IRBIS does NOT generate these documents with application-specific information.
Concise Summary examples can be found here .
Guidance on the use of plain language in consent forms:
There are a few additional forms that are not provided online and may be accessed below. As needed, these should be completed and uploaded to your IRB application.
COVID-19 Related Forms:
Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).
An EQUIP-TIPS Guidance document providing lay language for common medical / scientific terminology (source:
As part of the informed consent process, the consent document is designed to provide information to potential subjects about a research study so they can make an informed decision about their participation. The use of a form to document the consent process is required unless specifically waived by the IRB. One of the most common reasons for delay in IRB approval is an incomplete, inaccurate, and/or unclear consent form document. Informed consent templates (biomedical and social/behavioral versions) are available on the IRB Applications and Forms page. You can download a template and customize it to your research study.
Describe the purpose(s) of this research study in lay terms. Include a statement that indicates why this is considered a research study (e.g., testing how a non-FDA approved drug works and whether it is safe). Provide definitions for specific research design features (e.g., double-blind, randomization, placebo-controlled).
Include a thorough description of the specific procedures involved in the study, which procedures are considered experimental and why. Include detailed inclusion/exclusion criteria, length of involvement. If the subject will be interviewed or asked to complete a questionnaire, describe the types of questions that he/she will be asked to answer. Provide a procedures table if subjects would benefit from the addition of a table.
This element will ask if the study involves more than minimal risk. If so you will be prompted for a detailed description of the potential risks and discomforts involved (physical, psychological, social, and economic). For some procedures you may choose to use standard text (e.g., blood draw). If applicable, include a statement that the treatment or procedure may involve risks, which are currently unforeseeable, to the subject (or to the embryo or fetus, if the subject is or may become pregnant). You may build a table or cut and paste an existing table into the Word document.
Describe all expected benefits and who will benefit. Note: Compensation for participation is not a benefit; provision for free drugs or procedures is not a benefit.
If subjects will be compensated for their participation or reimbursed for costs (e.g., parking), describe in detail the type of payment, amount, and terms. Specify any additional costs to the subject that may result from participation in this study that will not be reimbursed.
When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject’s consent. Subjects should also be informed of procedures for safe and orderly termination should they decide to withdraw from the study before it is completed.
Include information about the protection of subject’s privacy, method of protecting research data, and who may have access to study records.
Standard text explains that significant new information will be provided to the subject by the investigator.
Include applicable information on alternative procedures or courses of treatment that may be advantageous to the potential subject if he/she refuses to participate or withdraws from the study. Social/behavioral research - if compensation for participation in the research is extra course credit, explain that the course instructor is to provide a reasonable alternative way to earn extra course credit.
Standard non-alterable text describes the provision for subject injury incurred as a result of this study, if applicable.
If a research team member has a disclosable financial interest in the outcome of this particular study or research program, a statement to that effect should be inserted. If the study involves collection of specimens, the appropriate standard language should be included.
Includes contact information to answer study questions and standard text that instructs subjects to contact the Research Protections office if they have any comments or questions regarding the conduct of the study and/or their rights as research subjects.
Standard text emphasizes that the decision to participate, or not participate, is solely up to the subject.
Signature lines should be included for the subject and for the researcher obtaining informed consent. A “Legally-Authorized Representative” signature line should be included if you will obtain surrogate consent or are developing a parental permission form for enrollment of a minor in research. Also, you may obtain the assent of a minor ages 13-17 (as well as parental permission) using this consent form.
A “Witness” signature line must be included for specific types of research. See How to Consent for more information on this topic.
An IRB may waive the requirement to obtain a signed informed consent document in two situations:
In cases where the documentation requirement for informed consent is waived, the IRB often requires the researchers to provide participants with a written statement regarding the research. This written statement requires IRB approval. The template Study Information Sheet can be used as a guide.
Researchers interested in obtaining a waiver of written (signed) informed consent should make sure that their research qualifies for one of the above options, and should address how the research qualifies for each of the option's requirements in the IRB Application.
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent , or waive the requirements to obtain informed consent if:
When an IRB waives the requirement to obtain informed consent, it waives the entire requirement for the informed consent process. However, when the IRB grants an alteration of some or all of the elements of the informed consent (e.g., removes a required element of consent from the document), the process of obtaining informed consent is still required. Researchers interested in obtaining a waiver or an alteration of the consent process should address how the research qualifies for each of the above requirements in the IRB Application.
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1 University of Messina, “G. Martino” Hospital, Messina, Italy
2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].
