Informed Consent

Sample Answer for Informed Consent Included After Question

Description

Topic: Informed Consent

In this learning activity, you will develop an informed consent as part of an ethical treatment of program participants. An informed consent is an essential part of the ethical treatment of health promotion program participants. This is true whether or not you plan to use data collected in the program in a research study. Fill in the “Informed Consent Template” to support a hypothetical educational program you might develop to address the objective you wrote and others like it. While much of the information you include in this template will have to be fictitious, consider the contents of a program intervention you may one day create to address similar needs and objectives. Each of the items on the template is an important part of a complete informed consent and must be responded to. Click on “Sample Informed Consent” to see a sample (included below).

A Sample Answer For the Assignment: Informed Consent

Title: Informed Consent

HLTH 509 LEARNING ACTIVITY 6 STANDARDIZED GRADING RUBRIC Criteria Content Use of provided template 3 points Advanced 3 points Template is fully used as it is intended. Question prompts: Completeness 8 points 6 to 8 points Correct responses to all questions and prompts according to directions and examples provided. Question prompts: Critical Thinking 5 points 4 to 5 points Expands responses into substantive, thoughtful, and/or critical responses, fully addressing all questions or prompts. 3 points The content and elements of the consent are appropriate given the target population and intended intervention. (For example, there is a consent line for parent/guardian if the intervention is dealing with minors). Advanced 5 to 6 points Communication follows Student Expectations, including AMA formatting. Proper spelling AND grammar are used. Consent appropriateness 3 points Structure Student Expectations and Mechanics 6 points Levels of Achievement Proficient Developing 2 points 1 point Template is somewhat Template is used but there are used as intended but did multiple areas where the tool is not fully use template to not used as is intended. develop consent form. 4 to 5 points 1 to 3 points Student answers most Some questions are answered incorrectly or some elements question prompts are missing. correctly. Not present 0 points Provided template not used. 0 points Submission contains both incorrect answers to question prompts and there are required elements that a missing completely. 0 points There is a lack of substantive, thoughtful and/or critical response in regard to the content of the post. 2 to 3 points There is evidence of critical assessment of the content on most areas of the assignment. 1 point There is some evidence of critical assessment but needs in improvement in major areas. 2 points The content and elements of the consent are mostly appropriate given the target population and intended intervention. 1 point Major portions of either the content or specific elements of the consent are not appropriate given the target population and intended intervention. 0 points Major portions of BOTH the content and elements of the consent are not appropriate given the target population and intended intervention. Proficient 3 to 4 points Communication follows all student expectations, including AMA formatting. Minor spelling OR grammar errors present. Developing 1 to 2 point Communication follows some student expectations, including AMA formatting. Multiple spelling OR grammar errors are present. Not present 0 points Communication does not follow student expectations in the majority of the post, including AMA formatting. There are multiple spelling AND grammar errors throughout post. Page 1 of 2 SAMPLE INFORMED CONSENT INFORMATION ABOUT: Acme Employee Diabetes Awareness Campaign. PRINCIPAL INVESTIGATOR: Minerva McGonagall CO-INVESTIGATORS: Ginny Weasley, Gilderoy Lockhart, Sybill Trelawney, Dolores Umbridge PURPOSE: The purpose of this campaign is to increase the level of awareness of Diabetes mellitus type 2, its risk factors and preventive behavior among Acme Company Employees. DURATION: I will conduct this campaign on the Acme Company Campus, Johnson City, TN. The duration of this program will be from May 1 through December 20, 2012. PROCEDURES: This is a three-phase program delivered by graduate students of the MPH Program: 1. Pretest will be distributed to Acme employees to assess the existing level of knowledge about diabetes, its risk factors, and related preventive behavior. 2. The intervention will be a health communication campaign about diabetes mediated through different channels like flyers, posters, and newsletters. 3. Posttest will be conducted after the intervention to evaluate the effect of the health communication campaign. POSSIBLE RISKS OR DISCOMFORTS: There are no possible risks from this project. If any questionnaire items produce discomfort the subjects are free to choose not to respond to that item. POSSIBLE BENEFITS: The participants have the potential benefits to increase their level of awareness of diabetes, its risk factors, and related preventive behavior. FINANCIAL COSTS: The possible financial costs to you as a participant in this research study are none. ALTERNATIVE PROCEDURES/TREATMENTS: No alternative procedures are available to you if you elect not to participate in this study. 9/28/2019 Page 2 of 2 VOLUNTARY PARTICIPATION: Participation in this program and related study is entirely voluntary. You may choose not to participate or you may quit the program at any time with no penalty to you. CONTACT FOR QUESTIONS: If you have any questions regarding this study, you may contact Professor Minerva McGonagall at 434-444-3333. You may also contact the Chairman of the Institutional Review Board at 434-444-0000 if you have any questions regarding your rights as a program participant or research subject. INJURY/COMPLICATIONS: No injuries or complications are likely to be caused by this program and the related study. COMPENSATION FOR MEDICAL TREATMENT: This study does not include any sort of medical treatment. CONFIDENTIALITY: All information from the surveys conducted in this program will be treated confidentially and will not be revealed except in the aggregate form. Any Acme employee may voluntarily respond to the Diabetes Awareness Survey/Risk Test via two methods: paper and website. No names or other identifiers will be collected. All paper responses will be mailed to a designated campus mail box. Web-based surveys will be set up through Information Technology on a secure website that removes personal identifiers from all respondents. No email responses will be solicited. CONSENT AND RELEASE: By signing below, I certify that I have read or have had this document read to me. I have also been given a signed copy of it. I acknowledge that I have been given the chance to ask questions and to discuss my participation in the program and related study. I freely and voluntarily choose to participate in this program and release any data collected from me for use by investigators in an anonymous and confidential manner. ____________________________________________________________________________________________ SIGNATURE OF PARTICIPANT DATE _____________________________________________________________________________________________ SIGNATURE OF INVESTIGATOR DATE _____________________________________________________________________________________________ SIGNATURE OF WITNESS DATE 9/28/2019 Page 1 of 2 INFORMED CONSENT TEMPLATE INFORMATION ABOUT: PRINCIPAL INVESTIGATOR: CO-INVESTIGATORS: PURPOSE: DURATION: PROCEDURES: POSSIBLE RISKS OR DISCOMFORTS: POSSIBLE BENEFITS: FINANCIAL COSTS: ALTERNATIVE PROCEDURES/TREATMENTS: VOLUNTARY PARTICIPATION: CONTACT FOR QUESTIONS: INJURY/COMPLICATIONS: COMPENSATION FOR MEDICAL TREATMENT: CONFIDENTIALITY: CONSENT AND RELEASE: 9/28/2019 Page 2 of 2 ____________________________________________________________________________________________ SIGNATURE OF PARTICIPANT DATE _____________________________________________________________________________________________ SIGNATURE OF INVESTIGATOR DATE _____________________________________________________________________________________________ SIGNATURE OF WITNESS DATE 9/28/2019

