Approved July 20, 2022
There has been recurrent frustration and confusion among the regulated community regarding the current OHRP standards for determining which entities are “engaged in research” for the purpose of specific studies. A determination that an entity is “engaged in research” – even if that entity and its staff have no role in designing the research, conducting the core activities of the study, or analyzing and publishing the data – requires the entity to have or initiate a Federalwide Assurance (FWA) and to meet all of the requirements thereof. Those requirements include, for example, adopting detailed policies and procedures that reflect adherence to the Common Rule requirements. Although adhering to OHRP guidance on “engaged in research” has been difficult over the past decades, the emergence of “single IRB” requirements in the revised Common Rule and in NIH grant requirements has exacerbated compliance challenges in this regard. This is primarily because the named “single IRB” for a multi-site study must now determine not just those entities “engaged in research” for one site, but for all sites in a study – which means, among other things, for all entities contracting with the primary research institutions involved. This has increased burdens on IRBs, given that applying the “engaged in research” standard was already challenging for IRBs even when there was no “single IRB” requirement. Also, the advent and increased practice of “decentralized research” and “remote clinical trials” have, by their very design, drawn into studies multiple business and non-profit entities that have never had an FWA and that if required to do so, may prefer to decline to obtain one and thus forego research involvement. Application of the existing “engaged in research” standards to these entities has caused additional confusion.
The actual “engaged in research” requirement is based on one, and only one, reference in the Common Rule:
Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under §46.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy.1
All of the OHRP guidance on this issue – although understandable for the circumstances under which the guidances were issued – therefore is solely a policy creation of OHRP and is in no way necessitated by the language of the regulation itself.
OHRP issued a baseline guidance document in 2008,2 followed by more specific examples and “exceptions to the engaged standards” that were embodied in additional guidance documents issued in 20093 and 2011.4 In multiple instances, the 2009 and 2011 documents reduced, in specific examples, the breadth of the 2008 guidance’s requirements, in response to the regulated community’s difficulties dealing with the results of a straightforward application of the 2008 standards. For example, although the 2008 guidance indicated that anyone “intervening” with research subjects for the purpose of the study would be deemed “engaged” in that research, the 2011 guidance stated that a polling organization conducting opinion surveys of subjects would be “interacting” with subjects, but not “intervening” with them, thus removing the polling organization from being classified as “engaged in research.” That the 2008 standards have been qualified by multiple “not engaged in research” exceptions articulated in the 2009 and 2011 guidances have added to the confusion of the regulated community.5 Although the resulting regulatory paradigm “works” in the sense that research has not stopped because of the ambiguities in this area, SACHRP has determined that the regulated community widely shares the belief that more coherent guidance on this issue is needed.
Perhaps most significantly, OHRP itself has acknowledged the complexity, ambiguities, and in some cases, odd and unintended results, in the application of the 2008, 2009 and 2011 guidances. OHRP in 2021 therefore asked SACHRP to undertake an examination of these standards, without any assumption that these existing standards should be continued, and to analyze whether other standards, more easily applied by the regulated community, and yet still protective of human subjects, could be identified. There ensued an 18-month discussion within SACHRP and its two working subcommittees during which many different recommendations and alternate regulatory approaches were evaluated. In the end, three different basic approaches to reform were identified: first, simply to add new difficult-to-interpret scenarios to those already set forth in the 2009 and 2011 guidances, with resolutions that would be reasonable and would, in general, restrain the excesses of the 2008 standards; second, to condense the three OHRP guidances into one document, with some potential marginal reforms to the standards, and including the new scenarios of the first alternative described immediately above; and third, to formulate an entirely new standard that would focus on including as “engaged in research” only those entities and persons who are in direct charge of the basic features of a study, and including multiple scenarios that would represent application of the new standard.
