Pre-Registration & Registered Reports Sub-Policy

This is a sub-policy of the University's Open Research Policy which promotes transparency, accessibility, and inclusivity in research by embedding open practices through infrastructure, guidance, and culture.

1. Updates to this policy

1.1 This policy has been updated to align to the new University of Bristol policy management framework. It has also been updated through copy and line edits to enhance clarity and raise the profile of Registered Reports.

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2. Introduction

2.1 The University of Bristol’s Pre-Registration Sub-Policy supports the institution’s commitment to open research by encouraging researchers to document and share study plans and protocols before starting their work. This approach enhances transparency, rigour, and reproducibility, aligning with ethical standards such as the Declaration of Helsinki and meeting regulatory or journal requirements in areas like clinical research. By fostering early scrutiny and accountability, the policy helps protect against bias, supports intellectual property considerations, and contributes to improving research quality and trust across disciplines.

2.2 The term must is used to denote actions that are compulsory or necessary, should denotes best practice and aspiration to lead by example.

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3. Scope

3.1 The Pre-Registration Sub-Policy applies to all staff and students at the University of Bristol engaged in research activity, or activity in support of research, across all disciplines, encouraging them to document and share study plans and protocols before beginning their research. It is relevant to activities involving the design, planning, and analysis of research, particularly where transparency and reproducibility are essential, such as in clinical research. While broadly applicable, it acknowledges that in certain cases - such as protecting intellectual property or maintaining participant blinding - study plans may be subject to embargo and not made public immediately.

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4. Definitions

4.1 Embargo: a period of time during which an output is deposited (archived) but is not accessible to the public. In the case of Pre-registration, the study plan or research protocol is deposited (‘registered’) but is withheld from public access to protect sensitive information or prevent influencing the research outcomes.

4.2 Research Protocol: a time-stamped record of decisions around the study design, methods, and analysis created before data are collected or become accessible. The term may be used interchangeably with ‘Study Plan’.

4.3 Study Plan: a time-stamped record of decisions around the research design, methods, and analysis created before data are collected or become accessible. The term may be used interchangeably with ‘Research Protocol’.

4.4 Pre-Registration, Reproducibility, Research output and Transparency are defined in the University of Bristol Open Research Glossary. The Glossary includes other definitions relevant to Open Research.

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5. Responsibilities

5.1 Researchers: Responsible, where appropriate, for pre-registering study plans or protocols before starting the research and considering publication via Registered Reports to enhance transparency and reproducibility. Detailed responsibilities can be found in Responsibilities of researchers (section 9).

5.2 University of Bristol: Provides guidance and training to support researchers in pre-registering study plans or protocols appropriately; monitors best practice in this area. Detailed responsibilities can be found in Responsibilities of the University (section 9).

1. Research Support Team (Library Services): Supports researchers by providing advice on pre-registration and registered reports.
2. Commercialisation Team: Advises researchers on protecting intellectual property before publication, especially where research may have commercial potential.

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6. Pre-registering study plans and protocols

6.1 Pre-register your study plan or research protocol, before the study begins, on a suitable repository so that it is free to read and reuse, either immediately or after an embargo period.

6.2 Amendments to study plans or protocols may occur throughout the research process. It is always important to maintain good documentation about these amendments and, where appropriate, pre-registration platforms may have the functionality to record amendments, providing a transparent record of the study’s evolution.

6.3 You may also wish to consider publishing a Registered Report, an extension of the pre-registration model which refers to a type of research article reviewed by a journal as a Stage 1 submission (including a peer review process). The journal offers an in-principle acceptance for a Stage 2 manuscript detailing the study’s results, regardless of the study outcome.

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7. Why should you pre-register?

7.1 Pre-registration provides transparency in the research process, and allows for the study team’s aims, objective, hypotheses, planned methods, etc. (as applicable) to be captured at the point when they were finalised.

7.2 Benefits include:

1. A record of what was decided a priori before the study begins.
2. Opportunities for others to comment and critique plans before the study begins.
3. The ability for readers to verify that the final report aligns with the pre-registration.

7.3 It is important to note that a pre-registration document does not necessarily bind researchers to those plans; it simply provides a record of what they were at that point, so that deviations from that plan are transparent.

7.4 In clinical research, pre-registration of minimal information (e.g., primary outcomes) in a recognised repository such as ISRCTN or gov may be a regulatory and/or journal requirement.

