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AGS Position Statement
The Responsible Conduct of Research
AGS Ethics and Research Committees

*Last Updated in 2007*

Research is an activity that is designed to produce generalizable knowledge. Human subjects research involves gathering knowledge using identifiable information derived from persons. Research is one of the key methods for producing valuable knowledge that has improved how healthcare providers and society understand aging and disease associated with aging, how healthcare providers diagnose and care for patients with geriatric syndromes, and how patients and healthcare providers appreciate the unique presentation and care of diseases in geriatric patients.

Geriatrics research presents ethical challenges. Although some of these challenges are not unique to geriatrics research, some are, or they are intensified because of the unique qualities of geriatrics research. Broadly, the contours of these challenges follow the relationships in which geriatrics researchers find themselves. They have relationships to subjects, colleagues, patient groups, society and industry. Moreover, the conduct of research often involves multi-site and multi-disciplinary collaborative relationships. These different relationships can generate obligations that can become complex, difficult to balance and even conflicted.

Recognizing that the American Geriatrics Society is an organization dedicated in part to promotion of high quality research that expands knowledge of the aging process and addresses the health care problems of older people, the focus of this statement is to guide healthcare professionals who engage in research and care for the elderly to conduct responsible research. Trust is the fundamental value that promotes investigator, patient and public participation in research. The proposed guidelines address steps that can be made by investigators that will allow them to avoid and even prevent potential conflicts and thereby promote trust in the research enterprise.

Elderly people may experience diseases (such as dementia) or live in places (such as a long-term care facility) that impair their ability to freely advance and protect their rights and interests. Thus, they may not be capable of participating in an informed consent or articulating their values and goals for research that can improve their health and well-being (see AGS Position Statement on research that involves the cognitively impaired for a detailed discussion). In addition, elderly people are likely to relate with a physician-scientist as both a patient and a subject. The roles of patient and subject create different expectations. The expectation of the provider-patient relationship is the preservation of the patient's health. The expectations of the investigator-subject relationship are the protection of the patient from harm and discomfort, and the pursuit of valuable knowledge. Institutional Review Board (IRB) review of research helps to assure that subjects are adequately informed and these expectations are not confused.

1. Investigators must always assure that the potential research subjects or their surrogates understand how the study's risks and potential benefits differ from those of the subject's daily life and routine clinical care. This obligation becomes more important as the risks of research increase.

   Rationale: Informed consent is necessary in the conduct of both clinical research and care. However, informed consent in research is generally more rigorous and is better documented. An investigator's guide for the degree of rigor of this process is the degrees that the potential risks or discomforts of the research exceed the risks encountered in the subject's daily life and routine care.

2. The research informed consent process should include staff and other necessary resources to assure an adequate informed consent process.

   Rationale: Informed consent means that the subject understands the relevant information in a manner that is voluntary. The sensorineural and cognitive deficits of some elderly persons may mean that they require more time to understand the information. In practical terms, this time requires the commitment of empathic and well-trained staff and may also need to include people who are responsible for the patient's health care. These research staff are as important to a well-designed protocol as the provision of adequate equipment and technical expertise.

3. Research involving ethnic minorities, persons for whom English is a second language, and persons with low literacy require focused efforts to assure that they are fairly represented in recruitment and enrollment.

   Rationale: Many cultures are unfamiliar with research or have experiences that have created suspicion and distrust in research. Investigators need to address these issues so that their studies achieve representative subject populations that leads to valuable and generalizable knowledge.

4. If an investigator has funds to cover subject compensation, these payments should be commensurate with the expenses a subject incurs in order to participate in the research. These expenses include the costs of travel and time needed to participate in the research. In the case of research that involves patients and their caregivers, compensation should address the caregiver's expenses too. Payments should be made in a timely manner after the subject incurs the expense.

   Rationale: If an investigator chooses to compensate subjects, payments should cover expenses that exceed those encountered in the routine conduct of clinical care. For example, additional trips or time beyond those of a routine clinical encounter may warrant reimbursement that reasonably recovers those additional expenses.

