G

Gene

A gene is an ordered sequence of nucleotides located in a particular position on a particular chromosome that encodes a specific functional product (i.e., a protein or RNA molecule).

Gene Expression

The process by which a gene’s coded information is converted into the structures present and operating in the cell. Expressed genes include those that are transcribed into mRNA and then translated into protein and those that are transcribed into RNA but not translated into protein (e.g., ribosomal RNAs).

Gene Therapy

The insertion, alteration, or removal of genes within an individual's cells and biological tissues to treat disease. It is a technique for correcting defective genes that are responsible for disease development. The most common form of gene therapy involves the insertion of functional genes into an unspecified genomic location in order to replace a mutated gene, but other forms involve directly correcting the mutation or modifying normal gene that enables a viral infection. Although the technology is still in its infancy, it has been used with some success. Also referred to as "gene transfer," particularly for research applications in which it is unknown whether the introduction of the gene will actually result in a therapeutic effect. See also Recombinant DNA.

General Controls

Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 USC 360(c) (Food, Drug and Cosmetic Act §513)].

General Purpose Equipment

Tangible, nonexpendable equipment which is usable for other than research, medical, scientific, or technical activities (e.g., office equipment, furnishings, copying / printing equipment, and motor vehicles).

Generalizable Knowledge

Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.

Genetic Information Nondiscrimination Act (GINA)

GINA is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health. The new law prevents discrimination from health insurers and employers.

Genetic Screening

Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.

Genome

All the genetic material in the chromosomes of a particular organism; its size is generally given as its total number of base pairs.

Genome-Wide Association Studies (GWAS)

A GWAS is an approach that involves rapidly scanning markers across the complete sets of DNA, or genomes, of many people to find genetic variations associated with a particular disease. Once new genetic associations are identified, researchers can use the information to develop better strategies to detect, treat and prevent the disease. Such studies are particularly useful in finding genetic variations that contribute to common, complex diseases, such as asthma, cancer, diabetes, heart disease and mental illnesses.

Genotype

The genetic constitution of an individual.

Gift

Gifts and bequests are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. (Also see: Donation)

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Good Laboratory Practice (GLP)

GLP Standard compliance monitoring program ensures the quality and integrity of test data submitted in support of product registration.

Good Manufacturing Practice (GMP)

GMP are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product. The basic concept safeguards the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the US a drug may be deemed adulterated if it passes all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guidelines. Complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

Grant

A type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A grant, as opposed to a cooperative agreement, is used whenever the awarding office anticipates no substantial programmatic involvement with the recipient during the performance of the activities. Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. Compare: Contract

Group C Treatment IND

"Group C" Treatment IND was established by agreement between the FDA and the National Cancer Institute (NCI). The Group C program is a means by which oncologists can use investigational drugs for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are generally Phase III study drugs that have shown evidence of relative and reproducible efficacy in a specific tumor type. They can generally be administered by properly trained physicians without the need for specialized supportive care facilities. Group C drugs are distributed only by the NIH under NCI protocols. Although treatment is the primary objective and patients treated under Group C guidelines are not part of a clinical trial, safety and effectiveness data are collected.

Guardian

An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. A guardian may be a grandparent, other family member, or other person, association, or agency other than the biological or adoptive parents who has been formally appointed as a guardian or legal representative by a court to care for a child, including to consent on behalf of a child to general medical care.

Health Care Provider

The term 'health care provider' includes a provider of services, a provider of medical or other health services, and any other person furnishing health care services or supplies.

Health Information

The term 'health information' means any information, whether oral or recorded in any form or medium, that--

• is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
• relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.

Health Information Technology for Economic & Clinical Health (HITECH)

The HITECH Act was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. Subtitle D of the HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by "covered entities" (generally, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions). By regulation, the DHHS extended the HIPAA privacy rule to independent contractors of covered entities who fit within the definition of "business associates". PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.

