Informed Consent for Participation in Research Project

Abstract

The participation in a research project as well as the process of obtaining informed consent for such participation are associated with many ethical, legal, and even logistical problems; therefore, they are subject to relevant laws, regulations, and policies at both national and international level. These regulations vary from country to country, and in some countries there are still no clear regulations dedicated directly for research. This chapter discusses most relevant issues of obtaining the informed consent for participation in a research project, including those concerning preservation of samples for future research. General guidelines for the construction of an informed consent form and an information sheet for participants have been outlined in this chapter. Additionally, sample forms have been included. These guidelines might be adopted with respect to current local law regulations and the nature of a particular research project.

Appendices

Appendix

1.1 Information for Patients, Parents, or Legal Representatives

EXAMPLE

‘Advanced molecular methods in hematology. Development and implementation of standards for molecular diagnostics of minimal residual disease, post-transplant hematopoietic chimerism, and chromosomal translocations in childhood acute lymphoblastic leukemia’

PROJECT MANAGER: name, surname, institution

PRINCIPAL INVESTIGATORS: names, surnames, institutions

INSTITUTION RESPONSIBLE FOR THE PROJECT REALIZATION: name and address of the institution

Dear Patient, Dear Parents/Guardians,

For further progress in the treatment of childhood acute lymphoblastic leukemia in our country, it is essential to implement therapeutic protocols including the adjustment of treatment intensity to the results of molecular testing. In many countries, modern molecular techniques have already been successfully used for reliable assessment of prognosis, accurate evaluation of treatment response, and early, thus giving a greater chance to cure, detection of disease recurrence. Below you will find information about a research project aimed at the implementation of molecular methods for monitoring the treatment of children with acute lymphoblastic leukemia. Consent to participation in this project might contribute to further improvement of the outcome of this malignancy in our country. It is also possible that the children participating in the project might directly benefit from the results of the performed molecular analyses, which may provide additional information helpful in clinical decision making.

1. Participation in the Project

A necessary condition for the realization of the project is to obtain your permission to collect samples of blood or bone marrow from you (to a patient)/your child/children (to parents/guardians). These samples will be subjected to molecular analyses aimed at the detection of the so-called minimal residual disease, and in case of children undergoing transplantation, these will additionally be used for the assessment of the functioning of transplanted bone marrow. Our procedures require some extra sampling which will be performed in due course. Sampling will be carried out according to the following schedule:

Patients with newly diagnosed leukemia

• additional 5–7 ml of bone marrow obtained during bone marrow collection for the diagnosis of leukemia

• additional 5–7 ml of bone marrow obtained during bone marrow sampling for routine assessment of treatment effects on 15th and 33rd day of treatment, in 12th week of therapy and at the end of treatment

Patients subjected to transplantation

• 5–7 ml of blood collected once a week until 14th week after transplantation, then once a month, until the end of 18th month after transplantation

Bone marrow or peripheral blood stem cells donors

• molecular tests will be performed with the use of a small volume (approximately 5 ml) of material collected for transplantation, without need for additional sampling

2. Potential Risk and Inconveniences

Blood/bone marrow will be collected in low volumes, i.e., 5–7 ml (equivalent to 1–1.5 teaspoons) on the occasion of blood/bone marrow sampling for routine diagnostics or treatment monitoring. In case of sick children the blood will be collected by the so-called central venous catheter or port catheter, installed at the beginning of treatment, thus avoiding the subsequent puncture of peripheral veins.

Since the research project will be performed with the use of blood/bone marrow samples that have already been taken for routine diagnostic or treatment monitoring procedure, you/your child will not be exposed to any additional physical risk.

3. Coding of Samples

Collected samples will be marked with unique codes. These codes will be used by the research team during the storage and handling of the samples, to ensure the anonymity and personal data protection according to the Confidentiality principle (see point 7). If necessary, decodification will only be made by the principal investigator (name) or by a person authorized by the principal investigator.

