Human Subject Protection
The Institutional Review Board (IRB) is a committee established to assist in protecting the rights and welfare of human participants involved in research activities.
Emory & Henry is committed to protecting the rights of and ensuring the safety of human subjects participating in research conducted by faculty, staff and students. The IRB reviews human subject research projects according to three principles of the Belmont Report: first, minimize the risk to human subjects (beneficence); second, ensure all subjects consent and are fully informed about the research and any risks (autonomy); third, promote equity in human subjects research (justice). All research involving human subjects should be reviewed by and approved by the IRB before the study is initiated.
Definition of Human Subjects Research
Human subjects research is any research or clinical investigation that involves human subjects.
Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable. When considering whether an activity meets the definition of human subjects research per DHHS regulations one must consider two federal definitions: research and human subject.
Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Examples of systematic investigations include:
- surveys and questionnaires
- interviews and focus groups
- analyses of existing data or biological specimens
- epidemiological studies
- evaluations of social or educational programs
- cognitive and perceptual experiments
- medical chart review studies
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.
Examples of activities that typically are not generalizable include:
- oral histories that are designed solely to create a record of specific historical events
- service or course evaluations, unless they can be generalized to other individuals
- services, courses, or concepts where it is not the intention to share the results beyond the Emory & Henry community
- classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
- quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the Emory & Henry community
A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
- Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). 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.
Does this need to be reviewed by the IRB?
There are several resources to help you with this. We now have a “Human Subjects Research Determination Form” to help you with this question. This form, will ask you a series of questions to help determine whether your project should be reviewed by the IRB.
In addition, the Office Of Human Research Protections (OHRP) has decision charts to help you decide whether an application should be submitted to the IRB and what kind of application it will be (exempt, expedited, or full board). We apply the regulations regardless of funding so that step in the decision chart does not apply.
Federal regulations and university policies require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students. At Emory & Henry, students may only conduct research under the supervision of a faculty adviser and that faculty adviser must serve, for the purposes of the IRB application, and regulatory oversight of the project, as the PI.
Student research activities can include, but are not limited to, projects that result in undergraduate honors theses, masters theses, or doctoral dissertations, and graduate student research. However, students may also be involved in activities only for educational purposes and not research, referred to as “classroom projects”.
IRB approval is required if human subjects are involved, either directly or through use of identifiable data about them, and the project involves a systematic investigation individuals with an intent to develop generalizable new or expanded knowledge about living individuals. A systematic investigation is one that involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing a theory. Generally, if there is an intention to publish the results in a peer-reviewed journal or to present results at a conference, then IRB review is required. (There are some exceptions in that research with publicly available data, oral histories, etc.) The E&H IRB generally considers honors thesis, independent undergraduate research projects, graduate research, and masters and doctoral theses work involving what is federally defined as human subjects as generalizable and subject to IRB review.
At the same time, many class projects are conducted for educational purposes and not as research, and will not require IRB approval, as it does not meet the federal definition of research. Please note that IRBs do not have the option of granting “retroactive” approval after research is done; you should err on the side of submitting or consulting with the IRB if there is any doubt.
For further information and guidance on these issues, there is a student research guidance document and published IRB policies (see specifically “Student Research,” Policy 6.0). These documents can be found in Self Service under the Academics Tab (sub-folder - Human Research, IRB Policies and Guidance)
FWA number assigned to Emory & Henry College, is FWA00027454, which expires 10/31/2023.
The Emory & Henry’s IRB Organization (IORG) number is IORG0009817, which expires 8/20/2021.
The registration number for Emory and Henry’s IRB is IRB00011658.
The signatory official listed on the FWA is the Provost, Dr. John Wells.
Current Policies and Procedures
The policies and procedures for the conduct of research with Human subjects applies to all faculty, staff, and students at Emory & Henry.
The current Policies and Procedures Manual applies to all research reviewed, approved, and/or provisionally approved before January 21, 2019. While many of the policies will remain the same, research conducted after that date will be subject to a new set of policies based on the changes to the federal regulations (See also Revised Common Rule - January 21, 2019.
Policy 6.0 Outlines Student Research Policies - includes faculty responsibilities and distinguishes between classroom exercises and human subjects research. Please also see the guidance document for student research for assistance.
The policies can be found can be found in Self Service under the Academics Tab (under Human Research Policies and Guidance)
Revised Common Rule - January 21, 2019
Changes to the Common Rule Coming Soon!
