Informing Research Participants

Informing Research Participants

PART I: Significance of informing participants

Informing potential research participants forms a crucial part of successful life cycle of research data. Informing participants in a correct manner lays the foundation for research that is both ethical and legal. In addition to participants and the research group, informing is also of significance to the organisation archiving the data, to the scientific community at large, and to data reusers.

The instructions and examples presented in this chapter are mostly general and applicable in the European context, but there are also references to acts, provisions and guidelines that have significance mainly in the Finnish context. If you are operating somewhere else than Finland, please ensure you follow the applicable national laws and guidelines.

1. Informing research participants as the duty of the data controller

According to the General Data Protection Regulation (GDPR), 'data controller' refers to the entity that determines the purposes and means of the processing of personal data. Depending on the situation, a data controller can be, for instance, a research organisation, a research group or an individual researcher.

Personal data must always be processed lawfully, fairly and in a manner that is transparent to research participants. It is the data controller's duty to make sure the data are processed in a lawful manner and that research participants are informed of data processing in accordance with the Regulation. The accountability of the controller entails documentation on how participants were informed (either orally or in writing) when obtaining consent.

From the point of view of the data controller, accountability and informing research participants involves at least three aspects. Firstly, the information provided to participants by the controller determines how their personal data can be processed. Secondly, the requirement of being able to demonstrate compliance with the Regulation emphasises the need for strong internal accountability mechanisms of the controller. Thirdly, the documentation on the informing activities provided to demonstrate accountability enables cooperation with supervisory authorities.

The requirement to draw up a description of the personal data file and a privacy notice in accordance with the Finnish Personal Data Act (to be repealed by a new national law in 2018) are closely connected to informing participants, in addition to the requirement to hold records of processing activities as stipulated in the GDPR. When data contain personal data, the Finnish Personal Data Act (in effect until 25 May 2018) requires that researchers complete a description of the file. Privacy Notice is an extended description of a personal data file and provides more detailed information. More information on the forms based on the Finnish Personal Data Act can be found on the website of the Data Protection Ombudsman.

2. Informing from researchers' perspective

For researchers, informing research participants may be an obligation both from the research ethical and legal point of view. The legal responsibility to provide research participants information on the use of their personal data lies explicitly with the data controller. However, if a research organisation is the data controller, in practice it is still the researcher who informs the participants. Regardless of who has the legal responsibility of informing participants as the data controller, researchers have an ethical obligation to respect the rights of participants and inform them in an appropriate manner.

The European Code of Conduct for Research Integrity, for instance, urges researchers to handle research participants "with respect and care, and in accordance with legal and ethical provisions". The "Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review" of the Finnish Advisory Board on Research Integrity (TENK) also emphasise the importance of informing research participants.

Informing research subjects is part of consistent data management. By documenting clearly and consistently how the participants were informed, researchers know how the data can be processed and the results reported. Even if participants' identifiers are removed from a dataset for archiving, it is ethically important to inform them about the fact that the data will be archived for further use.

3. Informing as the basis of participant's decision

A research participant can only give her/his informed consent to participate in a study when the consent is based on appropriate and sufficient information. Research participants also have the right to receive information on how their personal data are processed. The content of the information is discussed in more detail later in this chapter.

A confidential relationship between the researcher and the research participant is important. Appropriately informing the research participants increases the transparency of the research process and participants' confidence in the fact that research data containing their information are processed responsibly throughout the data life cycle.

1. Content of the information

Information given to research participants must fulfil research ethical as well as legal requirements. Research ethical requirements are general in the sense that they pertain to all scientific research. The legal requirements, however, become important in cases when the research falls within the scope of certain national or international laws.

The EU General Data Protection Regulation (GDPR) is among the key rules and regulations governing information given to participants in research that produces personal data. Although the enforcement of the Regulation does not begin until 25 May 2018, it is a good idea to take its requirements into consideration even before that date. If the research begins before the enforcement of the Regulation, but personal data collected for the study continue to be processed after the enforcement date, the participants should be informed in accordance with the Regulation. The instructions and guidelines provided in this chapter take the GDPR requirements on informing and valid consent into consideration.

The scope and level of detail required from the information given to research participants depend on the special features of the research. The significance of these features should be assessed in the planning stages of the research. Whether the research involves collecting personal data is crucial. The risk to research participants posed by processing personal data should also be taken into consideration. A more detailed and extensive information may be required if special categories of personal data - such as data on health, sexual behaviour and religious beliefs - are processed or if personal data are transferred to outside the EU/EEA.

