Details:This is a two-part assignment.Part 1-Create an informed consent form, 500-750 words,that you might use in practice. Find some examples or see the templates I have attachedPart 2 –Find someon

Research Ethics Review Committee

(WHO ERC)

20, avenue Appia – CH-1211 Geneva 27 – Switzerland – http://intranet.who.int/homes/rpc/erc – http://www.who.int/rpc/research_ethics

Informed Consent Form Template for

Clinical Studies

l C

(This template is for either clinical trials or clinical research)

(language used throughout form should be at the level of a local student of class 6th/8th)

Notes to Researchers:

1. Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.

2. The informed consent form consists of two parts: the information sheet and the consent certificate.

3. Do not be concerned by the length of this template. It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.

4. This template includes examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.

5. In this template:

• square brackets indicate where specific information is to be inserted

• bold lettering indicates sections or wording which should be included

• standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.

TEMPLATE ON FOLLOWING PAGE

[YOUR INSTITUTIONAL LETTERHEAD]

Please do not submit consent forms on the WHO letter head

[Name of Principle Investigator]

[Informed Consent form for ______________ _______]

Name the group of individuals for whom this informed consent form is written.Because research for a single project is often carried out with a number of different groups of individuals - for example healthcare workers, patients, and parents of patients - it is important that you identify which group this particular consent is for.

(Example: This Informed Consent Form is for men and women who attend clinic Z, and who we are inviting to participate in research on X. The title of our research project is "…………………………." )

You may provide the following information either as a running paragraph or under headings as shown below.

[Name of Principal Investigator]

[Name of Organization]

[Name of Sponsor]

[Name of Proposal and version]

This Informed Consent Form has two parts:

• Information Sheet (to share information about the research with you)

• Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction

Briefly state who you are and explain that you are inviting them to participate in the research you are doing. Inform them that they may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want to participate or not. Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions now or later.

(Example: I am X, working for the Y Research Institute. We are doing research on Z disease, which is very common in this country. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them of me, the study doctor or the staff.)

Purpose of the research

Explain in lay terms why you are doing the research. The language used should clarify rather than confuse. Use local and simplified terms for a disease, e.g. local name of disease instead of malaria, mosquito instead of anopheles, “mosquitoes help in spreading the disease” rather than “mosquitoes are the vectors”. Avoid using terms like pathogenesis, indicators, determinants, equitable etc. There are guides on the internet to help you find substitutes for words which are overly scientific or are professional jargon.

(Example: Malaria is one of the most common and dangerous diseases in this region. The drugs that are currently used to help people with malaria are not as good as we would like them to be. In fact, only 40 out of every 100 people given the malaria drug XYZ are completely cured. There is a new drug which may work better. The reason we are doing this research is to find out if the new drug ABX is better than drug XYZ which is currently being used.)

Type of Research Intervention

Briefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if they know from the very beginning whether, for example, the research involves a vaccine, an interview, a biopsy or a series of finger pricks.

(Example: This research will involve a single injection in your arm as well as four follow-up visits to the clinic. )

Participant selection

State why this participant has been chosen for this research. People often wonder why they have been chosen to participate and may be fearful, confused or concerned.

(Example: We are inviting all adults with malaria who attend clinic Z to participate in the research on the new malaria drug.)

• Example of question to elucidate understanding: Do you know why we are asking you to take part in this study? Do you know what the study is about?

Voluntary Participation

Indicate clearly that they can choose to participate or not. State, what the alternative - in terms of the treatment offered by the clinic - will be, if they decide not to participate. State, only if it is applicable, that they will still receive all the services they usually do whether they choose to participate or not. This can be repeated and expanded upon later in the form as well, but it is important to state clearly at the beginning of the form that participation is voluntary so that the other information can be heard in this context.

(Example: Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change. If you choose not to participate in this research project, you will offered the treatment that is routinely offered in this clinic/hospital for disease Z, and we will tell you more about it later. You may change your mind later and stop participating even if you agreed earlier.)

• Examples of question to elucidate understanding: If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study, if you do not wish to? Do you have any questions?

Include the following section only if the protocol is for a clinical trial:

Information on the Trial Drug [Name of Drug]

1) give the phase of the trial and explain what that means. Explain to the participant why you are comparing or testing the drugs.

2) provide as much information as is appropriate and understandable about the drug such as its manufacturer or location of manufacture and the reason for its development.

3) explain the known experience with this drug

4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects of all the other medicines that are being used in the trial

(Example: The drug we are testing in this research is called ABX. It has been tested before with people who do not have malaria but who live in areas where malaria is common. We now want to test the drug on people who have malaria. This second research is called a "phase 2" trial.

The drug ABX is made by Company C. You should know that it has a few side effects. One of the side effects, or problems, is that you may feel tired for the first day after being given the drug. Also, 20% of the people who tried the drug in previous research experienced temporary swelling where the injection entered the skin. We know of no other problem or risks.

Some participants in the research will not be given the drug which we are testing. Instead, they will be given the drug XYZ, the drug which is most commonly used in this region to treat malaria. There is no risk associated with that drug and no known problems. It does not, however, cure malaria as often as we would like.)

Procedures and Protocol

Describe or explain the exact procedures that will be followed on a step-by-step basis, the tests that will be done, and any drugs that will be given. Explain from the outset what some of the more unfamiliar procedures involve (placebo, randomization, biopsy, etc.) Indicate which procedure is routine and which is experimental or research.Participants should know what to expect and what is expected of them. Use active, rather than conditional, language. Write "we will ask you to…." instead of "we would like to ask you to….".

In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures and, secondly, a description of process.

A. Unfamiliar Procedures

This section should be included if there may be procedures which are not familiar to the participant.

If the protocol is for a clinical trial:

1) involving randomization or blinding, the participants should be told what that means and what chance they have of getting which drug (i.e. one in four chances of getting the test drug).

(Example:. Because we do not know if the new malaria drug is better than the currently available drug for treating malaria, we need to compare the two. To do this, we will put people taking part in this research into two groups. The groups are selected by chance, as if by tossing a coin.

Participants in one group will be given the test drug while participants in the other group will be given the drug that is currently being used for malaria. It is important that neither you nor we know which of the two drugs you are given. This information will be in our files, but we will not look at these files until after the research is finished. This is the best way we have for testing without being influenced by what we think or hope might happen. We will then compare which of the two has the best results.

The healthcare workers will be looking after you and the other participants very carefully during the study. If we are concerned about what the drug is doing , we will find out which drug you are getting and make changes. If there is anything you are concerned about or that is bothering you about the research please talk to me or one of the other researchers)

2) involving an inactive drug or placebo, it is important to ensure that the participants understand what is meant by a placebo or inactive drug.

(Example: A placebo or inactive medicine looks like real medicine but it is not. It is a dummy or pretend medicine. It has no effect on a person because it has no real medicine in it. Sometimes when we want to know whether a new medicine is good, we give some people the new medicine and some people the pretend or dummy medicine. For the research to be good, it is important that you do not know whether you have been given the real medicine or the pretend or dummy medicine. This is one of the best ways we have for knowing what the medicine we are testing really does.)

3) which may necessitate a rescue medicine, then provide information about the rescue medicine or treatment such as what it is and the criterion for its use. For example, in pain trials, if the test drug does not control pain, then intravenous morphine may be used as a rescue medicine.

(Example:. If we find that the medicine that is being used does not have the desired effect, or not to the extent that we wish it to have, we will use what is called a “rescue medicine.” The medicine that we will use is called QRS and it has been proven to control pain. If you find that the drug we are testing does not stop your pain and it is very uncomfortable for you, we can use the rescue medicine to make you more comfortable.)

If the protocol is for clinical research:

Firstly, explain that there are standards/guidelines that will be followed for the treatment of their condition. Secondly, if as part of the research a biopsy will be taken, then explain whether it will be under local anesthesia, sedation or general anesthesia, and what sort of symptoms and side effects the participant should expect under each category.

(Example: You will receive the treatment of your condition according to national guidelines. This means that you will be (explain the treatment). To confirm the cause of your swelling, a small sample of your skin will be taken. The guidelines say that the sample must be taken using a local anesthesia which means that we will give you an injection close to the area where we will take the sample from. This will make the area numb so that you will not feel any pain when we take the sample.)

For any clinical study (if relevant):

If blood samples are to be taken explain how many times and how much in a language that the person understands. It may, for example, be inappropriate to tell a tribal villager that blood equal to a wine-glass full will be taken but it may be very appropriate to use pictures or other props to illustrate the procedure if it is unfamiliar.

If the samples are to be used only for this research, then explicitly mention here that the biological samples obtained during this research procedure will be used only for this research, and will be destroyed after ____ years, when the research is completed. If the tissues/blood samples or any other human biological material will be stored for a duration longer than the research purpose, or is likely to be used for a purpose other than mentioned in the research proposal, then provide information about this and obtain consent specifically for such storage and use in addition to consent for participation in the study - (see last section)

(Example: We will take blood from your arm using a syringe and needle. Each time we will take about this much blood (show a spoon, vial or other small container with a small amount of water in it. In total, we will take about ……..this much blood in x number of weeks/months. At the end of the research, in 1 year, any left over blood sample will be destroyed.)

B. Description of the Process

Describe to the participant what will happen on a step-by-step basis. It may be helpful to the participant if you use drawings or props to better illustrate the procedures. A small vial or container with a little water in it is one way of showing how much blood will be withdrawn.

(Example: During the research you make five visits to the clinic.

• In the first visit, a small amount of blood, equal to about a teaspoon, will be taken from your arm with a syringe. This blood will be tested for the presence of substances that help your body to fight infections. We will also ask you a few questions about your general health and measure how tall you are and how much you weigh.

• At the next visit, which will be two weeks later, you will again be asked some questions about your health and then you will be given either the test drug or the drug that is currently used for malaria. As explained before, neither you nor we will know whether you have received the test or the dummy/pretend drug.

• After one week, you will come back to the clinic for a blood test. This will involve….)

Duration

Include a statement about the time commitments of the research for the participant including both the duration of the research and follow-up, if relevant.

(Example: The research takes place over ___ (number of) days/ or ___ (number of) months in total. During that time, it will be necessary for you to come to the clinic/hospital/health facility _______(number of) days , for ____ (number of) hours each day. We would like to meet with you three months after your last clinic visit for a final check-up.

In total, you will be asked to come 5 times to the clinic in 6 months. At the end of six months, the research will be finished.)

• Examples of question to elucidate understanding: Can you tell me if you remember the number of times that we are asking you to come to the hospital to complete the treatment? The research project? How many injections will you be given? How many tablets? How much blood will be taken from your veins, using a syringe and needle? Over how many weeks? Etc. Do you have any other questions? Do you want me to go through the procedures again?

Side Effects

Potential participants should be told if there are any known or anticipated side effects and what will happen in the event of a side effect or an unexpected event.

(Example: As already mentioned, this drug can have some unwanted effects. It can make you tired and it can cause some temporary swelling around the place where the injection goes into your arm. It is possible that it may also cause some problems that we are not aware of. However, we will follow you closely and keep track of any unwanted effects or any problems. We may use some other medicines to decrease the symptoms of the side effects or reactions. Or we may stop the use of one or more drugs. If this is necessary we will discuss it together with you and you will always be consulted before we move to the next step.)

Risks

Explain and describe any possible or anticipated risks. Describe the level of care that will be available in the event that harm does occur, who will provide it, and who will pay for it. A risk can be thought of as being the possibility that harm may occur. Provide enough information about the risks that the participant can make an informed decision.

(Example: By participating in this research it is possible that you will be at greater risk than you would otherwise be. There is, for example, a risk that your disease will not get better and that the new medicine doesn't work even as well as the old one. If, however, the medicine is not working and your fever does not go down in 48 hours we will give you quinine injections which will bring your fever down and make you more comfortable.

While the possibility of this happening is very low, you should still be aware of the possibility. We will try to decrease the chances of this event occurring, but if something unexpected happens, we will provide you with______.)

• Examples of question to elucidate understanding: Do you understand that, while the research study is on-going, no-one may know which medicine you re receiving? Do you know that the medicine that we are testing is a new medicine, and we do not know everything about it? Do you understand that you may have some unwanted side-effects from the medicines? Do you understand that these side-effects can happen whether or not you are in the research study? Etc. Do you have any other questions?

Benefits

Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation. Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides, and benefits to society as a whole as a result of finding an answer to the research question.

(Example: If you participate in this research, you will have the following benefits: any interim illnesses will be treated at no charge to you. If your child falls sick during this period he/she will be treated free of charge. There may not be any benefit for you but your participation is likely to help us find the answer to the research question. There may not be any benefit to the society at this stage of the research, but future generations are likely to benefit.)

Reimbursements

State clearly what you will provide the participants with as a result of their participation. WHO does not encourage incentives. However, it recommends that reimbursements for expenses incurred as a result of participation in the research be provided. These may include, for example, travel costs and money for wages lost due to visits to health facilities. The amount should be determined within the host country context.

(Example:. We will give you [amount of money] to pay for your travel to the clinic/parking and we will give you [amount] for lost work time. You will not be given any other money or gifts to take part in this research.)

• Examples of question to elucidate understanding: Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be re-imbursed? Do you have any other questions?

Confidentiality

Explain how the research team will maintain the confidentiality of data, especially with respect to the information about the participant which would otherwise be known only to the physician but would now be available to the entire research team. Note that because something out of the ordinary is being done through research, any individual taking part in the research is likely to be more easily identified by members of the community and is therefore more likely to be stigmatized.

(Example: With this research, something out of the ordinary is being done in your community. It is possible that if others in the community are aware that you are participating, they may ask you questions. We will not be sharing the identity of those participating in the research.

The information that we collect from this research project will be kept confidential. Information about you that will be collected during the research will be put away and no-one but the researchers will be able to see it. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. It will not be shared with or given to anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc].)

• Example of question to elucidate understanding: Did you understand the procedures that we will be using to make sure that any information that we as researchers collect about you will remain confidential? Do you have any questions about them?

Sharing the Results

Where it is relevant, your plan for sharing the information with the participants should be provided. If you have a plan and a timeline for the sharing of information, include the details. You should also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.

(Example: The knowledge that we get from doing this research will be shared with you through community meetings before it is made widely available to the public. Confidential information will not be shared. There will be small meetings in the community and these will be announced. After these meetings, we will publish the results in order that other interested people may learn from our research.)

Right to Refuse or Withdraw

This is a reconfirmation that participation is voluntary and includes the right to withdraw. Tailor this section to ensure that it fits for the group for whom you are seeking consent. The example used here is for a patient at a clinic.

(Example: You do not have to take part in this research if you do not wish to do so and refusing to participate will not affect your treatment at this clinic in any way. You will still have all the benefits that you would otherwise have at this clinic. You may stop participating in the research at any time that you wish without losing any of your rights as a patient here. Your treatment at this clinic will not be affected in any way.)

OR

(Example: You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.)

Alternatives to Participating

Include this section only if the study involves administration of investigational drugs or use of new therapeutic procedures. It is important to explain and describe the established standard treatment.

(Example: If you do not wish to take part in the research, you will be provided with the established standard treatment available at the centre/institute/hospital. People who have malaria are given….)

Who to Contact

Provide the name and contact information of someone who is involved, informed and accessible (a local person who can actually be contacted. State also that the proposal has been approved and how.

(Example: If you have any questions you may ask them now or later, even after the study has started. If you wish to ask questions later, you may contact any of the following: [name, address/telephone number/e-mail])

This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the IRB, contact [name, address, telephone number.]). It has also been reviewed by the Ethics Review Committee of the World Health Organization (WHO), which is funding/sponsoring/supporting the study.

• Example of question to elucidate understanding: Do you know that you do not have to take part in this study if you do not wish to? You can say No if you wish to? Do you know that you can ask me questions later, if you wish to? Do you know that I have given the contact details of the person who can give you more information about the study? Etc.

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

PART II: Certificate of Consent

This section should be written in the first person and have a statement similar to the one in bold below. If the participant is illiterate but gives oral consent, a witness must sign. A researcher or the person going over the informed consent must sign each consent. The certificate of consent should avoid statements that have "I understand…." phrases. The understanding should perhaps be better tested through targeted questions during the reading of the information sheet (some examples of questions are given above), or through the questions being asked at the end of the reading of the information sheet, if the potential participant is reading the information sheet him/herself.

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.

Print Name of Participant__________________

Signature of Participant ___________________

Date ___________________________

Day/month/year

If illiterate

A literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Print name of witness_____________________ AND Thumb print of participant

S

Date ________________________

Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1.

2.

3.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

 A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________

Day/month/year