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040618P - REQUIREMENTS FOR MEDICAL ETHICS APPROVAL

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Presented at the Orthopedics Research Seminar held at the Kulliyah of Medicine, UIA, Kuantan on 18th June 2004 by Prof Dr Omar Hasan Kasule, Sr. Deputy Dean for Research


OUTLINE
1.0 ETHICS COMMITTEES/INSTITUTIONAL REVIEW BOARDS
1.1 Functions of An IRB
1.2 Membership of IRB
1.3 Procedures of IRB
1.4 Criteria of Assessing Research
1.5 Follow-Up of Research
 
2.0 RESEARCH APPLICATION FORM
2.1 Identifying Information
2.2 Description of Research
2.3 Protocol And Dates
2.4 Methodology of Research
2.5 Ethico-Legal Issues
 
3.0 PATIENT/VOLUNTEER INFORMATION SHEET
3.1 Invitation and Title
3.2 Purposes of the Research
3.3 Procedures and Duration of the Research
3.4 Risks and Benefits
3.5 Ethical and Legal Issues
 
4.0 INFORMED CONSENT FORM
4.1 Over View
4.2 Understanding
4.3 Full / Adequate Information
4.4 Voluntary Participation
4.5 Right of Withdrawal
 
5.0 FOLLOW-UP QUESTIONNAIRES
5.1 Confidential Questionnaire for Research Subjects
5.2 Confidential Review Questionnaire for Researchers

1.0 ETHICS COMMITTEES/INSTITUTIONAL REVIEW BOARDS
1.1 FUNCTIONS OF AN IRB
A big institution undertaking several research projects should have its own committee on medical research ethics. Smaller institutions can use a committee in the region serving several institutions. The committee assesses research proposals and protocols that have ethical implications. These include research on patients, volunteers, the recently dead, fetal or embryological tissues. It also must assess any research involving access to medical records with a potential to breach confidentiality. It is the duty of the committee to ensure the highest ethical standards in any research. It has to protect the research subjects’ physical and mental well being as stipulated in the Helsinki declaration. It also has the duty to protect the researchers and the institution in which they work by advising them about ethical conduct so that they do not commit mistakes that will lead to criminal prosecution. The committee’s role does not end with the approval of the research. It has to continue monitoring the conduct of the study to detect any ethical violations.
 
1.2 MEMBERSHIP OF IRB
Membership of the ethics committee is designed in such a way that all professional and technical competences needed for proper evaluation of a research proposal are included. Membership should comprise representatives of the major medical and surgical specializations practiced in the hospital or region, hospital physicians, hospital nursing staff, general practitioners, pharmacists, statisticians, ethicists, and lay persons from the community. The lay members should not have any connection with medical work. In selecting members attempts should be made to make sure that all genders and age groups are well represented. Members should be selected on their own personal merit as people with knowledge, skills, and sound judgment. They should discuss the proposals as individuals and not representatives of any organization or profession. Members are appointed by the hospital, the health authority in the region or the government. The chairperson or vice chairperson should be one of the lay members. The period of service on the committee is usually three years. Membership may be renewed.

1.3 PROCEDURES OF IRB
The committee must be provided with adequate secretarial and logistic assistance to carry out its functions well. A quorum of at least half of the members will be necessary for holding a meeting. Members who cannot attend can send written comments. The proposals, protocols, and reports to be tabled must be send to the members in advance so that they have a chance to study them. The committee meets in private to preserve confidentiality. Any member of the committee involved in a project will recluse himself when that project comes up for discussion. The committee should normally decide by consensus but where this is not possible, a 2/3 majority carries the decision. Minority views should be recorded. The decision of the committee may be full approval, conditional approval, deferment, or rejection. Reasons should be provided for projects approved conditionally or those that5 are rejected. The chairperson may approve projects that had conditional approval if he is satisfied that the conditions were fulfilled. Any amendments to the protocol must be submitted for committee approval before they are implemented.


1.4 CRITERIA OF ASSESSING RESEARCH
The ethics committee will use the following criteria in assessing a submission. To make assessment easier the application is submitted in a standard format. Documentation showing informed consent must be submitted. The committee will look to see whether the research subjects were informed of the objectives of the study and of their rights to participate, abstain, or withdraw from the study. Special scrutiny of proxy consent will be made to ensure there is no abuse. The investigator must submit reasons in writing in cases in which full disclosure is deemed inappropriate. The committee will look to make sure that the objectives are clearly stated and are attainable. The research design and statistical methods must be judged adequate to produce clinically and scientifically useful results. The committee will compare the scientific merit and benefit of the research against risks and costs to patients. The submission must have detailed resumes of the investigators to enable the committee assess their competence to undertake the research successfully. The adequacy of research facilities is also assessed. The proposal must provide details on how confidentiality and security of the data will be assured.

