Information for researchers

Principles for undertaking sub-studies and limiting respondent burden

A sub-study is a project involving active collection of data from and/or interventions targeting 45 and Up Study participants, additional to the routine collection of data by the 45 and Up Study Coordinating Centre through baseline questionnaires, follow-up questionnaires and linkage of data.

Sub-studies can take many different forms, but fall under four main categories:

  • Additional questionnaire only
  • Direct contact with the participant, including interviews and measurements (e.g. blood pressure, height and weight)
  • Collection of blood samples and other biological specimens
  • Intervention studies

The principles guiding the conduct of sub-studies within the 45 and Up Study are:

  • The 45 and Up Study aims to facilitate high quality practice- and policy-relevant research
  • All research conducted within the 45 and Up Study must be of sound scientific merit, as judged by peer-review, must be in the public interest and must have appropriate ethical approval to proceed
  • All research conducted within the 45 and Up Study must be approved by the Study team and / or the 45 and Up Study Scientific Advisory Committee
  • Access to the Study cohort needs to be balanced to ensure that particular groups or individuals are not over-burdened and long-term participation is sustainable
  • All research conducted within the 45 and Up Study must be adequately resourced
  • No participant details will be released to collaborating researchers or other individuals or institutions, without the participant’s consent
  • Data gathered in the course of the conduct of a sub-study will be stored in the central 45 and Up Study data system and will be made available on request to other researchers, after an agreed period of exclusive use by the researchers who collected the additional data. It will be made clear to sub-study participants that this additional data will be available for use in a de-identified form (with appropriate confidentiality safeguards) by multiple researchers in the future


Managing participant burden

The 45 and Up Study relies on the generosity of Study participants in providing data for the Study, giving up their time and allowing their personal details and health information to be accessed by researchers. The Study has a duty to these participants to ensure that they are:

  • Treated with respect in all of their dealings with the Study
  • Treated in accordance with the terms of their written consent, including maintenance of confidentiality
  • Not over-burdened by excessive requests for and involvement in sub-studies
  • Informed of the Study progress and research projects taking place within the Study
  • Given the opportunity to withdraw from the Study if necessary
  • Given appropriate consideration in the case of any concerns or complaints

As well as acknowledging the importance of ensuring that the Study abides by its ongoing commitment to participants, it is also important to note that the long term validity of the Study depends on maintaining the involvement of participants over the coming years.

The following apply to the setting, monitoring and management of participant burden:

  • The total amount of time that participants are required to spend on contributing data to the 45 and Up Study should not exceed four hours annually up to a maximum of 2 contacts each 12 months, except where a specific exemption is granted by the 45 and Up Study Consumer and Community Sub-Committee
  • The 45 and Up Study Co-ordinating Centre has in place a system for monitoring any contact with Study participants
  • Researchers conducting a sub-study must inform the 45 and Up Study Co-ordinating Centre of any data collection or other routine contact with participants required, and provide a verifiable estimate of the amount of participant time required for the data collection, so that participant burden can be monitored and managed
  • Participants who have contributed the full four hours in a particular 12 month period will not be eligible for other sub-studies until the 12 month period has elapsed
  • Where possible, it is desirable for collaborators to work together to collect additional data to maximise efficiencies when contacting participants

Some sub-studies may be of special interest to participants (for example studies of people with specific health conditions, and intervention studies). If such a case can be made, the study may seek an exemption from the four-hour limit by applying to the 45 and Up Study Consumer and Community Sub-Committee.

All questionnaires and sub-study materials must be approved by the 45 and Up Study Scientific Advisory Committee. Standard criteria around reviewing and approving such materials will be devised.