Health Plan

An individual or group plan that provides, or pays the cost of, medical care.

Historical Controls

Control subjects who are used for comparison with subjects being treated concurrently. The condition of subjects may be compared with their own condition on a prior regimen, the effectiveness of which has already been established.

HUM Number

The number assigned to project applications through eResearch.  Through the life of a study, each project will only ever have one HUM Number, though for Amendments and AE/ORIO submissions will be given a second identifying number. For example: HUM0001234, ADV0004567.

Human Pluripotent Stem Cell Research Oversight Committee (hPSCRO)

The hPSCRO provides local oversight of ethical issues related to derivation and research use of human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. The HPSCRO also provides local oversight of research with human pluripotent stem cells in experiments designed or expected to yield gametes (oocytes or sperm) or with the intent or potential to integrate these cells into the central nervous system of animals.

Human Research Protection Program (HRPP)

The HRPP is an integrated institution-wide program coordinated by the Office for the Vice President for Research in concert with the Executive Vice President for Medical Affairs, Chief Financial Officer, Provost, and consultation with the Office of the General Council. Major components of the HRPP include the nine Institutional Review Boards for human subjects research and several additional committees that provide research review, such as the Institutional Biosafety Committee, the Conflict of Interest Review Committees, the Radiation Policy Committee, the Investigational Drug Service, the Comprehensive Cancer Center, the Michigan Clinical Research Unit, the Biomedical Engineering Unit, and the Tissue Procurement Service.

Human Subject

OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” 21 CFR 50.3 (g), 21 CFR 56.102 (e)

Humanitarian Device Exemption (HDE)

An application that permits the marketing of a humanitarian use device.

Humanitarian Use Device

An FDA regulated medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affect fewer than 4000 individuals in the US per year, but not yet approved for unrestricted use. The use of a HUD is subject to IRB oversight. Contact IRMBED Office for guidance.

Hypothesis

• A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.
• Is a proposed explanation for a phenomenon?  For a hypothesis to be put forward as a scientific hypothesis, the scientific method requires that one can test it. Scientists generally base scientific hypotheses on previous observations that cannot satisfactorily be explained with the available scientific theories. Even though the words "hypothesis" and "theory" are often used synonymously, a scientific hypothesis is not the same as a scientific theory. A working hypothesis is a provisionally accepted hypothesis proposed for further research.

I

Implant

A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more.

In Vitro

Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.

In Vivo

Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).

Incapacity

Refers to a person’s mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information and to make a choice. Often used as a synonym for incompetence.

Frequency

How often an event or effect occurred in a population.

Inclusion / Exclusion Criteria

The medical or other standards determining whether a person may or may not be allowed to enter a research study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

Incompetence

Legally, the inability to manage one’s affairs. Often used as a synonym for incapacity.

Incremental Funding

A method of funding grants and contracts that provides specific spending limits below the total estimated costs. Each increment is, in essence, a funding action.

Indemnify

To protect against damage, loss, or injury; to insure.

Independent Variables

The conditions of an experiment that are systematically manipulated by the investigator.

Indirect Cost Rate (IDC)

Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing. etc.), sponsored project administration, plant operation and maintenance, library expenses, department administration expenses, depreciation or use allowance for buildings and equipment, and student administration and services. See also: Facilities and Administrative Costs

Individual

Every individual is equal before and under the law and has the right to the equal protection and equal benefit of the law without discrimination

Individual Investigator Agreement (IIA)

This agreement is used when a collaborating investigator engages in research with a collaborating investigator who is not affiliated with the covered entity; a collaborating investigator who is affiliated with an institution/hospital/clinic that may not have its own IRB to review the study; a collaborating investigator who is not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the institution.

Individually Identifiable Health Information

The term 'individually identifiable health information' means any information, including demographic information collected from an individual, that--

• is created or received by a health care provider, health plan, employer, or health care clearinghouse; and
• relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and--
• identifies the individual; or
• with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.