Your data management plan or instructions on processing personal data provided by your organisation can be used as a starting point when planning the information given to research participants. If your organisation has appointed a data protection officer, you can ask her/him for advice and instructions on how to take the GDPR requirements into account when informing participants. However, the possibility to ask such advice might be limited to employees of the organisation and not necessarily available to other individuals, such as students who process data as independent data controllers.

There are also some sector-specific provisions relating to informing research subjects. If the research violates personal integrity and the study covers health, illness or health care issues, information and consent processes must comply with the regulations of the Finnish Medical Research Act and the Finnish Medical Research Decree.

»Medical Research Act 488/1999
»Medical Research Decree 986/1999 »Publications of TUKIJA, the National Committee on Medical Research Ethics

2. Form of the information

When data collected from participants are sensitive, supplying written information is mandatory. If no sensitive data are collected, potential participants can be informed orally. If practical, it is entirely possible – and preferable – to provide the participants both oral and written information. For example, the information given in a cover letter or information sheet can be complemented with oral information. Information is also increasingly provided in a digital form. Information provided to research participants binds the researcher regardless of the form it is provided in.

Researchers should carefully document the oral information they provide to the participants. Doing so also contributes to a systematic informing process.

If there are several data collection stages in the research, it is important to ensure the information provided is consistent. If several different information sheets are used, it is advisable to document when each of them were used. Furthermore, if information practices are changed while the research is ongoing, these changes and the reasons for them should be recorded.

Documentation on the information given to research participants should be preserved as part of the research data. Documenting the information is part of the data controller's accountability and allows the researcher to demonstrate compliance with the GDPR. Secondly, careful documentation enables the assessment of whether and to what extent the research data can be re-used.

When informing potential participants, it is important to find a good balance between intelligibility and comprehensiveness. The main purpose of providing information is to support potential participants' right to self-determination.

According to the GDPR, any information provided to research participants on the processing of their personal data should be transparent, concise, easily accessible, easy to understand, and expressed in clear and plain language.

The requirements of transparency and ease of understanding should be considered from the perspective of potential participants. Complex phrases, specialised jargon or ambiguous expressions should be avoided whenever possible.

Essential information provided to potential participants should include the contact details of the researcher or research group, information on the data controller, and the purpose(s) of data processing. This information can be given to participants in the participant information sheet or consent form. Clear layout, emphases and typographic choices can be used to increase ease of reading and facilitate finding the information.

Technical and audiovisual solutions can also be used in providing the information. Additional information can be given by providing a link to a website or other material introducing the study. A short video presentation may also be a practical way of giving a general introduction of a study to younger research participants.

3.1 Requirements of valid informed consent

Whether the consent given by a research participant is valid depends, firstly, on whether she/he has been given sufficient information about the research and whether the information was presented in a way the participant could understand. The information given to the participant must fulfil the ethical and legal minimum requirements. Secondly, the validity of consent depends on whether the participant has, after receiving the information, clearly expressed her/his will about participating in the study and allowed the processing of her/his data. There should be no ambiguity about whether the participants gave their consent voluntarily and based on sufficient information.

The GDPR requires that the participants give their consent by a statement or by a clear affirmative act. This requirement emphasises the fact that consent must be based on an active expression of the participant's will. The form of the consent, however, is not restricted, and the statement signifying consent may be given either orally or in writing. A statement signifying consent can be, for example, a consent form signed by the participant. Similarly, the research participants are considered to have given their consent if they, after having received information on the study, arrive at the interview location and answer questions posed by the interviewer.

Silence, pre-ticked boxes (opting out) or inactivity do not generally constitute valid consent. For example, it would be unclear whether consent was given if people in a room were told that if they do not leave, they will be videotaped or their speech recorded for research purposes. Especially if the people in the room had some other legitimate reason to be there, the consent could not generally be considered valid.

When sensitive data belonging to special categories are collected, consent must be explicit. Special categories of personal data include, for example, data concerning health and data revealing racial or ethnic origin or political opinions. As its name suggests, explicit consent emphasises the fact that consent is specific and clearly expressed. For example, research participants may be asked to tick a box that clearly indicates that by doing so they give consent for the processing of their personal data for research purposes.

It is advisable to obtain written consent from the participants when personal data belonging to special categories are collected. Written consent can also be used when research data are combined with official record or register data.

Although the form of consent is generally not restricted, written request for consent should be sufficiently distinguishable from other material. If consent for processing personal data is asked as a written declaration in a context where the written material also pertains to other matters, the request for consent should be clearly distinguished from the other matters. An example of such a context could be a situation where research participants are taking part in a workshop or training in addition to the research. The request for consent should in this case be clearly separated from contract conditions relating to the workshop or training - for example, on a separate form.

