Research ethics and consent

All research published in Jurnal Teknologi Laboratorium must have been conducted according to international and local guidelines ensuring ethically conducted research.

Research involving humans

All research studies on humans (individuals, samples or data) must have been performed in accordance with the principles stated in the Declaration of Helsinki.

Prior to starting the study, ethical approval must have been obtained for all protocols from the local institutional review board (IRB) or other appropriate ethics committee to confirm the study meets national and international guidelines for research on humans. A statement to confirm this must be included within the manuscript, which must provide details of the name of the ethics committee and reference/permit numbers where available.

Ethical considerations for different human study designs

This includes:

  • Prospective studies on humans
  • Clinical trials
  • Clinical Case reports
  • Organ or tissue transplants
  • Human embryos and human stem cells
  • Consent for research involving children, adolescents and vulnerable or incapacitated study participants
  • Retrospective studies
  • Survey studies
  • Covert observational research
  • Research on indigenous communities
  • Communication research
  • Social media research

Research involving animals, plants, and heritage sites

Studies involving vertebrates or regulated invertebrates (e.g. cephalopods), field studies and other non-experimental research on animals must have been carried out after obtaining approval from the relevant institutional ethics committee or the institutional animal use and care committee. Research procedures must be carried out in accordance with applicable national or international guidelines. In field studies authors must have also obtained any necessary permits for access to lands.

Authors must include a statement within the manuscript to provide details of the name of the ethics committee(s) which approved the study and include the permit or animal license numbers where available.

In the spirit of promoting best practice guidelines given by COPE (available at: https://publicationethics.org/core-practices), Jurnal Teknologi Laboratorium (Journal of Laboratory Technology) will not consider for publication manuscripts in which best ethical practice is not ensured, i.e. Informed consent is missing and/or Ethical approval is omitted. To simplify the decision-making process on whether a type of study requires Informed consent and/or Ethical approval, authors are encouraged to consult the table below reprinted from Borovecki A, Mlinaric A, Horvat M, Supak Smolcic V. Informed consent and ethical approval in laboratory medicine. Biochem Med (Zagreb) 2018;28(3):030201.

 

Type of Study

Study design

Informed consent

Ethical approval

Research

The material from patients/healthy donors is collected for research purposes.

Required

Required

Method/instrument validation

The use of residual material

Not required

Required

The material from patients/healthy donors is collected for research purposes

Required

Required

Research showing standard clinical/laboratory practice or the advancement of the standard practice

If it does not include a new method or instrument

Not required (it is implied that informed consent was previously given for the scope of the treatment)

Not required (it is considered that this is not research but clinical/laboratory practice)

Incidence/epidemiological research

The use of residual material or retrospective data collection.

Not required

Required

Laboratory Information System (database) data extraction

Retrospective data collection.

Not required

Required

Laboratory management

Studies that do not include human subjects but collect data for measuring quality indicators (i.e. turnaround time, test utilization, non-conformities, etc.).

Not required

Not required

Survey

The participants are notified in the survey about the nature of the research and the future use of the data (publishing, etc.).

Not required (it is implied)

Not required

A survey asking more intimate questions.

Required

Not required

Case report

 

Required

Not required

Preanalytical case report

Patient-specific information are not presented (the patient is not identifiable).

Not required

Not required