The principles of respect, beneficence, and justice should guide the process of conducting research with human participants – from assessing the risks/benefits of participating in your project, to selecting participants, to obtaining informed consent for their participation, to interacting with and collecting information from them, to dealing with the information they provide to you.
Tensions may arise between protecting human participants (on the one hand), and using the information they provided to you in your scholarly work and potentially sharing it with other scholars (on the other). Such tensions can be particularly acute in qualitative research when the information gathered from human participants is deployed and shared in a form that is very close to the form in which it was collected (i.e., when data undergo little transformation or reduction prior to deployment and sharing). When this is the case, using, sharing, and re-using qualitative data may be more likely to result in human participants’ identities being disclosed.
Obtaining informed consent should involve open communication between you and the individuals whom you invite to participate in your study. You have to ensure that these individuals can make voluntary, informed choices about participation.
You should describe to participants in an explicit and comprehensible manner what private/sensitive information and what project-relevant information you will collect from them through your interaction. You should also discuss how you will manage, use, and potentially share that information, and how other scholars might re-use it. If a participant requests confidentiality, you must describe what steps you will take to prevent them from being identified as you manage, use, and share their information and as others re-use it. You may describe strategies such as de-identification and placing access controls on the data when they are shared. These descriptions can be included in the project information sheet that you provide to participants as well as in your informed consent script. You should obtain participants’ explicit consent with regard to each process that you describe before beginning to collect information. Confirming that participants have fully understood your descriptions is your ethical responsibility.
Documentation for Soliciting Informed Consent
Formal regulations only specify basic components that should be addressed in the informed consent process. It is each researcher’s responsibility to solicit consent in a way that is appropriate for the research content and context (e.g., “group consent” in traditional societies). Two types of documentation are helpful in doing so: a project information sheet that describes your project, and an informed consent form (or verbal script) that solicits a potential participant’s consent to be included in it. Exactly how you use these documents will depend on your research and the context in which it is being conducted.
Project Information Sheet
The project information sheet should be included in the documentation submitted for approval by the Institutional Review Boards (IRBs) that have jurisdiction over your project. The sheet
- describes the general topic of the research project and its intended contribution;
- discusses the potential benefits and risks to each participant;
- lists institutional affiliation and contact information for those to whom a participant can turn with questions or concerns (e.g., for the research team member/s who will be interacting with the participants directly, as well as for any supervising researchers with responsibility over the project).
While the information may be related verbally to a participant (e.g., in cases of illiterate participants), the sheet must be left with the participant for their future reference unless this would expose them to additional risks.
Informed Consent Form
Traditionally, researchers have asked project participants to read and sign a written form that offers participants choices about how to engage with the project and how the information that they convey will be used.
When using a written form is inadvisable or impossible (e.g., in certain cultural or security contexts; for an anonymous phone survey), a verbal consent procedure can replace the written form, if approved by the IRB. Verbal consent may be less off-putting to a participant and does not leave a physical record that could put them at risk. However, it can be difficult to clearly convey all relevant issues verbally, as abstract ideas of privacy and the terms used to describe data collection and use might be unfamiliar to a participant. Additionally, the absence of a personal signature documenting a participant’s assent might bring greater risk for researchers should questions arise later about the participation. QDR thus recommends that researchers who employ verbal consent record that consent as part of the interview when possible, and/or obtain and retain some sort of written record of the consent.
Soliciting Informed Consent for Sharing Data
As data sharing norms emerge and data sharing mandates become more prevalent in the social sciences, you are increasingly likely to encounter research funders/sponsors and academic journals that require scholars to make data from their studies available to the research community. So that you can meet these expectations ethically and legally, we strongly recommend that you collect and manage your data with long-term preservation, sharing with the research community, and re-use in mind.
Doing so requires that you plan for data sharing while you are designing your project. In particular, we suggest that you include a discussion of data sharing in the script that you will use to solicit informed consent from your study participants. If you do not do so, you might not be able to share the data generated through the interaction without re-contacting your participants to obtain retroactive consent for data sharing, which may be difficult, if not impossible.
Your informed consent script should include the following types of information about data sharing:
- who will be able to access the data (typically, only scholars)
- what the data will be used for (research and/or teaching or other specifically non-commercial purposes)
- confidentiality protections (if the data are shared via digital repositories, secondary users may be required to agree [by signing an official form] not to try to identify participants in any research study).
In developing the language you will use, it can be helpful to discuss options with the venue through which you plan to make your data available. Repository personnel can help you consider options that you can then discuss with your study participants. These options will be impacted by the context of your research and the type of information your participants provide. Such options include:
- redaction/omission of certain portions of information that was provided;
- sharing of a subset of data files only;
- placing access controls or conditions on data that are not fully de-identified;
- conditions you might set for the secondary use of the data once they are shared;
- different choices for different forms of data (e.g., audio recorded materials vs. typed interview transcripts), etc.
Offering these details will allow your participants to make a better informed choice about the sharing of the information they provide to you. QDR recognizes that consent texts will be tailored to particular research projects. Our staff is happy to help you formulate the language best suited for your project, as well as to brainstorm alternatives. Please do not hesitate to contact us at firstname.lastname@example.org.
Soliciting Informed Consent for Sharing Data Retroactively
If you did not establish appropriate provisions for sharing data when you were collecting information for a research project, it may still be possible to share the data you generated. You should discuss the possibilities with your IRB. One option is re-contacting project participants and asking if they will grant consent retroactively for the information they provided to be preserved for the long term, shared, and used by other scholars. Please note that an amendment to your original IRB application will typically be necessary in such cases.