Another requirement of valid consent is that research participants must be able to withdraw their consent at any time. Withdrawing consent should be as easy as giving it. To enable withdrawing consent, research participants should have the up-to-date contact details of the data controller as well as the person/institution responsible for the study at their disposal at all times. The procedure for withdrawing consent does not have to be similar to the procedure of giving consent - the important thing is that withdrawing consent is easy.

If a research participant withdraws her/his consent, all analyses and other processing activities that were conducted before the withdrawal were legal based on the original consent. However, all personal data of a participant withdrawing her/his consent must be deleted from the research data. The data can continue to be analysed if the data were anonymised and the participant's information can no longer be identified.

It pays to bear in mind that withdrawing consent is not the same thing as withdrawing from research. Sometimes a research participant may want to withdraw from participation in, say, a study with several stages, but not necessarily to withdraw their consent regarding the earlier stages of the study. To avoid misunderstandings, the researcher should make sure whether the participant wishes to withdraw consent or to only withdraw from further participation in the study.

When research involves processing personal data, the data controller must be able to demonstrate that the consent obtained from participants is in line with the requirements of the Data Protection Regulation. In other words, in accordance with the accountability principle, the data controller must be able to demonstrate that personal data are processed in a lawful, fair and transparent manner. To effectively demonstrate compliance, the data controller should provide clear documentation on who has given consent. Additionally, it may be necessary to record the date and time when the consent was given, for instance, by marking the date on the consent form or using a digital timestamp. Because consent is based on the information provided to the participants, written information should be stored and oral information documented and appended to the data.

3.2 Scope of consent

The consent given by a research participant comprises the information provided to the participant and her/his response based on the information. The scope of consent defines the ethical and legal boundaries to the use of the participant's data. When processing personal data it should be kept in mind that collecting and processing excessive personal data that are not necessary for the study is not allowed even if participants have given their consent to do so.

Consent should cover all processing activities. If personal data collected for research are used for some other purpose, consent must also be obtained for this purpose.

If participants are presented with a written or online consent form that gives them several options regarding data collection and preservation, the scope of their consent is formed by the options they choose. If oral consent is obtained and participants are presented with several choices, their choices must be appropriately recorded in written notes. In cases where some participants do not consent to archiving and reuse of their data, researchers should document carefully which files are to be stored for reuse and which are to be deleted after the research has been completed.

Sometimes a research participant may consent to a study but independently add a disclaimer or reservation regarding their consent. For instance, although researchers inform the participants and ask for their consent using a single, consistent process, an individual participant may express, before, during or after the study, a restriction to the use of her/his data. The effects of such a restriction may be based on ethical or legal grounds, and its importance should be assessed case by case.

If a participant indicates that he or she does not wish certain part of the information supplied by him or her to be included in the research data, these parts need to be removed from the data to be archived. In addition, researchers should always remove from archived data any reports of discussions with participants taking place after the recording equipment has been turned off. If a participant, for any reason, wishes to discuss his or her personal issues with the researcher immediately after the termination of the data collection event, this discussion shall not be part of the data archived for reuse. It is up to researchers, however, whether they will use these discussions in their own research.

In cases where the data consist of texts written by participants, researchers should find out whether the writers have mentioned any restrictions in the texts themselves. Sometimes participants give their consent for archiving and reuse in the beginning of their text but indicate at the end that they do not wish their text to be used for anything else but the original research. In this case their text should not be archived at the Finnish Social Science Data Archive. Moreover, FSD does not archive texts where the writer has indicated that a permission must always be obtained from him or her before data reuse.

The consent obtained from participants should be sufficiently specific. The manner in which the consent is specified affects how the personal data can be processed.

With the introduction of the GDPR, it is possible, in addition to the original purpose, to obtain consent for secondary research use in certain areas of scientific research provided that the future research will follow recognised ethical standards. Moreover, participants should have the possibility to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose. FSD's Data Management Guidelines regarding broad consent will be updated when the Article 29 Working Party releases updated guidelines on consent and transparency.

4. Exceptions and observation

If the data to be collected will contain personal data, potential research participants must always be informed of this. In some rare cases exceptions can be made if the research design so requires. An ethical review must always be carried out before data collection if personal data are to be collected and research participants will not be informed of this on account of the research design, or if they are not given full or correct information. Not informing research participants must be well justified, the research must not cause harm to participants and data protection measures must be rigorous. Even if withholding or providing incorrect information is well justified, participants should always be given full and correct information on the data controller and the fact that data are collected for research purposes.