Based on these extensive discussions within SACHRP and its working committees, SACHRP recommends that OHRP adopt an entirely new definition of “engaged in research” for Common Rule purposes that would focus OHRP jurisdiction and attention, and the attention of researchers, research institutions and cognizant IRBs on those entities (and their researchers) that control the primary features of study design, conduct data analysis, and communicate generalizable results to the larger scientific and public communities. SACHRP further recommends that such new guidance be accompanied by multiple scenarios and their reasonable interpretation under the new standard, and that the regulated community be solicited to nominate scenarios for inclusion in the new interpretive guidance.
At the same time, SACHRP also would recommend that in new guidance, OHRP adopt a procedural standard that would respect a reasonable determination by a research institution or cognizant IRB as to whether an entity is “engaged in research.” Under this procedural approach, if that determination is reasonable and if its rationale of that determination is documented contemporaneously, then OHRP, as a regulatory matter, would afford that determination a presumption of validity, and would not second-guess that determination.
The standard that SACHRP would recommend is as follows:
A party is “engaged in research” if it (or its employees, staff, or agents) has a key role in designing the research, conducting the research, analyzing and interpreting the results, or gaining informed consent from human subjects.
In SACHRP’s view, this standard would firmly place the burden of ensuring that research supported by federal funding rests on the entities and persons that are actually in charge of the research in question. It would simultaneously eliminate from the “engaged in research” scope those parties whose roles are peripheral to the research and/or whose activities are pre-determined and directed in their entirety by those who are “engaged in research” under this new definition.
Substantial Harmonization with FDA, ICMJE and OMB Standards for Research Responsibility and Accountability
This proposed definition, though somewhat broader than, and not derived from, the authorship criteria of the International Committee of Medical Journal Editors (ICMJE), shares important features of that definition, which is meant to confer “responsibility and accountability” for research on those who accept the personal benefits of publishing manuscripts documenting research results.6
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
- Drafting the work or revising it critically for important intellectual content; AND
- Final approval of the version to be published; AND
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
It is important to note here that under the Common Rule, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” In turn, a means for knowledge derived from one or more studies to be “generalized” is for such knowledge to be published,7 although admittedly, research may occur without final publication. This renders the definition of who can be recognized in publishing as primarily responsible for content – while not entirely synonymous with those who are “engaged in research” under the Common Rule – as at least helpful in understanding who should be regarded as primarily responsible for research under the Common Rule.
There are other important standards in research –many of which also apply to, and overlap with, OHRP Common Rule jurisdiction – with which this proposed new standard would be more consistent, and in the context of which the standard could be more readily and reasonably understood. The Food and Drug Administration (FDA), for example, defines “investigator” as “an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.”8 By requiring investigators to sign a Form 1572, FDA commits that person – by dint of his or her leadership of, and ultimate control of, a trial – to full responsibility for the trial’s adherence to FDA standards. FDA enforcement actions therefore focus on that investigator, who must be answerable to FDA, and whose records must be kept and retained consistent with FDA standards. Although other staff members and entities are identified on the Form 1572 as involved in the trial, including subinvestigators, laboratories and facilities at which the research is conducted, the final responsibility for their actions rests on the investigator. The FDA focus on the investigator as primarily answerable for trial conduct has been used as a paradigm for decades as a regulatory strategy, apparently without multiple adverse consequences for regulatory oversight. By focusing on those entities and their researchers that exercise control over the research design and conduct data analysis, the proposed “engaged in research” definition, though broader than “investigator” under FDA regulations, nevertheless at least shares with the FDA approach a common purpose and strategy of focusing on those entities and persons who are best positioned to ensure compliance with human subjects research protections.
Another area of research administration in which key operational control of, and responsibility for, research is an operative factor relates to the standards by which a prime awardee of federal research funding distinguishes between a subawardee and a vendor. A subawardee is thought to be jointly responsible with the prime awardee to the funding agency for performance of the subawardee’s scope of work. A vendor to the prime awardee, on the other hand, is providing services for the research that it typically provides to other customers in a non-research setting; is not thought to be participating intellectually in determinations about research design, conduct, or data analysis; and is not directly responsible to the funding agency for its performance, but rather is responsible under contract to the prime awardee. As defined in Office of Management and Budget (OMB) Uniform Guidance (2 CFR Part 200), a subrecipient/subawardee is an entity “that receives a subaward from a pass-through entity [i.e., the prime awardee] to carry out part of a Federal program,” but a contractor/vendor is an entity that receives a contract, defined as “a legal instrument by which a recipient or subrecipient purchases property or services needed to carry out the project or program under a Federal award.” Recipients of federal research funds in their institutional policies have elaborated on these distinctions, separating those with operational and intellectual control of research (subawardees) from those recipients of federal funds who merely implement research programs without intellectual input or expectations of publication credit (vendors).9
- The entity is providing specified services in support of the research program.
