Section H Consent Assent Describe The Following 1 How Will C

Section H Consentassentdescribe The Following1 How Willconsentass

Assignment Instructions

Section H Consent/Assent Describe the following: 1) How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.) 2) If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research). 3) If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable). 4) If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: . ) SECTION I: Risks to Subjects IRBs must evaluate the risk-benefit ratio of proposed human subject research.

In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized. Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following: 1) The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants. 2) Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).

3) Describe the procedures/process which will be used to reduce or minimize risks : a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.). b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data) c. What actions would you take if a participant gets hurt or upset? ) a.) b.) c.) SECTION J: Deception/Incomplete Disclosure If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved. 1) Describe the deception/incomplete disclosure of information to the subjects. 2) Explain why such deception/incomplete disclosure is necessary. 3) Explain the debriefing process, or explain why there will not be a debriefing process. ) SECTION K: Benefits Describe any direct benefits participants could potentially receive (excluding compensation for participation) . If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank. SECTION L: Subject Incentives/Compensations L1.

Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No L2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provided to subjects, contingencies for payment, payment schedule, etc.), what records will be retained regarding payment and who will these records be provided to (e.g. signed payment receipt, names and social security numbers provided to accounts payable for check payments, etc.) : SECTION M: Additional Information Use this area to add any additional information that you believe is relevant to the IRB’s review of your study. SECTION N: Investigator Assurances As a PI or Co-PI, I certify the following: · I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator. · The information in this submission accurately reflects the proposed research. · I will not initiate this study until I receive written approval from the IRB. · I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects. · I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures and/or changes in personnel. · I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report. · All research personnel involved in the study have been appropriately trained in human subjects’ protection.

I accept responsibility for assuring adherence to applicable Federal and State research regulations and APUS polices relative to the protection of the rights and welfare of the subjects enrolled in this study. · I have obtained, or will obtain, all necessary permissions from study sites. · Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB which will occur at least yearly. ________________________________ ________________________ ________________ Principal Investigator (PRINT NAME) (SIGNATURE) DATE ________________________________ ________________________ ________________ APUS IRB Application for Students Version 1.2 Revised 2/2016 Week 1 – Review Sheet Exercise 1: Hanging-drop and wet-mount preparations 1.

How does true motility differ from Brownian movement? 2. What morphological structure is responsible for bacterial motility? 3. Why is a wet preparation discarded in disinfectant solution or biohazard container?

4. What is the value of a hanging-drop preparation? 5. What is the value of a wet-mount preparation? Exercise 2: Simple stains 1.

Define acidic and basic dyes. What is the purpose of each? 2. What is the purpose of fixing a slide that is to be stained? 3.

Why are the specimens to be stained suspended in sterile saline or distilled water? 4. How does a stained preparation compare with a hanging drop for studying the morphology and motility of bacteria? 5. List at least three types of bacteria whose names reflect their shapes and arrangements, and state the meaning of each name.

Exercise 3: Gram stain 1. What is the function of the iodine solution in the Gram stain? If it were omitted, how would staining results be affected? 2. What is the purpose of the alcohol solution in the Gram stain?

3. What counterstain is used? Why is it necessary? Could colors other than red be used? 4.

What is the advantage of the Gram stain over a simple stain such as methylene blue? 5. In what kind of clinical situation would a direct smear report from the laboratory be of urgent importance? Mock IRB Application-Part 2 MOCK IRB APPLICATION EXERCISE-PT. 2 Psychological experiments that are conducted on human or animal subjects must go through a review by an administrative body known as an Institutional Review Board (IRB).

Approval must be gained by an IRB before a study can be funded or conducted. Researchers, whether they are faculty, students, or other affiliated personnel, must complete a detailed application that is presented to the IRB for its review. APUS has an IRB, much like that of any research-producing university or institution. Attached you will find an amended version of the actual application that researchers must submit to the IRB in advance of conducting psychological research. *This is a mock version of the application. You are not actually submitting anything to the real APUS IRB while conducting this exercise.

For Part 2 of this exercise, you will use the completed application attached completed earlier in the semester. These are experiments that have already been conducted and published. Several are “classic” experiments in social psychology of which you should already be aware. You will read the published article carefully and then you will take the knowledge gleaned from the article to complete the IRB application AS IF you were the Principal Investigator applying for approval to conduct the study. For some of the questions included on the application, you may need to “stretch” your knowledge a bit.