7.5 The latest version (2024) of the Declaration of Helsinki, which applies to medical research, states that “Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.” (article 35). Researchers conducting studies involving human subjects must therefore consider pre-registration of the study in the set-up phase.

7.6 A Registered Report can offer additional advantages:

1. The publication decision is made independently of the research results, reducing publication bias to support dissemination of null or negative results as well as positive or novel outcomes.
2. An in-principle acceptance at Stage 1 allows researchers to include the forthcoming paper to their CV early, which may be particularly relevant for early career researchers.

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8. Why is it important?

8.1 Transparency throughout the research process helps to foster trust, and provides opportunities for scrutiny, allowing decisions and assumptions to be challenged or critiqued.

8.2 Pre-registration of design and analysis choices serves as a reminder to researchers, protecting against biases that can shape decision making once they reach the analysis stage.

8.3 Study plans and protocols are valuable research objects in their own right, providing recognisable outputs for researchers and allowing research methods to be shared widely.

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9. What does it mean in practice?

Responsibilities of researchers

9.1 Before beginning a study, researchers should consider:

1. Pre-registering their study plans or protocol on an appropriate third-party platform (e.g., the Open Science Framework, or see the UKRN pre-registration primer for a list of repositories by discipline).
2. It may be a requirement of the research funder(s) that the study plan or protocol be pre-registered and a specific platform may be recommended.
3. Disseminating these plans via social media or other networks for feedback/peer review.
4. Publishing via a Registered Report.

9.2 The content of a study plan or protocol will vary from discipline to discipline, but could contain:

1. The research question and motivation for/background to the study (i.e., the prior literature).
2. The methodology that will be used to answer the research question, including any choices/assumptions made, data collection methods, etc.
3. The approach that will be taken to analyse data / interpret source materials, including sample size justification where appropriate.
4. Information on ethics and governance arrangements, potential risks and how these have been mitigated, etc.
5. Details of how data, code, and other research outputs will be shared. The University of Bristol has sub-policies in those areas which may be relevant (see Open Research Policy webpage).

Responsibilities of the university

9.3 The University’s Research Support team (Library Services) will provide the guidance and resources to help researchers pre-register their study plans or protocols appropriately, including:

1. Providing advice and training on the use of pre-registration platforms and registered reports.
2. Monitoring best practice in this area to ensure guidance and training is current and relevant.

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10. When should study plans or protocols not be made public immediately (embargoed)?

10.1 In certain cases, researchers may be concerned about releasing methods or intellectual property before the study is complete (for example, so that potential participants remain blind to the study hypotheses, if appropriate).

10.2 In this case, many platforms that support the pre-registration of study plans and protocols allow for an embargo period to be set, so that the document is archived and date stamped, but not made public until a later date.

10.3 If materials discussed or included in the study plan or protocol may have commercial potential, researchers should consider whether intellectual property protection may be appropriate. This may need to be arranged before any dissemination activities occur (including registering the study plan, even under embargo). This also applies to intermediate research objects such as data and code which may be suitable for intellectual property protection. For advice on protecting intellectual property researchers can contact the Commercialisation Team.

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11. How being open will help your research

11.1 Transparency allows for greater scrutiny of the research process, potentially improving research quality and trust in research.

11.2 Pre-registration provides an opportunity to develop a clear study plan or protocol, and surface methodological choices and assumptions at an early stage, as well as receive feedback which can improve the rigour or robustness of the methodology.

11.3 By preparing a detailed study plan or protocol, issues such as preliminary authorship and contributions can be discussed and agreed early in the research process.

11.4 Engaging with open research practices, including pre-registration, enhances researchers’ credibility, visibility, and career progression. It also strengthens the University’s research culture and forms part of research assessment and promotion criteria.

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12. References and further information

1. Centre for Open Science Registered Reports
2. Cancer Research UK Registered Reports Funding Partnership
3. Creative Commons copyright licences
4. ICMJE recommendations on trial registration (section L)
5. UK Reproducibility Network Open Research Primers
6. University of Bristol Open Research Policy and Sub-Policies

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The University of Bristol’s Pre-Registration & Registered Reports Sub-Policy is made available under a CC BY 4.0 License.

The PDF version of the Pre-Registration & Registered Reports Sub-Policy available at 10.71706/6fc83325-ebf1-43fe-b40d-6959e8a846be is the definitive and authoritative version.