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consent document is required to include the following information,

TermDefinition
consent document includes: Invitation, Evidence voluntary; kept confidential, private; participant tasks Risks and benefits, Costs to participate, Alternatives to participation, signature panal
Deidentified data any information that may be used to identify participants (e.g., name, address, phone number) has been removed.
Pregnant women, fetuses, and neonates (and children in general), prisoners, detainees individuals with illnesses or conditions are considered vulnerable populations
Step 3: Submit Proposal for Review Common problems Insufficient detail or information; Conflicting information in different parts of the application; Missing elements in the consent document; or Failure to use approved templates, language that were provided by the IRB
Expedited research reviewed by the institutional review board through accelerated procedures
WAYS TO SPEED THE APPROVAL PROCESS ask questions of staff as you prepare your application; positive relationship; define exempt or expedited research; minimal risk
Studies posing more than minimal risk require an outline of steps that you will take to minimize risks and a clear explanation of how the benefits of the research outweigh the risks.
Although there are no direct benefits to individual participants, knowledge gained from this research will greatly enhance our knowledge of ...
new to research (or new to an institution), ask a colleague for a recent IRB protocol that has been approved
Most IRB committees review research projects annually to ensure that participants have been treated ethically, to check that proper records have been kept, and to evaluate potential changes to risks
Research records must include accurate, up-to-date counts of the number of participants and a signed consent form for every participant, unless the researcher has applied for a waiver of consent
keep track of the number of individuals who dropped out of the study and their reasons for dropping out.
the American Psychological Association states that you should keep “study materials" for at least five years post publication
Coercion The act of taking away someone's voluntary choice to participate through either negative or positive means.
researchers typically build a “firewall " between themselves and potential participants so that they do not know which students choose or refuse to participate
compensation should correspond to what is being asked of participants
The Beck Depression Inventory is a widely validated brief survey measure often used as a screen for depression in research.
students exposed to questions about suicide in a survey were no more likely to report suicidal ideation than students who were not presented with the survey
The best approach when facing a potential research risk is to have an effective plan in place to deal with the risk and to confer with your local IRB about best practices
Conflict of Interest: financial or other considerations may compromise or appear to compromise a researcher's judgment in conducting or reporting research
the only "remedy" for a conflict of interest is full disclosure so that the community of scholars can account for the conflict in vetting the research findings
Deception moderate or mild, more moderate forms of deception must include a thorough debriefing at the conclusion of the study.
Active deception The giving of false information to study participants.
Passive deception the withholding of some study details from participants.
deception is only considered justifiable if the question being answered is important enough to allow for the temporary breach of ethics
deception is viewed as justifiable only if a researcher can demonstrate that no other methods are available to study the given topic.
Debrief:To give participants study information that was initially withheld and the reasons that information was withheld.
Dehoax To make participants fully aware of any deception to prevent potential harm
Mandated reporters individuals who have a legal obligation to report incidents such as elder or child abuse to the authorities
Researchers are generally not considered by law mandated reporters
Created by: james22222222
 

 



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