Introduction

The social context in which biomedical research occurs is constantly changing, eg. social media is reshaping views and expectations about individual privacy; understandings of health are constantly evolving. At the same time, new research technologies are becoming available with increasing rapidity, eg. new 'omics tools for analysis. Any change in society or technology may raise new ethical questions for studies such as ALSPAC and may have implications for the policies used to govern these studies.

New policy issues emerge relatively frequently but not necessarily in predictable patterns. Recently emerging issues of concern to cohort studies and biobanks internationally have included: return of incidental findings, recall by genotype, commercial funding in research and data sharing. Legislation proscribes some actions related to these emerging issues, (eg. EU Directive 95/46/EC: 'Protection of personal data', 2012), funder policy provides broad guidelines for policy (eg. MRC/Wellcome Trust 'Framework on the feedback of health-related findings in research', 2014), and individual studies produce in house policy (ALSPAC 'Disclosure of biomedical information to participants', 2011).

Transparency of study policies and practice, especially as new issues emerge, is axiomatic to building and maintaining trust. For longitudinal studies maintaining trust with their participants is crucial to the establishment and maintenance of the long term relationships that characterise these studies; relationships that are realised in participant retention. But extant trust is not enough. Policies must also continue to be sensitive to and aligned with participant (social) values and norms. One way to achieve this is to ensure meaningful engagement of participants in the issues that impact them. Children of the 90s has always been keen to involve participants in the research and ethical decisions made about the study. As part of that commitment the Data to Knowledge Research Group, University of Bristol, will undertake a series of qualitative studies to explore, in depth, the views and perspectives of participants on key emerging research/ethical issues. Drawing from the findings of these qualitative studies ALSPAC will then invite the wider cohort to become involved in engagement activities to assess the views of the broader constituency.

This programme of work will address key issues as they arise over the duration of the current strategic award funding (2014-2019). In the first instance these will include return of incidental findings, recall by genotype, commercial funding in research. In each case the aims and objectives of the research will take the form:

Aim

To gain a better understanding of Children of the 90s participants' perspectives on the issue under study.

Objectives

1. To assess the attitudes of participants to the issue and to understand whether these attitudes may change over time.

2. To understand the potential impact of the issue on Children of the 90s participants.

3. To help inform the policy on the issue in Children of the 90s.

Proposed methods