accept payment for participation, they do not under any circumstances relinquish their rights. 

• Justice. The question of who within a society or group ought to receive the benefits of research and bear its burdens is a matter of research justice. Justice ensures reasonable, non-exploitative, and carefully considered procedures and their fair administration. There also must be fair distribution of costs and benefits among persons and groups such that those who bear the risks of research should be those who benefit from it. 

Sieber (1992) argued that when research supported by public funds leads to the development of therapeutic devices, procedures, or other information, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. This may be the most difficult for some foodstuffs where different socio-economic status groups have differing participation levels in research, as well as cost-benefit perception of many food products. 

If food research reaches discovery of information regarding significant improvements in health, welfare, and safety, its cost-effectiveness must not obscure the need for dissemination of the information to the general population, thus it becomes a policy issue. 

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Safeguarding Participants and their Data
It is the duty of the researcher to safeguard the participants and their data. Based on the information set out in this document, there are several conclusions that can be reached in how to accomplish this. 

First, ethical considerations are vital to the integrity of all research, and therefore must be considered by any study regardless of type, scope, or methodology. 

Second, under no circumstances should information be released about participants and their performance just because it is food related, but rather information should be kept as confidential as any other information. 

Third, if a researcher is unsure of the ethical implications of their study, ethical approval from an institutional review board must be sought. Many studies may be quite difficult in their ethical realities, and may even cause differences within the ethics review committee of an institutional review board. This difficulty is precisely the reason such entities exist. Perhaps the most difficult question for the majority of food-related research is whether or not a study requires ethical approval from an institutional review board. The uncertainty of approval needs is also why groups such as the European Commission Directorate of Health and Consumer Protection, the Food and Drug Administration, and the Food Safety and Inspection Service of the U.S. Dept. of Agriculture specify requirements for these types of studies. 

In many academic settings, students perform research as part of their course of study. In such instances, it is recommended that ethical approval should always be sought in order to develop the heightened awareness of the implications of their research and development of more appropriate technique. In corporate environs, the consideration is that the consent form may be viewed as a contract with the participant, breech of which is unacceptable. 

Organizations such as IFT need to formulate specific ethical guidelines for research with human participants. Such expert guidelines allow for the provision of expert opinion and scientific guidance which governmental bodies could use to formulate policy stances and requirements. As several organizations have enacted such works in their respective fields (e.g., WMA, 2000), it is time that food research assumes a leading role in ethics instead of maintaining a wait-and-see attitude. 

Research participants must all be respected and protected by the researchers. Their willingness to continue participation and influence on others to participate must be considered in the development of all studies. Following these recommendations will aid in ensuring research that contributes to the body scientific with minimum risk and maximum benefit. 

Preparation of this manuscript was funded through the HealthSense project, a study involving 24 research sites in 10 countries. The objectives of the study are to generate scientific data on the relationship between sensory physiology and food preferences; to study degradation of sensory capability in the aging and determine how this affects older adults’ food preferences and general well-being; to understand how older people deal with issues related to food and choice; and to publish the results for use by the food industry, policy makers, dietitians, nutritionists, medical and other care providers, and consumer organizations who support the elderly. HealthSense is supported by the European Commision Quality of Life and Management of Living Resources Fifth Framework Programme. QLK1-CT- 1999-000210. Further information can be found at http://HealthSense.ucc.ie .

by Robert J.F. Elsner, Caroline A. Martin, and Conor M. Delahunty
The authors are, respectively, Senior Research Officer, Project Coordinator, and College Lecturer, Dept. of Nutritional Sciences, University College Cork, Cork, Ireland. Send reprint requests to author Elsner.

Edited by Donald E. Pszczola
Associate Editor

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