For example, the published article may say that college students were given extra credit for participation, but may not go into a lot of detail regarding the process used to recruit those students. In such a situation, you may need to use your imagination to fill in some blanks. In addition, please remember that the goal here is to put yourself in the principal investigator’s shoes at the time that he/she conducted the experiment. If the experiment was conducted in the 1970s, for example, remember that the standards for human experimentation were different back then. Answer the questions as the investigator WOULD have answered them (based upon what you read about the experiment), not as they SHOULD have answered them based on today’s ethical standards.

Paper For Above instruction

The process of obtaining informed consent and assent is a fundamental ethical requirement in human subject research. It ensures that participants are fully aware of the nature of the study, potential risks, benefits, and their rights, enabling them to make an informed decision about participation. The methods of consent collection vary depending on the setting, population, and type of research but always aim to uphold autonomy and voluntary participation. When involving vulnerable populations, specialized procedures are necessary to adhere to ethical guidelines and protect their rights.

In this context, consent can be obtained through various means such as signing a physical consent form in person, electronic consent forms for online surveys, or verbal consent documented by researchers. For instance, in face-to-face interviews, participants typically sign consent forms after being provided comprehensive information about the study. Online surveys often utilize a front-page consent form that participants must agree to before proceeding. Ensuring that participation is entirely voluntary involves procedures to prevent coercion, such as avoiding undue influence, providing clear non-research alternatives, and emphasizing the right to withdraw at any time without penalty. When involving vulnerable populations like prisoners or individuals with cognitive impairments, extra care is taken to ensure that consent is voluntary, informed, and conducted in accordance with legal and ethical standards.

Research risks are an integral component of ethical review, requiring evaluation of potential harm and how to mitigate it. Risks can be physical, psychological, social, economic, or legal, and their likelihood and magnitude must be estimated based on existing literature or experience. Minimization strategies include data safeguards such as anonymization, pseudonyms, and limiting access to identifying information. Explicit communication about anonymity, or the lack thereof, is vital to ensure participants understand how their data will be handled. Additionally, procedures should be in place to address adverse events, such as providing support for participants who become distressed or hurt during the study.

Deception and incomplete disclosure are sensitive issues addressed by ethical guidelines in research. When deception is necessary—for example, to prevent participants from altering their behavior—the rationale must be clearly justified, and a thorough debriefing must follow to explain the true purpose of the research and address any misconceptions or distress caused. Without proper debriefing, ethical standards require justification and documentation of why this step is omitted.

The benefits of research extend beyond individual participants, potentially advancing societal knowledge and informing practice. Direct benefits in some studies may include educational or health-related outcomes, while societal benefits often involve improved policies, interventions, or understandings of human behavior. Participant incentives, such as monetary compensation, gift cards, or extra credit, are common and must be described in detail, including timing, contingencies, and recordkeeping procedures. Documentation of payments and confidentiality regarding such records are essential to maintain integrity and comply with regulations.

Additional information relevant to the IRB review might include specific procedures, recruitment strategies, or ethical considerations unique to the study. The investigator also provides assurances of responsibility, confirming familiarity with regulations, training, and ethical guidelines like the Belmont Report. These statements ensure accountability and compliance, fostering trust and integrity in the research process.

In conclusion, proper adherence to consent and assent procedures, risk minimization, transparency, and ethical rigor ensures the protection of human subjects, respects their autonomy, and enhances the credibility and societal value of research findings.

References

• Beauchamp, T. L., & Childress, J. F. (2019). Principles of Biomedical Ethics (8th ed.). Oxford University Press.
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report.
• Federal Policy for the Protection of Human Subjects ('Common Rule'). (2018). U.S. Department of Health & Human Services.
• Resnik, D. B. (2015). The Ethics of Research with Human Subjects: Protecting Participants and Promoting Scientific Knowledge. Springer.
• Nuremburg Code (1947). Trials of War Criminals before the Nuremberg Military Tribunals.
• Levine, R. J. (2016). Ethics and Regulation of Clinical Research. Yale University Press.
• Parfit, D. (2019). The Non-Identity Problem and Practical Ethics. Oxford University Press.
• Schuklenk, U. (2017). The Royal Free HIV Study: An Ethical Appraisal. Journal of Medical Ethics, 43(12), 823–825.
• Wendler et al. (2010). The Standard of Care in International Research. The Journal of Law, Medicine & Ethics, 38(2), 264–271.
• FDA. (2018). Guidance for Institutional Review Boards and Clinical Investigators. Food and Drug Administration.