Faculty of Health Sciences

Application to register an ongoing Database, Biobank or Registry for research purposes

(Adjusted from University of Cape Town documentation)

Researchers that want to establish a Database, Biobank or Registry must develop procedural mechanisms for secure collection, receipt, storage, management and sharing of data and/or biological samples. Although HREC approval is not required for Databases, Biobanks or Registries created for purposes other than research, we encourage registration of these resources, given the research potential of the information. Furthermore, no retrospective approval can be given and journals will not publish research that has not undergone prior research ethics review. Note: All research using registered Databases, Biobanks or Registries, including that undertaken for a master’s or doctoral degree, requires submission as a new study.
Please tick one to indicate your choice of Database, Biobank or Registry:
Database	A collection of information including images arranged in such a manner as to facilitate swift search and retrieval (DoH, 2015). It provides a system for collecting, organizing and storing health information (WMA, 2016)	☐
Biobank / repository	A collection, storage and distribution system for human biological materials for research purposes including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens, and so on. Usually demographic and/or medical information about the donors is included in the repository, as are codes that link the material to the donors (DoH, 2015).	☐
Registry	A collection of information (data) from multiple sources, maintained over time with controlled access through a gatekeeper organizer (DoH, 2015).	☐

1. Applicant’s details:
Title	Click here to enter text.	Name	Click here to enter text.	Surname	Click here to enter text.
Research Entity	Click here to enter text.
Telephone	Click here to enter text.	E-Mail	Click here to enter text.
Signature My signature certifies that I will maintain the Database, Biobank or Registry in accordance with the guidelines outlined in the HREC SOP_Ethics_1.9. If at any time I want to share or reuse the information for purposes other than those disclosed in the original approval, I shall seek further approval from HREC.
Signature of applicant	Date	Click here to enter a date.

2. Co-investigators:
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.
Name	Click here to enter text.	E-mail	Click here to enter text.	Telephone	Click here to enter text.

3. Who will be responsible for ensuring that any request for sharing information meets the Database/Biobank/Registry’s specifications? (Only complete if someone other than the applicant).
Title	Click here to enter text.	Name	Click here to enter text.	Surname	Click here to enter text.
Telephone	Click here to enter text.	E-Mail	Click here to enter text.
Signature	Date	Click here to enter a date.

4. Please provide the following information:
Name and site of the Database/Biobank/Registry: Click here to enter text.
Type of data/biological samples (including description of identifying details): Click here to enter text.
Describe the physical process by which items will be accepted into the Database/ Biobank/Registry: Click here to enter text.
Describe how informed consent will be obtained. (Please attach informed consent documentation): Click here to enter text.
Describe procedural mechanisms (receipt, storage, management) to protect privacy and confidentiality: Click here to enter text.
Describe procedural mechanisms for safe storage (e.g. arrangements to prevent storage in multiple sites across campus which could lead to risks in non-standardised practices; specimen and temperature maintenance; back-up generators and temperature alarms; data disaster management/retrieval - e.g. hard and soft copies, multiple sites, backup). Click here to enter text.
Describe conditions under which data/biological samples may be shared with or released to researchers: Click here to enter text.
For what period will data/ biological samples be maintained in the Database/Biobank/Registry? Click here to enter text.
How will data/biological samples be destroyed? Click here to enter text.
Will participants be able to withdraw their data/biological samples?	Yes ☐	No ☐

5. Director of the research entity
I approve the registering of this Database/Biobank/Registry.
Signature	Date	Click here to enter a date.
Print name	Click here to enter text.

6. Checklist for required attachments:
Informed consent documentation	☐
Checklist for compliance to informed consent requirements (See 8.4.2 of SOP 1.9).	☐
Application form to be used by researchers to use data/biological samples from the Database/Biobank/Registry.	☐
Annual progress report structure.	☐
Policy on procedural mechanisms that include: Secure data and biological sample-collection e.g. donor engagement and informed consent. Receipt of data or biological samples. Storage. Safeguards/security measures in storage. Management. How governance arrangements will be achieved (Section 8.2 of SOP_Ethics_1.9). Person responsible for management. Person responsible for handling the key list to identifiers. Researcher access to the Database, Biobank or Registry. The use by the researcher. Management of privacy concerns. Obligation of all stakeholders. How values and beliefs will be addressed. Regular ongoing communication and engagement with the donors. Sharing and transfer (Section 8.3 of SOP_Ethics_1.9).	☐

Original details: (23239522) G:\My Drive\2.2.4_SOPs_HSEthics\2.2.4_SOP_HSEthics_Data_and_Bio_samples_Application.docm
25 June 2018

File Reference: 2.2.4