Databrary Policy on Ethics Oversight
As stated in the Databrary Access Agreement, in order to access Databrary, we require that authorized investigators:
- Belong to an institution that maintains an ethics or Institutional Review Board with U.S.-equivalent standards that reviews and approves research involving human subjects;
- Have current research ethics training that addresses human subjects policy and issues; and
- Are eligible to conduct independent research at their institution.
The purpose of the first two requirements is to ensure that data shared on Databrary are collected in an ethical manner, with appropriate informed consent procedures, and that further research conducted using those data follows the same ethical guidelines. In general, Databrary has kept the specific language regarding ethics broad, to accommodate local norms and ethical standards.
However, there is a minimum standard of ethics oversight that remains a core requirement for Databrary access. Researchers have joined Databrary and shared their research data with this as a fundamental principle, and our funding sources (NIH and NSF) require human subjects oversight. Because of this, regardless of local norms regarding ethics boards, Databrary will not authorize researchers without human subjects oversight to have access to Databrary. This is particularly an issue in foreign countries with different research norms and customs.
To ensure the requirements of the Databrary Access Agreement are met, Databrary will require researchers whose institutions do not have human research ethics review committees which provide equivalent protections to those promulgated by the United States to obtain a Federalwide Assurance (FWA) before applying for access to non-public content in Databrary (see: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html).
In requiring researchers without institutional ethics oversight to obtain an FWA, Databrary is both upholding our agreement with data contributors, and placing a minimal burden on these researchers.
Researchers who have already executed Databrary Access Agreements in countries where we are aware that there is a non-institutional, or less formal, system for monitoring ethical human subjects research will be notified of Databrary's new policy on ethics oversight by October 1, 2017. Proof of institutional oversight, or an FWA, will be required by March 1, 2018 in order to continue as an authorized user of Databrary.
Databrary consulted with officials from the New York University (NYU) legal department, University Committee on Activities Involving Human Subjects, Office of Research Compliance, and Office of Sponsored Programs to develop this policy. This final version is the result of an iterative process between Databrary and these departments, as well as input from officials at the Pennsylvania State University.
We are aware of implications for international researchers in the following countries:
|Germany||Oversight only required for sensitive research (e.g., HIV, genetics)|
|Poland||Oversight external to the institution, by regional and central ethics boards|
|Sweden||Oversight external to the institution, by regional ethics boards|