Human Subject Protection

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] regarding the protection of human subjects research. 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:

• biographies
• oral histories, journalism activities, literary criticism, and historical scholarship 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 

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

 

(2) Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

(3) Interaction includes communication or interpersonal contact between investigator and subject.

(4) 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record).

(5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

(6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

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 or Non-Exempt (also known as the Full Board/Expedited Application) ].  We apply the regulations regardless of funding so that step in the decision chart does not apply.

If the decision charts are confusion just let us know.  We happy to chat by phone, video chat, or by email. 

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 04/29/2024.

 

The Emory & Henry’s IRB Organization (IORG) number is IORG0009817, which expires 8/02/2024.

 

The registration number for Emory and Henry’s IRB is IRB00011658. 

 

The signatory official listed on the FWA is Dr. Lou Fincher, Vice President for School of Health Sciences

 

 

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 have been 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.

 

Continuing Review:

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:

1. 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.
2. The revised regulations have added new required elements of informed consent which include:
1. 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,
2. 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,
3. Clarification of whether the research involving biospecimens will or might involve whole genome sequencing, and
4. Notification of whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
3. 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.
4. 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.

EXEMPT RESEARCH 2018 REQUIREMENTS

Studies that fit these category are not exempt from initial IRB review.  These studies should be submitted for IRB exempt determination.  Once the determination is made, exempt studies are not subject annual IRB review and do not have the same consent requirements that apply to other types of research. However, some of the new categories will require prospective participant agreement and a limited form of IRB review.

 

Even when research is exempt from further requirements of federal regulations, basic ethical standards still apply.

• Except in the case of chart reviews or database research, potential subjects must be provided enough information to be able to choose whether or not to participate. The information would typically include the voluntariness of their participation, the purpose of the research, the nature of the subject’s involvement, time commitments, and contact information for the
• Research data must be handled and stored securely.
• Access to research data must be limited to study team members and other authorized
• All members of the research team must be current on human subjects training and must have a current conflict of interest disclosure.

 

Each exempt category is described below. The regulatory text is in bold, and clarifications follow.

 

EXEMPT CATEGORY 1:

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

Most educational research on regular and special educational instructional strategies, and research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods may be exempt under this category.

 

Changes to this exempt category include the caveat that there must not be any impact of subject’s opportunity to learn or any negative impact if the research involves an evaluation of the instructors. If the research involves significant time and attention away from the delivery of regular curriculum or withholding of standard educational content, this exemption would not apply. Also, there must be protection against negative impact on employment if instructors are being evaluated. Research involving randomization to a unproven educational technique, or research conducted by supervisors involved in employment decisions may not be approvable under this exemption, and should be submitted for either expedited for full board review.

 

Applicability to vulnerable populations:

• Pregnant women may be included in this type of
• Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes
• Research involving children is eligible for this

 

EXEMPT CATEGORY 2:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.

 

This exemption category involves several changes from pre-2018 rules. The wording of this exemption was changed to clarify that the category applies to research that only involves interactions. Additionally, the use of potentially sensitive information might be allowable if appropriate protections are in place and the IRB conducts a new process called ‘limited IRB review.’

This category involves interactions (verbal and written responses) and data collection only. The data collection can include audio or video recordings. Research involving “interventions” would not be approvable under this category. Interventions include manipulation of the environment or physical procedures to collection information, such as a cheek swab.

 

Applicability to vulnerable populations

• Pregnant women may be included in this type of
• Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes
• Research involving children is eligible for this exemption only when it related to educational tests or observations in which the investigators don’t participate in the activities being observed. Additionally, children are not eligible for this exemption if the project records identifiable (direct or indirectly) information.

 

EXEMPT CATEGORY 3:

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.

 

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

 

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

 

This exempt category is completely new in the 2018 revisions to the federal regulations.

 

Applicability to vulnerable populations:

• Pregnant women who are adults may be included in this type of research
• Research that targets a prisoner population is not eligible for this
  • Research that could include children is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
• Research involving decisionally-impaired persons is not eligible for this

 

EXEMPT CATEGORY 4

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available;
• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
• The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with applicable federal privacy standards found in the E-Government Act, Privacy Act and the Paperwork Reduction

 

The 2018 changes significantly broaden the type of secondary research that can be done under this exemption category:

• The requirement that all study data be existing at the time of IRB submission has been eliminated. Data under this exemption may be both retrospective and
• The requirement that the study involves data only has been eliminated. The research may also involve the use of
• Creating a de-identified dataset for analysis is still an approvable option and continues to be the most straight-forward approach.
• If investigators need to retain data that contains any HIPAA elements or need to retain a linking list, then appropriate HIPAA protections could make the project approvable. Depending on the circumstances of the data, the HIPAA protections might include a Data Use Agreement or a waiver of HIPAA authorization with accounting of
• Certain sources of publicly available data require the recipient to sign an agreement outlining restrictions on access, use, security and transfer. Most often, those agreements will need review by the college’s general counsel and/or business office.

 

It is important to note the Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another approval path would be required.

 

Applicability to vulnerable populations:

• Data/specimens from pregnant women would be allowed
• Data/specimens from prisoners could be allowed as long as the research wasn’t designed to recruit prisoners and prisoners were only incidental subjects of the
• Data/specimens from children would be allowed
• Data/specimens from persons with decisional impairment would be allowed

 

EXEMPT CATEGORY 5  (Rare for E&H)

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

 

The scope of this category has been broadened. Prior rules required that the Federal demonstration projects be conducted by the Federal agency; this category has been updated to allow projects that are simply funded by a federal agency to study, evaluate, and improve these programs. Note that projects eligible for this exemption will be posted on a Federal website.

 

 

EXEMPT CATEGORY 6:

Taste and food quality evaluation and consumer acceptance studies: if wholesome foods without additives are consumed, or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture

 

This exemption category was not changed in the revised Common Rule. Note that it is the only exemption that is allowable for FDA-regulated research.

 

Applicability to vulnerable populations:

• Pregnant women may be included in this type of
• Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes
• Research involving children is eligible for this
• Research involving decisionally-impaired persons could be allowed if their inclusion was justified.

The safety of our faculty, staff, and students, as well as the members our Southwest Virginia community is very important to us.  We allow in person human subject research with COVID-19 mitigation and prevention strategies as needed as outlined in campus policy for your respective campus:  Main or School of Health Sciences.