- The entity has not significantly participated in the design of the research itself, but is implementing the research plan of the Harvard investigator.
- The entity is not directly responsible to the sponsor for the research or for determining research results.
- The entity markets its services to a range of customers, including those in non-academic fields.
- Little or no independent decision-making is involved in the design and conduct of the research work being completed.
- The agreement only specifies the type of goods/services provided and the associated costs.
- The entity commits to deliverable goods or services, which if not satisfactorily completed will result in nonpayment or requirement to redo deliverables.
- The entity does not expect to have its employees or executives credited as co-authors on papers that emerge from the research.
- The expectation is that the work will not result in patentable or copyrightable technology or products that would be owned by the entity.
The point here, for the purpose of understanding the analogy of these distinctions to the interpretation of “engaged in research,” is that those in direct control of research are answerable to the funding agency, while those who are merely providing research services at the specific direction of the grant recipient, are not. Instead, the prime awardee that engages the services of the vendor and controls the vendor is looked to by the funding agency as the responsible entity. The federal funding agency does not seek – because it does not need to seek to fulfill its mandate – direct control of all entities participating in the funded study, but only those that are in control of the research and that also control the actions of all the other participating entities – i.e., the prime awardees and subawardees.
Similarly, in the realm of human subjects research subject to the Common Rule, the effect of the revised proposed definition of “engaged in research” would be to place the burden of compliance with human research protections on those who are best positioned to ensure it – that is, those with direct control over (a) the intellectual content of the research, (b) the choice of service providers for the research, (c) the execution of the research, (d) the interpretation and publication of the research results, and (e) control over the content and methods of informed consent discussions, with ultimate responsibility for giving accurate and informative answers to the questions of prospective subjects. In this way, the revised definition would become conceptually consistent with these other approaches, in similar but not identical contexts, of ICMJE authorship standards, FDA investigator responsibility standards, and federal grants principles allocating responsibility among parties that have some role in research.
Applying the Revised Proposed Standard in the Context of Research under OHRP Jurisdiction
In applying this revised definition, research institutions, researchers and IRBs would need to determine those entities that are in direct control of the research, as opposed to those entities that are merely implementing the design and plan provided by others. One factor, though not definitive in all cases, would be the status of prime awardee or subawardee of federal funds used to support the research. Indeed, the Common Rule applies to entities that receive federal funding for human subjects research and that exercise intellectual authority over that research, thus aligning closely with the standards that should apply to what entities are “engaged in research” for Common Rule purposes.
Except in the case of a truly “pass-through” entity (such as the central entity of a recognized consortium that merely funnels federal funds to other entities actually designing and conducting research), it would appear that in the vast majority of cases, responsibility for adherence to the Common Rule standards in implementing a research design would certainly include awardees and subawardees. Those awardees and subawardees, in turn, typically bind their own vendors to adhere to study design and to comply with applicable law, including human subjects research standards, and moreover have duties under federal grants principles to select vendors with care, and to monitor vendors’ performance, which would include adherence to the contract scope of work and any quality standards embedded in the contract. These processes and duties regularly occur independent of any FWA obligations of the vendor. Further, in clinical research that falls under ICH standards, 4.2.6 places on investigators a plenary responsibility for careful selection and adequate monitoring of trial-related vendor performance:
4.2.6 If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
At present, some vendors deemed “engaged in research” under current guidance balk at any contractual obligation that they file an FWA and meet all its regulatory requirements. This vendor aversion to filing an FWA can result in difficulty to secure vendors or contractors for research projects. On the other hand, it may be that with a clearer contractual obligation that binds vendors to human subjects research standards, some vendors may also balk at agreeing to those standards. In either approach, some vendors – perhaps many – may not be pleased with being bound to any such standards, with or without an FWA in place. It is noteworthy that under the proposed approach here, however, the obligation of prime awardee and subawardee institutions to monitor vendors implementing research designs and hold them to these research standards will be more apparent. Some institutions may find this to be a new and unwelcome burden and would prefer that OHRP bear this oversight burden through a complex array of FWAs. In the judgment of SACHRP, however, given OHRP’s limited enforcement and monitoring resources, depending on the FWA process to ensure human subjects protections by vendors unacquainted with those standards provides slender assurance of compliance. As a formal matter, though, for all these many entities to have an FWA does, admittedly, give OHRP some increased leverage throughout the research enterprise, if OHRP had the resources and intent to use that leverage extensively– which it does not appear to have at the present time.
Some entities, even if not appropriately classified as subawardees, could also be regarded as “engaged in research.” For example, an entity could seek to participate in a human subjects research study even if not receiving federal funding for doing so, because the study is consistent with that entity’s for-profit or not-for-profit mission. If the entity is assisting in designing the research, conducting the research or analyzing and publishing the results, and will have actual control of any of those aspects of the research, the entity would appropriately be regarded as “engaged in research” and would be required under the new standard to have an active FWA and to comply with the FWA in all its aspects.
Because the proposed standard focuses on control of these aspects of research, however, it would militate against including as “engaged in research” consultants with defined deliverables, or community-based organizations (CBOs) that may assist in advising on research design, and/or assist in subject recruitment, but that do not make final determinations about study design or recruitment strategy, and whose leaders do not routinely expect publication credit for final results. This “non-engaged” status would pertain even if the CBO and its leaders in any published results may merit acknowledgement in any publication for their defined contributions, or even may merit co-authorship under ICMJE standards, if their involvement is sufficient to meet those standards but does not quality as the requisite degree of “control” under the proposed standard.
Another consideration in applying the new standard might be the degree of incremental risk that the entity may present as a consequence of its participation. A home health agency, for example, may not be intellectually involved in research design or analysis, but may perform home or community visits in order to collect data from human subjects. If the home health agency is administering a drug on-label and customarily does so for patients not enrolled in research, or measures their height and weight and records self-reported symptoms, then under the new standard it would correctly be regarded as not “engaged in research.” (By way of comparison, note that under the existing 2008 guidance, these agencies would generally be regarded as “engaged in research” if they were administering any intervention being tested or evaluated in the research, even administering an on-label drug, vaccine or device.) If, on the other hand, a home health agency is charged with administering an experimental chemotherapy agent with expected serious side effects, then even if that agency may be a “vendor” of services under federal grants policy, an IRB or research institution likely would be disposed to decide that the agency’s involvement is so directly linked to the delivery of the research intervention and the potential risks posed to participants that could require responsive actions to abate risk, and the clinical discretion accorded to the agency’s staff under the protocol is so broad, and the risk of agency staff’s actions so significant, that the agency itself should be regarded as “engaged in research.” In fact, it might appear that the only reasonable basis for not viewing the home health agency in this scenario as not “engaged” might be in the rare and perhaps even nonexistent case that the agency routinely, as part of its regular and frequent business operations, administers potentially highly toxic experimental agents in subjects’ homes and is fully prepared to deal with all expected sequelae as set forth in the protocol, and does so in immediate consultation with the investigator, so that the investigator is regarded as having contemporaneous “control” of that dire situation.
Other applications of the proposed revised standard may be found in Exhibit A, which defines in each scenario the likely results of analysis under the existing OHRP guidances and the new standard.
