Participation in research

Should you wish to participate in a research protocol you should be aware of several factors pre-participation and ask key questions to determine whether or not it is in your best interest. What is a protocol? The definition of 'Protocol' is - A formula, a treatment recipe. (16 Dec 1997) per Medic8 Medical online dictionary. In layman's terms it is the way in which a researcher is planning to evaluate a treatment, a procedure or the progression of a condition. It clearly lays out who, what, where, when and how and must be approved by a committee at a given hospital or research center.

What should you know about those who approve protocols? These people are on committees called Internal or Institutional Review Boards (IRB's). These individuals are not specialists in all of the diseases/conditions they evaluate protocols for; they review protocols for many diseases, conditions and procedures. One should not assume the IRB has evaluated all the medical details as they are not able to as they do not have the in-depth knowledge to do so. It is their job to ensure the administrative functions are completed and that the work being done is reasonable to their level of understanding. IRB's evaluate hundreds of protocols per year in addition to their other work. Many IRB members are doctors; others may be from the clergy, hospital administration, nursing or many other professions.

Let’s get started on evaluating a research protocol:

1.     Get a copy of the protocol and make sure it is explained to you clearly and that all your questions are answered. You may want to discuss the protocol with a medical professional that is not connected with the center conducting the research.

2.     Find out what it is the research team hopes to learn from the research.

3.     You should determine if the 'standard of care', ­ the normal treatment for someone with HCM, and your symptoms and presentation is what is being suggested or is an alternative to the 'standard of care'  being suggested with the protocol in question. If it is an alternative treatment you should ask why the standard of care is not being utilized.

4.     Ask what benefits you may receive from participation (example; the protocol may hope to reduce your lightheadedness or reduce chest pain). Ask how this benefit will be measured.

5.     Some research is only setting out to evaluate existing data, and you may only need to allow a researcher access to your medical records for data analysis.

6.     You will want to know who will have access to research results.

7.     You may want to do a little independent research on the researcher to ensure that you are being well cared for. Much of the research done in the USA today is done with grants many of which are provided by the National Institutes of Health (NIH). The NIH has firm guidelines for accountability, oversight and protection of participants. Under the Freedom of Information Act (FOIA) you can request a great deal of information that may assist you in making the choice to participate or not. You may ask for copies of the Internal Review Board Minutes to see for yourself if there are any questions, problems or concerns from those monitoring the research conducted by the researcher. You may request this information from the centers research office or information officer.

8.     The overwhelming number of research centers and researchers are doing wonderful work and have contributed to many of the advances that have improved our lives, however there are some who have injured people and have set research back due to their work. You are your own best advocate, ask questions, demand answers and make the best choice for yourself.

The following information is taken directly from the web site of the Office for Human Research Protection ­ US Dept of Health and Human Services OHRP Main Telephone Number: (301) 496-7005

§46.116 - Informed Consent Checklist - Basic and Additional Elements
Each consent form must contain these items:

• A statement that the study involves research
• An explanation of the purposes of research
• The expected duration of the subject's participation the research
• A description of the procedures to be followed
• Identification of any procedures, which are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others, which may reasonably be expected from the research
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 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
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
• A statement that the particular 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
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study

§46.117 Documentation of Informed Consent Checklist

a. Except as provided in paragraph "c" of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

WRITTEN
The consent form may be either of the following: 1. A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

DONE ORALLY
2. A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is 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 actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

WAIVER of req't for signed form
c. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:

1.     That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

2.     That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

IRB Latitude to Approve a Consent Procedure that Alters or Waives some or all of the Elements of Consent § 46.116
An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

The research could not practicably be carried out without the waiver or alteration.

The research involves no more than minimal risk to the subjects;

The waiver or alteration will not adversely affect the rights and welfare of the subjects;

The research could not practicably be carried out without the waiver or alteration; and

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Special Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research

Assent/Waiver
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. If the IRB 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 the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with §46.116 of Subpart A.

Parent
The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405.

Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

If the IRB determines that a research protocol is designed for conditions or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.