Bioethics issues in human studies

Informed consent

General considerations

Consent is any freely given specific, informed and express agreement of an individual to his or her genetic data being collected, processed, used and stored [14]

Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation [11].

An informed consent is challenged to balance out the participant's individual interest with those of the society for progress of knowledge. Research which is limited and restricted by too many clauses can inhibit progress and thus would not be of the interests of the majority of the society. Drafting an informed consent should take place under the aspect of the researcher and the participant being partners and under the respect of human rights. However, in practice it can be difficult to determine the type of information and every single fact that is necessary for the consent to be truly informed [32].

In the UNESCO document Human Genetic Data: Preliminary Study by the IBC on its Collection, Processing, Storage and Use [13] about informed consent it can be read:

A research sample may be collected from a person only after the person has first given a sufficient explanation in an appropriate style and language of:

the purpose of which the sample is collected;

the source of funding for the research;

the type of use which will be made of the sample or any information derived from it; and

any other implications which the collection and subsequent use of the sample might be reasonably be expected to have for the person providing it.

The consent should be expressed in writing unless there are cultural reasons for not doing so, in which case other possibilities of publicly recording consent should be explored.
Donors of samples for research purposes should not be subjected to any pressure or improper inducement in order to secure their consent. A person who refuses consent should not suffer any adverse consequences as a result of this refusal, and all potential donors should be given an assurance to this effect.
Samples donated for research purposes should not be made available for other purposes, such as policy use, and national legislation should seek to prevent such use.

Informed consent, thereby, is much more than a document obtaining a participant's signature on a consent form. Informed consent is a process of communication between an investigator and a potential research participant. The process of communication begins when the initial contact is made and it continues throughout the study [11]. The process of communication should take place in a language and at a level that is understood by the participant.

It is recommended to give information sheets to retain by the participants. These sheets resemble the consent form (without signature) and should give contact names and phone numbers of the principle investigator in case the subject has any questions.

Withholding information:

To ensure validity of research, sometimes it is methodically necessary to withhold certain information in the consent process. This is true for instance regarding the purpose of specific procedures (e.g. measures of compliance with the protocol, validation procedures etc.). Possibilities to handle this problem:

Asked for consent to remain uninformed until the study is completed,
Subjects are not told that some information was withheld until the study is completed because this information would bias the study results when told in advance.

Any such procedure must receive ethical approval [11]

Risk

The process of subject's information includes the explanation of risks and benefits [11, 14]. In observational studies, the physical risk that could be caused usually is limited to the procedure applied to obtain the DNA sample (invasive or non-invasive procedures). Intervention studies additionally will have to define the risk encountered by the intervention to the potential participant. Investigators should be completely objective in discussing the details of the experimental intervention and possible pain, discomfort, known risks and possible hazards associated to it.

Beside the physical, there might be a social, psychological or economic risk when identifiability exists. The researcher has the obligation to reveal also the potential risk of disclosure of genetic test results to third parties. Apart from illegal access to information deemed confidential, the participant and the research team could be obliged by court order or by law to reveal this information to third parties [32]. This situation is particularly crucial in terms of revealing genetic information to insurers and employers. The genetic information should not be disclosed without consent [13]. The WHO and the International Bioethics Committee, by recognizing the participant's vulnerable position with regard to the employer or insurer, particularly regarding the consent being freely given, states that genetic information should not be accessible (with or without consent) by employers or insurers [7, 33].

Benefit

Genetic research implies the promise of new diagnostic tools or treatment possibilities. In the nutrigenomics research a personalized nutrition to prevent the occurrence of nutrition related diseases more effectively is the future vision. However, the immediate benefit due to research participation might be small for the subject and no more than accumulation of knowledge. Therefore, consent forms should state clearly the type of anticipated benefit for the person. It has to be made clear what participants in research can hope for themselves.

In the International Ethical Guidelines for Biomedical Research involving Human Subjects, a comprehensive explanation of acceptable and unacceptable recompense is given (Commentary on Guideline 7). Whereas, for instance, reimbursement of transportation fees would be acceptable, monetary payments of larger extent would not be acceptable. This is of major importance concerning the consent being freely given [11].

Commercialization

Even though 'the human genome in its natural state shall not give rise to financial gains' [12], and researchers do not own genetic material, findings resulting from research may give rise to intellectual property or commercial products. Some participants might expect to share in the profits derived from such products. The researcher must advice participants of commercialization and of the fact that they will not personally profit from their contributions [32]. However, the study participant as member of the community can benefit from technology transfer, potential provisions of health care and free drugs, indemnities or use of a proportion of the financial gains for social affairs.

Conflicts of interests

To reveal potential conflicts of interests of researchers, the financial sources must be disclosed. The Ethics Committee should require the researcher to reveal conflicts of interests to the study subject. However, the burden of determining serious conflicts should not be shifted to the participants. Instead, it should be resolved at the institutional level and through the Ethics Committee.