325. w88 online sports betting Consent Requirements

Updated June 7, 2024

Obtaining w88 online sports betting consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be provided with information about the research project that is understandable and that permits them to make an w88 online sports betting and voluntary decision about whether to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. w88 online sports betting consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study.

The w88 online sports betting process involves the communication that takes place when a researcher provides information about a research study to a prospective participant and the participant indicates their agreement to take part in the study. Researchers and research staff should understand the concept of respect for persons and the obligation to obtain the w88 online sports betting of participants or their legally authorized representatives. Researchers and research staff should understand that w88 online sports betting is a continual process, and conduct the w88 online sports betting process in a way that meets the criteria for legally effective w88 online sports betting. Researchers and research staff should understand the difference between the w88 online sports betting process, itself, and documentation of the w88 online sports betting process. Researchers and research staff should know how to document the w88 online sports betting of a participant or a legally authorized representative.

Information necessary for w88 online sports betting consent may derive from recruitment materials, verbal instructions, question/answer sessions, and assessments of participant understanding of the research.

Both regulatory requirements and ethical considerations apply to the consent process. w88 online sports betting consent must be legally effective. w88 online sports betting consent must be sought only under conditions that a) provide the prospective participant sufficient opportunity to discuss and consider whether to participate and b) minimize the possibility of coercion or undue influence. w88 online sports betting consent must be in language understandable to the participant and at a level understandable. No complex scientific or technical language should be used without an explanation in lay or common terms. The consent document should be written in language that is at or below an eighth-grade level. Researchers should inform prospective participants of required disclosures, (e.g., mandatory reporting pursuant to state law).

NOTE: Department of Health and Human Services (DHHS) w88 online sports betting consent requirements do not limit the ability of a physician to provide treatment or emergency medical care. See IRB policy for Food and Drug Administration (FDA) exceptions from consent requirements.

Basic Considerations for w88 online sports betting Consent:

• Research involving multiple populations may require multiple w88 online sports betting processes and materials.
• Participant maturity, literacy skills, and susceptibility to undue influence warrant consideration in the design of w88 online sports betting processes and materials.
• The study team member conducting the w88 online sports betting process must have sufficient knowledge to answer prospective participants' questions about the research.
• The PI remains ultimately responsible ensuring participants are fully w88 online sports betting about the research, even when the task of obtaining w88 online sports betting consent is delegated to another member of the research team.
• Minimize the possibility of coercion or undue influence.
• Communicate with the w88 online sports betting or the legally authorized representative in language understandable to the w88 online sports betting or the legally authorized representative.

DHHS General Requirements for w88 online sports betting Consent

• Researchers must obtain the legally effective w88 online sports betting of each research participant (or a participant's legally authorized representative [LAR]) (unless the IRB waives DHHS requirements; or the research is exempt, including IRB Flex-exempt categories 7 and 8, and the IRB approves an alternative w88 online sports betting process).
• The consent process must provide sufficient information, time, and opportunity for discussion for the participant or LAR to make an w88 online sports betting decision about participation, as commensurate with risk and study procedures.
• The information provided to participants or LAR must be such that a reasonable person would want to have in order to make an w88 online sports betting decision about whether to participate and allow for the opportunity to discuss that information.
• The w88 online sports betting consent process must begin with a brief and focused presentation of this key information organized in a manner to enhance comprehension. For minimal risk and greater than minimal risk social behavioral and basic biomedical research, the information sheet and w88 online sports betting consent templates meet this requirement.
• For greater than minimal risk biomedical FDA-regulated clinical trials, materials such as a summary brochure, handout, or executive summary document or introduction on the w88 online sports betting form is necessary.
• The w88 online sports betting must begin with "a concise and focused presentation" of key information. Key information should include the fact that the w88 online sports betting is sought for research, participation is voluntary, the research purpose, the research risks and benefits, and the alternatives available to participation in the research. In general, the key information section should not be longer than two pages.
• The w88 online sports betting process must minimize the possibility of undue influence or coercion.
• The w88 online sports betting discussion must be in language that is understandable to the participant or the LAR.
• The w88 online sports betting discussion must be free of exculpatory language (see w88 online sports betting Manual Definitions).
• The participant or LAR must be w88 online sports betting of all required/applicable disclosures (e.g., researcher conflicts of interest, mandatory reporting).
• w88 online sports betting consent must present information in sufficient detail and organized in such a way that does not "merely provide lists of isolated facts, but rather facilitates the prospective participant's...understanding of the reasons why one might or might not want to participate."
• If Protected Health Information (PHI) is being collected, HIPAA requires an Authorization for Use, unless specifically waived by the w88 online sports betting in its role as the privacy board.