» Finnish Advisory Board on Research Integrity (TENK): Information on ethical review in human sciences

There is no legal obligation to obtain consent or inform research subjects when data are collected through observation in public events or spaces and no personal data are collected. When the data consist of observation notes on social interactions or events with changing participants (e.g. school yard), it is recommended that, rather than obtain consent from participants, no personal data are collected and entered into the notes. Asking consent from numerous individuals would be difficult, and the signed consent forms would form an unnecessary personal data file.

It is up to researchers to decide whether they inform participants of their role as a researcher even if they do not record any personal data in their observation notes. What they decide depends on the nature of the research. The decision made should be justifiable in research ethical terms.

Obtaining consent for observational research is mandatory in cases where personal data (e.g. names and other background information) are collected or events are recorded. Consent can be obtained orally but it is best to provide information on the study in writing. If information is given orally and not in writing, researchers must carefully document what they tell participants regarding the processing and use of the data created or recorded. It is advisable to include oral information in the audio or video files.

Regarding observational research, it should be kept in mind that if research subjects are not asked for their consent or informed about the fact that they are observed in any way, observing may be punishable as criminal eavesdropping or illicit observation. Both eavesdropping and illicit observation entail the use of a technical device, but not necessarily recording. Thus, any unlawful viewing, monitoring or listening using a technical device may constitute eavesdropping or illicit observation. For eavesdropping to be punishable, it has to occur in a space protected by "domestic peace" or, alternatively, outside of a private domicile if the speech is not intended to the researcher's knowledge or to the knowledge of others in general. Illicit observation may target domestic premises or areas protected by the "peace of public premises", such as offices and agencies. When illicit observation concerns public premises, the watching has to violate a person's privacy to be punishable.

PART III: Elements of informing

  1. Contact information
  2. Topic and objectives of the study
  3. Data collection
  4. Voluntary nature of participation
  5. Maintaining confidentiality
  6. Combining register or record data with data supplied by subjects
  7. Maintaining privacy in publications
  8. Informing about archiving and further use of the data

1. Contact information

It is essential to provide participants with the researchers' contact information. If there are several persons or bodies involved, it is advisable to specify the person or body responsible for the study and the role of each partner. Participants should also be informed whom to contact for additional information.

It may also be beneficial to provide information on the funders of the study, particularly if there are external funders. Revealing the funders adds to the transparency of research and increases the possibilities of potential participants to make an informed judgement on whether they want to take part or not.

When personal data are processed participants must be informed of who is the data controller, that is, the natural or legal person or other body who determines the purposes and means of the processing of personal data. In addition to the name of the controller, participants should be given the controller's up-to-date contact details. The data controller may be, for example, a research director or other person responsible for the study. It is also possible for more than one entity to be the controller, if the study is conducted by several organisations. Sometimes, the controller is the research organisation, such as the university. Before you collect personal data, you should find out about your organisation's practices regarding the assignment of responsibilities.

When a student collects research data containing personal data for a thesis etc., she/he is the data controller. However, if a student writes her/his thesis as part of a research project in the university, the controller is usually the controller appointed for the project.

If the researchers are not the data controller in relation to the personal data being collected, this should be clearly indicated. It may be necessary to give the contact details of your organisation's data protection officer to participants if, for example, the data protection impact assessment predicts significant risks which cannot be completely eliminated.

2. Topic and objectives of the study

The purpose and general goals of the study should be presented in comprehensible language, avoiding specialised terminology and technical language. The main purpose for providing information on the subject of the study is to provide background information which will help prospective participants to make an informed decision on whether they want to participate. Researchers should also be prepared to provide additional information, for instance, on the theoretical premises of the study, if requested by a participant.

It is good practice to motivate participants by telling them what kind of new knowledge is sought for and how the results may be utilised in the future. There is no need for detailed information on the research design and hypotheses, but main topics should be outlined in order to allow potential subjects to make an informed participation decision. If it is unclear what the final content of the study will be, information can be based on the plans at that moment.

If personal data collected from participants are used for another purpose besides research, e.g. artistic purposes, participants must be informed of this.

3. Data collection

Participants must be told how the data are to be collected and what the participation entails in practice. This includes information on the collection method, for instance, whether the study is based on an online survey, interview, focus group discussion, or written accounts sent by participants. It is also good practice to let participants know if they will receive the interview questions beforehand. If participants will be given an opportunity to receive information on the research findings later on, this should be mentioned as well. If the data collected include photographs taken by participants, or other recordings protected by copyright, copyright transfer should be agreed on as part of the informing process.