The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq
Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].
The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].
The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].
Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).
The information about the research should be given by a physician or by other individuals ( i.e. researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.
After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].
The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].
The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.
Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].
Conditions to be met in emergency clinical study
• Subjects affected by a life-threatening condition |
• The treatment is experimental |
• The clinical research allows verification of both the effectiveness and safety of the treatment |
• It is impracticable to obtain consent |
• The waiver of informed consent is needed for the clinical trial |
• The researcher will contact the legally authorised representative |
• The family members can decline the patient’s participation in the study |
Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].
In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].
In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].
In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].
In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].
All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].
Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].
A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].
Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].
For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].
Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].
Conditions to be met in research studies involving pregnant women and fetuses
• studies have also been conducted on pregnant animals |
• Clinical studies have been conducted on nonpregnant women |
• Clinical findings assessing potential harms to pregnant women and fetuses are available |
• The risk to the fetus is minimal and caused exclusively by the procedure/intervention |
• The study will achieve crucial knowledge not obtainable by any other means |
• The researchers will have no part in any decision influencing fetal viability or pregnancy |
• No incentive will be provided to influence the course of pregnancy |
Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.
Consent signature requirements for pregnant women and children
Direct benefit to mother | Mother |
Direct benefit to mother and fetus | Mother |
Direct benefit to fetus | Mother and father |
Direct benefit to individual subjects | One parent or guardian |
No direct benefit to individual subjects | Both parents |
No direct benefit to the subject or societal (indirect) benefit | Both parents |
Medical care related to pregnancy | Parental consent is not needed |
Medical care related to mental health treatment, or the diagnosis or treatment of infectious, contagious or communicable diseases | Parental consent is not needed |
Self-sufficient minors | Parental consent is not needed |
Aged ≥15 years | |
Living alone | |
Managing their own financial affairs | |
Emancipated minors | Parental consent is not needed |
Married or divorced | |
On active duty in the US armed forces | |
By a court | |
Having the legal right to consent on their own behalf to medical, dental or mental health treatment |
# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.
Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].
Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].
Studies that may involve prisoners
• Studies on the possible causes, processes and effects of incarceration |
• Studies on prisons as institutional structures or on prisoners as incarcerated persons |
• Studies on special conditions affecting prisoners |
• Studies on practices of improving the health or well-being of the prisoners |
• Epidemiological studies |
Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].
Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].
Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.
Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].
Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].
Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.
In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and and2 2 summarise the parental and assent permission requirements, respectively.
Flow chart of parental permission requirements.
Flow chart of child assent requirements.
When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.
Conflict of interest: None declared.
General consent form to participate in research (DOC)
Two stage project consent form (DOC)
Parent permission form for research with child (DOC)
Child assent form (DOC)
Multiple consent form including audio-recording and quotations (DOC)
Photo and video consent form (DOC)
Video-recording consent form (DOC)
Re-contact agreement form (DOC)
Post-debriefing consent form (DOC)
How to write an informed consent form .
Informed consent is commonly used as the legal basis to collect personal data in research. Explicitly asking participants whether their personal data can be collected for a particular purpose, gives them an opportunity to be informed, ask questions, and decide whether they wish to participate. By giving participants information and choice, you can fulfil both your legal and ethical requirements - that is, if you adequately formulate your informed consent forms.
When you collect personal data, it is crucial to inform participants about how you are using their data. You should at the very least describe:
In this document , you can find an overview of information that you need to include in your information to participants. Please note that this is a general template and there may be additional requirements imposed by your faculty and/or Ethical Review Board .
The information you provide should be easily understandable and accessible for your participants. So try to include concrete and active language, and consider whether text is the most suitable way to deliver the information (other formats such as audio and video are also allowed). The GDPR also permits layering information to improve readability: you can place the most relevant information in the information sheet preceding the consent and provide external links to pages that contain additional information. The additional information may provide participants with a more detailed breakdown of how their data will be processed, or include the way in which the data will be de-identified, or information on the security of the tools and technologies to be used. An external website with additional information can also be used to inform participants of small changes to the processing that may occur after consent.
To ensure consent is valid, you need to ensure that it is “freely given, specific, informed and unambiguous”, signified by a “clear, affirmative action” (Art. 4 GDPR):
Participants must have a real choice whether to participate or not. Although coercion and intimidation are obvious violations, be aware that disproportionate compensation and power imbalances should also be avoided. For example, students must not feel compelled to consent to a research study for the sake of their studies, nor should any participant consent because the compensation is vital to their survival or quality of life.