DHHS Additional Requirements for w88 online sports betting Consent

In addition w88 online sports betting general requirements, DHHS specifies:

• nine basic and nine additional elements of w88 online sports betting consent that must be provided to all research participants (at 45CFR46.116(b) and (c)); and
• requirements for documentation of w88 online sports betting (at §46.117(a) and (b)).

However, at §46.116(e) and (f) DHHS regulations allow the IRB to waive or alter the requirements for researchers to provide the basic/additional elements for w88 online sports betting consent; at §46.117(c), DHHS specifies when the IRB may waive for the researchers to obtain signed consent from some or all participants. (For more information about DHHS elements for consent and documentation of w88 online sports betting consent see IRB policy for consent for greater than minimal risk research. For information about IRB approved waivers for consent, see IRB policy for minimal risk, federally funded research.)

FDA Requirements for w88 online sports betting Consent

• The IRB determines that the required and appropriate additional elements of disclosure are included in the w88 online sports betting process.
• The w88 online sports betting form includes a statement noting the possibility that the FDA may inspect the records that will be provided to each participant.
• If applicable, the w88 online sports betting form includes a statement that a description of the clinical trial will be available on the w88 online sports betting Trials database as required by U.S. law. The website will not include information that can identify the w88 online sports betting. At most, the website will include a summary of the results. The w88 online sports betting can reach the website at any time.
• When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The w88 online sports betting document cannot give the participant the option of having data removed.
• A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. The researcher must obtain the participant’s w88 online sports betting for this limited participation in the study (assuming such a situation was not described in the original w88 online sports betting document). The IRB must approve the w88 online sports betting document.
• If a participant withdraws from the interventional portion of a study and does not w88 online sports betting to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's w88 online sports betting. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
• Short-form w88 online sports betting may be allowed.

Application of Regulatory Flexibility for w88 online sports betting Consent

The University IRB utilizes the flexibility in the DHHS regulations and the IRB Flexibility Policy (IRB-Flex) to optimize w88 online sports betting processes to ensure w88 online sports betting processes and materials are compliant yet commensurate with the research as follows:

1. For research conducted by University or affiliate PIs, when do the DHHS regulations for w88 online sports betting consent or documentation of consent NOT apply?
   • When w88 online sports betting is eligible for an exempt determination and researchers use an acceptable, alternative means to inform participants (when applicable).
   • Under the University IRB Flexibility Policy, when minimal risk w88 online sports betting is neither conducted nor supported by a federal agency and does not involve prisoners or incomplete disclosure or deception.
     
     NOTE: For these two types of research, investigators and the IRB to use equivalent protections for w88 online sports betting consent by applying the ethical considerations in the Belmont Report. (See IRB policy for w88 online sports betting consent for exempt and non-federal minimal risk research).
2. When does the University IRB require compliance with DHHS requirements for basic and additional elements for w88 online sports betting consent (see §46.116) and for documentation of w88 online sports betting consent (see §46.117)?
   • When w88 online sports betting poses greater than minimal risk.
   • When minimal risk w88 online sports betting is conducted or supported by a federal agency.
   • When minimal risk w88 online sports betting involves prisoners or incomplete disclosure or deception, regardless of funding.
3. What other regulations does the University IRB consider regarding w88 online sports betting for minimal risk research that is conducted or supported by a federal agency, or involves prisoners or incomplete disclosure or deception?
   • DHHS criteria for waivers/alterations of the w88 online sports betting process (see §46.116(e) and (f))
   • DHHS requirements for a waiver of the requirement to obtained signed consent (see §46.117(c) and IRB policy for w88 online sports betting consent in the case of federally funded minimal risk research).
4. Under what other conditions does IRB-Flex affect the IRB's application of DHHS requirements for w88 online sports betting consent?
   
   Under IRB-Flex, the IRB is not required to approve an alteration of w88 online sports betting consent when one or more select basic elements of disclosure are omitted from consent materials AND the IRB determines the elements do not apply to a given project.
   • w88 online sports betting materials need not list alternative procedures or treatments when no appropriated alternatives exist, from item §46.116(4).
   • w88 online sports betting materials need not disclose foreseeable risks or discomforts to participants when none are evident or when the risks/discomforts are minimal, from item §46.116(2).
   • w88 online sports betting materials need not include research-related injury statements when injuries are not reasonably anticipated or the research risks are minimal, from items §46.116(6) and (7).
   • w88 online sports betting materials need not specify that refusal to participate and discontinuation of participation will not involve penalty or loss of benefits when penalties or loss of benefits are not applicable to the research environment, from item §46.116(8).
5. Does the University IRB allow use of a short form written w88 online sports betting document (as referenced in the regulations under §46.117(b)(2))?
   • Yes, a short form written w88 online sports betting document may be used when a prospective participant or legally authorized representative cannot read the IRB-approved w88 online sports betting form. (For requirements, see the online HRPP Policy Manual for short form written w88 online sports betting).
   • DHHS regulations regarding use of a short form written w88 online sports betting document do not apply to exempt research or (under IRB-Flex) minimal risk research that is neither conducted nor supported by a federal agency unless the research involves incomplete disclosure/deception or prisoners.

