Request for Ethical Review in Human Sciences
In preparing a request for an ethical review and in evaluating the possible negative effects and risks of a study, the point of departure should be the ethical principles in the humanities and social and behavioural sciences (the autonomy of research subjects, avoiding harm, privacy and data protection).
Evaluation never shifts responsibility for research ethics to the committee. In research in the humanities and social and behavioural sciences, ethical questions focus on the encounter between the researcher and the subject, which can include unanticipated factors. The researcher is always responsible for the ethical and moral solutions in a study.
Researchers must submit their research plan to ethical review if a study contains any of the following features:
1. The study involves an intervention in the physical integrity of subjects.
2. The study 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 study 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 forbid the child from taking part in the study.
4. The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (for example studies containing violence or pornography).
5. The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life.
6. The study can signify a security risk to subjects (for example studies concerning domestic violence). A researcher can also request an ethical review if the research subject, the funding agency or a cooperation partner so requires or if the results are to be published in a scientific journal which requires ethical review. The reason for requesting an ethical review must always be specified. For example, according to the guidelines issued by the Academy of Finland, it is sufficient if a review is submitted after a positive funding decision.
Guidelines for reviewing studies
An ethical review examines the plan for collecting data, how the study will be carried out, the information that will be given to subjects and the plan for processing and storing data from the perspective of avoiding risks and harm. The review weighs possible negative effects or harm to subjects resulting from participation in the study in relation to the intended scientific value of the study. The starting point is always the ethical principles in the humanities and social and behavioural sciences (the autonomy of research subjects, avoiding harm, privacy and data protection).
If necessary, ethical guidelines in the particular research field should also be applied.
In the humanities and social and behavioural sciences, evaluating scientific value and risks is not a utilitarian cost-benefit analysis but rather a question of normative evaluation of values that are in themselves incommensurable. Evaluation ensures that a study does not contain unnecessary risks that could be avoided without reducing the scientific value of the study. Next, one must decide whether risks on the whole are morally acceptable. Research which entails higher risks may be morally acceptable if the scientific value of the study is very high, and the study does not cause harm to subjects (studies that are not based on informed consent), or the people participating in the study can evaluate possible harm themselves on the basis of the information that is supplied to them.
If a study does not have the features listed above (1-6) and does not present a risk of causing long-term mental harm beyond the risks encountered in normal life, this should be mentioned in the request for an ethical review. In this case, the committee will primarily evaluate the information supplied to subjects as well as matters concerning privacy and data protection.
If a study entails any of the features listed above (1-6), the ethics committees must also evaluate the proposed research methods in relation to research questions and the value of the new information that the study is intending to provide.
Information for subjects
The committee will check that the informing of research subjects is planned appropriately. Information regarding a study includes at least the following:
1) the researcher's contact information,
2) the research topic,
3) the method of collecting data and the estimated time required,
4) the purpose for which data will be collected, used in secondary research and archived, and
5) the voluntary nature of participation. In experimental studies, sufficient information must be provided concerning the design of the experiment.
Experimental designs vary considerably from one research field to another. Ethics committees will determine whether the proposed level of information is adequate. If a study intervenes in the physical integrity of subjects, the information given to subjects must comply with the guidelines issued on the basis of the Act on Medical Research, as far as these apply.
Privacy and data protection
An ethical review examines a study's data management plan and ensures that technical data security solutions have been planned. The data management plan must describe 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 secondary research or alternatively destroying personal data after the study has been completed. Ethics committees do not review the protection of privacy in research publications. Researchers and editors are responsible for compliance with ethical principles in research publications.
Special review guidelines regarding different research designs:
a. The study involves an intervention in the physical integrity of subjects
The ethical guidelines for medical research can be applied in planning and reviewing studies that involve an intervention in the physical integrity of subjects (see http://www.etene.org/tukija/dokumentit/Muistlco.pdf). The committee will evaluate anticipated negative effects (risks, harm and their probability) in relation to the intended scientific value of the study. Studies must be conducted in a manner that minimizes any negative effects and risks to subjects. Evaluating physical risks requires expertise and background information based on empirical studies. The ethics committee can if necessary request an ethical review from an outside expert if it considers its own expertise inadequate for risk evaluation.
b. The study deviates from the principle of informed consent
With regard to a study that deviates from the principle of informed consent, the ethics committee will evaluate whether conducting the study is ethically acceptable. Conducting the study is ethically acceptable if the following preconditions are met:
1. the research is justified, and it would not be possible to conduct the research if subjects were informed of the study and their consent asked for,
2. the data collection does not involve risks to participants,
3. if possible, research subjects will be informed afterwards of the nature and purpose of the research,
4. adequate attention is paid to the privacy of the research subjects and data protection issues.
c. The subjects are children under the age of 15, and the study 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 forbid the child from taking part in the study
A study involving children aged under 15 can be conducted without the consent of a parent or other guardian and without informing the parent or guardian if it does not involve risks to subjects, and the research design is justified by one or more of the following preconditions:
1) On the basis of subjects' age and level of development: The minors who are intended subjects are able to understand the research topic and what participating in the study requires of them in concrete terms.
2) On the basis of the research area and method: The research topic is not sensitive and asking for a parent's or guardian's consent is difficult in practice (for example, studies of youth clubs or school pupils' voluntary clubs etc).
3) From the viewpoint of the need for information: The subject matter of the study will prevent the collection of comprehensive data if parents’ consent must be requested for children's participation (for example, domestic violence, social problems etc), or the research covers issues which minors may not want their parents to know about (for example, use of intoxicating substances, sexual orientation etc).
d. The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (for example studies containing violence or pornography).
e. The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life.
f. The study can entail a security risk to subjects (for example studies concerning domestic violence).
The researcher must describe possible negative effects and risks so that the ethics committee can evaluate whether the study is ethical, weighing possible risks to subjects against the intended scientific value of the study. Studies must be conducted so as to minimize any negative effects and risks to subjects. The intended scientific value will be weighed against possible negative effects and the measures that are taken to reduce negative effects to subjects during or after the study (physical and mental harm) or to prevent them altogether (data protection). The evaluation must take into consideration subjects' free will and autonomy. After all, subjects themselves are always able to evaluate to some extent their own risks of participating in a study. In evaluating experimental studies, the ethical guidelines in the particular field can be applied in a supplementary manner.