Table 2 Impact of the “PPI Hawkers” on the population-based study design

After the “PPI Hawker” Pilot, members of the Steering Group were receptive to the public’s suggestions to allay concerns about data security by sharing more information on how participant data is stored and by requesting additional consent for data sharing with commercial collaborators (Question 1), to consider how the research data could be incorporated into the individual’s health records (Question 2) and to regularly update participants on the study’s progress (Question 3).

After the two subsequent “PPI Hawkers” the researchers on the population-based study introduced a number of changes to the research process in response to the public’s comments and support. Researchers began establishing new recruitment strategies, by formalising agreements with various employers (Question 1) and setting up a community Advisory Group to provide regular and more detailed advice on matters arising as the project progresses. (Question 3). Further changes included amendments to the informed consent form:

 i) An improved explanation of the term ‘incidental findings’, using simpler terms and detailing the pros and cons of being informed of these abnormal results.

 ii) Giving study participants the option to decide whether they would like to have their incidental findings communicated to them or not (Question 4).

 iii) Including a question relating to data sharing. It was decided to offer research participants at initial recruitment the opportunity to choose who in the future their data could be shared, thus negating the need to recontact them (Question 2). The four options to select from are (i) Universities/ academic institutions, (ii) Health institutions, (iii) Government institutions and/or (iv) Commercial bodies.