Other relevant information include whether it is a one-off data collection or a longitudinal study with several collection rounds, the estimated duration of the study, and what exactly taking part would mean in terms of time and effort.

The technique and method of data collection must also be specified. Participants must be informed beforehand if the data are to be collected by recording audio or video. The source of their contact information should also be mentioned when they are first contacted.

Processing personal data always requires a legal basis. According to the GDPR, participants shall be informed of the basis on which their data are processed. When data are collected with the consent of participants, the consent normally constitutes the legal basis. In such cases the information on the basis of processing provided to participants can simply be, for example: "We will process your personal data based on your consent".

In addition to consent, other legal bases for processing personal data include the legitimate interests of the controller or a third party, the performance of a task carried out in the public interest, and the exercise of official authority. For instance, a public research institution may have, as part of its official tasks based on the law, a task to conduct research and collect data from research subjects based on their consent. If there are several bases for processing, this may, for example, restrict the effects of a withdrawal of consent. For this reason the transparency principle requires more detailed information on the bases for data processing in some cases. If you are unsure on what basis you are processing data in your research, we suggest you contact the data protection officer of your organisation.

4. Voluntary nature of participation

Informed consent requires that participation is voluntary. Voluntary nature of participation is an important research ethical and legal requirement. To ensure that consent is given voluntarily, participants must be given sufficient information, not be subjected to any form of pressure, and be made to understand that there will be no negative consequences if they decline. Participants also need to know that they can withdraw from the research at any time. When consent is used as the basis of data processing, research participants must be informed of the fact that if they decide to withdraw consent, this will not affect the lawfulness of the processing activities carried out until the point of withdrawal, as these activities will have been based on the original consent.

If participants are recruited from an agency providing services funded by public administration, for instance, if they are the clients of a social services department or an employment office, it should be made clear to them that declining to participate will not affect the decisions regarding them, or the services or benefits they receive. In the same way, it must be made absolutely clear to potential participants living in institutions (hospitals, prisons, reform schools, residential homes for the elderly etc.) that participation is voluntary and declining will have no influence on any decisions affecting them or how they will be treated.

5. Maintaining confidentiality

There are three main aspects involved in maintaining confidentiality of research data: defining the purposes of use of the data, defining the extent to which the data contain personal information, and the arrangements made to ensure data security.

Participants must be told for what purposes the data related to them will be used. The GDPR requires that the purpose of processing personal data is clearly defined before data collection. Research data that contain personal information can only be used for previously specified purposes.

Defining the extent to which the data contain personal data includes determining in which form the collected data will be processed and what information related to participants will be stored in the data. Storing direct identifiers such as person names, addresses, personal identification numbers or audio and video recordings for the purposes of analysis and for combining information from different sources is possible only if participants have given explicit consent to this. However, if these personal data are not necessary for the research itself, they should be erased as early as possible and the participants should be informed of this. Whether it is necessary to retain direct identifiers depends on the nature of the research. If the planned anonymisation measures include removing both direct and indirect identifiers, it is good practice to mention this to participants.

Participants can also be informed of other organisational and technical measures taken to ensure confidentiality. If in addition to the researcher collecting the data, other people, for instance, research assistants or other researchers, will be processing them, it is best not to give the impression that data processing will be done by only one person. However, it is not necessary to name the other persons processing the data. If a signed undertaking of confidentiality is required from the persons processing the data, this can be mentioned as well.

Participants may also be given general-level information on the technical solutions made to ensure data security, including, for example, where the data will be stored and how outsiders will be prevented from accessing it.

Participants should be informed of whether their personal data will be shared and with whom. This information should include all potential data recipients and groups of recipients. If personal data are transferred to a country outside the EU/EEA which is not recognised by the European Commission as having adequate protection of personal data, participants must be informed of the transfer as well as of the fact that the country in question is not covered by the Commission decisions on the adequacy of the protection of personal data. Potential effects that the transfer of data to a third country might have on the participant should also be mentioned. The list of Commission decisions on the adequacy of protection and their detailed content are available on the website of the European Commission.

Information should also be provided to participants, for instance, when personal data is transferred to third countries on the basis of appropriate safeguards or Binding Corporate Rules (BCR). The EU-US Privacy Shield is not currently applied to transfers between universities. You can ask for more information on the rules regulating international data transfers from your organisation's Data Protection Officer.

6. Combining register or official record data with data supplied by subjects

If data collected from participants will be combined with official record or register data, participants must be informed of this in the manner required by the General Data Protection Regulation (GDPR). The information must specify what official record and/or register information will be linked to information supplied by research subjects.

