When is consent not required

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:. In cases in which the documentation requirement is waived, the Board may require the researcher to provide participants or the legally authorized representatives with a written statement regarding the research.

Please see Minors in Research: Consent. Waiver or 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 to the 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 practicably be 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.

There are important exceptions to the informed consent rule: The patient is unconscious. A patient who is unconscious cannot give informed consent. In an emergency, a doctor must act quickly to save a life.

The patient is mentally incapacitated or emotionally fragile. In addition, if a doctor believes that the details of a procedure will make a physically frail patient sick with anxiety, he may choose to withhold some information. However, the doctor must be able to demonstrate exactly why the risks of the procedure were not disclosed to the patient. Katherine Powell Reply. Rasansky Law Firm Reply. Cancel reply Message.

You have been more than awesome through all this. The entire group took such great care of me and I am extremely grateful! In the context of an earlier intervention study that we conducted comparing three different consent procedures for the use of residual tissue for scientific research [ 8 ], we perused the literature for examples of other studies in which consent was waived, and the conditions under which such a waiver was applied.

Most of the literature that we found was focused on only one subset of reasons, or reasons given for only one specific type of research in which the informed consent requirement can be waived.

For example, Biros et al [ 5 ] provided an overview of conditions under which the American Food and Drug Administration FDA permits research in medical emergency circumstances without consent. To the best of our knowledge, no paper has yet provided a more comprehensive review of the range of arguments and circumstances under which the informed consent requirement in intervention research might be waived.

We believe that such a review can serve as an important source document for researchers, institutional review boards, and policy makers involved in establishing the legal and ethical standards of research with human subjects. The discussion about when informed consent is necessary is not recent e. However, societal developments lead to new insights, and changes in research interests lead to new discussions.

Therefore, our aim is to provide a review of contemporary reasons to waive informed consent. For that reason, we reviewed the literature starting from the discussion in BMJ. In the discussion, we also reflect on the arguments brought forward in the reviewed papers. We searched Pubmed. Doyal and Tobias collected and published in book form all correspondence in BMJ regarding the two papers where a waiver of informed consent [ 12 ]. We included all letters in this book in this review.

When reasons in these letters were cited by other discussants, we only cited the original author. We only included reasons and conditions if they applied to informed consent for scientific research with an intervention, including research with a Zelen prerandomization design and deferred consent.

We excluded research on children and articles addressing reasons to use proxy consent surrogate consent from family members or partners instead of patients themselves e. Importantly, our search strategy was not aimed at identifying papers about the content of the informed consent procedure, such as the completeness or accuracy of information given to participants before the start of an intervention study. For example, there has been much discussion about the use of deception in informed consent about the research goal of a study in psychology e.

Although the content of informed consent forms is important and related to the topic of this review, it is beyond the scope of this paper. The process and decisions on the inclusion and exclusion criteria were discussed with all authors. Then, one of the authors SR made a selection of articles based on the title and abstract, and evaluated the selected articles for the inclusion and exclusion criteria Fig.

Selection process of eligible studies on reasons to waive informed consent. Search terms are described in the methods section of this paper. In total records were identified Fig. After detailed assessment of eligibility, papers were included in the review.

We would note that all arguments given, and the judgements given about these arguments, in the results section do not necessarily reflect the opinions of the authors of this paper, but refer to the opinions and judgements of the authors of the papers included in this review.

Major reasons for exclusion were papers describing research without an intervention e. Papers identified through pubmed. From the papers included, we identified three main categories of reasons for waiving the informed consent requirement: 1 decrease of data validity and quality; 2 distress or confusion of participants; and 3 practical problems.

Ethical issues play a role in each of the three categories, as an overarching theme. Therefore, we also included a fourth category focusing on ethical reasons or objections to waiving informed consent. We present here all arguments and conditions mentioned in these four categories the order of the categories and arguments were randomly chosen. For any given argument, all papers mentioning this argument are cited. Concerns about the effect of asking informed consent on the quality or validity of outcome data are prevalent in the literature.

These concerns are specifically relevant when study outcomes are self-reported, when bias is likely to occur, or when the inclusion rate is highly compromised because of asking informed consent. Many of the examples in this section come from proponents of the Zelen design, in which no consent is asked for randomization [ 15 ]. After randomization, researchers ask subjects allocated to the intervention group for informed consent, while subjects in the control group remain in the study without being informed of the randomization procedure.

Examples include studies of patient compliance [ 20 ], cluster randomized trials in which the effect of offering physicians an intervention to improve uptake of clinical guidelines is studied [ 21 ], and studies on the effect of offering a screening tool for the detection of violence at home [ 22 ].