Obtaining Informed Consent as a Stand-Alone Criterion for “Engaged in Research”
SACHRP is mindful that under existing OHRP guidance, involvement of an entity in obtaining informed consent from a prospective research participant by itself subjects the involved entity to the status of being “engaged” in the research study. Whether this involvement by its very nature should continue to merit this “engaged” result has been discussed in detail by SACHRP and its working subcommittees. In most cases, of course, the investigators and the research team seek informed consent and participate in the informed consent discussion with potential participants, but in these cases, the investigators and their team members are so deeply involved in other aspects of that research as well that they are already accurately deemed (through their employer entity) as “engaged” in that research. The consensus of SACHRP has been that in such cases, those investigators should be regarded as “engaged in research,” but they would already be so classified due to their other activities in the study.
Likewise, the obtaining of informed consent in interventional research that carries with it significant risk to participants is generally also regarded – even if done as an entity’s sole activity in regard to a study – as properly subjecting that entity to “engaged” status. In those cases, the informed consent process must convey complicated risks and possible benefits, and the discussion itself carries some serious risk of misunderstanding and even possible harm to prospective participants.
The more difficult cases, as set forth in Case Examples 3 and 4 in Exhibit A, arise when an entity is only engaged in seeking informed consent, and does so at the express direction of the investigator and research institution with direct responsibility for the entire study. This may arise, for example, when, in a longitudinal natural history study of a disease that involves no interventions with subjects, a regular health provider to a subject describes the study to the patient and obtains his or her consent to participate. In another scenario, a disease advocacy group may seek to expedite enrollment in such a study, because study results are seen as integral to development of new treatments, and/or to the authorization by a national health technology agency (HTA) to place an approved treatment onto a national formulary. In these cases, the only involvement of these entities is to obtain consent, and in the case of regular health care providers, to honor the consent to release past and future medical records of the participant to the research team. Further, if required to obtain an FWA and abide by all its requirements only due to consent discussion activities in low-risk studies, some CBOs and other entities may prefer not to assist – which itself is damaging to the research enterprise and derivatively, to populations affected by specific diseases or conditions to be studied.
Because the proposed observational research carries tangible risks only of a possible breach of privacy (which has been rare in organized medical research conducted by recognized entities) and not interventional risks, and because the instance of obtaining consent is a one-time incident that by itself carries vanishing small risk to subjects, some have opined that obtaining informed consent by itself, alone, should not subject an entity to “engaged in research” status. Some have also observed that with the advent of “decentralized” research, the allowance by OHRP and FDA of remote, internet-facilitated obtaining of informed consent already has decreased meaningful protections of the robustness of the consent process in studies much more risky than those at issue in this scenario.
To yield a rational and efficient result that is also adequately protective of human subjects, SACHRP would recommend that in guidance applying the proposed “engaged in research” standard, OHRP set forth a general presumption that obtaining informed consent by itself would render an entity “engaged in research.” At the same time, SACHRP recommends that the guidance accommodate the possibility that an entity whose only involvement is to obtain informed consent in low-risk, non-interventional studies could be considered (but is not required to be considered) by the research institution and the cognizant IRB as not “engaged in research” if in obtaining that consent, participants are offered meaningful and ready opportunities to engage in additional consent discussions with the primary research team, and if their access to that research team for this purpose is facilitated promptly by the entity that is seeking to obtain consent. Finally, the optional determination by an IRB or research institution that the third-party entity is not “engaged in research” in this scenario would be regarded by OHRP as presumptively valid, if reasonable and its rationales documented.
In response to OHRP’s request that SACHRP evaluate the existing “engaged in research” guidance, SACHRP believes that this existing guidance is confusing, inefficient, and not designed to address the most significant risks to subjects. SACHRP has proposed an alternative approach that focuses responsibility and accountability under the Common Rule on those who have control of the research and its underlying funding, and who are therefore best able to control, monitor and prevent risks to subjects. This recommendation appears more consistent than current OHRP guidance with parallel regulatory and professional standards of ICMJE, FDA and OMB (in its standard-setting for federal funding recipient responsibilities). SACHRP acknowledges that adopting an entirely new definition of “engaged in research” will require substantial effort by OHRP staff, and a process of engagement with the regulated community in order to refine application of the standard in various common scenarios, and to formulate meaningful guidance. SACHRP believes, however, that given the confusion that has attended the application of the current guidances, and given the increased prevalence of single IRB review and of “decentralized trials” involving multiple service providers to trials, this effort is needed, and will be needed even more acutely in years to come.