Research projects can often involve multiple types of processing. In such cases, the participants should be free to choose which purpose they accept, rather than having to consent to a bundle. For example, if a research project involves behavioral tests, interviews and surveys; the participant should be able to consent to each process separately if they are not all necessary for participation in your project. The concept of specificity also extends to the way in which the collected data is going to be used. Thus, the data should only be used for the purpose for which it was specified in the information sheet. Since this would compromise your ability to share data, the re-use of data for research purposes is allowed under the GDPR. To be able to share your data for reuse purposes for research, you must ensure that participants have been informed about the intent to share and the data should be adequately safeguarded with clear security and privacy measures (i.e., secure storage, access restriction, pseudonymization, aggregation and minimization).
Providing information is essential to a valid consent. How the information is provided however need not always be through a written information sheet. This means valid information may be presented in other ways, such as oral statements, or audio/video messages.
The information provided must be clear and understandable and “the action of giving consent” has to be unquestionable and explicit. To demonstrate a clear affirmative action, the participant must take a deliberate action. For this reason, pre-ticked opt-out boxes are invalid, since they require no action from the participant. Ambiguity can also be avoided by providing participants with the option to tick a “NO” or a “YES” box, instead of only a “YES” box. The deliberate action of consent can be both a written (e.g., ticking a box, writing an email) or a recorded oral statement.
In research, signing a consent form is rarely needed, as it often leads to the collection of unnecessary personal data, and a consent form is not a binding document anyways (it can be withdrawn at any point). Therefore, a signature only makes sense if the identity of the individuals is meant to be used in the process (e.g., in clinical trials), since that does not lead to additional data collection. If your research does not require the collection of names, or is using pseudonyms, using a signature leads to the collection of unnecessary personal data and is therefore not necessary. A check box (and possibly a statement/signature of the person/researcher who collected the consent) is often sufficient.
As we move towards more open science practices, researchers are faced with the dilemma of sharing the personal research data they’ve collected whilst protecting the privacy of their participants. To properly determine whether personal data can be shared, a privacy scan is strongly recommended. This is a crucial step wherein you will assess the potential privacy risks. By contacting [email protected] you will be put in contact with a privacy officer who is able to help you with this task. Once you’ve assessed the risks and have determined that the data is fit for sharing it is important to adequately phrase your informed consent form.
Information sheets and consent forms should address the possibility of sharing data, future data publication (including storage in a repository) or long-term retention of data for verification. In this way informed consent from research participants can be obtained.
If statements only mention the current study, sharing is not explicitly possible. You should add a sentence to make it clear to participants that the data could be used for further research, de-identified where possible, or identifiable with enough safeguards and security measures.
Try to avoid putting this in your consent form:
Sensitive data can legally be shared without explicit consent if the information given to participants prior to their consent for data collection indicated future use of the data, or if ALL of the following are applicable:
Be careful with tick-boxes. There must be an opt-in option. Tick-boxes may never be coloured in advance and they should allow for a “Yes” AND “No” option.
“I agree that research data gathered for the study may be published or made available provided my name or other identifying information is not used.”
“I understand that the research data, without any personal information that could identify me (not linked to me) may be shared with others.”
In many cases, you will be sharing data under restricted access. This means that the data will be placed in a repository where others are able to find it, but users will only be granted access to the data when approved by the dataset owner.
This enables you to gate who can use the personal data and under which conditions. Upon receiving a request, you will then send the requestors a data transfer agreement determining the purpose of re-use and the privacy measures that the requestors must adopt to use the data. A data transfer agreement template can be found here , although they will often always need adaptation to your particular case. Please contact [email protected] or check the data privacy handbook for more information on this topic.
Check the Data Privacy Handbook , a knowledge base and overview of tools to learn about data privacy. This guide was set up by RDM Support of Utrecht University (UU) with input from the UU Faculty Ethics Review Board (FERB) of the Faculty of Social and Behavioural Science.
Utrecht University Heidelberglaan 8 3584 CS Utrecht The Netherlands Tel. +31 (0)30 253 35 50
How to write informed consent form.
Writing an informed consent form is crucial for ethical research or medical practices. The form should provide participants with comprehensive information about the study, ensuring they understand the purpose, procedures, potential risks, benefits, and their rights. Here’s a general guide on how to write an informed consent form:
Introduction:
Study/Procedure Overview:
Voluntary Participation:
Inclusion/Exclusion Criteria:
Study/Procedure Details:
Risks and Discomforts:
Confidentiality:
Contact Information:
Questions and Clarifications:
Participant Rights:
Consent Statement:
Witness and Date:
IRB/Ethics Committee Approval:
Remember to adapt the language to the specific context and target audience. If your study involves specific legal or ethical considerations, seek guidance from relevant authorities or experts. Additionally, it’s crucial to comply with local and international ethical standards and regulations.
