Consent Form For Participation In Research Interview: Fill & Download for Free

[WARNING: long answer includes Clinical Trials 101: A Beginner’s Guide to Clinical Trials and A Step-by-Step Guide to Navigating the www.clinicaltrials.gov website.]I had an interview on TVOne with Roland Martin which has now had more than 14 million views on Facebook. In this interview, I showed pictures of how one of the cancer treatments I developed, Laser Activated NanoTherapy (LANT), resulted in a complete elimination of a mouse tumor after one treatment without any observed side effects. (In case you missed it, here is an abbreviated YouTube version: https://youtu.be/CsUow7AecbQ.) Since then, I have had thousands of desperate cancer patients reach out to me after they have been sent home, with terminal diagnoses, asking if I can do for them what I did for that mouse. Unfortunately, I have had to turn people away because I have not yet raised enough funding to start LANT human clinical trials even though the technology is ready and we can launch within 12 months of reaching our first fundraising goal of $10 million. Many are unaware that the average cost of all of the required clinical trials for a cancer treatment is nearly $100 million. My goal is to raise the money for LANT clinical trials through my nonprofit, the Ora Lee Smith Cancer Research Foundation, in order to keep the treatments affordable. Meanwhile, this is an opportunity to increase public awareness about clinical trials with a non-technical introduction:Clinical Trials 101: A beginners guide to clinical trialsWhat are Clinical Trials? According to Home - ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world, there are nearly 288,000 medical research studies being conducted nationwide and in over 200 countries as of October 2018. https://www.clinicaltrials.gov/ Medical research is the scientific investigation that leads to the discovery and development of new treatments for a variety of diseases and illnesses, like cancer. A clinical trial, also known as a clinical study or interventional study, is any medical research study that uses human participants to evaluate or learn the effects of treating or preventing a disease with a particular approach (i.e. drugs, medicine, medical devices). Some participants may receive a placebo instead of the treatment without knowing. The other category of medical research is an observational study in which only observations are made but there is no attempt to treat or prevent the disease. https://clinicaltrials.gov/ct2/about-studies/learn#WhatIsWhy would I participate in a clinical trial? Some patients may develop a disease that is too advanced for the drugs and technology that are currently approved by the Food and Drug Administration (FDA). If this happens, it is a common practice for a patient to be released from care. However, this is also the opportunity to discuss the possibilities of clinical trials with your healthcare provider. If your provider is not aware of any clinical trial options, you may refer your doctor to Home - ClinicalTrials.gov as a resource that will allow you and your doctor to locate clinical trials near you that are specific to your disease.Qualifying for Clinical Trials. To ensure the highest possibility of a successful outcome of the trial and to make sure it is an appropriate choice for someone with your background and medical history, you need to qualify to participate in a clinical trial.How do you qualify? Qualifying for a clinical trial is based on your medical history referred to as “inclusion criteria” and “exclusion”What is “inclusion criteria?” Inclusion criteria is a type of eligibility criteria, specifically the reasons that a person is allowed to participate in a clinical study. https://clinicaltrials.gov/ct2/about-studies/glossaryWhat is “exclusion criteria?” Exclusion criteria is type of eligibility criteria, specifically the reasons that a person is not allowed to participate in a clinical study. https://clinicaltrials.gov/ct2/about-studies/glossaryAre Clinical Trials Safe? The safety of clinical trial participants is ensured by the Food and Drug Administration (FDA) and the Institutional Review Board (IRB) which determines that the benefits outweigh the risks.What is Informed Consent? Informed consent is a process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue. It is also called the consent process. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/informed-consentBe mindful that informed consent is not just about signing the form - this means that you should understand what will happen during the study and what risks are possible. Before you are allowed to participate in a study, you will be asked to sign an “informed consent form.” This should be a process where you should ask all of the questions you may have. You should be provided with a copy of the “informed consent” form. If you do not understand something, ask questions. You should understand what will happen during the study and what risks are possible. You should be well informed before you agree to participate.Double blind studies (placebo vs. actual trial) - depending on the study design, you may be assigned to a section of the study where you may or may not receive the actual investigational drug; you may receive the “placebo” or an FDA approved medication.A Step-by-Step Guide to Navigating the www.clinicaltrials.gov WebsiteOn the homepage:Locate the Find a Study box.In the field Condition or disease enter your cancer diagnosis (ex. breast cancer).Leave Other terms blank.Select your Country (ex. United States) and select State, City and Distance (ex. Atlanta, GA, 300 miles.For distance - enter the amount you are willing to travel to participate in a clinical trial (this may need to be adjusted if your results are too limited).Select Search.To narrow the search results, on the next page select the filters on the left:Under Recruitment, select Not yet recruiting and Recruiting.Under Eligibility criteria, enter Age or select appropriate age group and select appropriate Sex.Under Study Type, select Interventional (Clinical Trial).Under Study Results, select All. (I prefer discussing the current results of the studies with your doctor to determine if this trial has been successful before and have them discuss with you the percentage of success and long term survival rate after participation.)Under Study Phase, I prefer Phase 3 and Phase 4 for my loved ones who want the lowest risk are but under desperate circumstances. I would explore Phase 2 if needed and Phase 1 only as a last resort. Note: this is not a replacement for medical advice but simply what I would tell my loved ones.Leave Funder Type unselected.Leave Study Document unselected.Select Apply.If you have too many results, be more specific about your Type of cancer and narrow the distance.If you have too few results, broaden your distance and under Study Phase include Phase 2 and as a last resort, Phase 1.Once you have a list of search results, discuss the options with your doctor or oncologist to decide which clinical trial is best for you. Your participation in a clinical trial will depend on your medical history and will be based on what is referred to as “inclusion criteria” and “exclusion criteria” found in the “eligibility criteria” section on each page. The “For Patients and Families” link, https://clinicaltrials.gov/ct2/help/for-patient, is an excellent resource to learn more about clinical trials.

