How do you manage consent in experimental research involving multiple sites or collaborators?

1 Clarify roles and responsibilities

Before you start your research, you should clarify the roles and responsibilities of each site or collaborator, and establish a clear communication plan. Who will be the lead researcher, the co-investigators, the data collectors, the data analysts, and the data custodians? Who will be responsible for obtaining and documenting consent from participants, and for ensuring that they are informed of their rights and risks? How will you coordinate and share information across sites or collaborators, and what protocols will you follow to protect confidentiality and security? Having a written agreement or contract that outlines these details can help you avoid confusion and conflict later on.

2 Adapt consent forms and processes

Depending on the nature and scope of your research, you may need to adapt your consent forms and processes to suit the different contexts and cultures of your sites or collaborators. For example, you may need to translate your consent forms into different languages, use different formats or media, or include additional information or questions. You may also need to consider different modes of obtaining consent, such as verbal, written, or electronic, and different levels of consent, such as opt-in, opt-out, or presumed. You should consult with your sites or collaborators to ensure that your consent forms and processes are culturally appropriate, accessible, and understandable for your participants.

3 Comply with ethical and legal standards

When you conduct experimental research involving multiple sites or collaborators, you may encounter different ethical and legal standards that govern your research. For example, you may need to obtain approval from different ethics committees, follow different data protection laws, or respect different intellectual property rights. You should familiarize yourself with the ethical and legal standards of each site or collaborator, and ensure that your research complies with them. You should also be transparent and honest about your research objectives, methods, and outcomes, and report any adverse events or incidents that may affect your participants or your research integrity.

4 Monitor and update consent

Consent is not a one-time event, but an ongoing process that requires monitoring and updating throughout your research. You should keep track of your participants' consent status, and inform them of any changes or developments that may affect their participation or their rights. You should also give them the opportunity to withdraw their consent or request their data to be deleted at any time, and respect their decisions. You should also review and update your consent forms and processes regularly, and seek feedback from your sites or collaborators on how to improve them.

5 Respect diversity and inclusion

One of the benefits of conducting experimental research involving multiple sites or collaborators is that you can access a wider and more diverse pool of participants, and generate richer and more varied data. However, this also means that you need to respect the diversity and inclusion of your participants, and avoid any bias, discrimination, or harm. You should ensure that your research design, methods, and analysis are sensitive and responsive to the different needs, preferences, and perspectives of your participants, and that you acknowledge and value their contributions. You should also ensure that your research results are disseminated and shared in a fair and equitable way, and that you acknowledge and credit your sites or collaborators.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?