In January 2017, the US Department of Health and Human Services (DHHS) published the “Final Rule,” which is a revised version of the Common Rule (45 CFR 46) first published in 1991. The last time the common rule was revised was 2005. The revisions come after years of discussion of the most appropriate changes in the changing world of research influenced by changes in technology and overall changes in U.S. culture. After several implementation delays, the “Final Rule” will be implemented January 21, 2019, with the expectation that IRBs, researchers, institutions will comply with those “Final Rule” on that date. For ease of communication we’ll refer to the “Final Rule” as the “Revised Common Rule,” and/or “2018 Requirements” below.
If you go to the DHHS site, the currently published regulations are referred to as pre-2018 requirements, and the Revised Common Rule is referred to as the 2018 requirements.
At Emory & Henry, the studies reviewed and either provisionally approved or approved prior to January 21, 2019 will be subject to the current common rule. Those that are reviewed and provisionally approved or approved January 21, 2019 will be subject to the revised common rule.
New forms and consent templates will be developed to facilitate meeting the new requirements for submissions on or before January 21, 2019.
The Final Rule (Revised Common Rule) 2018 Requirements are available for your review.
Summary of Major Changes
Revised Definitions of “Human Subject” and “Research:”
Human subject now includes biospecimens.
Research The definition now specifies certain activities are not considered research. A partial list is included below.
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
Exempt Categories Broadened:
Many of the existing categories have been revised and new categories have been added
Categories 1, 2, 4, and 5 have been revised. Categories 3, 7, and 8 are new. Category six (taste and food quality remains the same).
A description of the changes to exempt categories can be found in Self Service under the Academics Tab (sub-folder - Human Research, Revised Common Rule Summary)
A full description of the new exempt categories can be found in Self Service under the Academics Tab (sub-folder - Human Research, Revised Common Rule Summary). Or you can also go directly to The Final Rule (Revised Common Rule) 2018 Requirements under §46.104 Exempt research.
Under the previous Common Rule, Expedited (XP) and Full Board (FB) projects must be re-approved by the IRB on an annual basis (at a minimum). However, under the revised Common Rule (45 CFR 46.109(f)(iii)), expedited projects granted initial approval on or after 1/21/19 do not require annual continuing review by the IRB.
Further, if a Full Board project granted initial approval on or after 1/21/19 has progressed to the point that it only involves one or both of the following, then it will not require annual continuing review unless the IRB determines otherwise. However, you still must submit a final continuing Review to notify the IRB that your study status meets one of the two criteria below.
Remaining study activities are limited to data analysis, including analysis of identifiable private information or identifiable biospecimens, or
Remaining study activities only involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
Changes to Consent Requirements:
- A new regulation states that “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” (45 CFR 46.116(a)(5)(i)). The revised consent templates will explain what must be included in this summary of key information.
- The revised regulations have added new required elements of informed consent which include:
- A statement about whether identifiers will be removed from private information or biospecimens used in the research, and after such removal, the information or biospecimens could be used or distributed for future research studies,
- An explanation of whether biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this profit,
- Clarification of whether the research involving biospecimens will or might involve whole genome sequencing, and
- Notification of whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
- Broad consent may be obtained for the storage and maintenance for secondary research use of identifiable private information and identifiable biospecimens originally collected for other purposes (exempt category 7). Secondary research use of such materials may occur under exempt category 8. The new elements of informed consent required by the regulations for broad consent are now incorporated into the repository consent form template, and those projects that qualify for exemption category 7 must use the repository consent form.
- The revised Common Rule will require that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the Federal Department or agency. HHS has indicated that there are two publicly available federal websites that will satisfy the consent form posting requirement: ClinicalTrials.gov and Regulations.gov. HHS has also indicated that they are developing further instructions, which we are still awaiting.
Studies meeting exempt criteria (click on the hyperlink above for the exempt categories) and Human Subject Determinations requiring official documentation are processed within 7- 10 business days. For expedited submissions (clink hyperlink above for the expedited categories), researchers will receive initial IRB feedback within 10-14 business days. Time to approval, however, varies depending on required revisions.
Full Board Studies
Studies requiring Full Board Review:
- Do not fit in exempt or expedited categories
- Are more than minimal risk
- May involve collection of sensitive data and/or use of vulnerable populations
Meeting Dates for Spring 2019
Wed January 23, 2019
Wed Feb 27, 2019
Wed March 20, 2019
Wed April 24, 2019
Researchers must submit protocols at least 2 weeks prior to the full board meetings once meeting dates are established.