*Refer to template below for guidance.
Informed Consent Form
[Title of the Project/Procedure/Study]
I, [Participant’s Full Name], have been fully informed and understand the nature, purpose, risks, and benefits of participating in [Title of the Project/Procedure/Study]. I have had the opportunity to ask questions and have received satisfactory answers.
The purpose of this [project/procedure/study] is to [briefly explain the main goals and objectives].
Procedures:
I understand that I will be involved in the following procedures: [List and describe each specific procedure in detail].
I am aware that there may be risks and discomforts associated with my participation, including [enumerate potential risks]. The researchers/practitioners have explained these risks to me.
I understand that potential benefits of participating may include [enumerate potential benefits]. However, there may be no direct benefits to me.
I understand that my personal information will be kept confidential to the extent permitted by law. Only authorized personnel will have access to my information.
My participation in this [project/procedure/study] is entirely voluntary. I understand that I can withdraw at any time without penalty or loss of benefits to which I am otherwise entitled.
Compensation:
I have been informed of any compensation or reimbursement for my participation, including [details of compensation].
If I have any questions or concerns about the [project/procedure/study], I can contact [researcher/practitioner’s name and contact information].
Statement of Consent:
I have read and understood the information provided in this form. I have had the opportunity to ask questions, and my questions have been answered to my satisfaction. I voluntarily agree to participate in [Title of the Project/Procedure/Study].
Participant’s Name: ___________________________
Signature: ___________________________ Date: _______________
Researcher/Practitioner Certification:
I confirm that I have provided adequate information to the participant and have answered their questions to the best of my ability.
Researcher/Practitioner’s Name: ___________________________
Remember, this template is a general guide, and you should customize it to fit the specific requirements and regulations of your project or situation. Additionally, seek legal advice to ensure compliance with local laws and ethical standards .
Template can be downloaded at https://research.iium.edu.my/irec/?page_id=500
Below are some useful tips on writing a consent form for your proposed subject population. The procedures for obtaining consent should be documented on the Consent tab of the protocol application.
Coercion - The subject must be given the opportunity to consent or not consent without the intervention of any element of force, fraud, trickery, duress, coercion, or undue influence on the subject’s decision. Payments & credits should be pro-rated & not withheld until completion. Any payment or class credit must be appropriate to the tasks involved and the subject population.
Compensation - Compensation payments must be pro-rated or provided in full even if a subject withdraws from the study early. If the payment includes a lottery , participants must be at least 18 years of age to participate and be entered into the lottery and payment (e.g. prorating) cannot be withheld until the completion of the study. A participant may withdraw from a study and still be entered into a lottery. Approximate odds of winning need to be included in the consent form.
Class Credit - Any project where class credit is involved must be open to all members of the class AND there must be a non-research option to obtain the same credit for the same amount of effort. The Psych & Geography pools are currently the only pools at UCSB whose procedures are codified and do not need to be documented in this form. All other use of class credit & non research alternatives must be documented in the ORahs protocol application on the Consent tab.
Elements of Consent - Consent forms should include all the required elements of informed consent and additional elements (if applicable), unless a waiver of consent is requested, justified, and approved by the IRB.
Identifiable data - Consent for using identifiable data (e.g., video recordings) must be obtained, unless a waiver is requested, justified, and approved by the HSC. If participants are to be recorded or photographed, they must be informed as to how this media may be used (e.g., used in conferences, presentations, publications, shared with other researchers). The use of check boxes is recommended for varying levels of consenting to participate. If there are informational risks to the participant, additional safeguards may need to be put in place. These should be described in the risk tab and discussed in the participant consent. The disposition of identifiable data should be described in the consent form. Identifiable data may be retained indefinitely or destroyed. The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared.
Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms. For studies involving multiple subject populations (e.g., children and adults), multiple consent forms are required and must be tailored to the reading and comprehension level(s) of the subject populations to be enrolled.
Translation - If the subject population involves individuals who speak a different language, consent forms should be translated into the target language and translated back into English by two different individuals to ensure that the appropriate concepts are being conveyed. Using a translator app, such as Google translate should not be used to translate consent forms.
