OHRP would like to clarify some of our views about when institutions are engaged in research, in response to a recent query about when survey firms that are involved in the conduct of non-exempt human subjects research would be considered engaged in a research study under the HHS human subject protection regulations (45 CFR part 46). Specifically, two related issues were raised, so we have addressed each in turn: (1) clarifying when a survey firm may be engaged in human subjects research; and (2) clarifying the relationship between engagement and the Federalwide Assurance (FWA). This clarification was originally posted on an online discussion site, the IRB Forum, on January 13, 2009.
When determining whether a survey firm involved in administering a research survey would meet the "non-engaged" scenario described in (B)(1) of our 2008 engagement guidance document, the answer depends on whether the conditions of the scenario would be met:
(B)(1) Institutions whose employees or agents perform commercial or other services for investigators [are not engaged in human subjects research] provided that all of the following conditions also are met:
(a) the services performed do not merit professional recognition or publication privileges;
(b) the services performed are typically performed by those institutions for non-research purposes; and
(c) the institution's employees or agents do not administer any study intervention being tested or evaluated under the protocol.
In the hypothetical scenario posed in this query to OHRP, if the administration of the survey does not merit professional recognition, the survey firm typically performs surveys for non-research purposes, and the survey firm will not be administering any study intervention being tested or evaluated under the protocol, then we would not consider the survey firm to be engaged in the research study provided that the survey firm was not involved in obtaining the informed consent of human subjects for the research. Note that under scenario (A)(5) of our engagement guidance, institutions whose employees or agents obtain the informed consent of human subjects for the research generally would be considered engaged in human subjects research. The non-engaged scenario described in (B)(1) of the engagement guidance was not intended to apply to scenario(A)(5).
With regard to whether the survey firm typically performs surveys for non-research purposes, a survey firm would meet the condition described in scenario (B)(1)(b) of our engagement guidance provided that most of the surveys conducted by the firm were not performed for "research" purposes as defined at 45 CFR 46.102(d). This means that the firm could conduct some surveys that would meet the regulatory definition of "research" and still satisfy this condition described in our engagement guidance document.
With regard to whether the survey firm's employees or agents will be administering any study intervention being tested or evaluated under the protocol, we agree that the administration of a survey generally constitutes an interaction, not an intervention. In our view, an intervention typically involves something that is done to a research subject (such as administering an experimental treatment intervention, drawing blood, or altering the subjects' environment), while an interaction typically involves communication or interpersonal contact between investigators and subjects (such as conducting interviews or administrating questionnaires). In the case of survey research, there may not be a "study intervention" being tested or evaluated under the protocol. If a survey research study does not include a study intervention, the condition described in scenario(B)(1)(c) of our engagement guidance would be satisfied since the survey firm would not be administering any study intervention. In other words, assuming the first two conditions were met, if a survey firm was only administering a survey as part of a research study, then the survey firm would not be engaged in the research, provided that the firm's employees and agents did not obtain the informed consent of human subjects for the research.
Engagement and the FWA
Regarding the relationship between the engagement of institutions in research and the terms of the FWA, we want to clarify that the Terms of Assurance apply to institutions that have already been determined to be engaged in the conduct of human subjects research. Through the FWA, the institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the specific Terms of Assurance that identify certain requirements that the institution agrees to fulfill under the FWA. In contrast, OHRP's guidance document on engagement in research was developed to assist institutions in determining whether or not they are engaged in a particular human subjects research project. Therefore, the Terms of Assurance should not be used to determine whether an institution is engaged in a particular research project.
It is also important to note that while employees of a contracting firm may sometimes be considered to be agents of an engaged institution holding an FWA, neither the Terms of Assurance nor the guidance document on engagement in research are intended to suggest that every employee of a contracting firm carrying out some aspect of a research study on behalf of an engaged institution holding an FWA automatically will become an agent of the FWA-holding institution. In the OHRP guidance document on engagement we defined an institution's employees or agents as "...individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. ‘Employees and agents' can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation." We believe that the determination of whether an employee of a contracting firm is an agent of an FWA-holding institution is generally for the institution and contracting firm to determine.
Accordingly, in the case of the firm performing the surveys, the determination of whether or not employees of that firm are considered agents of the institution that hired it will largely depend on whether or not those two institutions have decided to characterize the survey firm's employees as agents of the hiring institution.
As to why it might matter whether or not employees of the survey firm are agents of the other institution, it is important to note that one of the Terms of Assurance relates to the requirement for assurances for collaborating institutions such as contractors (see Term 7 of the Terms of Assurance for institutions within the United States, and Term 8 of the Terms of Assurance for international institutions. Under this term of the assurance, when the institution holding the FWA is either a) the primary awardee under a federal grant, contract, or cooperative agreement supporting research to which the FWA applies, or b) the coordinating center for federally-conducted or -supported research to which the FWA applies, the institution is responsible for ensuring that all collaborating institutions engaged in such research operate under an appropriate OHRP-approved or other federally-approved assurance for the protection of human subjects. This means that if an external contractor is determined to be engaged in an HHS-conducted or -supported research study, then the contractor needs to be covered by an FWA.
This requirement could be met in any of the following three ways: (1) the survey firm could obtain its own FWA; (2) the FWA-holding institution and survey firm could agree that the employees of the survey firm were agents of the FWA-holding institution; or (3) the FWA-holding institution could determine that the employees of the survey firm were not agents of the FWA-holding institution and in certain circumstances could choose to extend the applicability of its FWA to cover the collaborating investigators who are employees of the contracting firm through an Individual Investigator Agreement (IIA) or another similar agreement developed by the institution holding the FWA. See OHRP's guidance on the use of the IAA and the link to the sample IIA document.
We hope these clarifications are helpful. Please feel free to reach out to us if it would be useful to have additional OHRP input on these issues.
Last Updated: January 26, 2009