National Bioethics Committee Pakistan

Ethics policy regarding human

General Principles

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.

·         Proposal includes planning for sharing study findings with the research subject/s and the relevant communities planned, as well as mechanisms for informing the research subject.

 

·         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:

• Literature review; and theoretical analysis. In such cases the only ethical Concern would be acknowledgement of sources.
• Analysis of data, documents, specimen, not linked to individual subjects.
• Evaluation studies of intervention programmes/projects, especially by those who were partners in planning the intervention.

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.

5.    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

6.    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.

7.     In the conduct of research, the investigator must at all times respect the personality, rights, wishes, beliefs, consent and freedom of the individual subject