Informed Consent Policy

Purpose

To describe the procedure of informed consent form in conducting research involving human participants.

Policy Statement

The informed consent form should be approved by the Ethical Review Committee (ERC) before obtaining the consent from the participants. The Office of Regulatory Affairs should ensure that the approved informed consent form is stamped with an authorized signature and validity date.

Definitions

Informed consent form: Informed consent form is one of the primary ethical requirements for research that involves human subjects. It reflects the basic principle of “Respect for Person”, which assures that the prospective human subject will understand the nature of the research and can knowledgeably and voluntarily decide whether to participate. It protects all parties, both the participants as well as the investigator, who otherwise faces legal liabilities. Therefore, “Informed consent” should be considered as a continuous process and not a piece of paper or discrete moment in time.

Legally Authorized representative: An individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

Procedure

Investigators should not engage in research involving human subjects prior to its approval by the ERC. Human subjects should not be enrolled in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

Investigators should minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in a language understandable to the subject or the representative. The language should be simple and jargon free, which should be comprehended by the lay man.

The Ethical Review Committee has prepared a standard format for the consent documents. The Investigator should use this template and modify the contents as per the study requirement. The English version should be properly translated into Arabic.

An informed written consent form is the most preferred method of obtaining subjects’ consent for participation in research. The Investigator should give adequate opportunity to read and understand the form before it is signed.

Basic elements of informed consent form: While obtaining informed consent form, the following information shall be provided to each prospective subject:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects’ participation, a description of the procedures to be followed, and identification of any procedures which are experimental,
2. A description of any reasonably foreseeable risks or discomforts to the subject,
3. A description of any benefits to the subject or to others which may be reasonably expected from the research,
4. A disclosure of appropriate alternative procedures or courses treatment, if any, that might be advantageous to the subject,
5. A statement describing the extent if any to which confidentiality of records identifying the subjects will be maintained,
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and if so, what they consist of, or where further information may be obtained,
7. An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of research related injury to the subject, and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which subject is otherwise entitled and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled to.

Additional element of consent form: When appropriate, one or more of the following elements of information shall also be provided to each subject:

1. A statement that the treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable,
2. Anticipated circumstances under which subjects’ participation may be terminated by the investigator without the regard to the subjects’ consent,
3. Any additional costs to the subject that may result from participation in the research,
4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject,
5. A statement that significant new findings developed during the research which may relate to the subjects’ willingness to continue participation will be provided to the subject, and
6. The approximate number of subjects involved in the study.

Documentation of Informed consent form:

1. Informed consent form must be documented using a written consent form approved by the ERC and signed by the subject or subject’s legally authorized representative except in situations where the ERC may waive the requirements to obtain a signed consent form. A copy of the consent form shall be given to the person signing the form; the original shall be kept in the investigator’s research records.
2. The consenting process shall be well documented in the participants’ medical or research records.
3. The consenting process varies according to the type of consent form. Below is the process involved for each type of consent.
   • Written consent form: A written consent form embodies all the elements of informed consent form as described in the above section 4.5. The consent process begins with the subject recruitment. Once the potential subject is identified, an investigator or a delegate of investigator who is knowledgeable to answer any queries raised by the subject should conduct the interview. The consenting process must provide sufficient opportunity for the subject to consider whether to participate. This should be done by allowing sufficient time for subjects to consider the information and providing time and opportunity for the subjects to ask questions and have those answered. The investigator (or other study staff who are conducting the informed consent interview) and the subject should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. If face to face discussion is not possible in certain situations like pandemic, other methods are acceptable if that method allows for an adequate exchange of information and documentation. For example, the consent form may be sent to subject or subject’s legally authorized representative by e-mail and the consent interview may be conducted by telephone or other platform where subject or subject’s legally representative can read the consent form during discussion. The informed consent form should be documented using the Ethical Review Committee (ERC) approved consent and signed/dated by the subject or subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form. In case of other than face to face interview, subject or subject’s legally authorized representative can sign and date the consent form and return to the investigator through scanning the consent form and returning it through a secure e-mail account.
   • Short consent: A short form written consent document stating that the elements of informed consent required as described in section 4.5 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be witness to the oral presentation. Also, the ERC shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary and the person obtaining the consent shall a sign a copy of the summary. It is recommended that the witness must be an impartial third party, (for e.g. A clinical staff not involved in the study or a patient advocate). Witnesses can be present either physically or by other means, phone, or video conference) during the entire consent process. The purpose of witness is generally to attest to the voluntariness of the subject’s consent. The ERC may consider approving the short form in situations where the subject or subject’s legal representative is unable to read due to illiteracy or blindness.

