Which group protects human subjects as they are involved in research activities?

Research is 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. Note Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.

Examples of activities that typically are not generalizable (not research) include:

• Biographies
• 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 UCI 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 UCI community.

Per federal regulations, the following activities are deemed not to be research:

• 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.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Research studies are done to discover new information or to answer a question about how we learn, behave and function with the end-goal of benefitting society. Some studies might involve simple tasks like completing a survey, being observed among a group of people or participating in a group discussion. Other studies might involve more risky procedures like invasive medical testing, testing new drugs or participating in other activities that might make participants feel uncomfortable.

Some studies are also referred to as 'clinical trials' or 'health research'. These types of studies test drugs, medical devices, vaccines or other types of treatment that might affect an individual’s health or well-being.

A research subject is an individual that participates in research. Information (or 'data') is collected from or about the individual to help answer the question under study. Sometimes research subjects are referred to as human subjects, research participants or study volunteers.

Each study has its own set of criteria to determine who can participate. This depends on the research question being ask and may include restrictions based on age, behaviors, health status or other traits.

Before enrolling in a study, researchers may ask questions to determine if you are eligible to participate. In some cases, you may have to undergo specific testing, like a blood test or physical exam, to determine whether you can participate.

Research is designed to benefit society. This might include learning how to live healthier lives, how to better treat conditions or diseases, why we do the things we do, or how we learn and develop. And while there are several reasons why people choose to participate in research, most people participate based on the possibility of helping themselves or others. It's important to understand that you may not directly benefit from participating in research. In fact, with a lot of research, you will not receive any benefit. Additional information on benefits is provided below.

As mentioned above, participating in a study may or may not be of direct benefit to you. With many types of research, you will not receive any benefit. With some types of research, there may be a possibility that you could receive benefit but there is no guarantee.

If you participate in a clinical trial involving drugs, medical devices or medical procedures, your health or your condition may get better, it may stay the same or it may even get worse as a result of your participation. No one can completely predict the outcome of a clinical trial or how it might affect you.

It's also important to understand that research and routine medical care are not the same. Research is done to answer to the question under study or to determine whether the drugs, medical devices or procedures involved work. Routine medical care is designed to improve the health of the person being cared for and the drugs, medical devices and procedures have already been proven to work.

Research studies involving humans must be approved and monitored by an Institutional Review Board (IRB). An IRB is a committee of individuals responsible for reviewing research to ensure adequate protections are in place to protect the people who take part. For each study reviewed, the IRB checks to see that:

• there is a good reason to conduct the study
• the risks related to participating are the least possible
• the risks related to participating are reasonable given the knowledge that will be gained from conducting the study
• the plan for selecting subjects to participate is fair
• subjects will be provided enough information about the study, in an understandable manner, to make an informed decision about participation

The University of Rochester's IRB is called the Research Subjects Review Board. The Research Subjects Review Board regularly works with several other offices, committees and workgroups within the University to carefully oversee research. As a unit these offices and committees function as a 'Human Research Protection Program', one that is accredited through the Association for the Accreditation of Human Research Protection Programs. This means that, as an institution, the University voluntarily complies with a high research standard (one that is stricter than those set by laws) and regularly goes through a rigorous evaluation process.

To start, you will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given an opportunity to ask questions about the study. This process is called informed consent and is described further here. Before you can start the study, you need to agree to participate (i.e., consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary widely and depend on what is being studied. Regardless, all the activities you will be asked to complete will be described during the consent process.

Protecting the information you provide to researchers is a high priority, particularly if you provide health-related or sensitive information. As part of the IRB approval process described above, all researchers must provide a plan to adequately protect the information they plan to collect in order for the study to be approved. This might include assigning a code to the information collected instead of using your name or other identifiable information, and storing the information in a secure manner.

Most studies involve some risk, though the risks can range from very small to very serious. Some examples of risks include:

• side effects or reactions to experimental drugs, treatments or procedures
• feeling anxious or uncomfortable
• breach in confidentiality or invasion of privacy

Side effects or other risks you might experience may be temporary or go away with treatment, but in rare cases they may be permanent, cause disability or be life threatening. There may also be risks in participating that we don’t know about.

You are free to withdraw from a research study at any time, for any reason, without penalty. Your relationship with the hospital, clinic, academic institution or employer will not be affected and you will not lose any benefits to which you are entitled.

Note that in some cases, a researcher may decide to end your participation in the study early. This may happen if the study is no longer in your best interest, if you can no longer complete study activities, or if the study ends early for some other reason.

Each study is different, so time requirements will vary. Some studies may require very little of your time, perhaps only 5-10 minutes, while others will require multiple visits over an extended period of time, sometimes up to several years.

Before you agree to be in a study, make sure you have a solid understanding of the following:

• the voluntary nature of the study
• why it is being done
• who is doing the study
• the procedures, activities, tests or treatments involved (including how long they will take, how often they have to be completed and whether there are any other treatment options available rather than being in the study)
• potential risks, discomforts or side effects
• potential benefits to participating, if any
• how your privacy will be protected
• how long your participation will last
• what will happen if you are injured while participating
• the costs to you, if any
• what to do if you change your mind about participating
• whom to contact for questions, concerns or problems

A more extensive list of questions to ask, in a printable format, is available here from the Department of Health and Human Service’s Office of Human Research Protections.

A summary of the information provided above, in PDF format (printable), is available here. Questions, concerns or feedback about human subject research conducted by the University of Rochester can be directed to the Research Subjects Review Board at 265 Crittenden Blvd., Box CU 420628, Rochester, NY 14642; or telephone (585) 276-0005 or (877) 449-4441.

What are the human rights that require protection in research quizlet?

Which of the following is the least important activity when protecting human subjects in international research?

Which of the following research studies led to the creation of ethical guidelines for research involving human subjects?

What was the first set of principles outlining professional ethics for medical research group of answer choices?