Informed Consent Form brief introduction and its Template

Informed Consent Form Template

STUDY TITLE…

 ‘The research institution’s name … ‘ is (type of) organisation that carries out medical research. Research is different from normal treatment because research aims to find better ways of preventing and treating illness in the future for everybody’s benefit. We are asking your permission for you/your child to participate in a research study.

·         What is this research about?

You/ Your child has [XXX]/[XXX] is a common and serious illness in this area. In this research we aim to find out [explain basic research question e.g.] whether a new (drug/vaccine/intervention) will work as well and be as safe as the one currently recommended in  xxxx. In research so far, the new drug/vaccine/intervention [XXX] has been shown to work at least as well, and to be as safe, as the currently recommended one, [XXX] [or similar for vaccines/interventions]. Both are given by injection/tablet/XX.

In this research we will give [XXX] children/adults [explain selection e.g] who attend this clinic/live in this area the new drug/vaccine and [XXX] children/adults the normal drug/vaccine for [disease name]. We will find out if there is any difference between these drugs/vaccines by closely watching the progress of everyone in this study. The decision on which person/child gets which drug/vaccine will be decided by a system based on chance, not by any of the research team. [Where study is blind or explain if diifferent] To make sure the findings of this study are accurate, it is important that no one knows which person/child is receiving which drug/vaccine until the end of the research.

What will it involve for me/my child?

1.      [Where 1st sample taken is equivalent to standard care] We will use a small amount of the blood that has been/will be taken as part of your/your child’s normal treatment to find out if it is possible for you/them to participate in this research. This extra amount will be less than ½ tsp (2ml).

[Where 1st sample taken is not equivalent to standard care] We will take a small sample of blood from you/your child to find out why you/they are sick; [explain research reasons for this sample] how your/their body is reacting to XXX disease; and if it is possible for them to participate in this research. This sample will be less than half a tsp (2ml) and will be taken from your/your child’s arm.

2.      If you/your child fits the requirements of this research, we will give you/them either the new drug/vaccine [XXX] or the normal drug/vaccine [XXX]

3.      [Explain follow up procedures, including number, timing and place of follow up visits; type, amount and site of sample removal; and any other procedures] We will check/visit you/your child after xx days at this clinic/home to assess your/their progress. This will include taking another small sample of blood (less than half a teaspoon of blood) from your/your child’s arm.  Altogether we expect the trial to  have X visits for you/your child and take x months.

Are there any risks or disadvantages to me/my child of taking part?

[XXX] has been shown to be safe (if this is true so any known/frequently occurring adverse effects must be explained here) and to work in all the research already done in other places. However there is a very small chance that there may be a reaction we do not expect, but we will be monitoring your child very closely and it is considered to be unlikely. If we learn anything new about [XXX] during this study, we will tell you. If for any reason the doctors thinks you/your child should not be in the trial for you/their best interest then you/they will be taken out and given normal standard of care.

Are there any benefits to me/my child of taking part?

The benefits for you/your child taking part are that they/you get close observation during the trial and in taking part you/your child may help us improve the care of children/adults who have xxx  in the future. [Explain any other benefits such as treatment during follow up but explain terms of access to treatment and care]

You will be asked to bring your child back for follow up at this clinic [where relevant], but we will pay for the costs of your transport for this visit. Follow up visits will take some of your time. [Explain any other /costs/re-embursements]

What will happen if I don’t agree to participate?

All participation in research is voluntary. You are free to decide if you want/you want your child to take part or not. You/your child will still receive the recommended standard of care if you/they do not take part. If you do agree you can change your mind at any time and withdraw your child from the research. This will not affect your/their care now or in the future.

What happens to the samples?

[Explain reasons for export] Some of the tests that are needed as part of this research cannot be done in xxxx  at the moment, so part of the samples will be sent to laboratories abroad for these tests.  [Explain archiving] After the research has been done, a small portion of the blood/other samples will be stored. In the future, new research may be done on these samples about [XXX illness, or indicate if any illness]. Future research must first be approved by a national independent expert committee in Nairobi to ensure that participants’ safety and rights are respected. Individual names will be removed and replaced by codes, so that information cannot be linked to the participants.

Who will have access to information about me/my child in this research?

All our research records are stored securely in locked cabinets and password protected computers. Only a few people who are closely concerned with the research will be able to view information from participants.

Who has allowed this research to take place?

All research at XXX is approved by national independent expert committees in XXX and a committee in XXX to make sure the research is conducted properly and that participants’ safety and rights are respected.

What if I have any questions?

You may ask any of our staff questions at any time. You can also contact those who are responsible for the care of your child and this research:

Dr ………………………  contact details

This research is supported by the (name of sponsor) who will pay for any treatment or compensation in the unlikely event of any injury resulting from this trial.

Xxx (institution) Consent Form.

Study title

1.            I, (Or add ‘ being a guardian of’’)_________________________________ (name of child), have had the trial explained to me. I have understood all that has been read and had my questions answered satisfactorily. I understand that I change my mind at any stage and it will not affect the benefits due to me/my child.