If sensitive information is involved in the linking of data from different sources, an explicit consent from participants must be obtained for this, preferably in writing. This can be done by adding a separate section on the data linkage in the consent form. Participants give their consent through the act of filling in the form. Please note that it is not enough to mention the intention to link official record or register data to data collected in the study in the cover letter or participant information sheet, as this does not constitute explicit consent. Neither is passive consent a valid substitute for explicit consent. Passive consent methods include, for instance, the opt-out approach where the participant adds a tick in the form if he or she does NOT allow the combination of data. Explicit consent requires a clear affirmative action by which the participant specifically indicates that he or she consents to data combination. In addition to signing, 'opt-in' methods are acceptable. These include clicking on 'I consent to the combining of data' button or ticking an option in the consent form that indicates giving consent to data combination.

When register data are combined with data from other sources, data security measures should be planned with care. The safest solution is that researchers only analyse the combined data from which personal identification numbers have been removed.

7. Maintaining privacy in publications

The requirement for maintaining confidentiality of information supplied by participants also applies to research publications. It is usually not necessary to reveal the identities of participants in published reports though this depends on the nature of the research. Using person names in publications may be justified, for instance, in connection with expert interviews. If it is considered necessary that the names of the participants appear in published reports, this has to be agreed in advance as part of the informing procedure.

Participants often consent to participate on the condition that they cannot be identified in publications or presentations related to the study. Concealing identities completely may sometimes be difficult to achieve in qualitative research. Therefore it is best not to promise more to participants than that their names will not be mentioned in publications or that direct quotations will be presented in a way that prevents direct identification. If the data contain names of individuals external to the research, participants can be informed that the names of such persons will be replaced with pseudonyms.

In case of research based on written accounts collected through writing requests, it may be necessary to publish extracts from the texts in publications. Written accounts from participants may be protected by copyright. The Finnish Copyright Act allows quoting written works made public in accordance with appropriate usage to the extent necessary for the purpose. If long quotations from texts supplied by participants or the whole texts are required in publications, this must be agreed on in advance with participants.

8. Informing about archiving and further use of the data

This section has been partly updated. The contents will be updated further when details of the new national data act become available. In the meantime, participants can be informed about the archiving of data according to these instructions.

If the dataset will be anonymised and archived at the Finnish Social Science Data Archive, participants can be informed, for example, that:

After the research has been completed, the data created during it will be archived at the Finnish Social Science Data Archive (FSD) for further research purposes. The data will be anonymised for archiving.

OR ALTERNATIVELY:

After the research has been completed, the data created during it will be archived at the Finnish Social Science Data Archive (FSD) for further research, teaching and study purposes. The data will be anonymised for archiving.

If the intention is to archive the data with personal data included for subsequent use by the scientific community at large, explicit consent for archiving and re-use must be obtained from participants. Information given to participants must cover:

  • what personal data will be deleted from and what retained in the archived data
  • in which form the data will be archived (for instance, only interview transcripts or audio recordings as well)
  • which areas of scientific research are covered by the consent
  • where the data will be stored
  • the body administering access to the data (access permissions and conditions and terms of use)

Names of research participants are not usually included in archived data. However, if the data are considered to fall under the scope of specific provisions on journalistic, academic, artistic or literary expression, the names of participants can be retained in the data deposited for archiving. If research data comprises textual works, authors' names can be retained in the archived data if the authors explicitly wish for this. Interviews of experts can also be archived with names if written consent for this has been obtained. Even if names are retained in the data, FSD removes all other unnecessary identifiers, such as the contact details of participants (data minimisation).

FSD has published an information sheet describing its activities, and its data processing and dissemination practices. If the data will be archived at FSD, the information sheet can be given to research participants as part of the information package, to augment information on future use of the data. Giving the information sheet to participants is not enough in itself, and researchers should still inform them on how the data will be used after the research has been completed, in line with the instructions given above. If informing is done over the Internet, a link to the information sheet can be provided instead of a paper copy.

» Information sheet on the Finnish Social Science Data Archive for research participants (pdf)

If you are planning to collect data that you may not be able to anonymise, and you wish to deposit them with FSD, you are welcome to contact our User Services before data collection for further advice (email: asiakaspalvelu.fsd at uta.fi).

PART IV: Examples of informing research participants

The following examples may help you to plan the information to potential participants of your study. Please note, however, that the information requirements depend on the nature of your research.

Please avoid copying the examples directly without carefully reading the guidelines above.

