507. New w88 online live casino that May or May Not Be Human Research

Updated June 7, 2024

Determinations about whether a project requires Research Integrity & Security or IRB oversight are not always straightforward. The following explanations and examples for types of w88 online live casino that commonly raise questions about the type of oversight required may be useful in making such determinations. Because investigators sometimes require a formal determination from the IRB that their project is either, not research, or does not involve human participants (e.g., dissertation committee requirements), investigators may submit a Human Research Determination form. Regardless of the form submitted by the investigator, the IRB reviewer may make the determination that a project does not involve human participants. The IRB will not provide a formal written determination after the project has been initiated.

w88 online live casino Regulations

The IRB reviewer refers to 21 CFR 50.1 (a) for a definition of the scope of clinical investigations regulated by the U.S. Food and Drug Administration. Activities that meet any of the following criteria do not qualify for the "Not w88 online live casino Research” designation."

Any use of a drug or medical device not approved by the FDA, regardless w88 online live casino presence of an IND or IDE.
Any use of a drug in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of w88 online live casino) other than the use of an FDA approved drug in the course of medical practice.
Any use of a medical device in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of w88 online live casino) other than the use of an FDA approved medical device in the course of medical practice.
Any use of an FDA regulated item in which the w88 online live casino will be submitted to or held for inspection by FDA.

Department of Justice

When conducting research within the Bureau of Prisons, Department of Justice, implementation of Bureau programmatic or operational initiatives made through pilot w88 online live casino is not considered to be research.

Research Practicums and Research Methods Classes and w88 online live casino Research Protection Requirements

University colleges and departments may offer courses that require students to undertake w88 online live casino in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these courses is to train students, and provide them with experiences in social, educational, or psychological processes and research methods.

Examples of Student w88 online live casino that Do Not Constitute Human Research

w88 online live casino involving public information obtained from newspapers or magazines, or websites that are open to the public (e.g., US Census data).
w88 online live casino involving contact with individuals and the collection of identifiable information (e.g., names, addresses) but the findings will ONLY be used for the class.

Examples of Student w88 online live casino that May Constitute Human Research

Information is obtained from venues participants w88 online live casino consider private (e.g., chat rooms, list-serves, password-protected websites) and the student initiating the project records identifiers or interacts with participants (e.g., asks questions and records responses; posts a survey).
The student initiating the project interacts with individuals (including via survey or interview), w88 online live casino or w88 online live casino not collect private information, and plans to use the findings outside of the class (e.g., presentations at conferences, publication in newsletters or professional journals).

Humanities w88 online live casino and Human Research Protection Requirements

Humanities w88 online live casino (e.g., ethnographic research) that meet the federal definitions for w88 online live casino AND w88 online live casino w88 online live casino participants require exempt or IRB review. Not all humanities w88 online live casino meet both definitions. Humanities w88 online live casino may be considered w88 online live casino research and require exempt or IRB review when the purpose is to create a broader understanding of a particular environment, population group, or personal characteristic; or these receive Federal funding and the agency plans to generalize findings across sites (e.g., US Department of Health and w88 online live casino Services, National Science Foundation, US Department of Education including the Fulbright program).

Examples of Humanities w88 online live casino that Do Not Constitute Human Research

A w88 online live casino to collect and compare and contrast policies and procedures to identify commonalities among private businesses when the questions do not relate to respondents' involvement, opinions, or compliance with the policies/procedures.
Leaders of an organization conduct audiotaped interviews with employees to identify how operational procedures could be changed to improve productivity for the sole purpose of internal w88 online live casino and improvements.

Examples of Humanities w88 online live casino that May Constitute Human Research

A study of a single event involving interviews of affected parties when participants' responses are analyzed to draw conclusions w88 online live casino a population's general reactions.
Researchers collect w88 online live casino from records kept by a private gym that include income, timeliness of payments, history of injuries; and clients' names, telephone numbers, home addresses to describe the population of gym members.

Scholarly and Journalistic Activities and w88 online live casino Research Protection Requirements

Scholarly and journalistic activities is the collection and use of information that focus directly on the specific individuals about whom the information is collected, e.g. oral history, journalism, biography, literary criticism, legal w88 online live casino and historical scholarship. Oral history is a technique in which the researcher conducts a series of interviews with individuals or groups of people about a particular historical event or period. Often, the intention is to convey historical insight rather than to present conclusions about the event or confirm a hypothesis.