In some cases, the consent process is also thought to bias the study outcome [ 23 ], for instance when the study is aimed at comparing patients who received information on a topic with patients who were not informed. An informed consent procedure gives patients in the control group information about the topic, which makes them more similar to patients in the intervention group than desirable.

Some authors also expect a bias if a preference for the intervention arm influences the validity of a study due to differential drop-out [ 28 ]. An example is a study in which researchers provided the drug heroin to addicted persons; many participants withdrew from the study after being randomized to the control group [ 24 , 29 ].

Institutional Review Board IRB approval is often mentioned as a necessity when waiving consent in these cases [ 16 , 18 ]. Some authors argue that selection bias or participation bias may also decrease the validity of study results [ 10 , 30 ].

Physicians might, for example, be less likely to ask certain patient groups e. They further argue, that some patient groups might be less likely to give consent than others [ 3 , 31 ], such as minority group members [ 32 , 33 ] or unskilled workers, while other patient groups, especially in emergency research, may not be able to consent at all [ 34 ].

In such situations, the outcome of such a study may address the efficacy of treatment among those who consent, while the investigators may be more interested in evaluating the effectiveness of the intervention in a real world setting i. It has been suggested that for a waiver to be acceptable in these cases, all identifiable data should be discarded at the end of the study [ 35 ]. Some also expect bias might be introduced when informed consent is asked from all health care workers in a cluster randomized trial [ 7 ].

In this case, it has been suggested that an IRB may grant a waiver, provided the researchers provide compelling evidence that the results would be non-interpretable without the waiver, and that a different study design could not overcome this problem.

Further, a cluster representative, i. A higher inclusion rate has also been mentioned as a reason not to ask for informed consent [ 10 , 24 , 36 , 37 ], especially in intensive care trials [ 37 ], where inclusion of a relatively small number of patients might otherwise take years. A low inclusion rate could further lead to poor data validity and quality, because it might result in physicians being less accurate in following the study protocol [ 38 ].

Moreover, especially in emergency research, where it may be unacceptable to delay start of treatment due to consent procedures, such a delay may also lead to an underestimation of the treatment effect [ 39 , 40 ]. The informed consent procedure itself may generate such distress or confusion. For example, severely ill patients who are focused on their treatment and recovery [ 41 ], and who may already be quite anxious [ 42 ], may find it disturbing to be informed about a study. Similarly, the stressfulness of the medical situation is thought to inhibit potential study participants from grasping the rationale of the study, especially in emergency research [ 36 , 37 , 43 ], for example when patients have suffered an acute myocardial infarction [ 36 ].

Others have argued that patients might also be negatively affected by the knowledge that their physician does not know which treatment is best [ 44 , 45 ]. Being randomized to the control group after being given information about the intervention arm of a study might be especially confusing or disappointing for patients [ 24 , 36 , 46 ]. Moreover, Homer [ 24 ] has argued that use of the Zelen design may also avoid damaging the doctor-patient relationship.

Emergency research is the most often mentioned example in all contexts described, and it is the most notable research discipline in which practical problems are forwarded as the primary reason why the informed consent requirement should be waived.

This is because it is simply impossible to ask temporarily incapacitated patients for informed consent [ 1 , 5 , 23 , 33 , 34 , 36 , 38 , 40 , 43 , 45 , 47 — 95 ]. Patient populations often mentioned in this context are those with acute head or brain injuries [ 5 , 25 , 34 , 38 , 39 , 74 , 96 ], and comatose, unconscious or sedated patients [ 49 , 92 ], although a much wider range of relevant patient populations has also been named [ 40 , 58 , 60 , 63 , 65 , 66 , 97 — ]. Specifically in the context of emergency research, an often-mentioned reason to waive informed consent is that the main alternative, proxy consent, is often not possible either [ 87 , 99 ].

Others have mentioned that asking proxy consent could be inappropriate, for instance when testing HIV status [ 90 ]. Prospective consent [ ], e. It has also been argued that deferred consent i. There has been much discussion in the literature about the conditions that should be met when conducting emergency research with a waiver of consent.

First, the condition preventing patients from giving informed consent should be a characteristic of the population being studied [ 63 , 68 , 75 , 91 ], and the study should be aimed at improving the care of that population [ 43 ].

In the absence of consent, it is thought to be particularly important to consider conducting minimal risk research if possible, and to always carefully weigh the risks in relation to the potential benefit to the patient [ 43 , 68 , 87 , 91 ]. There should be unanimous agreement among relevant individuals about the importance of the research and the impracticability of informed consent [ 90 ].

Further, an independent board should evaluate serious adverse events [ 99 ], and IRB approval is necessary [ 43 , 47 , 48 , 52 , 72 , 75 , 79 , 99 ]. In order to avoid a financial conflict of interest, researchers should not be paid to include patients in the study [ 99 ].

