285 w88 online game Use of Data or Specimens
Updated June 7, 2024
This policy applies to activities that involve the w88 online game analysis of data (such as medical records, student records, data collected from previous studies, audio/video recordings, etc.) or biospecimens that were or will be collected for non-research purposes or for research studies other than the proposed research study. Even though such projects do not involve interactions or interventions with humans, they may still require University IRB review, as the definition of "human subject" at 45 CFR 46.102(e)(1) means a living individual about whom an investigator (whether professional or student) conducting research:
(1) Obtains w88 online game or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the w88 online game or biospecimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private w88 online game or identifiable biospecimens.
w88 online game analysis activities that meet the definition of research with humans may qualify for an exemption or require expedited or even full committee review. Any such project must receive University IRB approval or a determination of exemption before the investigator accesses the w88 online game. Researchers are encouraged to contact Research Integrity & Security for consultation about whether and what type of review is required.
When does the w88 online game use of data or specimens not require review?
In general, the w88 online game analysis of data or biospecimens does not require University IRB review when it does not meet the regulatory definition of research involving humans, as referenced above.
Public use w88 online game sets: Generally, public use w88 online game sets (such as portions of U.S. Census w88 online game, w88 online game from the National Center for Educational Statistics, National Center for Health Statistics, etc.) are w88 online game sets prepared with the intent of making them available for the public. The w88 online game available to the public are not individually identifiable and therefore their analysis would not involve humans.
In addition to being identifiable, the existing w88 online game must include "private information" in order to constitute research involving humans. Private information is defined as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). Information that contains identifiers and can be accessed freely by the public (without special permission or application) is not "private" and the research therefore does not therefore involve humans. For example, a study involving only analysis of the published salaries and benefits of public university presidents would not need University IRB review since this information is not private.
De-identified w88 online game or specimens: If the dataset or biospecimens have been stripped of all identifying information and there is no way that the information or biospecimens could be linked back to the persons from whom it was originally collected (through a key to a coding system or by any other means), its subsequent use by the Principal Investigator or another investigator would not constitute w88 online game with humans, since it is no longer identifiable. Identifiable means the identity of the person is known or may be readily ascertained by the investigator or associated with the information. In general, information is considered to be identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals. Therefore, even though a dataset may have been stripped of direct identifiers (names, addresses, student ID numbers, etc.), it may still be possible to identify an individual through a combination of other characteristics (e.g., age, gender, ethnicity, and place of employment).
Example: Many student research projects involve w88 online game analysis of data that belongs to, or was initially collected by, their faculty advisor or another investigator. If the student is provided with a de- identified, non-coded w88 online game set, the use of the w88 online game does not constitute research with humans because there is no interaction with any individual and no identifiable private information will be used. The project does not therefore require University IRB review.
Coded w88 online game or specimens: w88 online game analysis of coded private information or biospecimens is not considered to be research involving humans and would not require University IRB review if the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or biospecimens pertain as a result of one of the following circumstances:
- The investigators and the holder of the key have entered into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (DHHS regulations for w88 online game with humans do not require the IRB to review and approve this agreement);
- There are IRB-approved written policies and operating procedures for a repository or w88 online game management center that prohibit the release of the key to the investigator under any circumstances, until the individuals are deceased; or
- There are other legal requirements prohibiting the release w88 online game key to the investigators, until the individuals are deceased.
An exception is if a student is analyzing coded w88 online game from a faculty advisor/sponsor who retains a key. This would be deemed research with humans, because the faculty advisor is considered an investigator on the student's protocol, and can readily ascertain the identity of the participants since they hold the key to the coded w88 online game. If the student's work fits within the scope of the initial protocol from which the dataset originates, the faculty advisor (or investigator who holds the dataset) may wish to consider adding the student and his/her work to the original protocol by means of an amendment application rather than having the student submit a new application for review.
Example: Researcher A plans to examine the relationships between attention deficit hyperactivity disorder (ADHD), oppositional defiance disorder, and teen drug abuse using w88 online game collected by Agencies I, II, and III that work with "at risk" youth. The w88 online game will be coded and the agencies have entered into an agreement prohibiting release of the key to the researcher that could connect the w88 online game with identifiers. The use of the w88 online game would not constitute research with humans and does not require UNR IRB review.
When is the w88 online game use of data or specimens exempt?
There are several categories of research activities involving humans that may be exempt from the requirements of the Federal Policy for the Protection of Human Subjects (45 CFR 46). Category 4 applies specifically to w88 online game research uses of identifiable private information or identifiable biospecimens. To determine if research qualifies for an exempt determination, researchers must submit an exempt application review of existing data or specimens form to Research Integrity & Security for review. Research involving collection or study of data, documents, records, or biospecimens for w88 online game uses can be exempted under Category 4 of the federal regulations if: (i) the sources of such data or biospecimens are publicly available; or (ii) the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. The latter condition of this category applies in cases where the investigators initially have access to identifiable private information or identifiable biospecimens but abstract the data needed for the research in such a way that the information can no longer be connected to the identity of the participants. This means that the abstracted data set or biospecimens do not include direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the participant's identity). Furthermore, it must not be possible to identify w88 online game by combining a number of characteristics (e.g., date of birth, gender, position, and place of employment). This is especially relevant in smaller datasets, where the population is confined to a limited participant pool.