Considerations for Ongoing w88 online sports betting

Situations sometimes emerge in ongoing research that may require researchers to confirm or re-obtain w88 online sports betting. For example:

1. When studies are of long duration (e.g., participant involvement lasts two or more years), or involve long-term follow up or multiple contacts/interactions, researchers are advised to periodically invite participants' questions and confirm continued involvement in the w88 online sports betting.
2. When new information (e.g., from interim research findings, publications related to the research, or communication/reports from the study sponsor) emerges that may affect participants' willingness to continue their involvement in the research, researchers must inform the IRB, obtain approval for the process and materials for informing enrolled participants of the new information, and re-obtain w88 online sports betting from enrolled participants. Following IRB approval, w88 online sports betting may be re-obtained by using an amended w88 online sports betting document and or an addendum to the original w88 online sports betting document.
3. A project amendment is requested that requires informing enrolled participants of changes to the research. The amendment must include the process and materials for informing enrolled participants of the amendments and re-obtaining w88 online sports betting from enrolled participants. Following IRB approval, w88 online sports betting may be re-obtained by using an amended w88 online sports betting document and or an addendum to the original w88 online sports betting document.

Obtaining w88 online sports betting in Languages Other than English

DHHS requires that w88 online sports betting is obtained in a language understandable to the participant. For research involving individuals who are not fluent in English, individuals who speak the participant's language must be available for the consent discussion and IRB-approved content for consent materials must be translated into the participant's language (see IRB policy for research involving persons who do not speak English).

IRB Review of w88 online sports betting Processes and Materials

To allow the IRB to adequately assess for the requirements for w88 online sports betting consent, researcher forms for exempt and IRB review, and consent waivers; templates (i.e., for consent forms and information scripts/sheets); and the relevant review worksheets address the following:

• the nature and circumstances of the w88 online sports betting process (including who will conduct the w88 online sports betting interview);
• the timing of obtaining consent (i.e., time from when a prospective participant is w88 online sports betting to when they agree to participate);
• the language in which the w88 online sports betting interview will be conducted and the language that is understandable to prospective participant or LAR;
• language in which w88 online sports betting documents will be provided to participants;
• compliance with ethical considerations and (as applicable to the research) DHHS requirements for the basic and additional elements of w88 online sports betting consent; and
• as applicable to the research, DHHS regulations related to waivers/alterations of the w88 online sports betting procedure, and waivers of the requirement for participants to sign a w88 online sports betting document.

The w88 online sports betting reviews the above information and verifies that:

• All required elements of w88 online sports betting consent are addressed as applicable to the research.
• The w88 online sports betting process provides sufficient opportunity for the participant or the participant’s legally authorized representative to consider whether to participate.
• The possibility of coercion or undue influence is minimized.
• The w88 online sports betting form is free of exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.
• The w88 online sports betting form includes a description of how research participants can contact the research staff to ask questions about the research or express concerns or complaints about the research.

The IRB requests revisions as necessary to ensure that proposed activities and documents are clear, and the w88 online sports betting process meets all applicable regulatory, policy, and ethical requirements.

Posting of Clinical Trial w88 online sports betting forms for clinical trials conducted or supported by a federal agency

One IRB-approved consent form used to enroll participants must be posted by the awardee (Principal Investigator) or the federal department or sponsor conducting the trial on a publicly available Federal Web site that has been established as a repository for such w88 online sports betting consent forms. If the Federal department or sponsor supporting or conducting the clinical trial determines certain information should not be made publicly available on a Federal Web site (e.g., confidential commercial information), the Federal department or sponsor may permit or require redactions to the information posted. The w88 online sports betting consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any participants, as required by the protocol.

Use of Electronic w88 online sports betting Consent (eIC)

Electronic w88 online sports betting consent (eIC) may be used to either supplement or replace paper-based w88 online sports betting consent processes. The consent process may take place at the study site when both the investigator and participant are at the same location, or it may take place remotely (e.g., at the participant’s home or another convenient venue) where the participant reviews the consent document in the absence of the investigator. The eIC materials may be provided for both on-site and remote access. Whether the eIC is obtained from the participant on-site or remotely, the eIC process must provide sufficient opportunity for the participant to consider whether to participate (see 45 CFR 46.116 and 21 CFR 50.20).

