Informed Consent Research Paper

Use this document as a template for designing an informed consent form for your research project for ENC1102

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

The Doctor and Patient relationship aspect of Medicine has changed drastically in the last twenty years. It has evolved from paternalism (the doctor makes the decision for the patient) to shared decision making where the patient is considered an equal partner in his/her own health related decisions. Informed consent is the cornerstone for this view. When a patient or a research subject makes an autonomous decision after understanding, the risks and benefits involved with the decision is Informed consent. Complete Informed consent covers the following components: competency, disclosure, comprehension and voluntary. Competency refers to the requirement for the individual to be of legal age and be mentally competent to understand the process.

The elements of the principles of confidentiality can be broken down into four separate categories: (1) Information provided by the patient is kept confidential unless consent from the patient has otherwise been given—unless it has direct legal implications or endangers the general public. (2) Informed Consent: is given freely, because the correct information has been supplied and the patient has sufficient information on the impacts involved. Information is otherwise given out on a need to know basis. (3) Duty of Care: Information is given out in order to protect the safety and health of others and the patient. Legal and general public health fall under this category. (4) Documenting Decisions: Consultations and actions that lead to

The HHS is required to oversee IRBs in order to ensure that they are functioning properly. Institutional Review Boards cannot function properly without being overseen by the HHS, and therefore lack of oversight would lead to weakened protection of human participants. An Institutional Review Board may not fulfill its purpose without the HHS’s close oversight. Two agencies within the Department of Health and Human Services, the Office for Protection from Research Risks (OPRR) and the FDA, are both tasked with reviewing IRBs. The OPRR utilizes an assurance document to oversee how IRBs are functioning. All IRBs using HHS funding must have an assurance document on file with the OPRR. Coleman adds, “The assurance is a written statement of an institution’s requirements for its IRB and human subject protections” (Coleman et al. 170). Meanwhile, FDA uses research investigators to determine whether IRBs are functioning in an effective manner. The OPRR and the FDA share the task of oversight of IRBs, and do so through documentation and research investigators respectively. Without this system of review, Institutional Review Boards would not be checked by any part of government, and thus would have free reign to do as they please. Thus, the interests of human participants

IND application submitted with pre-clinical safety data of pharmacology and toxicology study gathered during a clinical trial in an animal, drug composition, information of manufacturers, stability of the drug, and controls utilized to process the drug, a constant supply of batches, a copy of clinical protocols which has been permitted by the Institutional Review Board (IRB), and s information regarding investigators who is conducting the clinical trials (Manuts, 2008). Good clinical practices (GCPs) are followed in all phases of clinical trials conducted in human by law of the human subject protection (HSP) stated in the CFR 45, Part 46. The FDA website, the Clinical Trials.gov offers to register the clinical

The trial is first investigator-initiated; a steering committee will be the responsible to design, execute and conduct the study. The monitoring board (professional of the health system) will review the intern results, monitor the safety of the patients, and examine the efficacy of the therapies. Local ethic committee and FAMHP have to approve the study before initiating it.

The Clinical Research Monitors will review up to 10% of the study participants annually for appropriateness of the informed consent process, eligibility, SAE reporting (TRACKS), and patient protocol status. Additional information may be monitored at the request of the Internal Monitoring Committee (IMC), the IRB, or other institutional administration. The Monitor will generate a formal report which is shared with the Principal Investigator (PI), study team and the IMC.

Although regulatory departments in Canada, U.S., and Europe, follow the same principles to ensure the safety and wellbeing of the research participants and the integrity of the clinical research, their regulations for conducting clinical trials may have differences that need to be considered when sponsors are conducting multisite international trials. The variations in the regulatory requirements

According to the ICH-GCP guidelines, clinical trial monitoring is required to oversee the clinical trial, to ensure that the trial is conducted, recorded, and reported according to the protocol, the guidelines of good clinical practice, the SOPs, and the applicable regulatory requirements. Monitoring is an ongoing process conducted before, during and after clinical trials, and is classified into four distinct types of visits (pre-initiation, initiation, routine and close out visits). Monitoring is also a quality control measure that helps to ensure the integrity of clinical data and to protect the rights and well-being of the study participants.

Boswell and Cannon (2014) states that “the core ethical issue in medical research is the need for voluntary consent of the potential research subject so that a fully informed individual participates” (p. 93). It is important to make sure that all ethical concerns and specifications of the person giving consent for participation in the research should be detailed (Hoe & Hoare, 2012, p. 54). Guidelines have been made to follow, in regards to informed consent, to help ensure that any participant in any research be given the best information in the best way for the participant to make an informed decision. In combination with a participant being informed, it is equally important to make sure that the participant is not vulnerable.

Consent to participate in a research study should be thorough and complete. Consent information federally requires that certain information is provided to research study human volunteers. A Clinical trial is federally mandated to include 14 areas of consent that apply to the trial process and must be provided to human volunteers before commencement of a research trial.

A clinical trial is a prospective study comparing the effect and value of an intervention(s) against a control in human beings (Friedman & De Mets, 2010). It is an assured way of determining whether an intervention has the hypothesized effect since researchers have control of most of the cofounders involved in the studies. Each of the participants is followed onward in time from a defined point in time, which is the baseline for the study. Participants are randomly assigned to the various intervention options to create comparable intervention groups. A protocol is one of the requirements of a properly designed trial. A protocol, which is an agreement between the investigator, the participant and the scientific community, provides the background, objectives, design and organization of the trial. This is a document that is prepared way before participants are enrolled, and remains essentially unchanged unless for minor updates. Any major changes altering the direction of the trial need to be carefully justified; a rationale behind the changes should be clearly described.

This guideline was incorporated in Title 21 of the Code Federal Regulations (21 CFR) in 1997, and adopted by the United States Food and Drug Administration (US FDA) to be implemented in designing, conducting, monitoring, auditing, recoding, analysis, and reporting clinical trials to ensure that the documentation of reporting data are credible and accurate, and more importantly to provide safeguards for protecting the rights, safety, privacy, and confidentiality of participants (Allen & Vandenburg,1992). The 21 CFR regulations are updated annually in order to adapt with any emergent issues that require specific changes to ensure the ethical and scientific quality of clinical trials. In addition, these regulations are mandatory on all FDA-regulated products, and rigorous penalties are applied in case they have been violated (Allen & Vandenburg,1992).

Registration of clinical trials has been a controversial issue for years. According to ICMJE, a clinical trial is any research project that prospectively allocates people or a group of individuals to intervention, with or without concurrent comparison or control groups, to study the cause and effect relationship between a health related, intervention and a health outcome. Health-related interventions are those used in the modification of biomedical or health-related outcomes such as drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and the