NIH Guidelines on Inclusion

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This notice updates the NIH policy on the inclusion of women and minorities as subjects in clinical research. It supersedes the 1994 Federal Register notice (http://grants.nih.gov/grants/guide/notice-files/not94-100.html) and the August 2000 notice in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). It incorporates the definition of clinical research as reported in the 1997 Report of the NIH Director’s Panel on Clinical research. Also, this notice provides additional guidance on reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIH-defined Phase III clinical trials. The guidelines ensure that all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in NIH-defined Phase III clinical trials, to examine differential effects on such groups. Since a primary aim of research is to provide scientific evidence leading to a change in health policy or standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently.

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NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research

Research Terms to Know

Below is a glossary of terms that are helpful to know and understand when discussing medical research participation.

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A-D | E-H | I-L | M-Z

Blinded Study

A study design in which the participants (single-blinded) or participants and investigators (double-blinded) do not know which participants have been assigned to which treatment or intervention.

Clinical Trial

A research study designed to determine the safety and effectiveness of a new medical (drug, medical device or procedure) or behavioral (diet, physical activity, therapy, etc.) intervention.

Confidentiality

The assurance that the information provided by a participant in a study will be protected and will not be shared with others except as stated during the original consent process or with participant permission.

Control Group

In some research, it is the group that does not receive any treatment or intervention in order to compare to the group who does receive treatment.

Epidemiology

The study of health and disease in defined populations. Major areas of epidemiological study include causes, patterns, and effects of disease and health.

Exclusion Criteria

A list of conditions that make an individual unable to participate in a research study. Examples include: participants must not have taken drug XX in the past three months; participants must not have smoked tobacco in the past six months; participants must not have any allergies.

Focus Group

A small group of people who are asked to share, usually through answering questions and open discussion, their opinions, attitudes, beliefs, and perceptions on a specific topic.

Health Disparity

A particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion (Source: Healthy People 2020)

Health Research

An investigation done to learn more about human health and to find ways to improve heath and prevent and treat human illness and disease. Also referred to as Clinical Research or Medical Research.

HIPAA Privacy Rule

The Health Insurance Portability and Accountability Act. A Federal protection that regulates how health care providers, groups, and organizations handle individually identifiable protected health information.

Human Subject

A living person who becomes a participant in a research study. This individual is the object of study in the research project. Also referred to as Human Participant. 

Incentive

A payment or reward given to individuals who join, or remain in, a research study. Incentives are designed to motivate or encourage people to join a particular study.

Inclusion Criteria

A list of requirements that must be met by all study participants. Inclusion criteria determine whether or not an individual is eligible to participate. Examples include: participants must be within 18-24 years of age; participants must be female; participants must have a specific health condition being studied (such as asthma or cancer).

Informed Consent

The process in which researchers communicate information about a study to potential participants. Information delivered during this process includes, but is not limited to, the purpose of the study, the risks and benefits, and that participation is voluntary and can be discontinued at any time.

Institutional Review Board (IRB)

An independent group of researchers, non-researchers, and community members that reviews, approves, and monitors each research study that is conducted at an institution to ensure that the rights and safety of participants are protected. The IRB has the right to reject or discontinue any study that does not comply with federal, state, and institutional regulations.

Intervention

A procedure, action, drug, device, or other behavioral or medical process that is being tested in a research trial.

Non-therapeutic

Relating to something that does not treat, cure, or heal.

Placebo

A pill, liquid, powder, or other intervention that does not contain any active ingredients. It is made to be indistinguishable from the active intervention.

Population

The larger group of people of interest in a particular study. Examples include: adolescents (aged 13-16), African American males over 65, adults who suffer from a particular condition or disease. 

Randomization

The process by which participants in a research study are assigned to a treatment or intervention by chance.

Sample

This is the subset of the population who are asked to participate in the study. An example is: 500 men aged 18 or over, who have diabetes.  In this case, the sample of 500 will represent the overall population of interest, adult men with diabetes. 

Side Effect

A secondary, or non-intended, effect of a drug or treatment. Side effects are usually negative or bad.

Social Determinants of Health

Circumstances or situations in which people live that impact their health. These circumstances include, but are not limited to, where people live, work, their educational system, and access to health care.

Social Justice

The idea that all people within a society should equally share in the benefits of that society, and that all people should be able to participate fully in the economic, social, and cultural life of the society.

Social Science

The study of society and human behaviors. Major areas of social science study include: anthropology, archaeology, sociology, economics, history, linguistics, and geography, among others.

Stakeholder

Any person, group, or organization that has an interest in, or may be affected by, a project.

Survey Research (or Survey)

A type of research which is used to assess thoughts, attitudes, opinions, and beliefs and involves a set of questions given to a sample of a population.