The investigator should have methods in place to ensure that the eIC process allows participants the opportunity to consider whether or not to participate and to ask questions about the study before signing w88 online sports betting as well as at any time during the subject’s involvement in the research. This may be accomplished by in-person discussions with study personnel or through a combination of electronic messaging, telephone calls, video conferencing, or a live chat with a remotely located investigator or study personnel. When live chat or video conferencing is used during the eIC process, investigators and study personnel should remind participants to conduct the eIC discussion in a private location to help ensure privacy and confidentiality. The eIC may use interactive electronic-based technology, which may include diagrams, images, graphics, videos, and narration.

The eIC should be appropriate for the intended audience, taking into consideration the participant’s age, language, and comprehension level. The procedure for eIC may include an electronic method to capture the signature of the participant. The Investigator must verify the identity of an individual before it establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature or any element of such electronic signature. The electronic system must also capture and record the date that the participant provides consent. The IRB recommends that a copy of the signed w88 online sports betting consent form that includes the date when the eIC was signed be provided to the participant.

Best practices would request participants to take a picture or scan the entirety of the signature page, signed by the participant after the w88 online sports betting process took place. Using electronic signature (e-signature) software allows for better documentation of the process without the need to depend on the participant sending a good copy of the last page of the w88 online sports betting document. The study team should not send the w88 online sports betting form to participants via email unless the email is encrypted. A link to an online w88 online sports betting form may be sent via email. Alternatively, for in-person w88 online sports betting, the form may be presented to the participant via a touch-screen-enabled device.

For FDA regulated studies, investigators must use a platform that is also 21 CFR Part 11 compliant. The REDCap software is not Part 11 compliant. Researchers w88 online sports betting use the DocuSign software if using a Part 11 compliant account.

Elements of Broad w88 online sports betting

The IRB may allow broad w88 online sports betting for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or for non-research purposes). The study must undergo limited IRB review and meet the requirements for exempt Category 7 or Category 8. Required elements of broad w88 online sports betting:

1. A description of any reasonable foreseeable risks or discomforts;
2. A description of any benefits to the participant or others that may reasonable be expected from the w88 online sports betting;
3. A statement describing the extent, if any, to which confidentiality of records identifying the w88 online sports betting will be maintained;
4. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the w88 online sports betting is otherwise entitled, and the w88 online sports betting may discontinue participation at any time without penalty or loss of benefits to which the w88 online sports betting is otherwise entitled;
5. If appropriate, a statement that the w88 online sports betting’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the w88 online sports betting will or will not share in this commercial profit;
6. If appropriate, for w88 online sports betting involving biospecimens, whether the w88 online sports betting will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen);
7. A general description of the types of research with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect broad w88 online sports betting would permit the types of research conducted;
8. A description of the identifiable private information or identifiable biospecimens that might be used in w88 online sports betting, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct w88 online sports betting with the identifiable private information or identifiable biospecimens;
9. A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for w88 online sports betting purposes (which could be indefinite);
10. Unless the participant or their LAR will be provided details about specific research studies, a statement that they will not be w88 online sports betting of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
11. Unless it is known that clinically relevant w88 online sports betting results, including individual results, will be disclosed to the participant in all circumstances, a statement that such results may not be disclosed to the participant;
12. An explanation of whom to contact for answers to pertinent questions about the storage and use of information and specimens, and to voice comments or concerns about participants' rights, and whom to contact in the event of a w88 online sports betting-related harm.

If a broad w88 online sports betting procedure is used:

• The w88 online sports betting may not omit or alter any of the required elements of disclosure, and when appropriate, any of the additional elements of disclosure.
• If a study requests broad w88 online sports betting for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, the IRB cannot waive w88 online sports betting for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

Illiterate Participants and w88 online sports betting Populations Without a Written Language

When a researcher expects to enroll illiterate participants or participant populations with no written language, the IRB may approve a consent process using an IRB approved short form written w88 online sports betting consent document stating that the required elements of w88 online sports betting consent have been presented orally to the participant.

The IRB shall approve a written summary of what is to be said to the participant. When this method is used, there shall be a witness to the oral presentation. The witness shall sign both the short form and a copy of the summary. Only the short form itself is to be signed by the participant. The person obtaining w88 online sports betting shall sign a copy of the summary. A copy of the summary and a copy of the short form shall be given to the participant.