Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant. Return of results is particularly discussed in the field of

biobanks A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalize ...

, where a typical case would be that many members of a community donate biobank specimens for medical research. In the course of the research, especially in human genomics research, scientists may discover personal health information which could influence the behavior of specimen donors if they had this information. For different cases, there are arguments for and against revealing study information to participants and in many cases the morally correct choice is not self-evident.

Example situation

The following example shows some possible outcomes of trying to fulfill the return of results in genomic research. this example is a restatement of examples given in the article A healthy person donates a biological specimen and agrees to have that specimen and associated data put into a

genome-wide association study In genomics, a genome-wide association study (GWA study, or GWAS), also known as whole genome association study (WGA study, or WGAS), is an observational study of a genome-wide set of genetic variants in different individuals to see if any vari ...

. The goal of the study would be something unrelated to the donor's identified interests, and may be, for example, to build the base of fundamental research or to study

rare disease A rare disease is any disease that affects a small percentage of the population. In some parts of the world, an orphan disease is a rare disease whose rarity means there is a lack of a market large enough to gain support and resources for discov ...

. The sample is stored for years. Later a researcher gets access to data from the sample, and this data has been de-identified so that the researcher can use the data without invading the research participant's privacy. This researcher finds that the donor's specimen displays

biomarkers In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, pa ...

which indicate that the person is at risk for developing a genetic disease. If an individual's personal physician had this genetic information, the

standard of care In tort law, the standard of care is the only degree of prudence and caution required of an individual who is under a duty of care. The requirements of the standard are closely dependent on circumstances. Whether the standard of care has been b ...

might be to take action. One outcome of this scenario could be that the researcher contacts the specimen donor, gives this information, and the donor is more informed and happy for this. Another outcome of this situation is that the researcher may not be a medical doctor, and in any case, it is not usual for a person to receive a diagnosis outside of a doctor-patient relationship. Even if the participant understands that the information is not a diagnosis, it can be confusing to know what to do when getting health information from an unknown person. Even if the researcher ought to tell the specimen donor about this development, it may not be the case that the researcher has the means to contact the participant because time has passed since the sample was collected and the means of contacting the participant may be unknown because there are research protections in place to prevent researchers from knowing the identity of the donor for the donor's own sake and right to privacy. The donor, for whatever reason, may not even want to know about a genetic problem, and may find the information unwelcome if tracked and informed. In addition to these stated problems, other problems can arise.

Return of individual results

There is debate as to whether researchers should give participants in research studies individual results based on their contribution to the study. Some perspectives say that researchers should give individuals all information while others say that researchers generally should not offer this.

Arguments in favor

Proponents of offering individual results most often cite "respect for persons" as the ethical basis for this practice. The following reasons support this argument: some studies have shown that participants want such results; returning results is a way of demonstrating respect to for donors' contributions to research; research results, and especially genetic data, can be valuable information for individuals; and when participants have access to more information about themselves it increases their personal autonomy. Aside from medical health, having access to information may have social meaning to participants such as solidifying a cultural identity, membership in an ethnic group, or identifying a

non-paternity event In genetics, a non-paternity event (also known as misattributed paternity, not parent expected, or NPE) is the situation in which someone who is presumed to be an individual's father is not in fact the biological father. This presumption of NPE is ...

Arguments against

The definition of research is a major argument against offering research results. Research is not treatment and guidelines including the Belmont Report distinguish between "clinical practice" which has the goal of improving an individual's health and "research" which has the goal of developing general knowledge. Researchers must take care to not allow participants to be confused as to whether they are participating in research or receiving personal clinical care; a researcher is not a study participant's personal health advisor. Study participants often have a tendency to perceive researchers as their physicians and research as personal treatment designed to benefit them. When participants get information from researchers they may interpret it as health advice. The nature of the results is problematic as well. Research data is often not comprehensible to participants and no one would want them to take health action based on unsubstantiated misinterpretations of the data.

Alternate uses of term

"Return of results" usually refers to the return of study data of personal or community interest to participants. Research may result in other products besides data, such as the development of commercially valuable product which was a research goal. When the term "return of results" is used, it usually does not refer to the return of results of research (such as profit generated) other than an explanation of what the research showed. The debate about non-informational study results being returned is discussed as "ownership of results" or under other headings.

Issues relating to return of results

There is no universally recognized authoritative policy on whether or how researchers should return results to research participants, and the views and practices of researchers in the field vary widely.

Research

In September 2011 the

National Human Genome Research Institute The National Human Genome Research Institute (NHGRI) is an institute of the National Institutes of Health, located in Bethesda, Maryland. NHGRI began as the Office of Human Genome Research in The Office of the Director in 1988. This Office transi ...

awarded grants totaling US$5.7 million to study ethics relating to the return of results.