An informed consent process is the ethical foundation for any research involving human participants. In addition, federal regulations require IRBs to ensure that participants are fully informed about a study before they agree to participate. These regulations are based on the belief that researchers are ethically obligated to fully inform participants so the subjects can make a decision regarding participation that is based on a complete understanding of the risks and benefits of participation. In addition, informed participants are better participants; they are more serious about participating in a study and they are better able to understand what a researcher needs to know about them and what is required of them. The type and extent of the consent process will depend on the kind of research you are conducting and the level of risk that is involved.
Consent Process in Five Phases
1. Providing participants with realistic information through the recruitment process.
2. Having a conversation about the study between the researcher and the participant which may happen in person or using digital media and is usually supported by written documentation called a consent form.
3. Asking the individual for permission to include them in the research study and documenting consent either with a physical or electronic signature.
4. Providing on-going consent which means the researcher continues to check in with participants to make sure they understand what their participation means as the study progresses.
5. Keeping accurate records so that your consent forms match the number of participants in your data records, and the consent form versions match the versions provided in the protocol.
Depending on the study, this process could be a brief five minutes as a participant reads the study information prior to taking a one-time anonymous survey or could be a longer session with a researcher prior to starting a longitudinal psychology study. In order to develop a good consent procedure, you need to understand the needs of your participants and create a process that will support those needs throughout the study.
Essential Elements of Consent
- Research acknowledgment: Use this section to explain to the potential study participant that the study is for research purposes. Your consent form must disclose that participants are being asked to volunteer in a research study.
- Purpose of the project: Explain why the research is being conducted and why you are asking the potential study subjects to participate.
- Procedures: This section should give detailed descriptions of what will be performed in a language that the participant can easily comprehend. Include a description of all research procedures; the frequency, scheduling, and time commitment of each procedure and visit; and the total time commitment. Any audio- or videotaping should be addressed in this section in addition to specific language that details the activities, including the length of time the recording will be kept by the researcher.
- The number of subjects in the study: The number of subjects or approximate number should be stated here, or may be contained within one of the sections described above.
- Risks: Clearly explain the psychological, physical, and/or social risks involved in this research. This section should also outline how likely it is that any of these risks will occur, and what will be done if they do occur. Access to support services should be specified in this section, if applicable. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any treatments are available if an injury occurs and, if so, what they consist of, or where further information may be obtained.
- Benefits: Clearly outline any potential direct benefits to the subject. Explain clearly how likely it is that these benefits will occur and outline what the indirect benefits may be. If no benefits are known at the time of the research, state, “There are no known direct benefits.”
- Alternatives: Use this section to clearly explain what will happen if the subject decides not to participate in the study, whether the subject can get or do the same thing without participating and what else is available if they decide not to participate.
- Extent of confidentiality or anonymity: Explain how any collected information or participation status will be kept confidential. This section should outline who will know or need to know the information pertaining to this study. Where and how the data will be stored should also be included in this statement. · In some studies, the greatest risk to participants is that of inadvertent disclosure of personal information that could reasonably place participants at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. For other good reasons, researchers also desire to securely store research data. Web-based research has its own special set of privacy concerns. State, whether the server to be used, is a secure https server of the kind typically used to handle credit card transactions. What information will be stored on the server, for how long, and who has access to it?
- Compensation: For studies that have greater than minimal risk, explain who will pay if the subject becomes injured. For studies that have payments or reimbursement, this section should be used to explain how much will be paid, what kind of reward it will be, and what the schedule of payment will be. For studies that have multiple payment disbursements, this section should also explain the payment consequences of early withdrawal from the study.
- Freedom to withdraw: Participants must be free to withdraw at any time during the study without penalty. If financial compensation is involved, the subject will be compensated for the portion of the study completed. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. The statement regarding voluntary participation and the right to withdraw at any time can be taken almost verbatim from the regulations (§45CFR46.116(b)(8)). Studies using students need to clearly state that withdrawal from the study will not result in a reduction in points or grade in the course. Subjects are free to refuse to answer any questions or to decline to respond to situations that they choose without penalty.
- Subject responsibilities: This section should have a statement that clearly outlines the subject responsibilities or the study director can have the subject write the items in to confirm understanding of subject responsibilities.
- Contact information: Use this section to list the contacts for any pertinent questions about the research, conduct of the study, subject’s rights, and whom to contact in the event of injury, if applicable. The investigator, faculty advisor (if the student is performing the research), and the RU Institutional Official contact information must be included. Students’ personal phone numbers or other personal contact information, beyond their Radford University email address, may not be included in informed consent documents or any other documents the subject will see.
- Subject permission: This section should contain the following statement: "I have read the Consent Form and conditions of this project. I have had all of my questions answered and I hereby acknowledge the above and five my voluntary consent."
It may be necessary to include a statement addressing unforeseeable risks and any additional costs that the participant may incur.
A copy of the signed consent form should be given to the subject.
***Consent forms are not valid unless an unexpired, dated validation stamp from the RU IRB Office is present***
When Consent is Not Required
For some studies, consent is not a requirement or it can be waived. However, depending on the study the Board may advise or require that some level of informed consent is conducted.
- Exemption: Exempt submissions may or may not utilize informed consent documents. Internet-based survey research must utilize the RU Cover Letter for Internet Research (including Exempt, Expedited, and Full Board Surveys), to be located at the start of the survey or in (or attached to) recruitment material.
- Waiver of alteration of consent: The Board can alter or waive the general requirements for consent when the following apply:
- The research involves no more than minimal risk tot he subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not be practicably carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
- Waiver or alteration of the documentation of consent: The Board can waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if any of the following apply:
- That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, the Board may require the researcher to provide participants or the legally authorized representative with a written statement regarding the research.
Considerations for a Consent Process
- What is the anticipated reading level of your participants?
- Do all of the participants speak English? Are there any cultural expectations where a traditional Western consent process would be problematic?
- Are your participants capable of consenting (e.g. minors, adults with diminished capacity)? Could they be in situations where consent is challenging because of a lack of autonomy (e.g. prisoners) or because consent could put them at risk?
- What is your relationship with the participants? Could that relationship (or the relationship of anyone on the research study team) make participants feel pressured to participate? Do you need to adjust your consent process so that participants can decide freely?
- Will the participants' data be used in areas beyond the research project (e.g. in classrooms, public data sets, or archived in libraries)? Do you need to notify participants that their materials will be used elsewhere?
- Will the participants be deceived as part of your study? Will they need to be debriefed after the data collection is complete?