Institution Bulletin vol 4, issue 4
The Office for Human Research Protections (OHRP) recently posted correspondence with the National Health Registry in two letters dated August 11, 2011 and December 29, 2011 in hopes that the responses would be useful to sponsors, institutions, and IRBs. The correspondence relates primarily to the issue of whether various activities related to the registry require IRB review. The links below provide the full text of the letters:
OHRP points out that many of the activities related to the registry may not require IRB review. The infographic below gives a visual break-down of the activities related to the registry and whether the agency considers those activities to be human subjects research. You may download a full-size version of this infographic by clicking here.
OHRP statements corresponding to the image above can be found by clicking here, and are summarized in the bullets below:
- If research conducted by a registry is not part of or supported by HHS, or covered by an HHS Federalwide Assurance (FWA), then the regulatory requirements of 45 CFR 46 do not apply to that research activity even if it would be considered nonexempt human subjects research under those regulations.
- The application of the regulations to an activity depend in part on whether the activity meets the regulatory definition of “research,” which depends on the specific facts of the activity, and not whether it is labeled “quality improvement” or something else.
- A research registry could be designed so that the regulations would not apply to the creation and operations of the registry through various mechanisms, including the use of codes instead of identifiers in the original release of data to a registry, or the use of computer programming to merge identifiable data-sets without any person being able to view the data in identifiable form.
- Institutions holding information originally obtained for clinical or administrative purposes whose agents simply release identifiable private information to a registry are not engaged in any research conducted by the registry, and do not have to meet any regulatory requirements of the 45 CFR 46 in this regard.
- Outside researchers who request the release of non-identifiable private information from the registry for secondary research analyses are not conducting “human subjects” research, and therefore the regulations do not apply to this activity, and there is no requirement for either IRB review or informed consent.
- If healthcare providers enhance or extend their standard of care in follow-up interviews with their patients and those changes would have been implemented regardless of any secondary research purpose, then the data collected through those interviews would not be considered research; in contrast, if part of the reason for the change in interview data collected is for research, then the data collection would be considered part of a research activity.
Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) data through intervention or interaction with the individual, or
(2) identifiable private information. (45 CFR 46.102(f))
Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46.102(d))
- identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain, which has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
- a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. (OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens, available here, accessed 11/07/2014).
Tags: 45 CFR 46, Biological Specimens, Central IRB, clinical research, coded information, Coded Private Information, Federalwide Assurance, FWA, HHS, human subjects, Institution IRB, IRB review, OHRP, registries