03 · What You Need to Know
What information supports a meaningful decision?
Consent disclosure has two overlapping purposes. It must satisfy whatever requirements govern the study, but it must also help the participant decide.
Those purposes should not be confused. A researcher can mechanically include every required statement while still communicating poorly. Conversely, information that is not explicitly named on a standard institutional template may still matter greatly to a participant's decision.
Participants need to know that this is research
The distinction between research and ordinary activities can be important, particularly when research occurs in healthcare, education, workplaces, or other settings where participants already have relationships with the people conducting it.
Under the U.S. Common Rule, for example, the basic elements include a statement that the study involves research. In medical research, the Declaration of Helsinki likewise requires potential participants to be adequately informed about the research before freely agreeing to participate.
This is not merely a label. Participants should not be left with a materially mistaken impression about why an activity is occurring or what their involvement represents.
They need to understand the purpose
Participants should have a meaningful explanation of what the research is trying to investigate. That explanation does not necessarily require the full theoretical framework, literature review, hypotheses, or methodological justification found in the protocol.
The relevant level of detail is the level that helps the participant understand the nature of the activity they are being asked to join.
There are circumstances in which providing complete information about a research purpose before participation could compromise the study, such as some research involving deception or incomplete disclosure. Those designs raise additional ethical requirements and should not be treated as ordinary exceptions that investigators can make for convenience.
They need to know what will happen to them
A participant should be able to anticipate the practical experience of participation.
Depending on the study, this may include procedures, interventions, questionnaires, interviews, observations, recordings, biological samples, random assignment, placebo use, follow-up visits, access to records, or repeated contacts. Duration and frequency can matter just as much as the procedures themselves.
"You will participate in an interview" is less informative than explaining that the interview will take approximately 60 minutes, will be audio-recorded, and will include questions about a potentially sensitive topic.
They need to know about reasonably foreseeable risks and burdens
Risk disclosure should help participants understand what could happen as a consequence of participation. Depending on the research, relevant concerns might be physical, psychological, social, economic, informational, or otherwise specific to the study.
Burden matters too. A procedure need not be dangerous to affect someone's decision. Time, discomfort, repeated appointments, emotionally difficult questions, inconvenience, or demanding study procedures may reasonably matter.
The 2024 Declaration of Helsinki requires disclosure of potential risks and burdens in medical research. The U.S. Common Rule similarly requires a description of reasonably foreseeable risks or discomforts for research governed by its standard consent provisions.
The aim is useful disclosure, not an indiscriminate catalogue of everything remotely imaginable.
They need an accurate account of potential benefits
Participants should know what benefits, if any, they may reasonably expect from participation. This requires careful wording because benefit to the participant, benefit to other people, and contribution to knowledge are not interchangeable.
A study may offer no direct benefit to the participant while still having scientific or social value. If so, say that clearly. Conversely, when direct benefit is possible but uncertain, avoid language that makes it sound guaranteed.
They may need to know about alternatives
Alternatives are particularly relevant when research participation intersects with treatment or another activity for which meaningful alternatives exist.
Under the U.S. Common Rule, disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the participant is one of the basic elements when applicable. This issue is especially important when declining research does not mean declining care.
For many non-interventional studies, such as a simple questionnaire, there may be no comparable treatment alternative to explain. The relevant alternative may simply be not participating.
They need to understand privacy and confidentiality arrangements that matter to them
Participants may reasonably want to know what information will be collected, whether it is identifiable, who may have access to it, how confidentiality will be protected, and whether there are important limits to those protections.
The details needed vary substantially by study. An anonymous questionnaire creates different informational issues from identifiable interviews, genomic research, linked administrative records, or research involving future data sharing.
Do not promise "complete confidentiality" if the study cannot actually guarantee it.
Consent to participate also should not automatically be treated as unlimited permission for every subsequent use. Whether participation also permits sharing research data depends on what participants agreed to and the framework governing those uses.
They need to know whether participation is voluntary
Potential participants should understand that they can refuse participation when consent is being sought and, ordinarily, that they may discontinue participation without inappropriate penalty or loss of benefits to which they are otherwise entitled.
Both the Common Rule and the Declaration of Helsinki explicitly address voluntariness and withdrawal within their respective scopes.
The practical meaning should also be clear. A patient may need reassurance that declining research will not improperly affect clinical care. A student may need to know whether participation affects grades. An employee may reasonably wonder whether a supervisor will know who refused.
They need to know what withdrawal actually means
"You can withdraw at any time" sounds simple until someone asks what happens next.
Depending on the research and applicable rules, stopping future participation may not necessarily mean that previously collected data or specimens can or will be destroyed. There may also be procedures needed for safe discontinuation of an intervention.
When those consequences are relevant to the decision, explain them rather than allowing participants to infer more from the word "withdraw" than the study can promise.
They may need information about payment, costs, injury, or compensation
Financial information can materially affect a participant's decision. Participants should not have to discover after enrollment that participation creates expenses they were not told about or that an advertised payment depends on completing particular study activities.
Some regulatory frameworks require additional information in particular circumstances. Under the U.S. Common Rule, for example, research involving more than minimal risk requires specified information about compensation and medical treatment if research-related injury occurs. Additional costs may also need to be disclosed when applicable.
The Declaration of Helsinki requires information about incentives and provisions for treatment or compensation for participants harmed as a consequence of participation in medical research.
They need to know whom to contact
A consent process should give participants an appropriate route for questions about the research and their rights, and where relevant, research-related injury or other concerns.
The U.S. Common Rule expressly requires contact information for pertinent questions about the research and participant rights, as well as whom to contact in the event of a research-related injury.
Contact information is useful only if it gives participants a realistic way to obtain help. An unattended mailbox included because a template required one rather misses the point.
Some information is study-specific rather than universal
More complex research may require additional disclosures. Depending on the applicable framework and study design, these can include unforeseeable risks, circumstances under which investigators may end participation, significant new findings, future use of identifiable information or specimens, commercial profit, return of clinically relevant results, whole-genome sequencing, post-trial provisions, funding, conflicts of interest, or other matters.
For medical research, the 2024 Declaration of Helsinki explicitly includes researcher qualifications, funding sources, potential conflicts of interest, privacy and confidentiality provisions, incentives, and arrangements for treatment or compensation for research-related harm among the information to be disclosed to potential participants.
Watch Out
Do not copy a list of consent elements from one regulatory system and present it as the universal definition of adequate disclosure. Determine which ethical standards, laws, regulations, institutional policies, and ethics-review requirements actually govern your study.
Information must be usable, not merely present
Disclosure fails its ethical purpose if participants cannot make sense of what they receive.
This is why the question of what to disclose cannot be separated completely from how it is communicated. The revised U.S. Common Rule requires information to be organized and presented in a way that facilitates understanding, while the Declaration of Helsinki requires relevant information to be communicated in plain language in medical research.
Once you have identified the necessary content, the next task is turning that information into an understandable consent form.