It has further been argued that, for waiver of informed consent to be acceptable, no alternative procedures of equal effectiveness should be available, there should be no intention to give participants feedback of information, and no decisions should be made that affect them [ 71 ]. The FDA amended its informed consent regulations in in order to ensure that emergency research could be carried out without informed consent in certain situations.

The U. The IRB must then take these views into account when reviewing the request for the consent waiver. After IRB approval, researchers should publicly disclose the risks and benefits of the study before it starts and after its completion. It should be made clear that incapacitated individuals may be enrolled without consent from a proxy.

If this is not possible, the proxy or patient should be informed as soon as possible, and if the study is still ongoing at that moment, consent should be asked to continue participation. This committee must exercise oversight of the study, and may recommend continuing, modifying, or stopping the study, dependent on its progress. Moreover, there should be evidence from prior research that the intervention has the potential to benefit patients, while the available treatments are unproven or unsatisfactory.

Patients themselves should be in a life-threatening situation that necessitates intervention. For instance, there should be no way in which subjects can be identified prospectively. In the U. When it is not practical to obtain consent, the common rule states that an IRB may permit a waiver of consent when the study evaluates public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payments for benefits or services under those programs.

The Council of Europe has also developed a set of rules on bioethics, which sometimes allows research without consent in those who do not have the capacity to consent [ 4 ]. The Declaration of Helsinki also gives exceptions for the rule of informed consent under certain circumstances [ 4 , 39 , 45 , 54 , 99 , ].

A waiver of consent may be granted when subjects are physically or mentally unable to give consent, and when the condition that causes this inability is a necessary characteristic of the research population. Further, attempts to obtain proxy consent should have failed within the therapeutic window. IRB approval should be obtained, and consent to remain in the study should be obtained as soon as possible from the subject or proxy.

There are also other practical problems that authors have suggested may play a role in the argumentation to waive informed consent. A waiver could increase the recruitment rate [ 5 , 10 , 38 , ], and decrease the administrative task [ 16 , 45 ] and resources spent on the study [ 10 ]. Further, it may increase the speed at which the study treatment is initiated [ 37 , 38 , 68 , 76 , 87 ]. Not asking informed consent in these situations may be done under the condition that monitoring of adverse effects takes place, and that this may lead to an intervention [ ].

The Zelen design is considered to be an alternative. Another logistical difficulty that has been brought up is time. In case of a public health emergency, such as epidemics of dangerous contagious diseases, there may not be enough time to ask informed consent [ 25 ]. Examples of logistical difficulties are cluster randomized trials with large groups of participants [ 7 , 21 , ], or a study on large groups of military personnel going to the Middle-East [ 62 ].

This latter example has been explicated by Cummings [ 62 ]. The conditions under which a waiver might be allowed that were mentioned in this paper were the provision of information sheets, careful documentation of whom is given the vaccination and of adverse reactions, and approval of the IRB, FDA commissioner, and the President of the U. Further, there should be a public notice of the study. An example would be a study in which physicians in the intervention arm would, among other measures, be educated about procedures to prevent catheter-related infections, while the outcome, the number of catheter-related infections, is on the level of the patient.

It has been argued that informed consent is useless if it is impossible for both patients [ 21 ] and healthcare workers to avoid interventions conducted at the level of a complete department or hospital [ 7 ]. Ethical reasons that are proposed to legitimize a consent waiver often relate to, or are consequences of the arguments given in the above paragraphs. Therefore, they can also be divided into the same three categories decrease of data validity and quality; distress or confusion; and practical problems.

It might be unethical to conduct research knowing that the validity of the study results will be compromised. Further, it might be unethical to distress patients by discussing an experimental treatment with them, after which they are allocated to the control group of the study.

The practical problems with informed consent, especially those in emergency research [ 1 , 34 , 39 , 49 , 63 , 84 , 85 , 99 , , ], are thought to lead to ethical problems as well. For instance, it is considered to be unethical to delay treatment initiation because of an informed consent procedure when it is expected that this delay will adversely affect treatment outcome.

However, not all ethical arguments relate directly to arguments in the other categories. In these cases, authors often conduct an ethical analysis, in which they systematically explore the consequences of the different choice options on several fundamental values, such as autonomy, justice, beneficence, or non-maleficence.

Commonly, in intervention research, autonomy forms the basis of informed consent. It is argued, however, that respect for autonomy is not valid or is less valid for emergency patients, such as those with traumatic brain injury [ 34 ]. Other principles that are relevant for these cases are the prospect of therapeutic benefit, and the protection against potential harm of the intervention. These authors stress the importance of conducting a risk-benefit analysis. Further, it should be ensured that this vulnerable patient group is protected from exploitation due to their incapacitated status [ 34 , 43 ].