For the exact same reasons ethics matter in every other walk or facet of life.I would state, however, that some ethics procedures in the social sciences are veering somewhat into the ‘overkill’ territory. For example, when doing qualitative interviewing, it is considered vital to attaining informed consent to participate to detail the specific purpose and research question s of the study. Any qualitative researcher will tell you this can lead to demand characteristics and jeopardise the quality of your results. If I say ‘I am studying means-tested benefits in the UK from x, y, and z angles and asking a, b, c questions to answer problem q’ then that may prejudice their testimony due to social desirability and other forms of bias. Me saying ‘I am studying benefit claimants and their experiences with claiming Universal Credit’ ought to be perfectly sufficient, especially considering they have the right to review any materials I produce and withdraw their testimony from my data set after the interview. You do not need to prejudice the quality of your research beforehand if they have the right of review ex-post.I also know of people who have lost months of research time to central university ethics committees fighting with departmental/faculty ethics committees on specific protocols. They are so keen to ensure a gold standard for their research against one set of specific protocols which become hoops all research must jump through, they are loath to allow people to use other accepted professional ethics protocols or to allow students to adhere to two different sets of protocols (a ridiculous position- I have to adhere to a faculty protocol, a university protocol, and a professional body protocol but these are not considered to be in tension with each other, I simply conform to every demand made in all three so my research conforms to some super hybrid macro-protocol).

Before the Interview:1. Define your objectives → identify what you want toachieve and the information you need to gather. Make surean interview is the appropriate way to meet your objectives.2. Choose the type of interview → Review your requiredinformation, budget, time, and potential respondentsand decide whether you need to conduct structured,semi-structured, or unstructured interviews.3. Choose the appropriate respondents → Dependingon the type of interview, decide on the characteristicsof interviewees and the number of interviews required.4. Decide how you will conduct the interviews → Considertelephone or face-to face interviews. For large surveys,consider computer-aided interviewing and recording.5. Decide how to recruit your respondents → Obtain contactinformation for a number of respondents larger than thenumber of interviews you need, since some may notrespond. Contact them by phone, e-mail, or regular mailand introduce yourself, your organization, and your project.Explain the purpose of the interview, the importance oftheir participation, and set up an appointment.Tip Sheet #66. Decide how you will record the interviews → Depending on the type of interview, you may fill in a preparedform, use written notes, voice recorders, or computeraided devices.7. Make a list of questions and test them with a sample ofrespondents → the questions must be aligned with thetype of interview. If you are running structured interviews, see our Tip Sheets on “Questionnaire Design”and Survey Research Methods” for more information.8. Decide who will conduct the interviews → developan information kit that includes an introduction tothe research topic and instructions. For unstructuredinterviews, you may need to hire skilled interviewers.During the interview:1. Introduce yourself and initiate a friendly butprofessional conversation.2. Explain the purpose of your project, the importance of theirparticipation, and the expected duration of the interview.3. Be prepared to reschedule the interview if a respondent has a problem with the timing.4. Explain the format of the interview.5. Tell respondents how the interview will be recordedand how the collected information will be used → ifpossible, obtain their written consent to participate.6. Ask respondents if they have any questions.7. Control your tone of voice and language → remain asneutral as possible when asking questions or probingon issues.8. Keep the focus on the topic of inquiry and completethe interview within the agreed time limit.9. Ensure proper recording → without distracting therespondent, check your notes and voice recorder regularly.10. Complete the session → make sure all questionswere asked, explain again how you will use the data,thank the respondent, and ask them if they haveany questions.After the interview1. Make sure the interview was properly recorded →make additional notes, if needed.2. Organize your interview responses → responses fromunstructured and semi-structured interviews need tobe transcribed. Responses from structured interviewsneed to be entered into a data analysis program.3. Get ready for data analysis → search for resources foranalyzing qualitative and/or quantitative data.