New Requirement for Human Research Ethics Committee Approval
In their strive to improve clinical and psycho-social outcomes for couples who have IVF, many FSA members conduct research as part of their clinical role. The results of these endeavours are often presented at our society’s Annual Scientific Meeting. The importance of research to provide evidence for best practice cannot be emphasized enough. However, equally important is that the research is conducted according to the ethical principles set out in the NHMRC National Statement on Ethical Conduct in Human Research 2007.
In line with other societies and to comply with the NHMRC statement the FSA Board has decided that from 2010, abstracts submitted for presentation at the Annual Scientific Meeting which involve human subjects require Human Research Ethics Committee (HREC) approval. This requirement is implemented to maintain high standards of presentation, to protect the interests of patients/subjects, and to ensure that studies presented at the meeting have the potential to be submitted and accepted for publication. Studies that do not have HREC approval cannot be published in scientific journals and should not be presented at scientific meetings.
All HRECs operate under the guidelines of the NHMRC National Statement on Ethical Conduct in Human Research 2007. This document addresses the question of what constitutes ‘human research’:.
” Human Research is conducted with or about people or their data or tissue. Human participation in research is therefore to be understood broadly to involve human beings through
- taking part in surveys, interviews or focus groups
- undergoing psychological, physiological or medical testing or treatment
- being observed by researchers
- researchers having access to their personal documents or other materials
- the collection and use of their body organs, tissues or fluids ( eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens)
- access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database” NHMRC National Statement on Ethical Conduct in Human Research 2007, p.8
The NHMRC document also elaborates on the values and principles of ethical conduct in research, explores the themes of risk, benefit, and consent, and raises ethical considerations specific to particular research fields or methodology. FSA members who have not previously submitted HREC applications and are considering human research are encouraged to familiarise themselves with this document available at www.nhmrc.gov.au/guidelines/ethics_guidelines.htm
Research studies presented at the FSA Annual Scientific Meeting cover the whole range of human research including qualitative research, use of data collected from patients’ medical or laboratory records, clinical trials, surveys, and research relating to genetics and stem cells. All this research is extremely valuable and the FSA Board is concerned that members are not discouraged from conducting research because of the need for HREC approval. Whilst it may seem daunting, the process of obtaining HREC approval can be very helpful in developing the research proposal and being clear about the best methodology to answer the research question. The process also encourages researchers to think through and address the ethical issues relating to consent and the risks posed by the study to participants. This in turn helps researchers develop a comprehensive framework for the study and may encourage them to collaborate with colleagues with experience in their particular field of research.
Obtaining HREC approval can be time consuming with the committee sometimes suggesting changes and requesting information to be resubmitted. Most committees only meet monthly or bi-monthly so the process can take 2 -3 months to complete. It’s therefore important to include the time needed to obtain HREC approval when planning to conduct and present research. Smaller clinics that do not have access to their own HREC may need to contact the HREC of a nearby hospital and ask if they are willing to consider their application. To cover their cost the HREC may charge a small fee to review applications from researchers not affiliated with the hospital.
This is the sort of information that is usually required in an HREC application:
- Aims/objectives of the study
- Study design and methodology
- Study population (sample size, inclusion/exclusion criteria)
- Data analysis
- Investigator obligations (storage of data, confidentiality, adverse event reporting, handling of adverse events)
- List of references of other researchers in the field
- Information for participants and participant’s consent form
- Mechanism for reporting on progress of the study
Following are some hypothetical examples of abstracts with reference to whether or not they would require HREC approval.
- A clinic has introduced a new intake program for patients commencing IVF. A nurse wishes to present the content and format of this program. This paper would not require HREC approval providing it is descriptive of the program, and not inclusive of patient surveys.
- An embryologist wishes to present a retrospective analysis of embryo quality with the use of a new culture medium. The information will be collected from patients’ medical records but the data presented will be non-identifiable. This study would require HREC approval because even though the data is non-identifiable it involves the researcher accessing patients’ medical records.
- A medical student wishes to present a prospective study of the relationship between IVF outcomes and stress levels (assessed by a standardised measure) prior to commencing treatment. This would require HREC approval as it both requires psychological testing of patients and accessing information from their medical records.
- A counsellor wishes to present a literature review of evidence regarding mother/infant attachment following embryo donation. As this abstract involves only a literature review and no access to patient data, it would not require HREC approval.
The FSA Board is confident that the requirement for HREC approval for human research presented at the Annual Scientific Meeting will enhance the quality of the important research conducted by FSA members.