Case Example 1
In a Phase 3 multi-site, multi-national study for a rare, debilitating disease, funded by NIH, patients will be seen in their homes, and they will receive an investigational drug, X. AMC has contracted with Home Health Agency to see the patients in their homes. Home Health Agency nurses are not involved in designing the protocol, analyzing data or authoring papers, but they will infuse the investigational product during the home visits and collect certain information about the subjects during the study.
- Does Home Health Agency need to comply with the Common Rule, file a Federalwide Assurance (“FWA”) and obtain IRB review?
- Under both the existing and revised standards, the home health agency would be “engaged in research,” although in alternate scenarios of less risky involvement by the agency, it might be deemed as not “engaged” under the revised standard.
Case Example 2
An NIH-funded study is evaluating the effect of the influenza vaccination on U.S. college campuses. College students who volunteer to enroll in the study are randomized into two groups: one group will receive the influenza vaccine during the first week of the semester, while the second receives the influenza vaccine during the mid-semester break. The vaccine used in the study is an FDA-licensed vaccine used on label.
A consortium of U.S. colleges participating in the study contracts with a national pharmacy chain to administer the vaccine. Students enrolled in the study present at the pharmacy to receive the vaccination from a pharmacist in the same manner as they would if they were not participating in the study.
- Is the pharmacy “engaged in research” within the meaning of the Common Rule?
- Under the existing standard, it is “engaged,” because it is administering the intervention tested in the research, but under the revised standard, it is not.
Case Example 3
In a multi-site, transnational study, biospecimens and retrospective and prospective data are being collected for a natural history study of chronic lymphocytic leukemia (CLL). The lead site is a U.S.-based national cancer center, which will house the collected data, and whose investigators will use the biospecimens for biomarker research, perform the data analysis and publish the research results.
The enrollment locations are academic medical centers in Latin America, Japan and Europe, where patients who have been newly diagnosed with CLL are being treated according to standard of care and where they will be recruited into the study. Informed consent for the study will be obtained by research nurses at each of these ex-U.S. sites.
- Are these ex-U.S. recruitment locations engaged in this research?
- Under the existing standard, the enrollment locations are all “engaged.” They would also be “engaged” under the revised standard, although under certain conditions protective of prospective participants’ access to information, they could be deemed as not “engaged.”
Case Example 4
Same facts as Case Example 4, but COVID-19 is the condition whose natural history is under study; subjects must be 18 to 35 years of age and must not have been hospitalized with the illness. The recruitment/enrollment sites at which informed consent is being obtained from prospective subjects are free-standing internal medicine practices not typically involved in clinical research. Informed consent is being given by nurses, physician assistants, and non-professional office staff.
- Are these free-standing internal medicine practices engaged in research?
- Same result as Case Example 3.
Case Example 5
A community hospital nurse will administer an FDA-approved drug product to a research subject in consultation with a university research hospital, which is the study site. The community hospital is doing so only one time, due to the subject’s not being able to travel to the university research hospital. The investigational agent (which is provided by the university hospital) is within the regular community hospital’s formulary and is given frequently to non-research patients. There is nothing in the administration that would be outside standard practice, and the community hospital staff are not receiving publication credit and not otherwise part of the research team.
- Is the community hospital engaged in the research?
- The community hospital is not “engaged” under both the existing and revised standard.
Case Example 6
A community-based organization sends its representatives to a meeting with investigators to give input on study aims and design. The organization, after the study is approved, helps in its meetings and its media presence to publicize the study so that enrollment is completed in a timely way, and it encourages its constituency to enroll in the study, and assists them with day care and transportation to help them keep study visits. The CBO staff interact with the study site to ensure that subjects who don’t show up for visits are contacted and offered assistance.
