Assignent Solutionnurs

Use the information provided from the other sections (informed consent, lit review, variable and design etc) within the IRB application attached to complete sections 6 & 7 (These sections are part of the IRB)
6 Potential Risks and Benefits
6.1 Risks
Describe in detail any reasonably foreseeable physical, psychological, social, legal, economic, or any other anticipated risks to study subjects. Include risks of study intervention and other study procedures. Describe procedures to minimize risks.
If applicable, indicate:
– which procedures may have risks to the participants that are currently unforeseeable.
– which procedures may have risks to an embryo or fetus should the participant be or become pregnant.
– risks to others who are not participants.)
One or more of the following may serve as the source of risk information:
? Package insert for a licensed product
? Investigator’s Brochure (IB) for an investigational product
? Preclinical data reports
? Literature search and review (cite references and list them in Section 14)
Provisions to Monitor the Data to Ensure the Safety of Participants
(This section is required when research involves more than Minimal Risk to participants.)
Describe:
­ The plan to periodically evaluate the data collected regarding both harms and benefits to determine whether participants remain safe. The plan might include establishing a data monitoring committee (DSMB/DMC/IDMC) and a plan for reporting data monitoring committee findings to the IRB and the sponsor.
­ The frequency of DSMB Meeting.
­ What data are reviewed, including safety data, untoward events, and efficacy data.
­ How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants).
­ The frequency of data collection, including when safety data collection starts.
­ Who will review the data.
­ The frequency or periodicity of review of cumulative data.
­ The statistical tests for analyzing the safety data to determine whether harm is occurring.
­ Any conditions that trigger an immediate suspension of the research.)
6.2 Potential Benefits
If the research is beneficial, describe any physical, psychological, social, legal, or any other anticipated benefits to subjects. While it may not provide direct benefit to subjects, the importance of the knowledge that may result from the study may be mentioned. Note: Compensation to subjects is not considered a “benefit.”
1.
6.3 Analysis of Risks in Relation to Benefits
Describe how risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
7 Study Subject Selection
7.1 Subject Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
? Inclusion criteria
? Describe:
o how individuals will be screened for eligibility,
o the criteria that define who will be included or excluded in your final study sample,
o specify if you will include or exclude each of the following special populations (members of the populations below may not be included in your research unless you indicate this in your inclusion criteria):
? Adults unable to consent
? Individuals who are not yet adults (infants, children, teenagers)
? Pregnant women
? Prisoners
? Vulnerable Populations
? If the research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards included to protect their rights and welfare.
If the research involves non-English speaking participants indicate what language(s) other than English are understood by prospective participants or representatives. If participants who do not speak English will be enrolled, describe the process to ensure that the oral and written information provided to those participants will be in that language. Indicate the language that will be used by those obtaining consent.
7.2 Subject Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
? Exclusion criteria; do not duplicate what is already listed in the Inclusion criteria above; if no additional criteria, say “None.”
? If this study excludes certain populations, explain the rationale for the exclusion in detail.
7.3 Recruitment Methods
Describe when, where, and how potential participants will be recruited including the source of participants and any methods that will be used to identify potential participants.
Describe materials that will be used to recruit participants. (Attach copies of these documents in the appendix of the application. For advertisements, attach the final copy of printed advertisements.
When advertisements are taped for broadcast, attach the final audio/video file. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video file.
7.4 Compensation for Participation in Research Activities
Describe the amount, timing, and method of any payments to participants. (e.g., gift card, meals, check.)
If payment is by check, you must request name, address and Social Security Number in order to issue a check for participation. Study payments are considered taxable income and are reportable to the IRS.
If the investigator believes that the biologic specimens obtained could be part of or lead to the development of a commercial product, indicate if the participant will have any right to compensation or ownership interest related to such development.
Describe when and how participants will be informed of the results of the research.
7.5 Withdrawal of Participants
Describe:
– any anticipated circumstances under which participants will be withdrawn from the research without their consent,
– any procedures for orderly termination,
– procedures that will be followed when participants withdraw from the research, including partial withdrawal from procedures with continued data collection.