Why informed consent is important in research

The use of a Research Subject Advocate can improve objectivity in communicating the presented information about the study. It is important to note that informed consent is a continuous dialogue with the participant which reinforces the key elements of initial consent throughout the duration of the study. Clinical research studies that involve children, non-English speaking individuals or the use of a Legally Authorized Representative LAR have additional guidances, regulations and processes that may apply.

It is important to document the consent process at the time the informed consent form is signed by the study participant or legally authorized representative. The source document should state the date, participant name, medical record number, study number and study title.

It should state the key elements of the consent that were discussed with the potential participant and any further details of the discussion that are pertinent to the subject's understanding of the study or information that could impact their decision to participate in the study.

Some studies may also offer monetary compensation for the participants who complete the study. If you would like to enroll in one of our studies, please take a look at our patient resource center , or call us at Careers Contact Us Privacy Policy. Skip to content. What is the Informed Consent Process? It must contain the anticipated duration of the subjects participation. A detailed account of any procedures or experimental procedures the participant must complete over the course of the trial.

It must explain any potential risks involved with the trial. Any discomforts the participant may experience must be disclosed, such as injections. Expected benefits from research and information on alternative options that could also benefit the participant. It needs to explain clearly if any medical treatments or compensation are provided in the event of injury. If so, what they consist of. If not, where can pertinent information be found.

A statement listing the rights of the research participant. Subject must be informed that there may be unexpected risks involved with the study. Reasons that the participant may be removed from the study by the clinical trial investigator, such as failing to comply with procedures. Any costs the subject might expect to forego as a result of participating in the study. Any relevant advertising or recruiting material poster, email text, social media advert if applicable.

Researchers should always aim to inform people fully and obtain appropriate consent. However, in some cases the research may be straightforward enough that a separate, deliberate process for obtaining consent is not needed. In these cases participants, by their actions, imply consent.

This is seen most often in research:. Please note: consent cannot be inferred from inaction eg failure to move away from a camera. In this case please check if you can fully apply the CUREC approved procedure on research involving the deception of participants. If the deception raises ethical concerns such that the application is not covered by this procedure please complete a CUREC 2 application form. Some research settings evolve very rapidly for example in conflict studies.

Similarly, some research participants may only be revealed in time-poor or emergency settings eg heart attack patients. This infringes on the standard information-giving stage of research. The vulnerability of participants in those settings may justify an expedited or fully waived consent process.

Again it is important to describe the research setting clearly. Skip to main content. What is informed consent? There are two distinct stages to a standard consent process for competent adults: Stage 1 giving information : the person reflects on the information given; they are under no pressure to respond to the researcher immediately.

Stage 2 obtaining consent : the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term giving explicit consent before agreeing to take part in the project as a whole. Consent has been obtained. Most researchers in our study reported that their awareness of informed consent practices arose passively through on-the-job experience, rather than from the use of explicit guidelines or training materials, which is in line with previous research in this area [ 10 ].

This form of learning appears to have resulted in a good working knowledge of how to interact with potential participants, especially with regard to the importance of honesty, and of avoiding coercion or undue pressure. However, gaps exist especially in relation to knowledge about regulatory processes surrounding informed consent and ethics review more broadly. Specifically, awareness varied on the National Statement, the types of consent that are permissible, and the role and significance of the information form.

We found that regardless of reported logistical and administrative difficulties, researchers almost invariably believed that written consent was required from participants.

Interestingly, some researchers interviewed also worked in a clinical capacity, nurses, doctors, etc. Reasons for utilising written consent included views that convention dictated it, or that ethics boards required it. A recent study in the US showed that researchers perceived ethics review boards to hold more stringent views on the requirement for consent than they actually did.

In particular, researchers underestimated the availability of expedited review for lower risk studies [ 33 ]. This may be due to the fact that this type of informal learning magnifies the idiosyncrasies of a working team, and that this would be rarely challenged by external sources. Researchers reported learning about informed consent from creating consent forms from templates that predecessors had used.

This results in the preservation of errors which individual researchers may feel powerless to challenge, especially if these become legacy documents and there is lack of support from stakeholder institutions such as HRECs to create new ones. The inconsistencies suggest that practice across different research groups would also vary significantly. The main limitation of this study is that semi-structured interviews are not designed to capture behaviour, which will require observational or ethnographic studies.

Observational research would be timely to reveal the types of information actually disclosed to participants, and deviations of actual practice from perceived practice.

However, interviews allowed us to capture researcher views in depth, and helped us to draw richer descriptions of the informed consent process — descriptions that accommodate context in describing phenomena [ 21 , 27 ]. The use of secondary analysis, a transparent audit trail, and work in iterations, preserved the rigour of our findings, and ample quotes were included in supplementary data to verify interpretations.

Participation in this study was voluntary, which may have resulted in self-selecting bias towards researchers who are more interested in promoting a dialogue relating to informed consent. Another limitation is that the heterogeneous sample may mask some of the issues particular to some types of research, e.

Future studies should report on difficulties present in particular research types, e. This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs to ensure that individuals make good informed decisions about whether or not to participate in research. When the relationship with study participants was reported as more robust, researchers felt that they were able to ensure that participants were not only better informed, but also made better decisions.

Where the relationship with HRECs was more robust, researchers were also more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. While researchers understood the nature and importance of informed consent, they reported a lack in institutional support to navigate regulatory requirements.

Researchers reported little awareness of, and support in, implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. We propose that establishing an independent consultatory body to deal with issues on informed consent, which would assist in improving communication between researchers and HRECs, provide ethics support and support researchers in designing informed consent procedures.

Anonymised data from the study is available to bona fide researchers on application to the corresponding author. National statement on ethical conduct in human research Google Scholar. Miller FG. Henry Beecher and consent to research: a critical re-examination. Perspect Biol Med. Article Google Scholar. A history and theory of informed consent. New York: Oxford University Press; Sreenivasan G.

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