Information for participants

Thank you for your interest in our study! If you have been approached for an interview and agree to interviewed by us, we will be asking you questions on some of the following topics: 


·  Who organizes trials, what are different kinds of roles at different levels of work for the organization and conduct of the trial?

·  Various  aspects  of  the  conduct/implementation  of  trial  such  as  recruitment,  communication regarding  methodology of the trial, explaining risks, eliciting consent, ensuring compliance of scientific, ethical and legal standards, audit and monitoring of trials, etc. 

· What kind  of  collaborations  and  relationships  are  fostered  among  researchers,  local institutions,  contract  research organizations (or organizations coordinating the trial), sponsors, companies, donors and academic organizations?

·  Who are the individuals  who  conceptualize  and  design  trials,  the  role  of  local  researchers and what  kind  of knowledge is generated from the trials and the entities that receive and use such knowledge.

 

Thus, essentially  we  are  interested  in  learning  about  the  routine  practices  and organisational arrangements for  the conduct of clinical and public health trials about which you have personal experience and/or knowledge.

 

This interview may last from 30 to 60 minutes. We must emphasise that the participation in this study is completely voluntary. There is also no requirement that you answer all questions or provide information on all topics or issues. You may choose which information to provide. At any  time  during the interview, you have full right to withdraw  from  participation.  If  you  need  to  seek  permission  from  your  superior  authority for participation, you are free to consult and then decide about the participation. The interview will be conducted at the place of your choice at your workplace, organisation‘s office or any other place of your choice. In case of a need to interview you again, with your permission, we may contact you.

 

This study will not provide any direct tangible benefits to you for your participation in the study. But by enriching the scientific understanding of the way trials are organized, implemented and the kind of  knowledge  generated,  there  will  be  benefits  to  science  as  well  as  society.  The  scientific information from the reports and/or papers based  on the study may also contribute in improving policies,  laws  and  other standards related  to  the trials.  Since trials  are often organized  by the commercial organization, please share only information that you consider appropriate. The only risk is identification of the individual who is sharing information. We have therefore put in place the following procedures to protect the confidentiality of information provided by you,

 

All information provided to us by you will be kept confidential within the legal protection of the privacy available in the country. We will be removing information in the interview that can directly or indirectly identifies you, your  colleagues or your organization before using for analysis in the research. If we need to use any quote from your interview that could directly or indirectly identifies you or your institution, we will seek your separate permission for such use in our publication. The information provided by you on any topic will be merged with such information obtained from 150 to  200  interviews  we are conducting in  India, Sri Lanka and Nepal, thus providing additional protection for maintaining confidentiality of yours, and your organisation's the identity.

 

With your permission, we would also like to audio-tape your interview. If you have any objection to such audio-taping, please let us know and we will take notes on the information provided by you. If you allow us to audio-tape your  interview, it will be transcribed and then the digital files will be destroyed at the completion of research. We will remove information that has potential to identify you  and  your  organization  from  the  transcript  of  your  interview  before  sharing  it  with  other researchers in the research team.

 

This research project has been reviewed and approved by the ethics committees at the University of Edinburgh in UK, multi-institutional ethics committee of the Anusandhan Trust, in Mumbai, India,  Ethical Review Board of Nepal Health Research Council  in Nepal and  the ethics  committee  of  Faculty of  Medicine, University of Colombo in Sri Lanka.

 

If you have any query or complaint regarding the ethical conduct of this study in India, you are requested   to   contact:   Dr.   Divya   Bhagianadh,   Member-Secretary,   Multi-Institutional   Ethics Committee, C/O Anusandhan  Trust, Sai Ashray, Aaram Society Road, Vakola, Santacruz East, Mumbai 400055, India. Tel: +91-22-26661176.

 

For any query or more information on the study, please find our address details here, or follow the contact us link