The HHS regulations at 45 CFR (Code of Federal Regulations) part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB.
For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
- obtaining information about living individuals by intervening or interacting with them for research purposes;
- obtaining identifiable private information about living individuals for research purposes;
- obtaining the voluntary informed consent of individuals to be subjects in research; and
- studying, interpreting, or analyzing identifiable private information or data for research purposes.
Investigators can include students, among others. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
Investigators are responsible for obtaining IRB approval before beginning human subjects research (45 CFR 46.109(a) and (d)). Investigators are responsible for providing the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents) so that the IRB can fulfill its regulatory obligations, including making the required determinations under 45 CFR 46.111.
During the conduct of approved research, investigators are also responsible for ongoing requirements that include, in summary:
- obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117) ;
- obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)); and
- providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others 45 CFR 46.103(b)(5);
- providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)); and
- keeping certain records as required by the HHS regulations for at least three years after completion of the study (45 CFR 46.115(b)).
To determine whether the HHS regulations apply to a particular activity (that may not be considered research or research involving human subjects), the following questions should be addressed in order:
- does the activity involve research (45 CFR 46.102(d));
- does the research activity involve human subjects (45 CFR 46.102(f));
- does the human subjects research qualify for an exemption (45 CFR 46.101(b)); and;
- is the non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA approved by OHRP.
The definition of “research” under 45 CFR 46.102(d)is: “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”
The regulation defines a “human subject” as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information….Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
Thus, if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, the analyses do not involve human subjects and do not have to comply with the HHS protection of human subjects regulations.
Recognizing the time constraints imposed on projects that must be begun and completed within a single semester, the IRB will make every effort to work with researchers to process proposals promptly.
Investigators must plan for and allow adequate time for the review process (approximately 4 weeks, depending on the particular human subjects issues raised by the proposed research). The later in the semester a proposal is received, the more difficult it will be to accomplish the review in time for the projects to be completed during the current semester. It is very strongly recommended that investigators submit proposals within the first three weeks of the semester for projects that must be completed during the current semester.
***Given the additional documentation and review requirements for international research, investigators are strongly encouraged to plan ahead to allow greater time for submitting these protocol applications and obtaining IRB approval.
All students conducting research projects are required to list their advisors/mentors in the IRB application under Responsible Participant. The Responsible Participant is considered to be a member of the research team and must complete a Study Specific Disclosure Form and fulfill all required training. In addition, a Responsible Participant Statement must be signed by the Responsible Participant and attached to “Other Attachments” in the IRB application. A study cannot be reviewed until the Responsible Participant is added to the study as a Study Team Member and the Responsible Participant Statement is signed and attached to the application.
Investigators and all study team members (including the Responsible Participant) are required to follow institutional requirements and complete the course in “Human Subjects Protection” to maintain continuing knowledge of, and comply with, the following:
- relevant ethical principles;
- relevant federal regulations;
- written IRB procedures;
- OHRP guidance;
- other applicable guidance;
- state and local laws; and
- Institutional policies for the protection of human subjects.
In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health’s (NIH) requirement for the training of key personnel in NIH-sponsored or -conducted human subjects research.
International human research refers to research conducted outside the United States using participants from the local community. Such research involving Georgetown University researchers requires review and approval from the GU IRB. Human subjects outside of the United States who participate in research projects conducted or funded by HHS receive the same level of protections as research participants inside the United States.
The approval requirements can be time-consuming, such as translating consent forms, obtaining approval from the international research site, obtaining review and approval by a local ethics review board equivalent to an IRB, etc. Given the additional documentation and review requirements for international research, investigators are strongly encouraged to plan ahead to allow greater time for submitting the protocol application and obtaining IRB approval.
International research applications should identify whether there is a local IRB, Ethics Committee (EC), or government entity that will perform the review in the host country. If a local review has been conducted, a copy of the approval letter/notice should be included in the application. Please consult the International Compilation of Human Research Standards