National Bioethics Committee Pakistan
Ethical Research Committee-Guidelines
1. All research projects involving human subjects, including the use of fetal material, embryos and tissues from the recently dead, wherever conducted, shall be reviewed by the Research Ethics Committee (REC) of NBC before the study begins.
2. Some research that involves human subjects may be exempted from the regulations requiring REC approval. Examples include educational research, testing and survey procedures where no identifying information will be recorded that can link subjects to the data, and disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects financial standing, employment, or reputation. Such exemption would be conditional to:
· The informed consent is taken from the research subject.
· The information gathered being relevant/beneficial to the research subject and the community.
includes planning for sharing study findings with the research subject/s and the
relevant communities planned, as well as mechanisms for informing the research
Also exempted are the uses of existing data, documents or specimens, where no identifying information will be recorded that can link subjects to the data. Examples:
All researchers must give the subject participants the option of sharing the results and specify how this will be done.
3. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others.
4. The human subjects in the project must participate willingly, having been informed about the research. Please provide all information that is likely to affect the person irrespective of age, gender, or literacy level of the subjects. If the human subjects in the project are part of a vulnerable population, such as prisoners, children or mentally handicapped then the researcher should clearly state why is it necessary to have such groups as their research subjects and how do they plan to administer the informed consent.
Essentials of informed consent are:
Investigator must ensure that the informed consent is clearly comprehended by the subject / guardian
4.2 Purpose of research must be clearly explained.
In simple word describe the procedure that the subjects would be expected to undergo. Identify any procedures that are experimental/ investigational/ non-therapeutic. Indicate type and frequency of monitoring during and after the study.
4.4 Length of time subject is expected to participate. If subject's participation is expected to continue over a long period of time, please indicate that any new information that develops during the study and may affect the subjects' willingness to continue participation will be communicated to them. This would apply even when the intervention/investigation phase of the study has ended but monitoring continues.
Benefits of the research must be shared with/communicated to:
b. Other study participants
In studies evaluating drugs or other products the subjects should be advised as to the availability of the product after discontinuation of the study. Please indicate whether drug would be available to the patients free of cost. If not, kindly specify expected local cost.
4.6 Please specify financial burden to be incurred by the research subject while participating in the study.
4.7 Explain all foreseeable risks or discomforts to the subjects. Note this not only includes physical injury, but also possible psychological, social, or economic harm, discomfort, or inconvenience. If risk is unknown, state so.
4.8 Treatment for adverse experiences Explain what therapeutic measures would be available to the subjects in case of adverse reactions or injury as a result of being a participant in the study. All research related adverse reactions are the financial responsibility of the researchers.
Describe the extent to which confidentiality of records identifying the subject will be maintained.
4.10 Person to contact for answers to questions, or in event of research related injury or emergency.
4.11 Statement that participation is voluntary and that refusal to participate will not result in any penalty or any loss of benefits that the person is otherwise entitled to receive.
4.12 Subjects right to withdraw from the study at any time.
4.13 How sharing of results with subjects will occur.
4.14 No abbreviations should be used.
Consent document must be clearly written and/or verbally explained so as to be understandable to subjects (local language wherever applicable). The language must be non- technical (comparable to the language in a newspaper or general circulation magazine), and scientific, technical or medical terms must be plainly defined. It is PI's responsibility to ensure quality of consent procedure.
5. The researcher should submit to the committee, information regarding funding, sponsors, institutional affiliations, potential conflicts of interest and incentives for subjects.
6. Specify the cost of management directly related to the study and indicate what portion of the cost would be incurred by the study participants.
7. The researcher should also declare any personal and institutional benefits (monitory or otherwise including travel) accrued through study participation.
8. Please also specify benefits of the study to the funding agency or sponsors if any.
9. The research protocol should indicate that there is compliance with the principles of Helsinki Declaration. In case of conflict kindly specify the particular clause, which is being contravened.
10. a) Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person.
b) Non-medical research should be conducted by suitably qualified persons
11. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy and confidentiality of the patient. Minimize the impact of the study on the subject's physical, mental and social integrity.
12. In the conduct of research, the investigator must at all times respect the personality, rights, wishes, beliefs, consent and freedom of the individual subject.
13. Volunteers and patients should be reimbursed for travel and any out of pocket expenses e.g. any wage loss if applicable.
14. The researcher responsible for the ethical and scientific conduct of the research should submit a typed application for review of the ethics of proposed biomedical research. The procedure is as follows:
All information and application forms are available at PMRC website with a link to NBC www. pmrc.gov.pk Further
may be obtained from:
Pakistan Medical Research Council
Shahrah-e-Jamhuriat, G 5/2
15. ERC sends projects to its members and meets whenever required.
17. Applications will be acknowledged and PI shall be informed of any incompleteness of an application. This will obviously delay the review process.
18. The outcome of review shall be communicated to the PI within 12-16 weeks.
19. In cases where the ERC requests supplementary information or changes to documents from the applicant, such information should be provided as soon as possible.
20. In cases where clarification is sought and researchers fail to respond within 3 months, ERC will send a reminder and allow a further 3 months period for response. Beyond these 6 months, the file will be closed.
22. Application along with research protocol must be submitted as 2 hard copies along with a soft copy by e-mail to firstname.lastname@example.org
23. "Two hard copies of the ERC application form (see annexure) should be submitted in addition to electronic submission".
24. Two copies of research protocol (clearly identified and dated), together with supporting documents and annexes. This should always include description of the ethical considerations involved in the research.
25. Questionnaire (if applicable) intended for research participants should be included.
26. When the research involves a study product (such as a pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product, together with a summary of clinical experience with the study product to date (e.g. recent investigator's brochure, published data, a summary of the product's characteristics).
27. A description of the process to be used to obtain and document consent.
28. Informed consent form (clearly identified and dated) in the language(s) understood by the potential research participants and, when required in other languages.
29. A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants.
30. CIOMS guideline "Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependants are entitled to material compensation. The right to compensation may not be waived".
31. A description of the arrangements for insurance coverage for research participants, if applicable.
32. A statement of agreement to comply with ethical principles set out in relevant guidelines.
33. All significant previous decisions (e.g., those leading to a negative decision or modified protocol) by other ERCs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided.
34. Approval is given for a specified period. If the project takes longer than the specified period to complete, a request for an extension should be sought.
35. Approval is given on condition that any alterations proposed to the approved protocol are submitted to the Committee for approval prior to the alterations being effected.
36. Approval is given on condition that a copy of the research project final report is lodged with the Ethics Committee for its information.
37. Approval is given subject to researchers notifying the Ethics Committee if and when a project is curtailed, terminated or completed.
38. Approval is given for therapeutic trials subject to the principal investigator notifying the Ethics Committee within seven (7) days of any adverse event or occurrence that takes place during that trial.
39. Research could be audited by ERC during the research period to ensure compliance with guidelines.
· International Ethical Guidelines for Biomedical Research Involving Human Subjects Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), Geneva 1993.
· Institutional Review Board Guidebook, National Institutes of Health, USA Year 2000.
· Operational Guidelines for Ethics Committees that Review Biomedical Research, World Health Organization, Geneva 2000.