Other Helpful Hints -
Consent forms must be signed by the subject, and/or by the parent or legal guardian UNLESS a waiver of documentation or consent is requested, justified & approved. Signed consent forms must be stored securely in your UCSB Department.
For information on requesting a waiver of documentation or consent, visit the Waiver of Consent or Documentation page .
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Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. The consent process typically includes providing a written consent ...
Informed Consent in Research. Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of ...
CONSENT FORM FOR (INSERT NAME) RESEARCH TITLE: RESEARCHER/S: I have been given information about research title and discussed the research project with researcher's name who is conducting this research as part of a degree name supervised by supervisor in the department of department at the University of Wollongong. I have been advised of the potential risks and burdens associated with this ...
Considerations Before Writing the Consent Document. Tips for Developing a New Consent Form. Writing a consent form that uses plain language, and that is brief and clear, requires substantial effort. This effort can be lessened by using the consent template and adding the required information from the consent library (see more information below).
Sample Informed Consent Form - ©NCPI
• Write out all acronyms the first time they appear on each page, followed by the acronym in brackets. • Number the pages, e.g., 1 of 3, 2 of 3, 3 of 3, etc. ... The Research Ethics Board must approve any changes to the consent form before the research begins. Changes to an approved study and its documents are done via an Amendment. Your ...
Research Consent Template & Companion Document ... Write the consent form at or below an 8th grade reading level. We recommend using the Flesch-Kincaid score tool in Word to measure reading level. Replace or define scientific or technical terms in lay language. For example, use "blood draw" instead of "venipuncture."
Obtaining and Documenting Informed Consent
Creating the perfect consent form for research. Your consent form will no doubt be unique, depending on the nature of your research and the specifics of your study. But here are eight key components you won't want to miss out. 1. A study description and purpose. Kick off your consent form by outlining your study's purpose and objectives.
How to Write. Step 1 - Download in PDF, MS Word, or OpenDocument. Step 2 - The title of the research study being conducted must be included at the top of the consent form. Step 3 - Enter the following information related to the primary researcher in the fields provided: Step 4 - The purpose of the study, the procedures, the risks, and ...
Consent Addendum This is a consent addendum to allow already enrolled participants to agree to additional study procedures not disclosed in the initial consent form. This form supplements the consent and HIPAA authorization the subject already provided for a research study. Consent Addendum. 3-11-2020.
Assent Form Ages 7-14. 2023-06-27. Information or Fact Sheet. 2023-04-10. The following documents are samples. IRBIS does NOT generate these documents with application-specific information. Exempt Research Information Sheet. 2017-10-30. Addendum to provide additional information to subject after original consent.
Drafting the Informed Consent Form Format and Style of Informed Consent Documents- Key Points The IRB strongly encourages Investigators to use the standard UCI IRB consent template, which is available on the Applications and Forms page. The template is written in the 2nd person. IRB requires that the consent and assent documents be written in…
• Avoid research and medical terms when possible Use lay terms and common words throughout the consent • If complicated words are needed, define them in plain language • Avoid abbreviations and acronyms If you must abbreviate, define an abbreviation the first time you use it • Use words and terms consistently in the consent form
How to obtain informed consent for research - PMC
Contact. Sample consent and permission forms. General consent form to participate in research (DOC) Two stage project consent form (DOC) Parent permission form for research with child (DOC) Child assent form (DOC) Multiple consent form including audio-recording and quotations (DOC) Photo and video consent form (DOC)
Language Understandable to Subjects. HHS regulations at 45 CFR 16.116 and the FDA regulations 21 CFR 50.20 also require that the consent information be in language understandable to the subject or their legally authorized representative. This means the document must be written in plain language, using lay terms, and in a language the subject ...
How to write an informed consent form - Research Data ...
Informed consent language should be written in the second person ("you"), not in the first person ("I"). Minimize passive voice to the extent possible. Example of passive voice: "A summary of results will be sent to all study participants.". Example of active voice: "We will send you a summary of the results.".
Emergency Use of an Experimental Drug or Device. Other consent document templates. Assent of a Minor (for children 7-17 years old) Assent of an Adult Subject with LAR. Information Sheet Template - For use in Anonymous Survey Studies. Re-consent Form - For use with Subjects in Follow-up Only OR Minor subjects turning 18.
Here's a general guide on how to write an informed consent form: Title: Start with a clear and concise title such as "Informed Consent Form.". Introduction: Begin with a brief introduction explaining the purpose of the study or procedure. Include information about the researcher, institution, and contact details. Study/Procedure Overview:
Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms.