Human Subjects Research Glossary

According to the U.S. Department of Health and Human Services, Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.

IRB reviews help to ensure that research participants are protected from research-related risks and treated ethically, a necessary prerequisite for maintaining the public's trust in the research enterprise and allowing science to advance for the common good.

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A detailed or careful examination that has or involves prospectively identified approach to the activity based on a system, method, or plan.

The information is expected to expand the knowledge base of scientific discipline or other scholarly field or study and yield one or both of the following:

• Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
• Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships or to inform policy  beyond the study.

According to 45 CFR 46, a human subject is a "living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospeciments through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Deceased individuals do not meet the definition of human subject. For specimens, data, and other information gathered without direct interaction with the individual, it is assumed that the individuals are alive unless the researcher specifically knows otherwise.

Physical procedures or manipulations of the individual or individual's environment that are performed for research purposes.

• Manipulations may be physical, social, psychological, or emotional.
• Environment includes an individual's social, virtual, and physical environments.

Examples:

• Games, puzzles, or decision making activities
• Collection of biospecimens
• Imaging, scanning
• Diet or nutrition studies
• Use of instruments or devices to collect data or to monitor/influence behavior
• Clinical studies of drugs and medical devices

Communication or interpersonal contact between a member of the research team and the subject. Interactions can occur in person, by mail, email, phone, online/virtual mediums, or via social media, etc.

Examples:

• Surveys
• Questionnaires
• Educational tests (cognitive, diagnostic, aptitude, achievement)
• Focus groups
• Interviews
• Observation of behavior (including visual or auditory recording)

According to § 46.111 Criteria for IRB approval of research:

1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 
3. Selection of subjects is equitable. 
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § 46.116.
5. Informed consent will be appropriately documented or appropriately waived in accordance with § 46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the the privacy of subjects and to maintain the confidentiality of data.
8. For purposes of conducting the limited IRB review required by § 46.104(d)(7)).

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The HHS regulations for the protection of human subjects in research at 45 CFR 46 include five subparts. Subparts B, C, and D, of those subparts, provide additional protections for:

• Research with pregnant women and fetuses (B);
• Research with prisoners (C); and
• Research with children (D).

In addition, the following are examples of groups that are often considered vulnerable or in need of additional protections:

• Individuals with physical disabilities
• Individuals with mental disabilities or cognitive impairments
• Economically disadvantaged
• Socially disadvantaged
• Terminally ill or very sick
• Racial or ethnic minorities
• Institutionalized persons (for example, persons in correctional facilities, nursing homes, or mental health facilities).

A complete group of questions and documents that conveys all the necessary information pertaining to human subjects for the IRB reviewers. 

Protocol Personnel must be listed on the protocol and must take prerequisite human subjects research training.

Protocol Personnel are Investigators and all researchers who interact (includes intervention and interaction with participants or involvement with the informed consent process) with participants or who obtain or access their identifiable private information.

An Investigator is defined as the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of funded research, or proposed for such funding, which may include, for example, graduate research assistants, collaborators, or consultants.

*All Protocol Personnel must have appropriate human subjects training on file before the protocol may be approved or prior to new personnel beginning work on an existing protocol. 

*Faculty Advisors who oversee student research are also considered Protocol Personnel. 

*See more details from the Office for Human Research Protections about Who are "investigators"? 

According to §46.104 Exempt research, the following categories of human subjects research are exempt from this policy:

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.
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).
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.
4. Secondary research for which consent is not required.
5. 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.
6. Taste and food quality evaluation and consumer acceptance studies.
7.  Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
8. Secondary research for which broad consent is required.

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more categories by the federal Office for Human Research Protections may be reviewed by the IRB through the Expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

1. Such applications will be reviewed by at least two members of the Committee with the following possible outcomes: (A) The reviewers will unanimously approve or disapprove the proposal. Either reviewer may required that modification to the proposal be made prior to approval or (B) Reviewers can recommend that the application be reviewed by the full IRB, in which case it will be considered at the next meeting.
2. The decision of the reviewers will be presented to the full IRB for approval at the next meeting.
3. Minor Amendments in previously approved research may be reviewed and approved by the Chair.

Research involving more than minimal risk and/or vulnerable populations (e.g. children, economically or educationally disadvantaged persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the Full Committee. Research proposals that involve a conflict of interest may also be subject to FCR.

Application received which require FCR will be reviewed at the next scheduled meeting.

Includes systematic, data-guided activities, designed to bring about immediate improvements in healthcare delivery in particular settings. Initiators of QI/QA projects identify promising improvements, implement small scale changes, monitor results, and decide about additional changes. QI/QA is a core function of good clinical care.

Refers to the handling, and safeguarding, of sensitive information related to research participants. This includes personal data, medical records, and other identifiable information that researchers collect during the course of their studies.

A situation where the identities of research participants are entirely unknown to the researchers. In anonymous research, even the researchers cannot link specific data or responses to individual participants.

Any representation of information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means.

Further, PII is defined as information(i) that directly identifies an individual, such as:

• Name
• Address
• Social security number or other identifying number or code
• Telephone number
• Email address
• Digital files such as photographs, videos, or audio recordings that reveal an individual's identity
• Any information permitting the physical or online contacting of a specific individual

PII can also include indirect identification with an intention to identify specific individuals. A combination of the following data elements could identify an individual in small samples:

• Gender
• Race
• Birth Date
• Geographic Indicators
• Other Descriptors

Information that is a subset of health information, including demographic information, collected from an individual, relates to the past, present, or future physical or mental health or condition of an individual; 

AND

Either (i) identifies the individual (see PHI identifiers below); or (ii) where there is a reasonable basis to believe the information can be sued to identify the individual;

AND

Used within or disclosed from a covered entity: 1) health plans; 2) health care providers that conduct certain financial and administrative transactions electronically (i.e. billing, funds transfer); and 3) healthcare clearinghouses, which process or facilitate the processing of health information in a non-standard format to standard format or vice versa. Most healthcare and mentalhealthcare providers, hospitals, insurance companies, and clinics are considered covered entities under HIPAA.

PHIIdentifiers

1. Names (individual, employer, relatives, etc.)
2. Address (street, city, county, precinct, zip code - initial 3 digits if geographic unit contains >20,000 people, or any other geographical codes)
3. Telephone Number
4. Fax Number
5. Social Security Number
6. Medical Record Number
7. Dates (except for years) connected to subjects, including date(s) of birth, admission, discharge, death, ages >89, and all elements of dates indicative of such age (except that such age and elements may be aggregated as "Age <90")
8. Email Address
9. Health Plan Beneficiary Number
10. Account Numbers
11. Certificate/License Number
12. Vehicle Identifiers and Serial Numbers (e.g., VINs, LIcense Plate #, etc.)
13. Device Identifiers and Serial Numbers
14. Universal Resource Locator (URLs)
15. Internet Protocol (IP) Address Number 
16. Biometric Identifiers (e.g., finger or voice prints)
17. Full Face Photographic Images (and any comparable images)
18. Any other unique identifying number, characteristic, or code

A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Designed to protect individuals' sensitive health information, ensuring its confidentiality and security. It has several key provisions, including:

1. Privacy Rule: This establishes national standards for the protection of individuals' medical records and other personal health information.
2. Security Rule: This sets standards for the security of electronic protected health information (ePHI), outlining safeguards that must be implemented to ensure its integrity and confidentiality.
3. Transactions and Code Sets Rule: This rule standardizes electronic transactions in healthcare, such as billing and claims processing, to improve efficiency and reduce costs.
4. Identifier Standards: HIPAA mandates the use of standard identifiers forhealthcare providers, health plans, employers, and individuals to facilitate the efficient electronic exchange of health information.
5. Enforcement Rule: This establishes procedures for investigating complaints and enforcing HIPAA's privacy and security regulations, including penalties for non-compliance.