The person obtaining consent form: Ideally the Principal Investigator (PI) should obtain informed consent form from each individual participant, especially interventional studies. However, the PI may delegate this authority to one of the research staff who is familiar with all aspects of the study.

The Environment: The surrounding in which informed consent is sought should be such that research participants can feel free and exercise their capacity as autonomous agents and should be free from sense of obligation, dependency, undue influence, coercion, and time constraints.

Participant’s competence: To give the informed consent, participants should be competent and capable of self-deliberations. For example, the very ill and individuals under the influence of drugs, sedatives, and pre-anesthetic medications are not considered to be capable of giving informed consent.

Signatory requirement: The consent should be signed and dated by:

1. The participant or participant’s surrogate, where applicable
2. The primary investigator or his/her delegate and,
3. A witness, if applicable

Validity of informed consent form: The ERC recommends approval of a study for a maximum of twelve months at a time. The approved consent document shall bear stamp and validity dates, which corresponds to the approved duration of a study. Upon the acceptance of a progress report, a copy of the consent document that bears new validity dates should be forwarded to the PI.

Waiver of Informed consent form: When the research design involves no more than minimal risk and a requirement of individual informed consent would make the conduct of the research impracticable, the committee may waive some or all the elements of informed consent. The investigator can fill in the waiver form and submit it to the ERC for review and approval.

Criteria for the waiver of informed consent: The ERC may approve a consent procedure which does not include, or which alters, some or all the elements of informed consent, or waive the requirements to obtain informed consent in the following situations:

1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects,
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
5. The research or demonstration project to be conducted by or subject to the approval of government officials of the state of Kuwait and is designed to study, evaluate, or otherwise examine public benefit or service programs.
6. The research cannot be carried out without a waiver or alteration.

Additional protection of vulnerable subjects: Any research project or any class of research that involve vulnerable subjects (children, prisoners, pregnant women, mentally disabled persons, economically and educationally disadvantaged person) the ERC may impose additional conditions as deemed necessary for the protection of human subjects.

Additional protections for children involved as subjects in research: Minors or children are persons who have not attained the legal age for consent to treatments or procedures involved in the

research, under the applicable law of the jurisdiction in which the research will be conducted. In the State of Kuwait legal age for consent to treatments or procedures is 21 years.

1. Assent of minor: It means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
2. Parent: It means a child’s biological or adoptive parent.
3. Guardian: It means an individual who is authorized under applicable law of the State to consent on behalf of a child to general medical care.
4. Parent(s)’/guardian’s permission: It means the agreement of parent(s) or guardian to the participation of their child or ward in research.
5. Ward: Means a child who has been legally put under the protection of a person, agency, institution, or entity.

Requirements for permission by parents or Guardians and Assent by children: Wherever it is found that the children can provide assent, the ERC shall determine that adequate provisions are made for soliciting the assent of the minors (children). In determining whether children are capable of assenting, the ERC shall consider the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the ERC deems appropriate. If the ERC determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with this kind of research. Child assent, when appropriate, and parental (or guardian) permission taken together meet the ethical requirement to obtain informed consent form.

Additional Protection for pregnant women, fetuses, and neonates involved in research: In addition to other responsibilities assigned to ERCs under this part, each ERC shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable regulations. Pregnant women or fetuses may be involved in research if all the following conditions are met:

1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses,
2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means,
3. Any risk is the least possible for achieving the objectives of the research,
4. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of as explained in the earlier section for an adult,
5. Everyone providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate,
6. For children who are pregnant, assent and permission are obtained in accord with the provisions described in section 4.17,
7. No inducements, monetary or otherwise, will be offered to terminate a pregnancy,
8. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy, and
9. Individuals engaged in the research will have no part in determining the viability of a neonate.

Applicable To

This policy is applicable to the Office of Regulatory Affairs staff and researchers conducting research involving human subjects at Dasman Diabetes Institute or supported by Dasman Diabetes Institute.

References

Code of Federal Regulations, Title 45 (Public welfare), Part 46 (Protection of Human Subjects), Office for Human Research Protections (OHRP), US Department of Health and Human Services.