If you are planning to collect data that you wish to deposit with FSD with personal data included, you are welcome to contact our User Services before data collection for further advice (email: asiakaspalvelu.fsd at uta.fi)

The examples below are not sufficiently exhaustive if the data contains special categories of personal data and/or if the data are transferred and shared to research partners (particularly to a country outside the EU/EEA). Furthermore, the examples are not directly applicable in situations where the legal basis for the processing of personal data is something else than the participant's consent.

  1. Questionnaire survey
  2. Qualitative interview
  3. Writing request
  4. Combining register data with questionnaire or interview data
  5. Observation

1. Questionnaire survey

The cover letter or the attached information sheet introducing the study must contain contact details of the researcher(s) and the data controller, information about the study, and information on where the contact details for potential participants were obtained from.

Potential participants can be informed of the voluntary nature of participation, privacy protection in research publications, and reuse of the data in the following manner, for instance:

Participation in the study is voluntary. It is important, however, for the reliability and representativeness of the study that people with different opinions and viewpoints participate.

The names and contact details of the respondents are stored securely and erased when the data have been collected and edited for analysis. Your responses will be kept anonymous and confidential.

The data collected will be analysed using statistical methods, and therefore the information supplied by any individual participant cannot be identified. Research findings will be reported in publications in the form of statistical tables and graphs.

The electronic data that will be formed of the responses given will be permanently archived at the Finnish Social Science Data Archive (FSD) for further research, teaching and study purposes. The archived data will be processed to prevent identification of any individual participant (anonymisation).

If the data will be archived at FSD, information provided to participants can include an information sheet describing the activities and practices of the data archive. If the informing is done over the Internet, a link to the information sheet can be provided instead of a paper copy.

» Information on the Finnish Social Science Data Archive for research participants (pdf)

2. Qualitative interview

Contact details of the researcher(s) and the data controller as well as information on the study should be presented at the beginning of the information provided. Voluntary nature of participation, data collection method, measures for maintaining confidentiality, privacy protection in research publications and data archiving plans can be expressed in the following manner, for instance:

Participation to the interview is voluntary. The interviewee has the right to terminate the interview at any time or to decline to answer any question.

The interview will take 30 minutes. The interview will be audio recorded and subsequently transcribed into a text file.

The confidentiality of the interview will be ensured by the procedure whereby researchers and research assistants processing the recordings will sign an undertaking of confidentiality. The recordings will only be accessible to individuals with specified user accounts. Participants' personal data will not be shared to outsiders at any time.

A transcribed text file will be produced of the interview. During transcription, the name of the interviewee and any third parties mentioned in the interview will be removed or replaced by pseudonyms. If need be, place names and other proper names (e.g. names of workplaces) will also be removed or altered in order to prevent any risk of identification.

The audio recording will be erased after the interview is transcribed.

Publications or presentations on the interviews will be written in a manner that no interviewee or third parties mentioned in the interview will be identifiable.

Research publications may include direct quotations from the interviews. The gender, age and occupation of the interviewee will be mentioned in connection with the quotation.

After the research is completed, the interview transcripts will be stored permanently at the Finnish Social Science Data Archive for research purposes OR for research, teaching and study purposes. If necessary, further identifying information will be edited or removed from the transcripts during archiving (anonymisation).

In the example above, participants are told what information will be given of them if they are quoted in research publications (gender, age and occupation). Sometimes just gender and age, or age group, are sufficient as background information. Occupation or the less revealing occupational group can be replaced or completed with other background information. The amount of background information given of an interviewee with a quotation depends on the nature and requirements of the study.

If interview topics are not sensitive, it may be enough to give oral information to participants. If there is intention to deposit the data with FSD, the key content of the oral information given must be carefully documented in writing. Researchers can also begin interviews by repeating the oral information to participants and obtaining their oral consent again, thus capturing both into the recorded interview file.

If the data will be archived at FSD, information provided to participants can include an information sheet describing the activities and practices of the data archive. If the informing is done over the Internet, a link to the information sheet can be provided instead of a paper copy.

» Information on the Finnish Social Science Data Archive for research participants (pdf)

3. Writing request

General information on the study as well as contact details of the data controller and the person or body responsible for the study should be presented at the beginning of the writing request. Data collection arrangements, privacy protection measures in research publications and reuse of the data can be explained in the following manner, for instance:

Add your name, municipality of residence, age and occupation or former occupation to the beginning of your written account. If you wish, you can send your text using a pseudonym but even in this case, please add information on your age, gender, municipality of residence and occupation or former occupation to the beginning of the text. No limits have been set for the length of the text. There is no reward for participation nor will the text be returned to the person who provided it.

Research reports will contain extracts from the written accounts. Person names or other names enabling identification (school or workplace names etc.) will be removed or altered in the published extracts. The author's gender, age and occupation will be mentioned in connection with a published extract.

