Guidance for users of the Human Subject Information Template
Also referred to as SIS: Subject Information Sheet

Model for any type of study
This template information sheet can be used for any type of study. The template was designed for both interventional and observational research. All sections of the sheet also apply to observational research, although there is often less to report (see guidance for each individual section).
Examples of interventions: medicinal product (registered/not registered), medical device, food product, physiotherapy, medical intervention/surgical technique, behavioural therapy, psychosocial intervention.

Aim of Subject information sheet
The participation in medical research requires informed consent from the study subject. This is a process during which oral information, exchanging views and asking questions are very important. The written information is also part of this. The aim of the process and the written information is to give potential subjects sufficient information to enable them to take an informed decision on whether or not to participate in the study. To this end, the subject should be informed about the study and the interventions to be carried out. Nevertheless, this document is not intended as a detailed (day-to-day) guidance of the study protocol. The aim of the information sheet is not to safeguard the investigator from possible claims.

Guidance on typography: complete the template starting from the next page as follows for a specific study:
1.	Plain text should be used by default and should only be amended if it is incorrect for the study concerned.
2.	Replace [description/options] with the factual information OR choose the term most suitable to the nature of the study.
3.	Text marked EXAMPLE PASSAGE can be used as desired. Please note: this text often does not cover the content of the entire section.
4.	Sample text in table format: copy/move the desired text and then delete the table.
5.	Make sure that all aspects mentioned in the remark per section are addressed (if applicable)
6.	Finally, delete: 	- this page (explanation for users)
				- top line of the header
				- the comments
			- the text between <explanation> and any subsequent 
text 
				- any example passages that have not been used
				- any texts for special situations that has not been used

Numbering sections: Topics from the template sheet that are not applicable and are not relevant for the study subject can be omitted (please adjust the numbering in this case).

Subject information versus online medical research information
For an explanation or elaboration of terms, reference is sometimes made to the Central Government's website: www.rijksoverheid.nl/mensenonderzoek. Key issues such as voluntary participation, termination of participation, data handling and insurance should also be addressed in the subject information (see this template).

Perspective, length and language level
Perspective, length and language level must be in line with the purpose of the SIS: write from the subject's perspective (not the investigator's). Make sure the information sheet is concise and easy to read. Writing in this way is a profession in its own right. Use the expertise of a professional editor, information officer or communications officer where possible. Have your text proofread by a layperson who is not a content expert and preferably with a prevocational secondary education level (VMBO level).
The information sheet for the study subject should not exceed 4,000 - 5,000 words. This does not include the consent statement(s) and the following appendices: contact details, insurance text, schedule of study activities and, for example, additional information about the side effects or mode of action of the product or treatment to be investigated. The appendices should also be concise and easy to read.
The basic principle is that the sheet is written at B1 level. The standard and sample texts in this model comply with this requirement (tested by Bureau Taal). Exceptions are possible if the target group differs significantly from the 'average' Dutch population (for example, children under the age of 12 or higher - for whom separate templates are available -  professional education (HBO) or university students). 

This model was developed in collaboration with and is supported by the 'Vereniging Innovatieve Geneesmiddelen' ('Association of Innovative Medicines'), NFU, STZ, V&VN Research Professionals, ACRON, the Hart&Vaatgroep, the association of insurers, NVMETC and VWS. Please use the feedback form on the DCRF website to report inaccuracies or bottlenecks. General information about medical scientific research can be found on the website of the Dutch government at www.rijksoverheid.nl/mensenonderzoek.

Subject information for participation in medical research

[Lay study title]
Official title (in Dutch):

Introduction
Dear Sir/Madam,

With this letter, we would like to ask you to take part in a medical study. Participation is voluntary. <if applicable> You have received this letter because you have [disorder]/the doctor has found you have [clinical picture]/you will soon be undergoing [describe the procedure].
You can read about the medical study in this information sheet, what it means for you, and what the pros and cons are. It is a lot of information. Can you please read the information and decide if you want to take part? If you want to take part, complete the form in Appendix [X].

Ask your questions
You can take your decision based on the information in this information sheet. We also suggest that you do this:
- Put your questions to the investigator who gave you this information.
- Talk to your partner, family or friends about this study.
- < if applicable> Ask questions to the independent expert. For contact details, go to appendix A.  
- Read the information on www.rijksoverheid.nl/mensenonderzoek.

1.	General information
	Example passage	
Investigator-initiated	[Name of institution] has set up this study. Below, we always call [name of institution] the 'sponsor'. 
Investigators, these can be [Doctors/therapists/research nurses], conduct the study in different [hospitals/doctor's practices/…]	
Company is sponsor	 [name of company] has set up this study. Below, we always call [company name] the 'sponsor'. 
Investigators, these can be [Doctors/therapists/investigators/research nurses], conduct the study in different [hospitals/doctor's practices/…]. [Company name] pays for this research.	
<if a commercial party (also) pays for this study, you should mention this in this section>
Participants in a medical study are often called subjects. Subject can be healthy subjects as well as patients.
.

EXAMPLE PASSAGE This study needs [X subjects] from different countries. In the Netherlands, it is expected that [X subjects] will take part. END OF EXAMPLE PASSAGE
The Medical Ethics Review Committee [X] has approved this study. 

2. What is the purpose of the study?
< purpose description: select an example from the table, or describe it yourself>

Situation	Sample text	
Intervention research with a medicinal product	
Safety/Phase I	In this study, we look at how safe the new medicinal product [X] is when [healthy subjects/patients with [disorder]] use this medicinal product.	
Dose ranging	In this study, we look at how safe the new medicinal product [X] is. <if applicable> And how well it works. We are testing [X] in different strengths in [healthy subjects/patients with [disorder]].	
Effectiveness and safety

-	With placebo

-	With comparator	In this study, we look at how safe the new medicinal product [X] is for the treatment of [disorder]. And how well it works. 
We compare the effect of [medicinal product] with the effect of a placebo. A placebo is a product without the active ingredient: a 'fake medicinal product'.
OR
We compare the effect and safety of [medicinal product] with the effect and safety of [comparator]. [comparator] is already being used for the treatment of [disease].	
Intervention with a product other than a medicinal product (for example, food product/food ingredient, medical device, etc.)	
Medical device (MD)	See examples above for medicinal product research, but also:
- In this study, we look at how reliable the new [MD] is/how often it gives the right value. 
- In this study, we want to find out if subjects can use the new [MD] properly.
- In this study, we examine whether the [doctor/other care provider] can work well with the new [MD].
	
Effectiveness of food ingredient/product	In this study, we look at whether daily [eating/use of] [product/ingredient] can reduce [cholesterol/blood pressure/hunger/…] in [healthy subjects/people with overweight/slightly elevated…].	
Other type of research (examples)	
Surgical procedure	- There are 2 different techniques for [surgery]. In this study, we compare these 2 techniques/In this study, we want to find out with which technique [subjects recover the fastest/can go home the fastest/have the least pain/…]
- For [disorder], there are 2 possible treatments: 
- an operation
- [physiotherapy/...] 
In this study, we want to find out which treatment gives the best results after [… six months…]. 	
Physiotherapy	In this study, we compare 2 different physiotherapy treatments. 	
Behavioural therapy	In this study, we look at whether treatment [x] [reduces/lessens/increases/…] [anxiety disorder].	
Brain function (in children)	In this study we compare the functioning of the brain in 2 groups of children:
- children with behavioural problems
- children without any behavioural problems.	
Lung problems/function/exercise test (in children)	In this study, we compare the endurance of 2 groups of children: 
- [children with asthma]
- [children without asthma]	
	(for example, after RS virus infection)
In this study, we look at the effect of the infection on lung function after one year. We also look at whether there are differences between children who were and who were not on a ventilator during the infection.	
Measurement methods	In this study, we look at whether we can also use the [x-test] to measure the effects of stimulants.	
	In this study, we look at whether a blood test gives the same information as a food challenge test. [explain test in section 4, for example: If you take a food challenge test, you will be given the food that gives you symptoms. You will be given a little more of the food every time. We will keep a close eye on you.]	

3.	What is the background of the study?

<background description>

4.	What happens during the study?

How long will the study take?
Are you taking part in the study? It will take about [X weeks/months] in total.

Step 1: are you eligible to take part? 
First, we want to know if you are eligible to take part. That is the reason that the investigator is doing some checks: EXAMPLES (use if applicable)
-	Physical examination. For example, the investigator can listen to your heart and lungs and measure your blood pressure and heart rate. 
-	Blood test. The investigator will take some blood from you. We test blood for [HIV and hepatitis B]. We will tell you if you have any of these diseases. 
-	Heart ultrasound. 
-	Checking your [medical history/race/ethnicity/...]

<for healthy subjects> Please note: it is possible that you are not eligible for this study, even if you are healthy. The investigator will tell you more about this.

[Step 2: the treatment/the operation/the use of…/]
EXAMPLE PASSAGE We will treat you for [x weeks] with study medication /you will use [product] for [x weeks]. 

<if applicable> For this study, we will have 2 groups:
•	Group 1. The people in this group will get [treatment x].
•	Group 2. The people in this group will get [treatment y]. 

<in case of randomised research>A draw will decide which [treatment] you are given. <in case of blinded research> You and the investigator do not know which group you are in. But if it is important for your health, we can look this up. 

Step 3: study and measurements
EXAMPLE PASSAGE For the study, you need to visit [the investigator/research centre/hospital/...] [X] times in [X weeks/months]. A visit lasts [X minutes/hour/X to approximately X hours]. 
We will carry out these checks <mention the most frequent/important checks, for other checks refer to the appendix>: 
-	Physical examination. For example, the examiner may listen to your heart and lungs and measure your blood pressure.
-	Heart ultrasound (ECG).
-	Blood test. For this, the investigator takes X tubes of blood at a time. In total, we will collect [XX ml] of blood from you. <if applicable> This amount does not cause any problems in [adults]. For comparison: if you give blood at the blood bank, you will give 500 ml of blood at a time. With the blood test, we test these things: <don't mention all analyses, but, for example> 
o	Does your blood take up [...] well? /
o	What has been the effect of […]? 
o	Do you have any side effects from [...]? 
-	You fill in a questionnaire. The questions are about […].
Appendix C has a list of the [treatments/measurements] we carry out during each visit. 
OR 
The investigator will call you [X] times in total. You will be asked questions about [...]. This telephone call will take around [...]. 
OR 
We will send you a questionnaire [X] times. The questions are about […]. It will take you around [X minutes] to complete this questionnaire. 

<if applicable> Step 4: follow-up check

What is the difference with standard care? 
EXAMPLE PASSAGE This study is not very different from standard care OR Normally, you might see your doctor once every 2 months to check your [condition]. Your doctor [would then take 1 tube of blood (XX ml)/examine your…/make…]. The checks during this study replace these checks by your doctor/are extra. 

5.	What agreements do we make with you? 
We want the study to go well. That is why we want to make the following agreements with you <use if applicable>:
•	You take the medicine/do the exercises/…] in the way the investigator explained to you. 
•	You do not take part in any other medical research during this study.
•	You go to every appointment.
•	You carry the participant card of the study with you. In your wallet, for example. It states that you are taking part in this study. And who should be warned in an emergency. Show this card when you visit [another] doctor.
•	You should contact the investigator in these situations: 
o	You want to start taking other medication. Also, if these are homoeopathic remedies, natural remedies, vitamins or over-the-counter medicines. 
o	You are hospitalised or get treatment in a hospital.
o	You suddenly have problems with your health.
o	You no longer want to take part in the study.
o	Your telephone number, address or email address changes. 

EXAMPLE PASSAGE <split up into text for women and text for men if necessary > 
Is it OK for you or your partner to get pregnant during the study?
Women who are pregnant or breastfeeding cannot take part in this study. Women should also not get pregnant during the study. Are you male and do you have a female partner? Then you need to make sure that she cannot become pregnant with your child. 

This study can have consequences for an unborn child. [if known, state consequences] OR The consequences are not known. 
The investigator will tell you how best to prevent pregnancy. Talk to your partner about this. 

Pregnant after all?
If you do become pregnant during the study, inform the investigator immediately. In this case, you should stop participating in the study as soon as possible in consultation with the investigator. AND/OR Did your partner become pregnant with your child during the study? Ask her permission to let the investigator know. Then the pregnancy can be monitored more closely and information about the course and outcome of the pregnancy can be requested from other healthcare providers. But only if you/your pregnant partner give permission for this. [Finally, we report the pregnancy to the sponsor of this research].

<If applicable> ‘ Pregnant after the study?’
EXAMPLE PASSAGE The investigator will discuss with you whether taking part in the study may have consequences if you want to become pregnant later. 

6.	What side effects, adverse effects or discomforts could you experience? 
[The medicinal product/procedure/therapy to be investigated] may cause [side effects/adverse effects]. 
EXAMPLE PASSAGE <if dangerous/urgent side effects are to be expected>
Please note: notify the investigator immediately if you experience:
- …
- …
- …

The following side effects are common:
-	…
-	…
<if there is advice on relief of side effects, please mention this with the side effect, i.e. 'it may help to...'> 

The following side effects are rare and can be serious: [rare or possible side effects that can be serious and/or for other reasons influence the decision to participate]. 
<if there is advice on relief of side effects, please mention this with the side effect, i.e. 'it may help to...'> 
 
[The medicinal product/surgery/therapy we are investigating] can also have [side effects] that we do not know about at the moment. 

<if it is about a registered product> More information about [product] can be found in the information leaflet, see appendix [X] OR Are you taking part in the study? Then you will receive the information leaflet with the medicinal product.

<optional, if many side effects to be described, or much explanation is required, or if applicable in case of very rare side effects>
…. You can read more about this in appendix [X] 

[Comparator] <if applicable>
[Comparator] can also have side effects. The most important ones are:
< mention the most important/most likely side effects>
You can find more information about the [comparator] in the leaflet, see appendix [X] OR Are you taking part in the study? Then you will receive the information leaflet with the medicinal product.

What are the possible discomforts you may experience with checks or measurements during the study? <state the most important discomforts and refer to the appendix for  other discomforts >
-	… For example: taking a blood sample can be a little painful. Or you could get a bruise as a result.
-	….

EXAMPLE PASSAGE What are the cons of research that uses radiation? 
For [fill in test CT scan, PET, ...], we use [X-rays and/or radioactive materials]. In this study, you will get around [XX] mSv of radiation in total. For comparison: the standard radiation that everyone in the Netherlands is subject to, is about ~2.9 mSv per year. It is not dangerous if you have to have an examination or treatment with radiation for a medical reason.
•	If you have other checks involving radiation, you should discuss with the investigator if it is wise for you to participate 
•	The radiation we use during the study may cause damage to your health. But this is a small risk. We do, however, advise you not to take part in another medical study involving radiation in the near future. 

7.	What are the pros and cons if you take part in the study?
Taking part in the study can have pros and cons. We will list them below. Think about this carefully and talk to other people about it. 

Situation	Example text (advantage)	
No benefit for healthy subject	You yourself do not benefit from taking part in this study. But if you take part you will help the investigators to get more insight into [the treatment of [disease/disorder]/the effects of/...]. /
But if you take part you will help in the search for a better treatment for ...	
No benefit for subject	If you participate in this research, it does not mean that [your disease will be cured/you will suffer less from your disease/…]. But if you take part you will help the investigators to get more insight into the treatment of [disease/disorder]/the effect of/...]. /But if you take part you will help in the search for a better treatment for ...	
Possible benefit for subject	[the medicinal product/therapy/...] may [name concrete beneficial effect, such as lowering blood pressure/reducing abdominal complaints/etc.], but that is not certain.
<if applicable, add>
[Your disease/your symptoms] may come back or get worse at any time during this study.	

Taking part in the study can have these cons: : <use if applicable>
-	You may experience side effects or adverse effects of [the intervention].
-	There may be some discomfort from the measurements during the study. 
-	Taking part in the study will cost you extra time.
-	You need to be hospitalised. Or longer than usual. 
-	You have to comply with the study agreements. 
-	<if applicable> It is possible that a coincidental finding is made [during the study/during an MRI scan/during a genetic examination/other] that is not directly related to the research, but does concern your health or that of your family members. Please go to section 10 for more information on coincidental findings.

You do not wish to participate in the study? 
It is up to you to decide if you wish to participate in the study. You do not wish to participate? <if applicable> Then you will receive the standard treatment for [illness/disorder]. <if there is a clear standard treatment, name it, if not:> Your doctor can tell you more about the available options for treatment. And about the pros and cons.
 
8.	When does the study end?
The investigator will let you know if there is any new information about the study that is important to you. The investigator will then ask you if you want to continue to take part.

In these situations, the study will stop for you:
•	All checks according to the schedule are finished. 
•	The end of the whole study has been reached <if applicable, so if the study continues until an end point has been reached, do explain this here, for example: so many cases of Y>
•	You have become pregnant.
•	You want to stop participating in the study yourself. You can stop at any time. Report this to the investigator immediately. You do not have to explain why you want to stop. You will then get the standard treatment for [illness/disorder] again. The investigator will still invite you for a follow-up check OR For your safety, the investigator may arrange one or more check-ups. 
•	The investigator thinks it is better for you to stop. The investigator will still invite you for a follow-up check.
•	One of the following authorities decides that the study should stop:
o	[sponsor name],
o	the government, or
o	the Medical Ethics Review Committee assessing the study

What happens if you stop participating in the study?
The investigators use the data and body material (give an appropriate example of blood/tissue sample/…) that have been collected up to the moment that you decide to stop participating in the study. <if applicable> If you wish, we will destroy the collected body material. Please let the investigator know. 

<if applicable> The entire study ends when all the participants have finished.

9.	What happens after the study has ended?

Can you continue taking the medicinal products?
<if applicable> You [can/cannot] continue to use the medicinal products you were taking during the study after the study has finished. The investigator will discuss with you what other medical care you will get. 

Will you get the results of the study?
About [term] after the study has ended, the investigator will inform you about the most important results of the study. The investigator may also tell you [which treatment you have had/what group you were in]. Do you prefer not to know? Please tell the investigator. He/she will not tell you in that case.

10.	What will be done with your data <if applicable> and body material?
Are you taking part in the study? Then you also give your consent to collect, use and store your data <if applicable> and body material. 

What data do we store?
We store these data <use if applicable and complete if necessary>:
- your name
- your gender 
- your address
- your date of birth
- information about your health
- (medical) information that we collect during the study

<if applicable> What body material do we store?
We collect, use and store [tubes of blood/tissue samples (biopsies)/other]. 

Why do we collect, use and store your data <if applicable> and body material?
We collect, use and store your data <if applicable> and your body material to answer the questions of this study. And to be able to publish the results. <if applicable>  Data and/or body material can be used by the sponsor and companies that help the sponsor with [the practical performance/ the analysis of data/ measurements on tissue samples/ …]  <if applicable> We also need these data and the material to be able to market the investigated medicinal product.

How do we protect your privacy?
To protect your privacy, we give a code to your data <if applicable> and your body material. We only put this code on your data <if applicable> and body material. We keep the key to the code in a safe place in [the hospital/doctor's practice/research centre]. When we process your data and body material, we always use only that code. Even in reports and publications about the study, nobody will be able to see that it was about you.

Who can see your data?
Some people can see your name and other personal information without a code. This could include data specifically collected for this study, but also data from your medical file.  These are people checking whether the investigators are carrying out the study properly and reliably. These persons can access your data:
•	Members of the committee that keeps an eye on the safety of the study.
•	An auditor who is hired by the [investigator/sponsor]. OR An auditor who works for the [investigator/sponsor]. 
•	National and international supervisory authorities. 
•	[other]
These people will keep your information confidential. We ask you to give permission for this access. The Health and Youth Inspectorate can access your personal information without your permission. 

For how long do we store your data and body material?
We store your data [in the hospital/doctor's practice/research centre] for […] years. <if applicable> And for […] years with the sponsor. 
We store your body materials [in the hospital/research centre/…]. They will be stored for [xx] years in order to be able to make new assessments related to this study in the course of this study. If no longer needed, we will destroy your body material. 
OR Your [blood and tissue] will be destroyed immediately after use. 

<if applicable> Can we use your data and body material for other research?
Your collected data <if applicable> and your (remaining) body material may also be important for other medical research on [your condition and/or the further development of the product/treatment method]. For this purpose, your data <if applicable> and body material will be stored [in the hospital/research centre/...] for [...] years. Please indicate in the consent form whether you agree with this. Do you not want to give your consent? Then you can still take part in this study. You will get the same healthcare.

<If applicable> What happens if there are coincidental findings? 
It is possible that during the study we discover something that is not directly relevant to the study but is important to your health <if applicable> or to the health of your family members. In that case, the investigator will contact your [doctor, specialist, other]. You will then discuss what needs to be done with your doctor or specialist. The cost of this will fall under your own insurance policy. With the form, you give consent to inform your doctor or specialist. 

Can you take back your consent for the use of your data?
You can take back your consent for the use of your data at any time. Please tell the investigator if you wish to do so. <in case of other research This applies both to the use in this study and to the use in other medical research>. But please note: if you take back your consent, and the investigators have already collected data for research, they are still allowed to use this information. <if applicable> The investigators will destroy your body material after you take back your consent. But if assessments with your body material have been carried out, the investigator can continue to use the results. 

<If applicable> We send your data to countries outside the European Union
In this study, we will send your coded data <if applicable> and body material also to countries outside the European Union. The privacy rules of the European Union do not apply in those countries. Choice> But your privacy will be protected at a similar level. OR We ask your permission for this. 

Do you want to know more about your privacy?
•	Do you want to know more about your rights when processing personal data? Visit www.autoriteitpersoonsgegevens.nl.
•	Do you have questions about your rights? Or do you have a complaint about the processing of your personal data? Please contact the person who is responsible for processing your personal data. For the present, this is: 
o	<For investigator-initiated research> [Institution name] See Appendix A for contact details, and website.
o	<In case of sponsor-initiated research> [Name of sponsor and institution] See Appendix A for contact details and website(s).
o	<if applicable> Because the sponsor is located outside the EU, [name of representative] has been appointed to act as its representative. For contact details, see Appendix A.
•	If you have any complaints about the processing of your personal data, we recommend that you first discuss them with the research team. You can also contact the Data Protection Officer of [the institution]. Or you can submit a complaint to the Dutch Data Protection Authority. 

Where can you find more information about the study? 
You can find more information about the study on the following website (s). EXAMPLE www.onderzoekmetmensen.nl, www.ClinicalTrials.gov and/or https://euclinicaltrials.eu/ . After the study, the website may show a summary of the results of this study. You can find the study by searching for '....' (number: XXX) 

11.	Will you receive compensation if you participate in the study?
EXAMPLE PASSAGE The [study medication, additional testing and treatment] for the study will not cost you anything. Neither will you get any compensation if you take part in this study. But you will be paid for your (extra) travel expenses. OR You will get an expense allowance of € [xx/xx per visit] for taking part in this study. You will also be paid for your travel expenses. <if applicable> The compensation for taking part in this study may need to be declared to the Tax and Customs Administration as ‘income from other resources’. If necessary ask the Taxservices. 

12.	Are you insured during the study?

Situation	Standard text	
Insurance taken out	Insurance has been taken out for everyone who takes part in this study. The insurance pays for damage caused by the study. But not for all damage. You can find more information about this insurance and any exceptions in Appendix B. It also says who you can report damage to.	
The sponsor is a government agency without an insurance obligation	[name of the sponsor] will pay for the damage caused by the study. But not all damage. You can find more information about damage and any exceptions in Appendix B. It also says who you can report damage to.	
When comparing 2 standard treatments and obtained exemption from the insurance obligation	You are not additionally insured for this study. Because if you participate in the study, you run the same risks as with the standard treatment of your [illness/disease]. That is why the [sponsor/investigator] of the [review committee] does not have to take out additional insurance.	
In case of no risk and obtained exemption from the insurance obligation	You are not additionally insured for this study. Because taking part in the study has no additional risks. That is why the [sponsor/investigator] of the [review committee] does not have to take out additional insurance.	

13.	We will inform your [doctor and/or attending specialist and/or pharmacist].
The investigator will send your [doctor and/or attending specialist and/or pharmacist] a [letter/email] to let them know that you are taking part in the study. This is for your own safety. <If applicable– ad-hoc situations> [situation] we may contact your [(doctor], for example, about [your medical history or the medication you are taking]. 

<other information exchange, if applicable> 

14.	Do you have any questions?
You can ask questions about the study of [the investigator/research team]. <if applicable> Would you like to get advice from someone who is independent  from the study? Then contact the independent expert, for contact details go to appendix A. [He/she] knows a lot about the study, but is not a part of this study. 
Do you have a complaint? Discuss it with the investigator or the doctor who is treating you. If you prefer not to do so, please visit [complaints officer/complaints committee of your hospital/institute/Dutch Data Protection Authority/other]. Appendix A tells you where to find this. 

15.	How do you give consent for the study?
You can first think carefully about this study. Then you tell the investigator if you understand the information and if you want to take part or not. If you want to take part, fill in the consent form that you can find with this information sheet. You and the investigator will both get a signed version of this consent form.

Thank you for your attention.

Texts for special situations 

Situation	Insertion point	Example passage	
Participation of children and/or legally incapable subjects	After point 7, as a separate section
(adjust numbering of subsequent sections)	Resistance from [your child/the person you represent] 
It is possible that [your child/the person you represent] resists (does not cooperate) at some point during the study. The investigator must immediately stop the study if this happens. It is difficult to describe exactly what resistance means. Before the start of the study, we will discuss with you what we see as resistance. 
The investigator will follow the rules of the Code of Conduct for resistance [minors/mentally handicapped/geriatric patients].	
Studies with healthy subjects	End of introduction	<in case of VIP check> You are allowed to take part in a (medicinal product) study up to 4 times a year. And only 1 study at a time. We check this in a central system that is also connected to other research institutes. The information in this system is protected. 	

16.	Appendices to this information
A. 	Contact details <to be adjusted per participating centre>
B. 	Information about the insurance <mandatory, unless exemption has been obtained>
C. 	Schedule of study interventions/description of study interventions or overview of measurements 
[D and further]. <other, for example, more information about how the intervention works, or other possible treatment options, or more information about side effects>
[X] 	<other, for example, an existing brochure about a measurement/invasive procedure/donorship to be performed (with version indication)> <to be handed over separately> 
[X]	Consent form(s) <select correct model(s)>

Appendix A: contact details for [name of participating centre]

[Investigator]: [for principal investigator of centre: name, contact details and accessibility]

< if applicable> 
 [Study nurse/study doctor/nurse specialist]: 

<if applicable> Independent expert [: [name, type of doctor/expert, contact details and accessibility]

Complaints: [service or person with contact details and accessibility]

Data Protection Officer of the institution: 

<if applicable> Data Protection Officer of the Sponsor: 

For more information about your rights: [Contact details [including website] of the person(s) responsible for processing personal data]:

<if applicable, to be supplemented with, for example, a coordinating investigator and/or an emergency number/24-hour availability> 

Appendix B: information about the insurance

The [sponsor/other] has taken out insurance for everyone who takes part in the study. The insurance pays for the damage you have suffered because you participated in the study. This concerns damage you suffer during the study or within 4 years after you participated in the study. You must report damage to the insurer within 4 years. 

Have you suffered damage as a result of the study? Please report this to this insurer: 
<also indicate here how subject should act/report in the event of damage: telephone/mail/post, other instructions?

The insurer of the study is:
Name insurer:	…
Address:	…
Telephone number: 	…
Email:	…
(Policy number:	…)

< include only if there is a claims representative – this is compulsory if the insurer is established outside the Netherlands>
The claims representative of the study is:
Name:		…
Address:		…
Email:
Telephone number:	…

The insurance pays a maximum of <amount to be copied from policy, this must be at least €650,000 > per person and <amount to be copied from policy, this must be at least €5,000,000> for the entire study (and <amount to be copied from policy, this must be at least € 7,500,000> per year for all studies by the same sponsor). 

Please note that the insurance does not cover the following damage:
•	Damage due to a risk about which we have given you information in this sheet. But this does not apply if the risk turned out to be greater than we previously thought. Or if the risk was very unlikely.
•	Damage to your health that would also have happened if you had not taken part in the study.
•	Damage that happens because you did not follow directions or instructions or did not follow them properly.
•	<if applicable> Damage to the health of your children or grandchildren.
•	Damage caused by a treatment method that already exists. Or by research into a treatment method that already exists. 

These provisions can be found in the 'Besluit verplichte verzekering bij medisch-wetenschappelijk onderzoek met mensen 2015' ('Medical Research (Human Subjects) Compulsory Insurance Decree 2015'). This decision can be found in the Government Law Gazette (https://wetten.overheid.nl).

Appendix C: Diagram of study interventions and/or overview of measurements/description of study interventions <optional>

If necessary, in addition to the main text, a simple (time) schedule or a point-by-point description of measurements/interventions in layman's terms.

(If there is a standard treatment for which the subject is eligible, add a comparative table for the experimental therapy and the standard treatment (with probability of success, side effects, risks and burden) if necessary.

Appendix D –<optional>

Appendix E - Side Effects, Adverse Effects and Discomforts <optional>

Appendix [X]: Informed consent form – subject
Belonging to
[Short title of the study as stated on page 1 of the information sheet]

−	I have read the information sheet. I was able to ask questions. My questions have been answered well enough. I had enough time to decide if I wanted to take part.
−	I know that taking part is voluntary. I also know that at any time I can decide not to take part in the study. Or to stop taking part. I do not have to explain why.
−	I give the investigator consent to inform my [doctor/specialist (s) who treats me/pharmacist/...] that I am taking part in this study. 
−	<if applicable>: I give consent to request information from my [doctor/specialist (s) treating me/...] about [...]. 
−	<if applicable> I give consent to give my doctor or specialist information about accidental discoveries made during the study that are important for my health. 
−	I give consent to collect and use my [data and/or body material]. The investigators only do this to answer the question of this study. <if applicable> And to register the medicinal product. 
−	I know that some people will be able to see all of my data to review the study. These people are mentioned in this information sheet. I give consent to let them see my data for this review. 
−	I know that my coded data <if applicable> and body material will also be sent to countries outside the European Union where the privacy rules of the European Union do not apply. Choice> I know that a similar level of privacy protection is arranged. OR I consent to this.
−	<if applicable> I know that I [cannot get pregnant/cannot get my partner pregnant] during the study [and until xx after xx].
−	<if applicable> The investigator discussed with me how I can best prevent [becoming pregnant/my partner from becoming pregnant].

−	Please tick yes or no in the table below.
<if applicable> I give consent to store my data to use for other research, as stated in the information sheet. 	Yes ☐	No☐	
<if applicable> I give consent to have my (remaining) body material
 stored for use in other research, as stated in the information sheet. The body material is stored for this purpose for another [xx] years.	Yes ☐	No☐	
<if applicable> I give consent to ask me after this study if I want to participate in a follow-up study.	Yes ☐	No☐	
<if applicable> I give consent to let me know after the study which treatment I received/in which group I was. 	Yes ☐	No☐	

-	I want to take part in this study.

My name is (subject): ………………………………..		
Signature: ………………………				Date	: __/__/__

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I declare that I have fully informed this subject about the study mentioned.

If any information becomes known during the study that could influence the subject's consent, I will let this subject know in good time. 

Investigator name (or their representative): ........................
Signature:………………………				Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

<if applicable>
Additional information was given by: 
Name:………………………………..
Job title:………………………………
Signature:………………………				Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

The study subject will receive a complete information sheet, together with a signed version of the consent form.

Appendix [Z]: Informed consent form - Parent , carer or guardian
Belonging to
[Short title of the study as stated on page 1 of the information sheet]

I have been asked to give consent for my child to participate in this medical study:

Name of subject (child):	……………………..		

-	I have read the information sheet for subjects/parents/guardians. I was able to ask questions. My questions have been answered well enough. I had enough time to decide if I want my child to take part.
-	I know that taking part is voluntary. I also know that I can decide at any time that my child will not take part after all. I do not have to explain why. 
-	I give consent to inform my [doctor/specialist (s) who treats my child/pharmacist/...] that my child is taking part in this study. 
-	<if applicable> I give the consent to request information from the [doctor/specialist (s) treating my child/...] about [...]. 
-	<if applicable> I give consent to give my child's doctor and/or specialist information about accidental discoveries made during  the study that are important for my child's health. 
-	I give consent to collect and use my child's [data and/or body material]. The investigators only do this to answer the question of this study. <if applicable> And to have the medicinal product registered. 
-	I know that some people will be able to see all of my child's data to review the study. These people are mentioned in this information sheet. I give consent to let these people see my child's data for this review. 
-	I know that my child’s coded data <if applicable> and body material will also be sent to countries outside the European Union where the privacy rules of the European Union do not apply. Choice> I know that a similar level of privacy protection is arranged. OR I consent to this.
-	<if applicable> I know that my child [cannot become pregnant/cannot get his partner pregnant] during the study [and until xx after xx]. The investigator discussed with my child [how she can best prevent becoming pregnant/how he can best prevent his partner from becoming pregnant]. 
-	Please tick yes or no in the table below.
<if applicable> I give consent to have my child's data stored for use in other research, as stated in the information sheet. 	Yes ☐	No☐	
<if applicable> I give consent to have my child's (remaining) body material stored for use in other research, as stated in the information sheet. The body material is stored for this purpose for another [xx] years.	Yes ☐	No☐	
<if applicable> I give consent to ask my child after this study if he/she wants to participate in a follow-up study.	Yes ☐	No☐	
<if applicable> I give consent to inform us after the study what treatment my child received/in which group my child was. 	Yes ☐	No☐	

-	I agree that my child takes part in this study.

Parent/guardian name**: ………………………………			
Signature:	…………………………………             	Date: __/__/__
Other parent/guardian name**: …………………….		
Signature: ………………………………………		Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

I declare that I have fully informed the person(s) mentioned above about the said study.

If any information becomes known during the study that could influence the parent/guardian's consent, I will let them know in good time.

Investigator name (or their representative): …………………………				
Signature: ………………………				Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

<if applicable>
Additional information was given by: 
Name: ………………………………………..
Job title: ………………………………………					
Signature: ……………………………….			Date: __/__/__

-----------------------------------------------------------------------------------------------------------------
	
* 	Delete what is not applicable.
** If the child is younger than 16, the parents who exercise custody or the guardian will sign this form. Children between the ages of 12 and 15 who are able to make independent decisions (are able to give informed consent) must also sign a form themselves. 

The parent/guardian will receive a complete information sheet, together with a signed version of the consent form.

Appendix [Z]: Informed consent form - Representative
Belonging to
[Short title of the study as stated on page 1 of the information sheet]

I have been asked to give consent for the following person to take part in this medical study:

Subject’s name:	……………………..		

-	I have read the information sheet for subjects/representatives. I was able to ask questions. My questions have been answered well enough. I had enough time to decide if I want this person to take part.
-	I know that taking part is voluntary. I also know that I can decide at any time that this person will not take part after all. I do not have to explain why. 
-	I give consent to inform the [doctor/specialist (s) who treats this person/pharmacist/...] that this person is taking part in this study. 
-	<if applicable> I give consent to request information from the [doctor/specialist (s) treating this person/...] about [...]. 
-	<if applicable> I give consent to inform this person's doctor and/or specialist about accidental discoveries made during the study that are important for this person's health. 
-	I give consent to collect and use this person's [data and/or body material]. The investigators will only do this to answer the question of this study. <if applicable> And to have the medicinal product registered. 
-	I know that some people will be able to see all of this person's data to review the study. These people are mentioned in this information sheet. I give consent to let these people see this person's data for this review. 
-	I know that the coded data <if applicable> and body material of this person will also be sent to countries outside the European Union where the privacy rules of the European Union do not apply. Choice> I know that a similar level of privacy protection is arranged. OR I consent to this.
-	<if applicable> I know that this person [cannot become pregnant/cannot get his partner pregnant] during the study [and until xx after xx]. The investigator has discussed with me how this person can best prevent pregnancy
-	Please tick yes or no in the table below.
<if applicable> I give consent to have this person's data stored for use in other study, as stated in the information sheet. 	Yes ☐	No☐	
<if applicable> I give consent to have this person's (remaining) body material stored for use in other research, as stated in the information sheet. The body materials are stored for this purpose for another [xx] years.	Yes ☐	No☐	
<if applicable> I give consent to ask this person after this study if he/she wants to participate in a follow-up study.	Yes ☐	No☐	
<if applicable> I give consent to let us know after the study what treatment this person received/in which group this person was. 	Yes ☐	No☐	

-	I agree that this person takes part in this study.

Name of legal representative: ........................................................................			
Relationship to the subject: ……………………………………
Signature:	…………………………………             	Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

I declare that I have fully informed the person(s) mentioned above about the said study.

If any information becomes known during the study that could influence the representative's consent, I will let them know in good time.

Investigator name (or their representative): ........................
Signature: ……………………				Date: __/__/__

-----------------------------------------------------------------------------------------------------------------

<if applicable>
Additional information was given by: 
Name:……………………………………..
Job title:……………………………………					
Signature:…………………………….			Date: __/__/__

-----------------------------------------------------------------------------------------------------------------
	
* 	Delete what is not applicable.

The representative will receive a complete information sheet, together with a signed version of the consent form.