ÿ please tick   I agree to ( allow my child to ) take part in this research

ÿ please tick  I agree to samples being stored

ÿ please tick  I agree to samples being exported

Parent/Guardian’s Signature:		Date:
Parent/Guardian’s Name:		Time:
	(please print name)

2.            I certify that the above was explained verbally to the parent/guardian by _______________________________ (Name of person taking consent), and that s/he understands the nature and the purpose of the study and consents to the participation of the child in the study. S/he has been given opportunity to ask questions which have been answered satisfactorily.

Investigator’s Signature: Or Designee		Date:
Name:		Time:
	(please print name)

                                                         

Only necessary if the Participant / Parent/Guardian cannot read:

3.    I* attest that the information in this consent form was accurately explained to, and apparently understood by, the parent/guardian, and that informed consent was freely given by the parent /guardian

Witness’ Signature:		Date:
Witness’ Name:		Time:
	(please print name)

*The witness should be independent from trial or a member of staff who was not involved in gaining the consent.

Thumbprint of the parent as named above if they cannot write: ______________________

­­­­­­­­­­­­­­­THE PARENT/GUARDIAN SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP

Take time to understand

A recent survey of 672 study volunteers offers insight into the informed consent process and whether or not it is working to help volunteers understand their roles and responsibilities. Some key takeaways from the study are:

• Nearly 98% of volunteers said they received the informed consent form and 90% said they read the form completely.
• The vast majority of volunteers said they understood the expectations of the study, including additional risks and their ability to withdraw at any time.
• More than three-quarters understood that they could contact someone outside the study if they had additional questions about their rights during the trial.
• More than half the volunteers were unaware that neither their doctor nor they would know what medication they would receive during the study; more than two-thirds understood that they could receive a placebo in the trial.
• Nine out of 10 volunteers said that the information received prior to the trial matched their actual experience during the trial.
• Approximately 75% of the volunteers indicated that the main reason for participating in a study was to help themselves or others and to advance science.

Research studies are very involved so it is important to learn as much as possible about the study you may participate in before you consent. The U.S. Food and Drug Administration (FDA) guidelines state that study volunteers should understand the risks they're taking, which may mean spending additional time with the research staff to make sure you get the information you need. If you want to know details, such as any documented side effects of a particular drug observed in earlier clinical trials, you must ask for that information as well as any other information you may want to know.

The decision to participate in a clinical trial is a personal one and one that you are entitled to make freely, without influence or coercion. Being properly informed so that you fully understand the responsibilities of becoming a study volunteer is the best way to ensure that you are making the right decision for you.

Glossary for Clinical research,pharmacovigilance,Clinical Trails,

1.1 Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.2 Adverse Event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.3 Amendment to the protocol
See Protocol Amendment.

1.4 Applicable Regulatory Requirement(s) 
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

1.5 Approval (in relation to Institutional Review Boards)
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

1.6 Audit
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.7 Audit Certificate
A declaration of confirmation by the auditor that an audit has taken place.

1.8 Audit Report
A written evaluation by the sponsor’s auditor of the results of the audit.

1.9 Audit Trail
Documentation that allows reconstruction of the course of events.

1.10 Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

1.11 Case Report Form (CRF)
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

1.12 Clinical Trial/Study
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

1.13 Clinical Trial/Study Report
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).
1.14 Comparator (Product)
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

1.15 Compliance (in relation to trials)
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

1.16 Confidentiality
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

1.17 Contract
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a
contract.

1.18 Coordinating Committee
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

1.19 Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

1.20 Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.

1.21 Direct Access
Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should
take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.

1.22 Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.

1.23 Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).

1.24 Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

1.26 Impartial Witness
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the subject.

1.27 Independent Ethics Committee (IEC)
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being
of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourableopinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.

1.28 Informed Consent
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. Informed consent is documented by
means of a written, signed and dated informed consent form.

1.29 Inspection
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

1.30 Institution (medical)
Any public or private entity or agency or medical or dental facility where clinical
trials are conducted.

1.31 Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and
providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

1.32 Interim Clinical Trial/Study Report
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

1.33 Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

1.34 Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.

1.35 Investigator / Institution
An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.

1.36 Investigator’s Brochure
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure).

1.37 Legally Acceptable Representative
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.

1.38 Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.39 Monitoring Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

1.40 Multicentre Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

1.41 Nonclinical Study
Biomedical studies not performed on human subjects.

1.42 Opinion (in relation to Independent Ethics Committee)
The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

1.43 Original Medical Record
See Source Documents.

1.44 Protocol
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

1.45 Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol.

1.46 Quality Assurance (QA)
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 Quality Control (QC)
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

1.48 Randomization
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

1.49 Regulatory Authorities
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction
(Serious ADR)
Any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity,
or
- is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.51 Source Data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

1.52 Source Documents
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or
transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

1.53 Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

1.54 Sponsor-Investigator
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than
an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

1.55 Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of the performance of a specific function.

1.56 Subinvestigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also
Investigator.

1.57 Subject/Trial Subject
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

1.58 Subject Identification Code
A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.

1.59 Trial Site
The location(s) where trial-related activities are actually conducted.

1.60 Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.61 Vulnerable Subjects
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

1.62 Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.