‘My vision is that the ACRO (India) membership should become a stamp of assurance for the CROs in India performing with the highest quality of systems and ethical standards over a period of time’
The Association of Contract Research Organizations India (ACRO) was founded and registered in India in February 2005, under the aegis of Confederation of Indian Industry (CII) as an independent non-profit organisation with a global perspective aiming to bring all CRO’s operating in India on one common platform. In February this year, ACRO India released a Business Code of Conduct for its members. Apurva Shah, Chairman, ACRO India gives more details to Viveka Roychowdhury
What was the rationale for instituting the Business Code of Conduct for ACRO members?
The Code is the first step towards the harmonisation of ACRO’s activities with respect to quality and ethics. The Code talks about supporting companies while they adhere to the basic principles of clinical research, like Good Clinical Practices (GCP), etc. so that clinical research is conducted in the most ethical manner. These are the steps we have started taking, considering our industry is not very well understood and suffers from a negative image issue.
We are looking at raising the bar each year, hoping that all companies can make the commitment so that there is mutual respect among all members and respect for our industry from the community we work in. Only then will we get respectability as an association. Considering our industry is governed by strict laws and procedures to ensure safety of the patients and volunteers and they constantly change to attain that requirement we need to ensure all our members also evolve and adapt to these requirements.
Our intention is to bring together only the CROs who work with a high standard of quality and ethics over a period of a few years. We hope that ACRO will have built a reputation and
have the gravitas to tell a company who is not working to these standards, that either they fall in line or lose their ACRO membership.
Is there a global precedent of such a Code of Conduct for CROs?
You need to have such a Code in any highly regulated industry with high quality standards. While the majority of the companies work to high levels of quality, we don’t want the industry to suffer and get a bad name if any one CRO deviates from the standards for short term gains. It would be counterproductive to sit with such members at the same forum. So there has to be a strong association, respected both within and outside the industry.
What has been the response of members of the ACRO to this Code?
There was excitement among the 40-odd members of the ACRO when this was released and more CROs want to sign up as well. Joining the ACRO requires two current members to second the membership. We eventually plan to appoint an independent panel of auditors who will audit all our members and give a certificate of compliance to those who pass muster. This entire process I believe will take around two years, given the complexity and fragmented nature of our industry.
The research community takes pride in what they do for the nation and the betterment of life for mankind and want to get the respectability due to them so they welcome the vision of being able to be part of an association which wants to represent that.
CROs often complain that regulations are stifling the growth of the clinical research and trials industry. Will this Code be also seen as yet another restriction on the growth of the industry?
The clinical research industry has no issue with raising the bar. The problem is with restrictions or regulations which add no value or do not increase the quality standards. If the aim is to protect the volunteers and patients, then the regulations need to reflect this. Our complaint is that the rules are made with a certain mindset which actually has no connection with clinical research. They (the rules and regulations) are just slowing down the process, without improving the process. Our stand is that the process should be improved, without hampering the speed, because then the world will start looking at India as the best place to do clinical research. There are always some companies who might want to take the short way out but a majority of CROs and pharmaceutical sponsors would not agree to taking short cuts because it causes them more harm.
| Ethical and quality code of conduct |
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The Association of Clinical Research Organizations (ACRO) and its members (Members) are dedicated to ethical and lawful behavior in performing clinical research. To evidence this commitment, ACRO has adopted the following principles: 1. Members are dedicated to the protection and maintenance of the rights, safety and well being of human participants in all aspects of clinical research. For further details, please log on to: www.acroindia.org |
What is the process by which this Code will be implemented?
The Code was formulated after a lot of deliberations and now that its put up, we will start accepting self-compliance statements from our members, with the head of the company saying that his company complies with the Code. In the second phase, by the second year, we will start raising the bar with an external party conducting compliance checks on our members.
What is the process to deal with non adherence to the Code and what is the time period to deal with such matters?
We intend to revoke membership of defaulting members and hopefully this will send a message to the regulators that something is amiss with that particular company and they could instigate some checks on them. We’d like to differentiate between the good and the bad, so that automatically we will be able to punish the wrong (the erring companies) thus giving our industry the right image.
As ACRO may not cover the entire CRO industry, will the impact of such a Code be limited? Or are there plans to take it further? For example, get Government backing?
Part of the ACRO’s stated mission is to establish benchmarks and share best practices. We believe that once the stamp of the ACRO gets a value, which will obviously happen only after independent external auditing starts, it will become like an ISO mark. Once we allow member CROs to start putting the ACRO India Member mark on their letterheads, communication, etc., we hope it will become a benchmark. Our idea is to get to the benchmark level, so that whenever a CRO starts up, it is motivated to get the ACRO membership so that they can flaunt what this affiliation means with respect to sound systems and ethical standards. The ACRO India membership should become one level of a benchmark meaning that the bearer has achieved a certain level and is not a fly-by-night operator. Of course, that will take time and the ACRO too needs to do its part by then, in terms of earning the respectability and credibility not just from the industry but also the regulators and other stakeholders involved like the media, the volunteers, etc.
| Industry view |
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On the flip side, everyone wants to lead but consensus is difficult to form. Importantly, there is no machinery for enforcement and accountability does too not exist. Moreover, codes lay down model behavior but do not detail how this is to be followed. And lastly, those who need to follow such a code shy away from such efforts. – Dr Shreekant Sapatnekar |
Any effort towards auto-regulation must be welcome. The pros of this move are that a code helps identify deviations from model practice, provide a reference point for discussion, helps to augment Standard Operating Procedures and being voluntary, is more likely to be followed. 