1.5 FOLLOW-UP OF RESEARCH
The committee must monitor progress of the research project and must receive reports of all adverse reactions whether related to the drug tested or not. Members of the committee can make on-site inspections to make sure that the approved protocol is adhered to and to inspect research documents and records. Regular monitoring meetings are held to review the following: progress of recruitment of research subjects, changes to the protocol, adverse reactions, the process of informed consent, refusals and withdrawals, and case record forms. The committee keeps full records of all its actions. It submits an annual report listing all proposals considered in the past year, the number approved, and any matters that deserve attention from higher authorities.
 
2.0 RESEARCH APPLICATION FORM
2.1 IDENTIFYING INFORMATION
  • Title of the research project
  • Information on each of the principal investigators: name, address, professional title, qualifications, name and address of employer, experience in clinical research, and recent research projects involved in
  • Information on the person completing the application form: name. Qualifications, address, professional status
  • Name, address, and telephone of person to be contacted about the project in urgent and non-urgent matters
  • Sponsor of the research: name, contact person, address, level of support, conditions attached to the sponsorship, equipment and staff provided by the sponsor, payments to research subjects, restrictions if any on the publication of research results.

2.2 DESCRIPTION OF RESEARCH
  • Description of the research: type of research subjects (healthy volunteers, inpatients, outpatients), scale of the research (single center, national multi-center, international multicenter), Sponsor (commercial or academic institution), commercial research (drug development, testing devices of equipment), academic and non-commercial research (therapeutic study, non-therapeutic study, laboratory research, epidemiological research)

2.3 PROTOCOL AND DATES
  • Study protocol: existing protocol, new protocol submitted with application
  • Dates: starting date, closing date, duration

2.4 METHODOLOGY OF RESEARCH
  • Methodology of the research: background, justification, research subjects, research design, data collection, data analysis, power of the study
  • Research subjects: proposed cases, proposed controls, method of selection including inclusion and exclusion criteria, age range, gender distribution, number anticipated

2.5 ETHICO-LEGAL ISSUES
  • Informed consent: patient/volunteer information sheet, use of a standard consent form, who will seek consent? method of approaching potential research subjects, time given to respondents to make up their mind about participation,
  • Potential benefits
  • Potential hazards and discomforts
  • Methods of assuring confidentiality
  • Insurance
  • Signed declaration
 
3.0 PATIENT/VOLUNTEER INFORMATION SHEET
3.1 INVITATION AND TITLE
  • Invitation to participate
  • Full title of the proposed research that is self explanatory to lay readers

3.2 PURPOSES OF THE RESEARCH
  • Purposes

3.3 PROCEDURES AND DURATION OF THE RESEARCH
  • Procedures of the research
  • Duration

3.4 RISKS and BENEFITS
  • Description of foreseeable risks and side effects
  • Description of benefits of the research
  • Description of alternative treatments

3.5 ETHICAL AND LEGAL ISSUES
  • Statement on confidentiality
  • Compensation for research subjects in case of injuries
  • Statement that participation is voluntary
  • Contact person for further information
 
4.0 INFORMED CONSENT FORM
4.1 OVER VIEW
The consent form should be constructed as a series of questions that the research subject answers. Both the research subject and the investigator should sign the statement. The research subject should be given a copy of the consent to keep.

4.2 UNDERSTANDING
  • Have you read and understood the patient information sheet?

4.3 FULL / ADEQUATE INFORMATION
  • Have you received enough information about the study?

4.4 VOLUNTARY PARTICIPATION
  • Do you understand that participation is voluntary?
  • Do you agree to participate in this study?

4.5 RIGHT OF WITHDRAWAL
  • Do you understand that you are free to withdraw from the study at any time and without having to give any reasons and that such withdrawal will not affect your medical care?
 
5.0 FOLLOW-UP QUESTIONNAIRES
5.1 CONFIDENTIAL QUESTIONNAIRE FOR RESEARCH SUBJECTS
The following elements should be included
  • Study Title and study number
  • Information sheet: was it provided? Was it easy/difficult to understand? Did it answer most of your questions? Did someone explain the information sheet to you?
  • Voluntary consent: did you feel pressured to join the study? Were you given enough time to make up your mind?

5.2 CONFIDENTIAL REVIEW QUESTIONNAIRE FOR RESEARCHERS
  • Start and end of the study
  • Protocol amendments
  • Progress of recruitment
  • Provision of information
  • Obtaining consent
  • Withdrawal of consent
  • Adverse events
  • Outcome of research