Infant

An ex utero fetus judged viable (i.e., likely to survive to the point of sustaining life independently).

Informed Consent

Informed consent is the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required.

• Use of a written consent form that includes all of the basic elements.
• The process of learning the key facts about a research study.
• A process by which a subject voluntarily confirms his or her willingness to participate in a particular research project.
• Informed consent is documented by means of a written, signed, and dated informed consent form unless such documentation is waived by the IRB. (45 CFR 46.116)
• In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence (21 CFR 50.20 and 50.25).
• It is a continuing process throughout the study to provide information for participants.

Informed Consent Document (ICD) or Informed Consent Form (ICF)

A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Institute of Medicine (IOM)

The IOM is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public. Established in 1970, the IOM is the health arm of the National Academy of Sciences.

Institution

• Any public or private entity or agency (including federal, state, and local agencies).
• A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.

Institutional Animal Care and Use Committee (IACUC)

A faculty committee charged with reviewing and approving the use of animal subjects in research and teaching activities. The IACUC serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to the use of animal subjects in research.

Institutional Biosafety Committee (IBC)

An institutional committee created under the NIH Guidelines to review research involving recombinant DNA. The role of IBCs has evolved over time, and many committees also review other forms of research that entail bio-hazardous risks as part of their institutionally assigned responsibilities.

Institutional Conflict of Interest (iCOI)

A common understanding is that an institutional conflict of interest (iCOI) occurs when the university, members of senior administration (chairs, deans, vice chancellors, directors), or affiliated organizations have a financial interest in a company that is associated with university research that may financially benefit the institution. Examples include, but are not limited to, grant and contract dollars, license fees and royalty payments, gifts to the institution, investments in start-up companies associated with faculty inventions, research relationships with companies that make significant contributions for facilities or endowed chairs, or stock ownership in companies that conduct research at the university.

Institutional Official (IO)

The individual who signs and has the authority to sign the institution's Assurances, making a commitment on behalf of the institution that federal regulations and policies with be followed. The Institutional Official is the Vice President for Research.

Institutional Review Board (IRB)

• Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520 (g) of the act. (FDA)
• A specially constituted review body established or designated by an institution to protect the welfare of human subjects recruited to participate in biomedical or behavioral research (OHRP)

Institutional Review Board (IRB) Approval

The determination of the IRB that the proposed clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. On IRBMED studies, approval is communicated to the investigator by a document called a "Notice of Outcome" which is faxed to an investigator.

Institutional Review Board of the Medical School (IRBMED)

IRBMED has 5 individual review Boards.  They are designated as A1, A2, B1, B2 and C1.  Boards A and B meet on alternate Thursdays and C1 meets on Friday.

Institutionalized

Confined, either voluntarily or involuntarily (e.g., a hospital, prison or nursing home).

Institutionalized Cognitively Impaired

Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

Institutionalizing

Confined, either voluntarily or involuntarily (e.g., in a hospital, prison, or nursing home).

Integrated Review Group (IRG)

Term used by NIH in relation to peer review. A cluster of study sections responsible for the review of grant applications in scientifically related areas. These study sections share common intellectual and human resources.

Intellectual Property

Any product of the human intellect that is unique, novel, and unobvious and has some value in the marketplace. Some intellectual property is protectable by statute or legislation, such as patents, copyrights, trademarks, trade secrets, service marks, and plant variety protection certificates. Protection of IP also occurs through agreements that control use of intellectual property.

Intent to Treat

Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment. See Randomization.

Interaction

A research related communication or interface between an investigator and a research subject other than those that involve an investigational agent or procedure as it relates to a disease or disorder (an intervention). Interactions may occur in person, by phone, computer, fax, or mail. Examples include surveys, focus groups, fMRI, and tests on healthy normal subjects.

Interim Funding

Authorization to expend funds on a project to a specified limit before the award document has been received from the sponsor.