Grid View

	Excellent	Good	Fair	Poor
Main Posting	45 (45%) – 50 (50%) Answers all parts of the discussion question(s) expectations with reflective critical analysis and synthesis of knowledge gained from the course readings for the module and current credible sources. Supported by at least three current, credible sources. Written clearly and concisely with no grammatical or spelling errors and fully adheres to current APA manual writing rules and style.	40 (40%) – 44 (44%) Responds to the discussion question(s) and is reflective with critical analysis and synthesis of knowledge gained from the course readings for the module. At least 75% of post has exceptional depth and breadth. Supported by at least three credible sources. Written clearly and concisely with one or no grammatical or spelling errors and fully adheres to current APA manual writing rules and style.	35 (35%) – 39 (39%) Responds to some of the discussion question(s). One or two criteria are not addressed or are superficially addressed. Is somewhat lacking reflection and critical analysis and synthesis. Somewhat represents knowledge gained from the course readings for the module. Post is cited with two credible sources. Written somewhat concisely; may contain more than two spelling or grammatical errors. Contains some APA formatting errors.	0 (0%) – 34 (34%) Does not respond to the discussion question(s) adequately. Lacks depth or superficially addresses criteria. Lacks reflection and critical analysis and synthesis. Does not represent knowledge gained from the course readings for the module. Contains only one or no credible sources. Not written clearly or concisely. Contains more than two spelling or grammatical errors. Does not adhere to current APA manual writing rules and style.
Main Post: Timeliness	10 (10%) – 10 (10%) Posts main post by day 3.	0 (0%) – 0 (0%)	0 (0%) – 0 (0%)	0 (0%) – 0 (0%) Does not post by day 3.
First Response	17 (17%) – 18 (18%) Response exhibits synthesis, critical thinking, and application to practice settings. Responds fully to questions posed by faculty. Provides clear, concise opinions and ideas that are supported by at least two scholarly sources. Demonstrates synthesis and understanding of learning objectives. Communication is professional and respectful to colleagues. Responses to faculty questions are fully answered, if posed. Response is effectively written in standard, edited English.	15 (15%) – 16 (16%) Response exhibits critical thinking and application to practice settings. Communication is professional and respectful to colleagues. Responses to faculty questions are answered, if posed. Provides clear, concise opinions and ideas that are supported by two or more credible sources. Response is effectively written in standard, edited English.	13 (13%) – 14 (14%) Response is on topic and may have some depth. Responses posted in the discussion may lack effective professional communication. Responses to faculty questions are somewhat answered, if posed. Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited.	0 (0%) – 12 (12%) Response may not be on topic and lacks depth. Responses posted in the discussion lack effective professional communication. Responses to faculty questions are missing. No credible sources are cited.
Second Response	16 (16%) – 17 (17%) Response exhibits synthesis, critical thinking, and application to practice settings. Responds fully to questions posed by faculty. Provides clear, concise opinions and ideas that are supported by at least two scholarly sources. Demonstrates synthesis and understanding of learning objectives. Communication is professional and respectful to colleagues. Responses to faculty questions are fully answered, if posed. Response is effectively written in standard, edited English.	14 (14%) – 15 (15%) Response exhibits critical thinking and application to practice settings. Communication is professional and respectful to colleagues. Responses to faculty questions are answered, if posed. Provides clear, concise opinions and ideas that are supported by two or more credible sources. Response is effectively written in standard, edited English.	12 (12%) – 13 (13%) Response is on topic and may have some depth. Responses posted in the discussion may lack effective professional communication. Responses to faculty questions are somewhat answered, if posed. Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited.	0 (0%) – 11 (11%) Response may not be on topic and lacks depth. Responses posted in the discussion lack effective professional communication. Responses to faculty questions are missing. No credible sources are cited.
Participation	5 (5%) – 5 (5%) Meets requirements for participation by posting on three different days.	0 (0%) – 0 (0%)	0 (0%) – 0 (0%)	0 (0%) – 0 (0%) Does not meet requirements for participation by posting on 3 different days.
Total Points: 100