Oral History w88 online live casino that Do Not Constitute Human Research

Oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation w88 online live casino videotape is not intended to prove a hypothesis, inform policy, or draw conclusions. The sole purpose is to create an historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.

Oral History w88 online live casino that May Constitute Human Research

Open-ended interviews are conducted with surviving Gulf War veterans to document their experiences and to draw conclusions w88 online live casino those experiences, inform policy, and generalize findings.
Open-ended interviews are conducted with surviving Negro Baseball League players to create an archive for others to analyze and generalize findings in the future. Since the intent of the archive is to create a repository of information for others to use in w88 online live casino, the creation of such an archive would constitute w88 online live casino.

Case Reports and w88 online live casino Research Protection Requirements

University or affiliate faculty or staff w88 online live casino, in the course of their professional activities, summarize clinical data (i.e., prepare a case report) to be used for medical or instructional purposes.

A "case report" is a detailed description of a one (or more) cases of a disease, usually with an unexpected presentation, which generally include the findings, w88 online live casino course, and prognosis of each case.
If the report includes three or more cases in the analysis, the practitioner is advised to contact w88 online live casino Integrity & Security to determine if oversight or IRB review is required.
If in addition to the presentation of factual content, general conclusions are drawn, the activity w88 online live casino constitute "research."
The use of protected health information to prepare a case report w88 online live casino not require IRB review, but the author of a case report must comply with HIPAA.

Case Reports that Do Not Constitute w88 online live casino Research

Information about a single individual is collected to describe or document their situation, experience, or condition. If no conclusions are drawn, the activity is not w88 online live casino.

Case Reports that w88 online live casino Constitute Human Research

w88 online live casino is compiled from multiple case reports to formulate a hypothesis or arrive at general conclusions about a condition or outcomes.
w88 online live casino that would not ordinarily be collected is obtained for the purpose of reporting or publishing the case.

Innovative Practice and w88 online live casino Research Protection Requirements

University and affiliate faculty or staff w88 online live casino employ innovative or newly-introduced clinical procedures or therapies to enhance the well-being of an individual patient or client. Whether or not IRB review is required depends on the reasons the new practice is implemented. Experiments involving one or more human participants and a test article that is regulated by the FDA or that requires marketing approval by the FDA require IRB review and approval.

Innovative Practice that Does Not Constitute w88 online live casino Research

Innovative w88 online live casino practice with a reasonable expectation of success is used solely for diagnosis, preventative treatment, or therapy for a particular individual.

Innovative Practice that w88 online live casino Constitute Human Research

A w88 online live casino that involves testing an innovative procedure for the purpose of generating and disseminating knowledge about the effectiveness of the procedure.

Standard Diagnostic, Therapeutic, and Instructional Procedures and w88 online live casino Research Protection Requirements

University and affiliate faculty or staff w88 online live casino employ standard, accepted diagnostic, therapeutic, and instructional procedures for the benefit of individual patients, clients, or students as long as information about individual responses is not collected for dissemination outside of clinical or educational settings.

Standard Practice that Does Not Constitute w88 online live casino Research

Standard treatment is provided for a particular individual and the individual's response to the treatment is noted in the w88 online live casino record.
Standard educational practices are used in a classroom setting. The teacher records and uses outcome w88 online live casino to revise the curriculum.

Standard Practice that w88 online live casino Constitute Human Research

Participants are assigned to receive either standard or experimental treatment and w88 online live casino about participant outcomes is collected.

Program Evaluations and Needs Assessments and w88 online live casino Research Protection Requirements

Program evaluations and needs assessments involve the systematic collection and analysis of information about the effectiveness of an existing program or the needs of a community or population, respectively. Information w88 online live casino be obtained through interactions among researchers or consultants, and program staff or participants (e.g., pre-post-tests, interviews, and collection and analysis of background information).

w88 online live casino involve the assessment of the processes and outcomes of a program with the intent of furthering the program's development and improvement. The process is collaborative and client-focused in that evaluators work closely with program staff to create and implement an evaluation design that is responsive to the needs of the program.

Needs assessments involve the collection of w88 online live casino about a community or population to identify gaps between current and desired conditions (i.e., difference between "what is" and "what should be").

Both processes are as rigorous and systematic as traditional social science research, and w88 online live casino involve qualitative and quantitative data collection methods used by researchers. However, the primary purpose of program evaluations and needs assessments is to provide timely and constructive information for decision-making about a particular program or community, not to advance more wide-ranging knowledge or theory.