Internal Adverse Event

From the perspective of an Investigator engaged in a multi-center clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the Investigator(s) or at their site. In the context of a single-site study, all adverse events would be considered internal adverse events.

International Classification of Diseases (ICD)

ICD is the classification used to code and classify mortality data from death certificates. The International Classification of Diseases, Clinical Modification (ICD-9-CM) is used to code and classify morbidity data from the inpatient and outpatient records, physician offices, and most National Center for Health Statistics (NCHS) surveys.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH is a project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. Harmonization would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health. ICH guidelines have been adopted as law in several countries, but are only used as guidance for the US FDA.

Interpreter

A qualified interpreter is an individual who is fluent (can speak, read and write) in English and the language of the subject, and (preferably) understands human research informed consent requirements. The interpreter should not be a member of the potential subject's family. Family members may have their own biases regarding research participation.

Intervention

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. Interventions may occur in person, by phone, computer, fax, or mail. Examples include clinical trials, behavioral or nutritional counseling, and surgeries.

Invention

A product of the human intellect that is a new, useful, and non-obvious process, machine, or product.

Investigational

Clinical investigation means any experiment in which a test article, even an approved drug, is administered or dispensed to, or used involving, one or more human subjects. (FDA) The use of a marketed drug in the course of medical practice that is outside the label indications ("off-label" use or innovative care) does not in and of itself constitute investigational use of a drug, unless that use is part of an experiment or systematic investigation meeting the criteria for human subject research.

Investigational Device

A device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Devices are classified as significant and non-significant risk. A significant risk device means an investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject. (FDA)

Investigational Device Exemption (IDE)

Approval by FDA for investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully across state and international boundaries for the purpose of conducting investigations of that device. (FDA) Most devices under investigation should have an IDE.

Investigational Drug

A new drug or biologic (i.e., not approved for marketing by FDA) used in a clinical investigation, including a biological product used in vitro for diagnostic purposes.

Investigational Drug Service (IDS)

The IDS at UMHS ensures that investigational drug studies and other drug related research at the Hospitals and Clinics are conducted in a safe and efficient manner. In doing so, the IDS assists investigators in complying with the requirements of the FDA, study sponsors, Michigan State Board of Pharmacy Regulations, JCAHO and hospital and pharmacy policies. The IDS will only handle protocols that have approval of IRBMED.

Investigational New Drug (IND)

A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Use of investigational drugs requires application to the FDA and is usually limited to subjects enrolled in clinical studies covered by an Investigational New Drug agreement with the FDA.

Investigational New Drug Application (IND)

An application that permits an investigational drug that would otherwise be required to have pre-market approval by FDA to be legally shipped for a clinical investigation.

Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Investigator

• A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH Guidelines)
• An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader. (FDA)

See also Co-Investigator and/or Sub-Investigator.

Investigator Response

An assessment made by the investigator and/or sponsor regarding whether or not an adverse event, or DSMB or other Report, necessitates a change to the study protocol, informed consent document or process, or investigator's brochure in order to promote subject safety and/or autonomy.

Investigator’s Brochure (IB)

The IB is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is critically important throughout the drug development process and is updated with new information as it becomes available.

• The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other trials.
• An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.
• An IB may introduce key aspects and safety measures of a protocol, such as:
• Dose (of the study drug),
• Frequency of dosing interval,
• Methods of administration, and
• Safety monitoring procedures.
• The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.

Investigator-Initiated Proposal

A proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.

Ionizing Radiation

Any radiation capable of displacing electrons from atoms or molecules, thereby producing ions. Examples include alpha, beta, gamma, and X-rays. High doses of ionizing radiation may produce severe skin or tissue damage.

IRB (Institutional) Authorization Agreement (IAA)

This agreement is used when one institution engages in research with: A performance site with whom institution ‘a’ currently does not have a Cooperative Review Agreement and Only one institution's IRB will review the study to avoid the need for dual review - Either institution ‘a’ or the performance site.