Registry and Biobank Ethics and Governance

From WikiAdvocacy

Ethics and Governance

Research Ethics and Stewardship

With any registry or biobank, you are conducting a research study, and research ethics are an important consideration. Broadly, each research study must consider the following:

  • Respect for persons – How can our research processes enact respect?
  • Beneficence – How can we assure our research is achieving benefits? And clear benefits for whom?
  • Justice – How can we proceed equitable and fairly while addressing current injustices in the system?

Several recent events have influenced the public narrative on research ethics, including Rebecca Skloot’s book “The Immortal Life of Henrietta Lacks”, the destruction of 5 million discarded newborn blood spots in Texas, and the Havasupai/ Arizona State University settlement. Given these events, it is possible that business as usual practices can cause harm, and we often cannot anticipate what harm looks like.

Traditional systems for managing risk, including IRB review and the informed consent process, may not be sufficient, and additional standards and stewardship practices may be needed to guide us. As good stewards, we must engage our community and the public, be transparent about research practices and intentions, communicate openly and clearly, and ask permissions before using samples outside of original scope or intentions.

Listen to Sharon Terry discuss stewardship and The Immortal Life of Henrietta Lacks.

Ownership and Access

Ownership and access to data and samples are two important issues that should be discussed early in the planning phase of your registry or biobank. While a number of viable models can be used, it is critical to know the answers to the following questions to decide which model is best for your organization:

  • Who will own your data and samples? Many advocacy organizations choose to own their data and samples, as it gives them the most autonomy over their collection. This often requires using a third-party vendor for registry and biobank services. If you want to own your data and samples, it is important to make sure that the model you select supports advocacy ownership of the collection.
  • Who will govern/ make decisions about your collection? It is critical to understand who has the power to make decisions about your registry or biobank. Many advocacy organizations also choose to be the decision maker, with support from their advisors or biobank oversight committee.
  • Who will be able to access data and samples? To leverage the most research activity, many registries and biobanks make their data and samples available to all qualified researchers. Other models include making it available to a subset of researchers such as a consortium, or researchers at a single institution.
  • Who will determine access to data and samples? In addition to broadly deciding who can have access, you will also need a process to release data and samples to specific researchers. Many organizations have a committee that reviews researcher applications and approves the release of data and samples.

Find these questions and more in our Start-up Guide: 54 questions to consider.

The Institutional Review Board

Any research study, including registries or biobanks, requires approval from an Institutional Review Board (IRB). IRBs, established by the National Research Act in 1974, are charged with approving, monitoring and reviewing research, with the primary goal of protecting the rights of human subjects. IRBs are mandated by the Federal Government as part of the Code of Federal Regulations (CFR) (Part 46 [Protection of Human Subjects] of Title 45 [Public Welfare] and FDA regulations on IRBs at 21 CFR 56). This document compares the FDA and HHS Human Subject Protection Regulations.

Several types of IRBs exist, including local IRBs associated with universities and hospitals, and non-profit or for-profit IRBs, also know as external, central or independent IRBs. IRBs typically have at least five members, including one non-scientist and one community member not associated with the institution. Regardless of type, all IRBs are governed by the same regulations and have the same responsibilities.

According to the ICH GCP guidelines, IRBs should review the following documents:

  • Research protocol(s)/amendment(s)
  • Written informed consent document(s) and document revisions
  • Participant recruitment procedures including advertisements
  • Written information provided to participants
  • Investigator’s brochure
  • Available safety information
  • Information about payments and compensation available to participants
  • Investigator’s current curriculum vitae and/or other documentation evidencing qualifications
  • Any other documents that the IRB may need to fulfill its responsibilities

IRBs also review the research protocol and other related documents at regular intervals (usually at least once a year). The principal investigator is responsible for reporting to the IRB any protocol deviations or changes to the protocol, all adverse reactions, and any new information that may adversely affect the safety of the participants.

Watch videos from OHRP (Office for Human Research Protections) to learn more or read the ICH GCP guidelines.

Tips for working with your IRB

A good working relationship with your IRB is vital to a successful research project. The IRB can helpful you navigate issues surrounding consent, participant withdrawal, incidental findings, returning results, and other questions that may arise during the study protocol. Susan Brown Trinidad shared these tips for working with your IRB at the Genetic Alliance 25th Annual Conference in June.


  • Behave like a colleague
  • Learn the ropes
  • Consult early & often
  • Respect the IRB’s time
  • Offer to attend a meeting in person
  • Cultivate friends
  • Remember “please” and “thank you”


  • Assume the worst
  • Expect (or demand) immediate results
  • Cut and paste the grant text into the application
  • Try to guess what they want to hear
  • Attempt to sneak anything past the IRB

The IRB Protocol

When establishing a biobank, IRB approval is usually required for oversight of the collection, storage, and secondary use of samples. It is important to provide enough information in the protocol to satisfy obligations under applicable regulations and institutional policies, including 45 CFR 46 (the common rule), FDA human subjects regulations, HIPAA privacy regulations, and state and local laws. The following is an overview of information you should consider including in your research protocol. This information is summarized from a presentation at the 2011 ISBER meeting.

1. Name, purpose, and overall goals of your biobank.

2. Information about research that will be conducted using specimens and data in your biobank.

3. Information about administrative oversight, including the name of the individual with overall responsibility and the oversight mechanisms in place.

4. Procedures for specimen and data collection, including details of the donor population, what data and specimens will be collected, how will they be collected, and where will they be collected.

5. Protocols for recruitment and informed consent, including who will be recruited, how will they be recruited, and when will they be recruited, a description of collection sites, and information about the consent process and form.

6. Procedures for participants to withdraw consent, and information about what will become of specimens and data when consent is withdrawn.

7. Information about protection of subject autonomy and privacy of information, including information about access to identifying information and key codes, polices to protect participants, and policies for ensuring data and sample uses are consistent with consent.

8. Specimen and data storage and retention procedures, including where data and samples are stored, how they are coded, processes for secure storage, and the length of storage.

9. Specimen and data distribution procedures, including conditions of distribution, processes for ensuring appropriate access, secondary distribution policies, commercial use policies, user fee policies, and investigator usage agreements.

10. Return of research results, including when individual results and incidental findings can be returned, and when aggregate or generalized results can be returned.

11. Other issues, including plans if the PI/ manager leaves and policies on rights to IP resulting from future research.

Remember to begin a dialogue with the IRB in advance of protocol preparation. The IRB is an important resource, and you should engage your IRB early and often during preparation of the protocol.

Related Information