Paper presented at the Third Working Meeting of the International Study of Ethical Codes and Ethical Control in the Social Sciences, London, Great Britain, April 1-2, 2009
In November 2007, the National Advisory Board on Research Ethics appointed a working group to look into the need for ethics review in the humanities and social sciences. The working group submitted its report in January 2009. The report is currently circulated to universities and research institutes for comments. The comments were due by the end of March. The Advisory Board then decides what happens next.
In the following, we describe the proposals of the working group in present tense as if they would already be in force, although they may change on the way.
Basic principles
The report is based on a number of basic principles.
1. Participation in research should be voluntary and based on informed consent.
2. The privacy of the participants and the confidentiality of the information collected should be protected.
3. Research participants should not be exposed to undue risk or harm.
4. It is the intrusiveness of the methods of data collection and not the branch of science that should determine the need for ethical review.
5. It is important to respect the autonomy and good sense of research subjects. In social research, participants usually are fully competent to assess the risks involved without outside expertise. Ethics committees should avoid paternalism.
6. The principle of respecting the autonomy and good sense of research subjects should be extended to minors, particularly in situations where a conflict of interest or values may exist between the under-age subject and his or her guardian.
7. Social research cannot and should not always be based on informed consent but all exceptions from it should be reviewed by an ethics committee.
8. Clear criteria should be formulated for what kinds of projects require ethical review, but it should be up to the researcher to determine whether a project meets these criteria.
9. In social research, special expertise is usually not required for an assessment of the risks involved in the data collection process. On the other hand, breaks of confidentiality can cause serious harm. Therefore, the review process should put special emphasis on adequate data management.
10. The work of ethics committees should be as transparent and open as possible and a system of appeals should be put in place.
Administrative
arrangements
The system for ethical review will not be based on legal rules, but universities and research institutes will be invited to join the system on a voluntary basis. In so doing they commit themselves to adhere to the principles and arrangements laid down by the Advisory Board. Joining the system is up to each research organization, but afterwards the system is mandatory from the perspective of individual researchers. Its rules are not legal rules but should meet the same requirements of clarity and predictability.
It is the responsibility of research organizations and particularly university rectors to establish local ethics committees. The goal is that the committees have a regional mandate so that all researchers can submit their project plans to a committee irrespective of where they work. Research institutes can also establish committees of their own, preferably as subcommittees of the regional committees. Some overlap is possible and the division of labor between different committees active in the same city or region may require fine-tuning. This will not be a serious problem as long as all committees adhere to the same principles and methods of work.
The working group presents no suggestions concerning the financing of the system but emphasizes that no fee should be charged for the review. This is a serious issue. Experiences from other countries show that a well functioning review system requires adequate resources. It is crucial that the National Advisory Board on Research Ethics sets up a concrete and realistic budget and that funding is made available at the national level.
Scope of the proposal
The new system is intended to cover the following fields of research: humanities, social sciences, behavioral sciences, nursing science as well as health sciences and sports sciences insofar they use social and behavioral research methods.
The division of labor between the new system and medical ethics committees requires special attention.
In the Medical Research Act, medical research is defined as "research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of disease in general". The act thus covers only research involving an intervention and aiming at specifically medical knowledge. In practice, institutions of health care require ethical review of all projects to be carried out in their setting irrespective of whether they are medical or not. In practice, this means submitting behavioral and sociological projects to medical review boards. The working group suggests that non-medical studies carried out in institutions of health care should be reviewed by the new ethics committees.
The commentary of the government proposal to parliament explicitly states that the Medical Research Act does not apply to experimental psychology or sports science. The working group suggests that the act should be revised to cover all research involving intervention in the physical integrity of a person.
Projects to be reviewed
Researchers must submit their research plan to ethical review if the project is based on direct interaction with the subjects and contains one or more of the following features:
1. The project involves an intervention in a person's physical integrity.
2. The project deviates from the principle of informed consent (ethical review is not required if the research is based on public documents, registries or archived data).
3. The subjects are children under the age of 15
and the project is not part of the normal activities of a school or an institution of early childhood education and care
and the data are collected without parental consent
and without providing the parents or guardians the opportunity to prevent the child from taking part in the study.
4. The project uses methods that require special expertise to assess the risks involved.
5. The project exposes research subjects to exceptionally strong stimuli.
6. The project may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life.
The aim has been to formulate as clear criteria as possible, but all criteria are not unequivocal. For example, it is a matter of judgement to decide what kinds of stimuli are "exceptionally strong". To avoid unnecessary bureaucracy, it nevertheless should be up to individual researchers to decide whether their project falls into the categories listed above and needs to be submitted to ethical review. It is highly unlikely that this will lead to transgressions, and ex post facto sanctions will be enough to keep any exceptions under control.
The researcher can also request ethical review when the research subject, the funding agency or a collaborative partner so requires or when the results are to be published in a scientific journal which requires ethical review.
The reasons for the review request must be specified.
Privacy and
data protection
The request for ethical review should include a data management plan describing
1. how data containing identifiers will be protected or identifiers removed,
2. whether signing a pledge of confidentiality will be required from persons using or processing the personal data and
3. the plan for archiving the data for further research or alternatively destroying the personal data after the research has been completed.
It is the task of the ethics committee to make sure that the technical solutions for data security are adequate.
Exceptions
from informed consent
The requirement for informed consent may sometimes be justifiably waived, if advance information would distort the results of the study. As a matter of principle, studies of the use of power should be allowed without the consent of those in power. There are also groups and subcultures that researchers cannot approach without using an assumed identity for the sake of their own safety.
Data collection can deviate from the principle of informed consent in a number of ways:
1. Research subjects may be given all the relevant information but participation is not voluntary (e.g., a study based on participant observation of military conscripts).
2. Research subjects may be given misleading or insufficient information about the role of the researcher. The researcher may not identify him/herself as a researcher but does not give misleading information (e.g., observational data collected from an emergency room or riding with a police squad) or the researcher may work under a covert role (e.g., to mislead research subjects in a field study of discrimination).
3. The researcher identifies his/herself but gives misleading information about the content of the study.
Ethics committees may approve exceptions from the principle of informed consent if the following preconditions are met:
1. The research is justified, and there are no suitable alternatives involving fuller disclosure by which the aims of the research can be achieved;
2. The data collection does not involve more than low risk to participants;
3. If possible, research subjects will be informed afterwards of the nature and purpose of the research; and
4. Adequate attention is paid to the privacy of the research subjects and data protection issues.
Research
with minors
According to the Medical Research Act, no parental consent is required if a minor over 15 years decides to participate in a research project if he or she "in view of his or her age and maturity and the type of illness and research, is capable of understanding the significance of the research procedure". The working group proposes that the same principle should be extended to all types of research.
Parental consent is required for research with children under 15 years of age that is not carried out as part of the normal activities of a school or an institution of early childhood education and care. Ethics committees may approve exceptions from this principle if no risk of harm is involved and the approval can be justified by one or more of the following conditions:
1. The under-age research subjects are capable of understanding the subject of the research and what is actually involved in participation.
2. The theme of the research is not sensitive and it would be unpracticable to ask for parental consent (e.g., data are collected in youth clubs).
3. The research is about a subject which cannot be studied if parental consent is required (e.g., domestic violence) or about a subject that minors do not want their parents to know about (e.g., drug and alcohol use or sexual orientation).
Transparency
and appeals
The working group emphasizes that the ethics committees should work as openly as possible. Minutes and review statements with attachments should be publicly available on the home pages of the committee. Parts of the application can be kept secret if the researcher provides sufficient reasons for this to occur.
If the researcher disagrees with the changes required by the local ethics committee, she has the right to submit the review statement to the National Advisory Board on Research Ethics.
Follow-up
and evaluation
The new system should be evaluated by the end of 2011. The local committees should keep records on their membership composition and meetings. Records should be kept on all requests for review by field of science, reasons for the review request and methods of data collection. Records should also be kept on all changes required by the committee. The National Advisory Board on Research Ethics will prepare a form for the data collection.
eferences
Working Group Appointed by the National Advisory Board on Research Ethics. (2009). Humanistisen, yhteiskuntatieteellisen ja käyttäytymistieteellisen tutkimuksen eettiset periaatteet ja ehdotus eettisen ennakkoarvioinnin järjestämiseksi (Ethical principles of research in the humanities and social and behavioral sciences and arrangements for ethical review). Helsinki: National Advisory Board on Research Ethics.
Medical Research Act. http://www.finlex.fi/fi/laki/kaannokset/1999/en19990488.pdf
(March 20, 2009)