5. Investigators should establish adequate protections for data privacy protections to assure that information that can identify a person is kept secure and restricted from unmonitored and unauthorized access.

   Rationale: Identifiable datasets contain information that has links to match the information to a particular patient. Anonymized datasets contain information that has no links to any patient identifiers. De-linking data means that the subjects' identifiers are kept in a dataset that is separate from the research dataset. Researchers can use the de-linked data without fear of violating subject confidentiality. In the case of research that involves sensitive information, a process defined in the research protocol should protect access to the separate linking information (e.g., a data privacy officer who is unaffiliated with the research).

6. Geriatrics healthcare professionals should serve on IRBs in order to provide input about the experiences of care and research that involves elderly patients.

   Rationale: IRBs that review research that involves the elderly should include people who have expertise with caring for elderly patients. Their informed perspective can serve as a valuable guide for the assessment of research risks and benefits, the presentation of informed consent materials and the importance of the knowledge to be gained.

Although a single principal investigator is responsible for each research project, many research projects are multidisciplinary and collaborative efforts that may involve investigators at multiple sites. Successful collaboration relies upon trust among the co-investigators. Investigators also have relationships with colleagues who are peer reviewers. Peer review describes the unbiased assessment of the validity and value of a scientific project. Peer review is a key mechanism for deciding what kinds of research should be funded, approved by an IRB, and what kinds of completed research should be published. Hence, it is a key mechanism for how investigators regulate the responsible conduct of geriatrics research.

1. Investigators must instruct trainees on the fundamentals necessary to peer review the ethics and the science of grants and manuscripts.

   Rationale: Investigators acquire the skills of science by mentored practice and instruction. Trainees acquire the skills of peer review in a similar manner. Investigators should provide practical and hands-on training to trainees in the fundamentals to identify and prevent conflicts of interest and to perform IRB review of research. This will help to reduce the variations in the quality and consistency of IRB review that often hinders the conduct of multi-site research projects.

2. Investigators should adhere to accepted standards for publication and requirements for authorship.

   Rationale: In order to be listed as an author, an investigator should contribute substantially to the work that is reported. That is, an investigator should be involved at one or more stages of the project, including but not limited to design, data collection, data analysis, and presentation. Review of the final manuscript does not warrant authorship and "courtesy" authorship is not acceptable. See for example Kassirer J.P., Angell M. On authorship and acknowledgements. N Engl J Med. 1991;325:1510-12.

Research is recognized as one of the principal ways to improve the standard of care. Public funding and patient participation in research demonstrate the strength of this commitment. Investigators not only have relationships with individual patients but also with organizations that represent patients and society. Patient organizations and society are increasingly active in shaping a research agenda. This creates both opportunities and challenges for investigators. The opportunities include the input of an informed patient view into the design and conduct of research. The challenges include competing claims about what is the most valuable research to improve the standard of care. This is especially challenging in geriatrics research because professional and public understandings of aging and diseases associated with aging are changing as a result of both research and social understanding of what it means to be elderly. These changes can produce disagreements upon the value of certain kinds of research.

1. Investigators should cultivate relationships with patient organizations in order to include expertise derived from the direct experience of aging and disease.

   Rationale: The claim that science is valid rests with the expertise of scientists, but the claim that valid science is valuable is informed by the input from people who live with the disease. Whereas informed consent is the subject's opportunity to assess the research risks, benefits and value, this does not allow subjects to participate as a collective. Patient groups can assist investigators in the review of research risks and benefits and the assessment of the value of the research. Scientists should welcome this kind of participation at consensus conferences and workshops in order to decide whether to pursue particularly risky or innovative research.

2. Investigators should disseminate the results of their research including so-called "negative studies."

   Rationale: The overall goal of research is to advance the standard of care. To accomplish this, researchers should design studies that can produce valid and valuable scientific knowledge. Valid results, regardless of the outcome, represent valuable knowledge to the medical community, patients and caregivers. All have a legitimate interest in receiving relevant information as soon as possible. In recognition of this, investigators should be committed to disseminate to others all knowledge generated by their studies in a timely manner consistent with current scientific and ethical standards. In particular, investigators have an obligation to publish expeditiously the results of treatment trials. Investigators and journal editors should foster mechanisms to disseminate rapidly findings of significant public health impact. This includes results that demonstrate that the primary null hypothesis cannot be rejected (commonly known as "negative studies"). Investigators should create mechanisms to disseminate these so-called "negative" results, such as research letters and public access reference databases.