After the research has been completed, the written accounts will be archived at the Finnish Social Science Data Archive (FSD) for further research purposes (OR for research, teaching and study purposes). The authors' person names, contact details and other identifying information (for example, proper names and geographical information) will be removed from the archived data.

If you do not wish your text to be archived after the study has been completed, please indicate so clearly in the beginning of your text. If you choose this option, your text will be erased at the end of the study.

The example above says that the author's gender, age and occupation will me mentioned in connection with a published extract. Sometimes it is sufficient to give only the writer's gender and age, or age group. Occupation or the less identifiable occupational group can be replaced or completed with other background information. The information given on the writer depends on the nature and requirements of the study.

If the data will be archived at FSD, information provided to participants can include an information sheet describing the activities and practices of the data archive. If the informing is done over the Internet, a link to the information sheet can be provided instead of a paper copy.

» Information on the Finnish Social Science Data Archive for research participants (pdf)

If needed, inform participants also about the transfer of copyright and ownership

» Agreement with external parties concerning the transfer of copyright and ownership rights

4. Combining register data with questionnaire or interview data

Information given to potential participants includes contact details of the data controller and researcher(s) as well as information on the study. Voluntary nature of participation must also be mentioned.

If register information will be combined with survey data, information supplied should specify what register information will be linked to the survey data, for which purposes the data will be used and where it will be stored. If the invited participant decides to respond to the survey, this decision constitutes his or her consent to the linkage of register and survey data. Information regarding the linking of register data to data supplied by participants should be clearly visible (for example, a separate sentence in its own paragraph and in bolded text).

If the linkage of register or record data to questionnaire or interview data requires consent from research participants, consent can be obtained in different ways. If the combined data do not contain sensitive data, clear information on the linking of data from different sources will be enough (see example 1 below).

If the linkage includes sensitive data, an explicit consent must be obtained for this, generally in writing. For consent to be explicit, the participant has to signify his agreement by a clear affirmative action. This can be done, for example, by asking participants to tick or circle in the consent form the option where they accept that the information they supply will be combined with register or official record data. Alternatively, the questionnaire may include an option that the participant needs to tick to allow the linking of data (example 2) or participants can be asked to sign a separate written consent for the linking of data (example 3).

Example 1:
Responses supplied by research participants in the questionnaire/interview will be combined with information relating to them in the registers N and M.

Example 2:
[ ] Data relating to me in registers N and M can be linked to the information I supply in the questionnaire.

Example 3:
Data relating to me in registers N and M can be linked to the information I supply in the questionnaire/interview.

Date

________________________
Signature of the participant

Procedures for maintaining confidentiality, privacy protection in research publications and reuse of the data can be explained like this, for example:

Information relating to research participants will not be disclosed to registrars, other public authorities or outsiders. Therefore, participation in or withdrawal from the study will not in any way affect the services research subjects receive from these authorities.

The names and contact details of the respondents are stored securely. Participants' personal data will not be shared to outsiders at any time. Analyses are conducted using a version of the data that does not contain social security numbers of the participants.

Research findings will be reported in a manner which prevents the identification of any individual participant.

After the research has been completed, the data will be anonymised in a way that will prevent identification of any participant. The anonymised, combined dataset will be permanently archived for further research, teaching and study purposes.

If the data will be archived at FSD, permission for archiving register data must be obtained from the authority/organisation that provided them. The information provided to participants can include an information sheet describing the activities and practices of the data archive. If the informing is done over the Internet, a link to the information sheet can be provided instead of a paper copy.

» Information on the Finnish Social Science Data Archive for research participants (pdf)

» Check the basics for combining survey data with register/record information

More information on combining register or administrative data with survey data can be obtained from the Office of Data Protection Ombudsman

»Office of the Data Protection Ombudsman

5. Observation

If a researcher is observing breaks at school, for instance, he or she can give oral information to the pupils or ask the tutors to do the informing. The custodians of the pupils can be informed by asking the school to forward a letter from the researcher where he or she tells about the study and the observational activities involved.

I'm conducting a study on play and social interaction in your child's primary school. I will observe and make notes of pupil activities and interaction during school breaks during the first weeks of August and September. I will not record the names of the pupils nor show my notes to the teachers or other staff members. The anonymous notes recorded during my observation will be used in my study. After my research has been completed, I will archive my notes as text files at the Finnish Social Science Data Archive for subsequent research use.

More information on my study [web address].

Information on the Finnish Social Science Data Archive (pdf brochure).

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updated 2017-11-14