Kompanje further argues that an independent safety committee should be instituted to assess these cases [ 34 ]. Risk-benefit analyses sometimes also include benefits on the broader societal level. Some then argue that not asking informed consent may be the most ethically correct thing to do, because it is beneficial for future patients or for society as a whole [ 3 , 35 , 39 , 41 , 54 , 57 , 63 , 76 , 84 , 85 , , — ]. Informed consent might, for example, prevent or delay progress being made in critical clinical situations which, in turn, could lead to increased mortality or disability, such as in traumatic brain injury [ 34 , 40 , 41 , 55 , 57 , 61 , 68 , 71 , ].

Moreover, if it was not possible to conduct research on emergency care patients without informed consent, patients could be exposed to potentially hazardous effects of invalid and ineffective clinical practice [ 63 ]. Evans also noted that it could be argued that patients should participate in scientific research in countries with publicly funded health care, provided the studied treatments are equal in expected treatment outcome [ ].

Specific conditions, such as the removal of identifiable data [ 7 ], the possibility to have data removed on request, or providing information after the end of the study [ 20 ] may apply. Main examples are low-risk research types, such as cluster randomized trials [ 7 , 16 , 21 , 37 , , ].

Figure 2 visualizes the relationships between different study types and different reasons for not requiring informed consent. Visualization of the relationship between the different study types and reasons to waive informed consent. We summarized the different arguments given in the literature to make an exception to the general rule of informed consent. We deliberately did not weigh the number of times arguments were mentioned, because we felt frequency was not related to legitimacy of the argument.

However, here we will put the arguments in a broader perspective, in which the frequency of arguments may sometimes be relevant. Three themes emerged from reviewing the literature about reasons to make an exception to the general rule of informed consent for research with an intervention: distress or confusion, practical problems, and data validity and quality.

Further, the meta-category of ethical reasons or objections was found to overarch these categories. In the reviewed papers, ethical reasons not to ask informed consent were almost always mentioned alongside arguments in one of the main three categories. For example, in many cases it was argued that it is unethical to conduct research that will yield poor quality data and invalid study results. Practical arguments against the informed consent requirement come primarily from the field of emergency research, implementation science and proponents of the Zelen design.

Key issues in these categories are that research should be of societal importance, should expose participants to no or relatively low risks, that IRB approval should be obtained, and that data should be appropriately protected.

These issues are more explicitly discussed in the category of practical problems rather than the categories of data quality and participant distress. This might be because emergency research has been discussed more thoroughly than other types of research. We would argue, however, that such conditions, describing when research with a waiver might be conducted responsibly, could also be valuable for researchers in other fields of research in which a waiver might be used.

Data validity and quality is mentioned as the main argument to waive consent for some types of research, such as research with self-reported outcomes or research in which the intervention consists of giving information in such a way that informing people about the study arms would interfere with the outcome.

Our review also indicates that not all types of reasons receive equal attention in the literature. Distress or confusion does not seem to be an important category in and of itself. No important research types mentioned only the distress caused by a consent procedure as a reason not to ask informed consent. The distress argument was always given in addition to arguments in one or more of the other categories. Also the argument of practical problems was often given in addition to other arguments, with the exception of very large studies.

Importantly, this does not mean that practical problems are not important: for emergency research many authors have raised concerns about practical problems with asking informed consent. Although it is not the only argument, it is the most important argument given by many authors. Arguments such as inferior data quality, the potential distress caused to patients, and serving societal goals, often provide an additional basis for requesting a waiver.

The most often discussed research designs and disciplines can be found in two or three of the categories Fig. The distress or confusion that a consent procedure might cause to potential participants and the practical problems accompanying it most often are used to justify the consent waiver for cluster-randomized trials or other studies in implementation science. This is also the case for emergency research and studies for which a Zelen design has been suggested, with the addition of a decrease in data quality.

Professionals thus saw different types of reasons why it is undesirable to always ask informed consent in these research situations. It seems clear that the likelihood of the perceived need for an informed consent waiver in a specific type of research increases when the difficulties related to informed consent span different categories. Although it should be no surprise that more reasons take up more space in the literature, it seems equally likely that when there are several types of difficulties with asking informed consent, more researchers find a waiver acceptable, for instance because it becomes more difficult to find other solutions.

This often involves subjective judgment since, to the best of our knowledge, no criteria have been put forward that indicate the extent to which any argument e. Statements found in the literature that researchers only consider a consent waiver after careful consideration of different factors corresponds with our own experience.

As noted in the introduction, we conducted a study that inspired us to review reasons to waive informed consent.