A significant portion of research is designed and supported by industry. Industry has an interest in conducting research in a manner that minimizes the costs of research and maximizes the potential profits derived from research results. In general, investigators should scrutinize their relationships with industry to assure that they are free of conflicts of interest that can lead to undue incentives to complete research rapidly, and inordinate pressure to expedite the assessment of the validity and value of research results.

1. An investigator may accept compensation for enrolling a person in research only to the extent that it is commensurate with the expenses of that effort. An investigator should refuse bonuses and related incentives to increase subject enrollment.

   Rationale: Research costs time and money. Investigators and their staff require and deserve adequate reimbursement for their efforts. This should be commensurate with the reimbursement they receive for similar professional activities. Reimbursement above this level as well as incentives to increase subject enrollment can introduce bias in study performance that threatens the validity and value of the knowledge. This presents unacceptable threats to the preservation of trust among investigators, patients and the public.

2. An investigator should assess whether an industry-sponsored research protocol is likely to advance knowledge about the safety, efficacy, or novel use of an intervention. An investigator should decline to participate in a trial that does not achieve at least one of these goals.

   Rationale: Human subjects' commitments to participate in research are justified in large part by the value of the knowledge to be gained. This means that the knowledge will contribute to a better understanding of the safety, efficacy, or novel use of an agent. In general, subjects trust the investigator's research will lead to valuable knowledge. This trust in the potential clinical value of knowledge substantiates their altruism. Recruiting a subject for a clinical trial that is not likely to advance knowledge about the safety, efficacy, or novel use of an intervention, such as a trial designed to promote a drug, represents an unnecessary and potentially exploitative use of a human subjects' trust and altruism.

3. An investigator should disclose to peers, subjects, and relevant regulatory agencies the nature of relationships with companies that are involved in the research and any funds received from those relationships. This disclosure should occur during the design, execution, and dissemination of the research.

   Rationale: Relationships with industry, even those that involve pay, are a common way to foster collaboration and to promote the study of new treatments. But these relationships can present the potential for conflicts of interest. The origins of such conflicts include the different responsibilities of industry and investigators. For example, industry has responsibilities to shareholders and employees that investigators should not have. Investigators should avoid relationships that create these kinds of responsibilities. A first step to identifying and managing potential conflicts of interest is disclosure of relationships to peers. Throughout the research process, this disclosure should occur and any conflicts should be addressed.

4. Investigators should foster public and fair procedures for deciding the appropriate pace of research to develop new treatments. This process must recognize that there are trade-offs between the time to develop a new treatment versus the value of the knowledge that a new drug is safe and effective.

   Rationale: New treatments that arrive rapidly in the clinic as a result of modifications to the usual methods to test a drug may allow patients to benefit quickly, but they may also introduce treatments that are later found to be ineffective or unsafe. The decision whether to pursue rapid drug development should feature issues of the severity of the disease and the safety and efficacy of existing treatments. Although rapid drug development may also serve an economic advantage, this consideration is secondary to the balance of the burdens and benefits of disease and treatment.

This AGS position statement was developed and reviewed by the AGS Ethics Committee and approved November, 2001 by the AGS Board of Directors. Reviewed and updated in May 2007. This statement will next be reviewed in 2010. The AGS thanks Mary Kane Goldstein, MD, MSc, Greg A. Sachs, MD and Charles P. Mouton, MD, MS for their work on this position statement. Address correspondence to: American Geriatrics Society, The Empire State Building, 350 Fifth Avenue, Suite 801, New York, NY 10118, Tel: 212-308-1414; Fax: 212-832-8646; E-mail: info.amger@americangeriatrics.org.