What is informed consent?
An informed consent consists of two parts, (1) an information sheet which provides information on the study’s purpose, applied procedures and handling of personal data, (2) a consent form which is signed by the participant.
Why is informed consent important?
Obtaining informed consent is an inevitable part of each psychological research activity. As the American Psychological Association states (2010, section 3.10):
When psychologists conduct research or provide assessment, therapy, counseling or consulting services in person or via electronic transmission or other forms of communication, they obtain the informed consent of the individual or individuals using language that is reasonably understandable to that person or persons except when conducting such activities without consent is mandated by law or governmental regulation or as otherwise provided in this Ethics Code.
Psychological research is only dispensed from the obligation of obtaining informed consent under special circumstances (Section 8.05):
Psychologists may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.
Guidance on Obtaining Informed Consent
- You should phrase your informed consent comprehensibly, using easy language without technical terms. It is important that the participant (and not you as researcher) understands the consent. Furthermore, participants should have sufficient language skills in order to understand the consent. You should also keep this in mind for rather unproblematic data collections with students (e.g. when exchange students participate).
- The study’s information sheet and consent form should be clearly combined (e.g. within the same document). However, the consent form should be separated from the study information (e.g. not located on the same page).
Psychology-specific aspects of obtaining informed consent:
- In psychological research, data collection often involves participants which are unable to give consent, e.g. children or psychiatric patients. In this case, researchers should preserve the interest of the person concerned while at the same time involving the legally authorized representative.
- Deception: In psychological research, there can be compelling reasons for deceiving participants about the research’s aim or withholding information. In this case, the DGPs guidelines state that information about the true aim of the study needs to be given as soon as possible. Subsequently, participants should have the possibility to disconfirm their deception-based consent and to demand the deletion of their data.
- Special kinds of personal data have to be deleted as soon as possible. Sometimes, this may not be possible because (psychological) diagnoses, statements on sexual life or health related data are research objects themselves. If you plan to (re)use this kind of data, these plans have to be explicitly explained in the informed consent.
Your informed consent form should include:
- information on the voluntary character of participation
- information on alternative treatments and risks of the treatment
- information on personal data that will be collected
- information on the project’s plans on data sharing
- if personal data are not deleted, you should include information on the type of stored data and on measures to comply with data protection laws
- Limit your ability to share research data by including overly restrictive statements like
- all data will only be used in this study or by this research team
- instead you can state that no personal information that can possibly reveal the identity of the subject will be published, while de-identified information may be shared for scientific reasons
- Limit your ability for long-term archiving of research data
- do not state that all data will be deleted as soon as possible
- instead state that any information that could identify a subject will be removed as soon as possible; in general, there is no reason to include expiration dates for data which are de-identified
The ICPSR recommends explaining which information can be considered as personal information and will not be shared (e.g. all information that could identify a subject such as name, address) when obtaining informed consent. Subsequently, you should consistently differentiate between (de-identified) research data and personal data in the consent form. Thus, it is possible to explain that research data may be shared while personal data will be deleted as soon as possible.
Additional guidance is provided by the German Psychological Association (DGPs) in its Guidelines on Data Management in Psychological Science (Schönbrodt, Gollwitzer & Abele-Brehm, 2016) based on ‘an excerpt from the guidelines of the ethics committee’:
- If personal data are stored in order to contact subjects at a later date, an addendum to the informed consent has to be included which describes data protection measures for this information.
- If research includes video recordings, audio recordings or psychophysiological measures (e.g. EEG, MRI), informed consent has to be obtained separately for these measures.
Moreover, it is important to take into account that some repositories assign CC0 licenses (see the knowledge base’s section on (Unintentionally) Waiving Copyrights for further information) to their data and, therefore, rights for commercial usage of your data is granted to others. If you want to publish your data using one of those repositories you should state this in the informed consent; even though the commercial usage of anonymized research data is legally feasible, it is best practice to mention it in the information sheet and obtain the participant’s approval.
Sample Consent Forms
If you plan on obtaining approval by an Ethics Committee for your study, you should check if the respective Ethics Committee offers templates. The following organizations provide sample informed consent forms:
- the DGP’s Ethics Committee (in German), see also the DGP’s Recommendations on Data Management in Psychological Science (p.13)
- the Institutional Review Board of the Michigan Technological University (in English)
- the TMF, an umbrella organization for networked medical research in Germany, offers informed consent templates for clinical trials
- the Faculty of Psychology and Pedagogy of LMU Munich’s Ethics Committee (in German) offers sample information sheets and consent forms within its application form, that are explicitly geared to the needs of Open Science and Data Sharing
- the Open Brain Consent Initiative provides out-of-the-box consent forms for sharing neuroimaging data
- American Psychological Association (2010). Ethical principals of psychologists and code of conduct. Retrieved from http://www.apa.org/ethics/code
- Schönbrodt, F., Gollwitzer, M., & Abele-Brehm, A. (2016). Data management in psychological science: Specification of the DFG guidelines. Advance online publication. Retrieved from http://www.dgps.de/fileadmin/documents/Empfehlungen/Data_Management_in_Psychological_Science_20160928.pdf
- forschungsdaten-bildung created a (German) checklist on the topic informed consent in conformity with the law with focus on data collection in schools (Checkliste zur Erstellung rechtskonformer Einwilligungserklärungen mit besonderer Berücksichtigung von Erhebungen an Schulen) in collaboration with external lawyers, with special focus on problems of educational science. In addition you find links to other sample informed consent forms on their site.
- The UK Data Archive and the ICPSR provide further information, recommendations and examples on informed consent.