Examples:
- A researcher conducts a study of treatment outcomes for a certain drug that involves the review of patient charts at a non-UCB medical facility. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the w88 online game cannot be linked back to the patient. This project could qualify for an exemption.
- Student B will be given access to w88 online game from her faculty advisor's health survey research project. The w88 online game consists of coded survey responses, and the advisor will retain a key that would link the w88 online game to identifiers. The student will extract the information she needs for her project without including any identifying information and without retaining the code. The use of the w88 online game does constitute research with humans because the initial w88 online game set is identifiable (albeit through a coding system); however, it would qualify for exempt status.
Expansion of Exempt Category 4 under the University w88 online game Flex Policy
Non-federally funded research on w88 online game data where the data contains identifiers or a master code list linking codes to an individual would be eligible for exempt level review under the University IRB Flex policy.
When is the w88 online game use of existing data or specimens non-exempt?
If w88 online game analysis of existing data w88 online game involve research with humans and does not qualify for exempt status as explained above, the project must be reviewed either through expedited procedures, and researchers should submit the exempt core application review of existing w88 online game or specimens form to Research Integrity & Security for review for IRB review. Expedited review would be required if identifiers or master code lists are included with the w88 online game for federally funded research.
w88 online game: Researchers using data previously collected under another study should consider whether the currently proposed research is a "compatible use" with what participants agreed to in the original consent form. For non-exempt, federally-funded projects, a consent process description or justification for a waiver must be included in the research protocol. The University IRB may require that informed consent for w88 online game analysis be obtained from participants whose data will be accessed. Alternatively, the University IRB can consider a request for a waiver of one or more elements of informed consent under 45 CFR 46.116(f)(3). In order to approve such waiver, the IRB must determine that the research:
- presents minimal risk (w88 online game risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests); and
- the w88 online game could not practicably be carried out without the waiver or alteration; and
- if the w88 online game involves using identifiable private information or identifiable biospecimens, the w88 online game could not practicably be carried out without using such information or biospecimens in an identifiable format; and
- the waiver or alteration will not adversely affect the rights and welfare w88 online game participants; and
- whenever appropriate, the participants will be provided with additional pertinent w88 online game after participation.
See University w88 online game policies for more details regarding informed consent and waivers of consent.
"Restricted Use w88 online game": Certain agencies and research organizations release files to researchers with specific restrictions regarding their use and storage. The records frequently contain identifiers or extensive variables that combined might enable identification, even though this is not the intent of the researcher. Research using these w88 online game sets most often requires non-exempt level review.
Examples:
- Student C will be given access to coded mental health assessments from his faculty advisor's research project. The student plans to analyze the w88 online game with a code attached to each record, and the advisor will retain a key to the code that would link the w88 online game to identifiers. The use of the w88 online game does constitute research with humans and does not qualify for exempt status since participants can be identified. This student project would require an application to be submitted for non-exempt review by the University IRB.
- Student D is applying to the National Center for Health Statistics for use of w88 online game from the National Health and Nutrition Examination Survey that includes geographic identifiers and date of examination. The analysis of this restricted use w88 online game would require non-exempt review by the University IRB.
w88 online game Data Research Classification
When is w88 online game data (e.g., medical records, purchased data, data from the Internet, etc.) considered research with humans? Research involving w88 online game data analysis is considered research with humans when data about individuals is both private and identifiable.
Projects that are unlikely to be human w88 online game because they involve only:
- Public use w88 online game sets such as w88 online game from the National Center for Health Statistics-w88 online game is available to the public at large and not restricted to researchers.
- w88 online game sets from an outside source that have been stripped of all identifying information and of links back to identifiers before being provided to researcher.
- Facebook public profiles found w88 online game Google searches.
- Twitter tweets not in a w88 online game setting.
- Publicly accessible forums or comments sections w88 online game users have no expectation of privacy (e.g., New York Times, YouTube, etc.).
Projects that might be human w88 online game because they involve:
- Purchasing/obtaining enhanced w88 online game sets-w88 online game on individuals which may include enough information to potentially identify the individuals. This would include w88 online game sets where the owner or vendor requires local IRB approval and a w88 online game use agreement prior to allowing access to the w88 online game.
- Certain agencies and research organizations release files to researchers with specific restrictions regarding their use and storage. The records frequently contain identifiers or extensive variables that combined might enable identification, even though this is not the intent of the researcher. Research using these w88 online game sets most often requires expedited or full committee review.
- Receipt of coded w88 online game where w88 online game holder has code key-depending on whether the w88 online game holder only provides w88 online game or is a collaborator in the research, and whether an agreement between institutions prohibits receiver from ever receiving identifiers, etc.
- Forums or chats w88 online game users must register as belonging to a certain group (e.g., cancer survivors) or housed in areas that are not public, e.g., w88 online game special passwords are needed to join.
Projects that are human w88 online game because they involve:
- Private w88 online game sets obtained with identifiers (e.g., traffic violation w88 online game with driver's license numbers, survey w88 online game with email addresses, medical records with protected health information [PHI], restricted use datasets, etc.).
- Stolen, hacked, accidentally released w88 online game about individuals-although w88 online game may now be publicly available (such as on the surface web or the dark web), the individuals whom the w88 online game is about had expectation of privacy, i.e., that the w88 online game would not be hacked, stolen, etc. Human research must be reviewed and either determined exempt or obtain University IRB approval before the research begins.