Concept↦Ethics and Laws↦Study Planning↦Institution Requirements
What is it? Why is it important?
In addition to ethics and regulatory requirements, institutions define internal policies that must be complied with during study planning and conduct.
A hospital can provide directives and/or guidelines on:
- Medical confidentiality
- Data protection and secure infrastructure (e.g. processes for processing and sharing health related data)
- Further use of biological material and health-related personal data (e.g. general informed consent procedures, NDA and MTA)
- The development of data registries
- Handling of biological material and biobanking
- Insurance and legal policies (e.g. approval of study contracts, study insurance)
- Corporate communication policies (e.g. publication of study results)
- Restriction policies (e.g. restriction on the recruitment of study participants during a pandemic)
- Study archiving policies
- Quality control policies for internal institutional activities (e.g. study conduct, institutional audits)
What do I need to do?
Familiarise yourself with institutional or hospital internal policies relevant to your study:
- Search the hospital intranet for documents describing institutional policies
- Sign-up for a training course where new institutional directives / guidelines are presented
- Contact your legal department for established institutional processes and/or documents (e.g. general consent -, study contract agreements, NDA, MTA documents)
- Contact your local CTU, who is knowledgeable about how to conduct studies at your institution. They can offer you valuable support and means on how to move forward
Before sharing health-related personal data and biological material with an external researcher, make sure that:
- Participants have signed an ICF or a hospital general consent, confirming their agreement to share their health-related-personal-data (HRpD) or biological material (BM)
- Ideally, a Non-Disclosure Agreement (NDA) is signed between SP-INV and external interested groups
- A signed DTA (for HRpD) MTA (for BM) is in place which defines conditions for sharing data and biological material
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch