10 Pre-Registration and Ethical Considerations
Once the basics of your methodology are sorted out, the next crucial step is to develop a comprehensive research plan. This plan should outline each phase of your project, from the initial planning stages to the final stages of data collection. Ensuring that every aspect of your methodology is meticulously planned and implemented is key to the success of your research. In this context, consider the option of pre-registering your study.
Pre-Registration
Pre-registration involves publicly declaring your research plan, including hypotheses, methodology, and analysis strategy, on platforms like the Open Science Framework (OSF) before data collection begins. Pre-registering a study offers several key benefits:
- Enhances Transparency and Integrity: By declaring the research plan publicly beforehand, it prevents selective reporting and post-hoc hypothesis adjustments, fostering honesty in reporting results.
- Improves Credibility: Pre-registration signals to the scientific community and readers that the research is conducted without bias, enhancing the study’s credibility.
- Facilitates Clear Distinction Between Exploratory and Confirmatory Analyses: It helps differentiate planned analyses from those that are exploratory, adding clarity to the research process.
- Increases Reproducibility: By providing detailed methodological plans, pre-registration aids other researchers in replicating the study, crucial for verifying results and advancing scientific knowledge.
- Avoids Publication Bias: It helps in reducing publication bias, as the study’s existence and its core hypotheses and methods are recorded publicly before the results are known.
- Builds Researcher Accountability: Knowing that their plan is publicly accessible can motivate researchers to adhere more strictly to their original study protocol.
- Structured Planning: It encourages a more structured approach to planning your study, requiring a clear outline of your research objectives, methodologies, and analyses.
- Timeline Management: Having a pre-registered plan helps in setting a realistic timeline for your research, ensuring that each phase of the study is allocated sufficient time.
- Focus on Objectives: Pre-registration keeps the research team focused on the original objectives and hypotheses, reducing the likelihood of veering off course.
- Efficient Resource Allocation: Knowing the research plan in advance allows for more efficient allocation and use of resources, including time, personnel, and materials.
- Minimizes Last-Minute Changes: With a detailed plan in place from the start, there’s less likelihood of needing significant changes mid-study, which can disrupt organization and timelines.
Ethical Considerations
Most research, especially those involving human subjects require approval from the Research Ethics Board (REB) also known as an Institutional Review Board (IRB). The REB is responsible for reviewing and evaluating the ethical implications of proposed research to ensure it aligns with established ethical standards. Researchers must apply, often through an online portal, detailing the purpose of their study, experimental design, and how they plan to address potential ethical issues among other factors. The REB plays a crucial role in the oversight of research, particularly research involving human participants. The primary purpose of an REB is to protect the rights, well-being, and dignity of research participants. It ensures that research is conducted ethically and responsibly, adhering to established standards and guidelines. The key functions of an REB include:
- Risk-Benefit Analysis: The board evaluates the potential risks to participants against the potential benefits of the research. The aim is to minimize harm while maximizing the value of the research to society.
- Informed Consent: The REB ensures that researchers provide clear, comprehensive information to participants about the nature of the study, their rights, and what participation involves. Participants should give informed consent, free from coercion or undue influence.
- Ongoing Monitoring: Once a study is approved, the REB continues to monitor its progress. This might involve reviewing amendments to the study, handling complaints from participants, and ensuring ongoing compliance with ethical standards.
- Promoting Ethical Standards: The REB also plays a role in educating researchers about ethical principles and practices, fostering a culture of integrity and respect for human rights in research.
- Regulatory Compliance: The board ensures that research complies with local, national, and international ethical guidelines and legal requirements related to research involving human subjects.
By fulfilling these responsibilities, the Research Ethics Board safeguards the integrity of the research process, ensuring that scientific exploration advances in a manner that respects and protects individuals who contribute to this vital pursuit. When planning your research project, it’s essential to account for the time it will take to gain approval from your institution’s REB. The review process can be intricate, often requiring revisions and careful consideration of the reviewers’ feedback and concerns. Therefore, it’s wise to allocate at least a month in your data collection timeline for obtaining this ethical clearance. This foresight ensures you have sufficient time to address any required modifications to your application and prevents any unexpected delays in commencing your data collection phase. Therefore, plan your ethics application concurrently with your experimental design. Data collection cannot commence without ethical clearance, making it integral to your research timeline. If your research involves human participants, work closely with your supervisor to prepare the necessary documentation, including consent and debriefing forms. These documents must clearly outline the nature of the research, any potential risks, and the rights of the participants, ensuring informed consent.
Your Role in Ethics Applications
- Undergraduate Students: Typically, undergraduates are not directly responsible for creating and submitting ethics applications. However, they are often involved in the research process under the supervision of a faculty member.
- Graduate Students: At this level, students are more likely to take an active role in preparing and submitting ethics applications. This involves detailing the research methodology, potential risks to participants, and how these risks will be mitigated.
Even if you are not directly responsible for the submission, understanding the ethics approval process is crucial. It provides valuable insights into responsible research conduct and helps prepare you for future independent research projects. Moreover, learning to navigate the ethics application process is a highly regarded skill in academic and research settings. Involvement in this process can enhance a student’s desirability as a candidate for research assistant positions or future research roles.
Power Analysis: Determining the Number of Participants
Before initiating data collection for your study, it’s highly advisable to conduct a power analysis. This statistical process is essential for determining the minimum sample size required to reliably detect your effect of interest. Conducting a power analysis early in your research planning can ensure that your study is adequately powered, meaning it has a sufficient sample size to achieve statistically significant results if there is indeed an effect to be found. This step is crucial not only for the validity of your research findings but also for the efficient use of resources and ethical considerations in research conduct.