4. Sample Storage and Further Use

Due to the enormous scientific value of the obtained blood/bone marrow samples, the unused portion of the biological material, with your permission, will be retained and secured for further research into leukemia and related diseases. This material will be deposited in: name and address of the institution; contact details of a person responsible for the repository. Any study with the use of this material will only be possible after approval by the respective Ethics Committee, whose task is to protect the rights of patients. By agreeing to preserve and share the residual material for further research, you and your children may greatly contribute to medical advances in the diagnosis and treatment of leukemia, which can bring benefits to future patients.

If you consent to the use of biological samples in future research projects, it is possible that the obtained results might potentially have an impact for your health/for the health of your relatives. Participants donating their samples for future research have the right to decide whether they want to be informed about such outcomes, depending on available options for treatment, prevention, and genetic counseling. Therefore, if you wish to be informed on such results, please provide us with your contact details (point 3 of the form ‘Informed consent of patients, parents or legal representatives’) and communicate to us via the resource person (see point 8) any changes regarding your contact details.

5. Access to Medical Record

For the purpose of this research it will be necessary for the research team to get access to medical records of the participants. Data collection and processing will be performed according to the Confidentiality principle (see point 7).

6. Voluntariness Principle

Consent to participate in the study is entirely voluntary. Each participant has the right to withdraw their consent, at any stage, without giving reasons thereof. In order to withdraw the permission, please contact the resource person (see point 8).

7. Confidentiality Principle

This ensures the confidentiality of any data obtained from the patient, i.e., the collection, storage, and analysis will be held to rules and regulations regarding the protection of personal data of patients (local legislation should be specified; safety systems according to local law should be described).

8. Resource Person

Should you need additional information regarding participation in the project or wish to withdraw your consent, please contact: name, institution, contact details of the responsible person.

……………………………………………………………………………

Name and surname of the person asking for consent

……………………………………………..

Signature of the person asking for consent

……………………………………………..

Date

Informed Consent of Patients, Parents, or Legal Representatives

EXAMPLE

‘Advanced molecular methods in hematology. Development and implementation of standards for molecular diagnostics of minimal residual disease, post-transplant hematopoietic chimerism, and chromosomal translocations in childhood acute lymphoblastic leukemia’

PROJECT MANAGER: name, surname, institution

PRINCIPAL INVESTIGATORS: names, surnames, institutions

INSTITUTION RESPONSIBLE FOR THE PROJECT REALIZATION: name and address of the institution

…………………………………………………..	……………………………………………….
Name and surname of the patient/donor	Date and place of birth

I declare that I have been informed about the objectives and the manner of implementation of the project, including procedures, to which participants are subjected, and about potential related risk, inconveniences, and benefits. I have also been informed about the possibility of retaining the remains of my biological samples for future research into leukemia and related diseases. I have read and understood ‘Information for patients, parents or legal representatives’. I have had the opportunity to ask questions and I have understood the answers.

I had been given enough time to make a decision to carry out molecular tests with the use of blood/bone marrow samples collected from me/my child and to use the remnants of biological material for further research. I understand that the confidentiality of my/my child’s personal data will be protected, and the use of residual biological material will be placed under the control of the Ethics Committee.

I am aware that the participation in this research is voluntary, and the expressed consent can be withdrawn at any time. I have received a copy of the form ‘Information for patients, parents or legal representatives’, and the copy of the form ‘Informed consent of patients, parents or legal representatives’.

I hereby give consent (please mark YES/NO):

• (1) for my participation/participation of my child in the above-mentioned research project

….. YES ….. NO

• (2) for the preservation of blood/bone marrow samples obtained from me/my child and their further use in future research projects (under the control of Ethics Committee)

….. YES ….. NO

• (3) to be informed about scientifically validated results of research with the use of my blood/bone marrow samples that might potentially influence my/my relatives’ health

….. NO….. YES in all cases….. YES, but only if preventive or curative treatment and/or genetic counseling is available

……………………………………………..

Name and surname of the patient/donor

……………………………………………..

Contact details (address, telephone) of the patient/donor

……………………………………………..

Signature of the of the patient/donor giving consent ** Signature of patient/donor required only for children over 12 years of age

……………………………………………..

Name and surname of the parent/legal representative of the participant

……………………………………………..

Signature of the parent/legal representative of the participant

……………………………………………..

Name and surname of the person asking for consent

……………………………………………..

Signature of the person asking for consent

……………………………………………..

Date