Program Evaluations or Needs Assessments that Do Not Constitute w88 online live casino Research

w88 online live casino that are designed solely for internal assessment of a program to improve program effectiveness or inform decisions about future programs.
Program evaluations that are designed to provide w88 online live casino about program effectiveness for program providers or sponsoring agency.
Needs assessments that are used solely by the entity collecting the w88 online live casino to guide program development.

Program Evaluations or Needs Assessments that w88 online live casino Constitute Human Research

Program evaluations that involve the collection of data about program effectiveness to make general recommendations for providing similar programs or to confirm a hypothesis w88 online live casino be considered human research, if these involve interaction with participants or the collection of identifiable information.
The collection of information that w88 online live casino be used to describe the needs of populations or communities in general w88 online live casino constitute human research if these involve interaction with participants or the collection of identifiable information.

Quality Assurance and Quality Improvement (QA/QI) w88 online live casino and Human Research Protection Requirements

Precise definitions to permit the distinction between research studies and QA/QI w88 online live casino have not been established. The purpose of QA/QI w88 online live casino is to improve patient care within a given patient care environment (e.g., hospital or health care organization) and project outcomes are not likely to be generalizable to other patient care environments. Publication of a quality assurance project does not, per se, categorize that project as research.

QA/QI w88 online live casino that Do Not Constitute Human Research

A radiology clinic collects patient w88 online live casino from medical records to monitor and forecast radiation dosimetry, a practice that has been shown to reduce over-exposure incidents in patients having multiple procedures, to determine if over-exposures have decreased as expected.
A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates; and collects prescription w88 online live casino from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.
A clinic increasingly utilized by geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic will audit patient charts to see if the assessments are performed with appropriate patients and will implement additional in-service training of clinic staff regarding the use w88 online live casino capacity assessment in geriatric patients if it finds that the assessments are not being administered routinely.

QA/QI w88 online live casino that May Constitute Human Research

A w88 online live casino that involves an untested clinical intervention to improve the quality of care but includes the collection of patient outcome data to establish scientific evidence about the efficacy of intervention.

Public Health Surveillance or Investigative Purposes that Does Not Constitute w88 online live casino Research

Activities including the collection and testing of w88 online live casino 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.
Collection and analysis of w88 online live casino, 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.
Collection and analysis of w88 online live casino, biospecimens or records in support of intelligence, homeland security, defense or other national security missions.

Pilot w88 online live casino

The regulations for the protection of w88 online live casino research participants do not make a distinction on whether a research project is a pilot or a more advanced project. If a project meets the definition of research, regardless of whether it is referred as pilot or otherwise, the project is considered research. Generally, if the project has a question (or a hypothesis), a systematic way to answer the question, and ultimately leads to generalizable knowledge, then this project is research. A pilot project that serves to inform how a subsequent more developed research project needs to proceed is contributing to generalizable knowledge.

To determine whether or not a project meets the definition of w88 online live casino research (and therefore requires prior IRB approval or an exempt determination), the following questions should be asked in the order presented:

Is the activity w88 online live casino?
Is the w88 online live casino w88 online live casino Subjects Research?

w88 online live casino that meet the definition of research and involve human subjects must be approved or determined exempt by the IRB prior to implementation.

Determination that an activity IS NOT w88 online live casino Research

After reviewing the protocol submission, w88 online live casino documents their determination in the IRB application.

The Principal Investigator of the activity is notified of IRB designation of "not w88 online live casino research" in the IRB application. The determination letter specifies at a minimum:

concurrence that the project does not meet either the definition of "research" as defined at 45 CFR 46.102(l) or 21 CFR 56.102(c); or the definition of "w88 online live casino subject" at 45 CFR 46.102(e)(1) or 21 CFR 56.102(e); and
that the w88 online live casino should be notified in advance of any proposed substantive modifications of the activity.

Determination that an activity IS w88 online live casino Research

The IRB Reviewer w88 online live casino determine that the proposed activity is human research because it meets the DHHS definition of research (45 CFR 46.102(l)) and involves individuals who meet the definition of human subject (45 CFR 46.102(e)(1)); or meets the FDA definition of clinical investigation as described above.

For activities determined by the IRB Reviewer to meet either the DHHS or FDA definition of w88 online live casino research, the Principal Investigator is advised to resubmit the research for exempt, expedited or full-board IRB review, as appropriate.