**If any protocol personnel are collecting or accessing PHI--the Information Privacy Security Training course in CITI is required**

For more information on HIPAA, please visit the U.S. Department of Health and Human Services website.

In HIPAA (Health Insurance Portability and Accountability Act) research, a limited data set refers to health information that excludes certain direct identifiers of individuals and their relatives, household members, and employers. These direct identifiers include names, postal address information other than town and city, telephone and fax numbers, email addresses, social security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers and serial numbers, web URLs,internet protocol (IP) address numbers, biometric identifiers (including finger and voice prints), full face photographic images, and any comparable images.

However, a limited data set may include certain indirect identifiers such as dates (birthdates, admission dates, discharge dates, and death dates), city, state, ZIP code, elements of dates (except year) for dates directly related to an individual (such asbirthdate, admission date, discharge date, date of death), and other unique identifying numbers, characteristics, or codes that are not listed as direct identifiers (ages in years, months or days or hours).

Measures taken to protect the privacy, confidentiality, and security of research participants' data. 

Adequate provisions must be in place to protect the privacy of subjects and to maintain the confidentiality of data. Review UIT's File Storage Options. See the Data Stewardship Standards and the Data Storage Security Grid to ensure that your data will be stored in an appropriate location.

A federal law that protects the privacy of students' education records. FERPA applies to all educational institutions that receive funding from the U.S. Department of Education.

Key provisions of FERPA include:

1. Access to Records: FERPA grants eligible students (typically those who are at least 18 years old or attending apostsecondary institution) the right to access their education records. These records include grades, transcripts, disciplinary records, and any other personally identifiable information.
2. Control over Disclosure: FERPA prohibits educational institutions from disclosing students' education records without their consent, except in certain specified circumstances. Exceptions include disclosures to school officials with legitimate educational interests, certain government agencies, and in response to a subpoena or court order.
3. Amendment of Records: FERPA gives students the right to request the amendment of inaccurate or misleading information in their education records. If the institution refuses to amend the records, the student has the right to a formal hearing.
4. Parental Rights (for Dependent Students): FERPA affords certain rights to parents regarding their dependent children's education records. These rights transfer to the student once they reach the age of 18 or attend a postsecondary institution.
5. Notification of Rights: Educational institutions must annually notify eligible students and their parents of their rights under FERPA.

For more information regarding FERPA, please visit the U.S. Department of Education's website.

MSU researchers, both faculty and students, wear many hats. In particular, MSU Education Graduate Students may also be teachers, principals, administrators, and superintendents. In those school roles, educators have natural access to Student Education Records like tests, grades, and homework, to fulfill their regular job duties. However, in the MSU research context, these same individuals must put on their “researcher hat” and view the students they see daily under a special research lens. This means that the Student Education Records that they regularly access must be treated differently for research purposes because this research activity is subject to FERPA.

In the research context, it is no longer possible to simply log into the gradebook and pull data for research – this action requires parent or Eligible Student consent. An MSU Educator Researcher has an academic task to conduct research to fulfill their graduate school requirements. Per the regulations, that research is considered a personal objective rather than a legitimate educational interest in the records they otherwise freely handle on a regular basis.

Please see FERPA in Research for additional information.

Conflict of interest may exist:

• When a University employee has a personal interest that could or could appear to compromise or impinge on the employee's obligation to the University to exercise the employee's best judgment in pursuit of the interest of the University and its students;
• Examples include, but are not limited to, consulting or ownership interest with a company that has contracts with MSU, or a family member or significant other who works with you.

For more information regarding conflict of interest, please see the Office of Research Compliance Conflict of Interest page.

According to NIH.gov, human subjects research is anticipated within the period of the award but definite plans for this involvement cannot be described in the application.