- Is the CBO engaged in the research?
- Under the current standard, application is ambiguous; under the revised standard, it is not “engaged.”
Case Example 7
A PI of a federally funded study hires a commercial public opinion survey firm to conduct a public opinion assessment in Pakistan of the ethics and effectiveness of American foreign policy in central Asia. The survey firm has offices throughout Pakistan and routinely has conducted similar studies without incident.
- Is the firm, which is intervening with and/or engaging with, subjects, engaged in the research?
- Under exceptions carved out by OHRP, it would not be “engaged,” even though under 2008 standards, it arguably would be “engaged.”
- Under the revised standard, it is not “engaged.”
Case Example 8
A start-up company owned and controlled by a faculty member is the prime awardee in an SBIR grant, and the faculty member for the funded HSR will be using the university’s resources and space, under a subaward to the university. The faculty member will be identifying himself in the research and in any resulting publications as a university faculty member.
- Who is engaged in the research – company, university, or both?
- The company and university are likely “engaged in research” under both current and revised standards. There is a possibility under the revised standard that the university might be regarded as not “engaged,” if the university negotiates to be a vendor and not a subawardee and makes clear that the faculty member’s involvement is solely in his/her company capacity, and that any reference by the faculty member to his/her university title must be stated as for identification only.
Case Example 9
Two institutions are collaborating on a federal grant that involves HSR. Institution B is prime awardee, with subaward to Institution A, and Institution A is doing all the HSR. Institution B is only receiving coded specimens for which there is an agreement in place that A won't give B the key to the code etc.
- Is institution B engaged in the research because of its prime awardee status?
- Under both existing standard and revised standard, B would likely be “engaged.”
- Under the revised standard, B would be “engaged” if B’s faculty/employees helped in the design of the research and collaborated in publication of results.
Case Example 10
An external biostatistician consultant is called in to assist the research team in interpreting study results. The biostatistician has had no role in designing the research or in conducting the study, and will not be a co-author on any publication of study results.
- Is the biostatistician engaged in the research?
- Under the current standard, likely is not “engaged,” under the exception that allows a vendor of services not to be “engaged” if it typically provides such services for non-research purposes to other customers/entities and does not merit publication credit.
- Under the revised standard, the biostatistician would be more clearly not “engaged,” without need for a defined “exception.”
- What about independent social workers who are paid to conduct in-depth interviews of incest survivors for a study? They too are not co-authors on any publication, did not plan the study, and although collecting data, will not analyze those data.
- Same as above.
Case Example 11
A research project seeks to measure dust and noise exposures in landscape workers by providing electric battery-powered lawn mowers instead of the gasoline-powered mowers now in use. The electric equipment is available for general public purchase.
The PI will provide electric lawn mowers to a few landscape companies, which will then train their workers on the electric mowers and the use of masks while mowing. These companies routinely provide training to their workers on any new equipment. The companies are not collecting worker-specific data about these interventions, although supervisors are called to assist workers who are not using equipment or masks correctly.
Informed consent will be obtained from individual workers so that the PI can assess noise and dust levels and the protective efficacy of masks.
- Are the landscape companies engaged in research?
- Under the existing standard, they are “engaged,” because they are administering the intervention under test in the research, but under revised standards, they are not “engaged.”
1. 45 CFR 46.103(a) (emphasis added).
- back to note 1 2. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html
- back to note 2 3. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html
- back to note 3 4. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/september-22-2011-non-engaged-scenarios/index.html
- back to note 4 5. Other scenarios that have been challenging in this regard are set forth in Exhibit A to this recommendation, and not belabored here.
- back to note 5 6. Specifically, ICMJE requires that to be recognized as an author, an individual must meet these criteria:
- back to note 6 7. Research may occur without any publication of results, but publication of results of research with human subjects is almost invariably a means of “generalizing knowledge” gained in that research.
- back to note 7 8. 21 C.F.R. 312.3(b).
- back to note 8 9. Harvard University, for example, defines various factors for determining vendor status as including:
- back to note 9