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this video was prepared by the human subjects protection unit of the National Institute of Mental Health established to enhance protections for research subjects especially vulnerable populations and to ensure that the informed consent process is appropriately conducted the informed consent process requires that certain elements be present both for subject protection and as a safeguard for the investigators and institutions conducting the research the required elements are defined by title 45 part 46 of the Code of Federal Regulations and are supplemented by NIH requirements further information pertaining to informed consent may be found at the NIH office of human subjects research website [Music] we're going to take a look at an informed consent conversation emphasizing the required elements for effective consent everyone has his or her own style of discussing a research study and consenting subjects in this video you'll see the investigator using a style and technique intended to make the process comfortable for the subject while conveying all of the required information informed consent is not just a form that is signed it is also an ongoing conversation with a research subject that begins with the initial contact your informed consent document should be obtained from the clinical Center website [Music] utilizing this website ensures that you're not using an expired version the following are recommendations for making the consent process smooth thorough and comfortable for all from the very beginning make sure that the staff emphasizes that the primary mission of the NIH is to conduct research and that the care research subjects received during protocol participation is different from receiving standard medical care in the community prospective research subjects should understand that they may derive no direct medical benefit from participation screening staff must be familiar with the study and comfortable answering questions regarding its elements sendy the prospective subject the consent form in advance is a good way to have the subject become familiar with the study details prior to the first visit having prior knowledge of the elements of the study may ease anxiety for the participant and streamline the process for the investigator it is helpful to have the subject mark their copy with questions or concerns they want to discuss during the informed consent meeting reading the consent form word-for-word is arduous monotonous and may be overwhelming for the subject you must review the entire consent with a subject the elements should be discussed although the details can be presented in a more conversational manner you want to encourage a relaxed and open atmosphere in which the subject will feel comfortable asking questions maintain good eye contact and aim for a fluent conversational tone of voice naturally you should be aware of your body language professional appearance and rate of speech personal style may dictate variations on this formula it is not advisable to consent a subject to more than one study in a single session reasonable exceptions can be made but multiple consents can be overwhelming or intimidating for subjects and this practice is unlikely to result in meaningful understanding and appreciation of study involvement the consent should be written and discussed in simple language that is consistent with an eighth grade education consider that some subjects may not be literate or have achieved an eighth grade reading level so it is important to be sensitive and responsive to this possibility conduct the consent conversation in an area where there is privacy and where the subject can have enough time to review and digest the content the room should be comfortable and well-lit limit the number of research staff members present for confidentiality sake and to curse the subject to be more at ease asking questions give him or her the option of having a significant other present during this process an independent consent monitor may be present for studies that are greater than minimal risk involve a vulnerable population or require an additional layer of protection if mandated by the institutional review board or at the request of the principal investigator let's take a look now at an example of a properly conducted informed consent meeting [Music] Davis won't you come in have a seat you're more than welcome good morning miss Davis good morning it's nice to see you my name is dr. Bingham my research group studies mood and anxiety disorders in the National Institute of Mental Health as you know we're here to talk about your participation in one of our studies of major depression did you have a chance to read the consent form that we mailed several weeks ago yes I did good do you have any questions no not at this time the most important thing to remember here is that the research is voluntary if you choose to enroll you can decide to stop your participation at any time now if you withdraw from this study it won't affect your participation in any other studies at NIH I see so I can back out of the study even after a week or two you can stop participating at any time just let us know so we can discuss this with you and we can talk about what happens next you understand this yes I do okay great you should also be aware that you may not receive any benefit from participating in this study I understand okay and finally if you have any ethical or religious beliefs that may affect your participation please let me know okay okay good now you have been invited to participate in this study because you have a major depressive disorder I went through a telephone screening interview with a member of your staff and was told I probably am eligible for this study well this is a copy of the consent form for you to follow along as we discuss the study I like to explain the purpose of the study we are trying to discover if compound X is helpful in improving symptoms of major depression compound X has not been approved by the Food and Drug Administration for the treatment of major depression we hope that our study will help determine if the drug could be used for treatment for major depression this is an outpatient study and all of your business will be here in the fourth floor clinic of the clinical Center I'm the principal investigator of the study and I'll be medically responsible for you during the duration of your participation in this study other staff members on my team will assist me in the study do you have any questions by that well said to you so far and not really no other medication has worked for me so I'm willing to try something new we will use what is called a randomized double-blind placebo-controlled study let me explain randomized means that you will be assigned by chance to receive either the drug or placebo but you send any active substance or what you might refer to as a sugar pill now the reason why we use placebos and studies like this is because some people feel better even on a placebo and we want to make sure that compound X produces significantly better results than that when we say a double-blind study we mean a study in which neither you nor the research staff know whether you're getting compound X or the placebo I don't decide what you get it's like it's kind of like flipping a coin the reason for the research staff to be blind is to make sure our feelings and ideas about the compound X don't influence the results of it it's important that you understand that during the main part of the study if you're randomized to receive placebo you will not be receiving any active medication for your depression well anybody know if I'm getting the real drug or the placebo well yes the pharmacists will know and if for some reason you develop any serious side effects we can call the pharmacy to find out what you are taking and then we can make decisions from there as to how to proceed okay compound X is manufactured by the ABC drug company they'll supply the medication and will provide them data on the outcome of the study and no participants names will be given with the data at all now the researchers here at NIH are not affiliated with the company and will not receive any payment as a result of their collaboration we at NIH are responsible for their analysis of the data only okay I'm glad no drugs are being tested now I'm going to review some of the qualifications for you to be involved in this study you must be between the ages of 18 and 65 and you must have been diagnosed with chronic or major recurrence symptoms of depression and the severity of your depression symptoms must meet the study criteria you must be willing to fill out rating forms to determine this also you must be willing to abstain from alcohol for the duration of the study and you cannot participate if you have serious medical illness such as diabetes or hypertension our physical exam will help us rule out those conditions also if you become pregnant or breastfeeding or you're taking certain medications that might interact with the study medications you cannot participate also now we're going to review all of your medications and you will also be ineligible if you have a history of drug and or alcohol abuse I understand my only question is about multivitamins and st. John's wort your staff member told me I had to stop taking the Saint John's wort which I did but can I continue taking multivitamins well you are correct about the st. John's wort it might interfere with your response to the study medication but you can't continue to take the mug together this is a 10-week outpatient study in the first two weeks of the study we're going to perform some medical and psychological screening tests to determine whether you meet the qualifications that we just discussed if you are eligible we'll gradually take you off your current medications over a two-week period and then the next phase of the study will then last eight weeks during which time you'll either be on compound X or the placebo at the end of the 10-week study we're going to have a conversation with you about what happens next which may include time limited standard clinical treatment as you transition your care back to the community what happens if my depression gets really bad during the study well this is a double-blind study and only the pharmacists will know which pill you are receiving and since we won't know if you're taking the placebo or the experimental medication you'll be monitored very closely mm-hmm and there are a number of things we can do if your depression becomes worse we need to know how you're doing so that we can discuss this with you if you become so depressed that you have thoughts of self-harm let me know immediately we would then have the option of admitting you to the patient care unit as an inpatient or another option would be for us to stop the study and then just provide the standard clinical care that you need okay how many visits will I have to make to this clinic well you need to visit the clinic once each week for the duration of the study is a total of about ten visits the first part of the study is a screening phase and we'll take two visits and we'll perform a battery of tests including blood and urine tests EKGs a physical exam and a chest x-ray this will ensure that you are in good physical health and that's important and we'll also do HIV and drug testing and you will be informed of these results now certain conditions can exclude you from the study if we find a medical problem we can discuss it with you and then make appropriate referrals for medical care in the community okay once we follow up with the medical test we're going to proceed with interviews with you and mood rating scales these scales are to assess your symptoms of depression and anxiety now we're going to use the same scales every week during the study the neuropsychological testing is a way of determining how you think and remember things and usually involves either computer or paper-based testing do you have any questions about the procedures that I mentioned so far yes can you tell me how much of my blood will be drawn Oh certainly so we're going to be taking probably about two tablespoons during the screening visits we may also ask if you're interested in participating in other related studies such as an MRI which is a scan of your brain using a powerful magnet prior to participating in other research studies you'll have another discussion with your doctor and if you agree to participate then you'll be asked to sign a separate consent form for that study you mentioned an MRI I have claustrophobia and I get very anxious in enclosed spaces would that be a problem for me well yes that could be that's the case then brain imaging studies may not be appropriate for you and we would like to save some of your blood to use for future research projects now if you agree please indicate your wishes here on the consent form I might be willing to agree to this but I would like to be recontact at first fine fine just check this box here let's talk about the risk involved in the study before you decide to participate the major risk is the possibility that the symptoms of your depression may worsen if they do worsen to a degree that you or the clinical research staff thinks that is not in your best interest to continue the study the study actually will be stopped at that time we're going to talk with you how about how best to provide you with time limited clinical treatment there is also a possibility of experiencing side effects and the most common side effects of compound X include dizziness restlessness tiredness nausea and headache which are generally temporary and go away on their own but should you experience any side effects that don't go away just call us immediately at the number provided here on the consent form and that's staffed 24 hours every day okay because you're going to have blood work done as a part of the study you will need to know the possible effects of blood draws they may consist of bruising numbness or infection in the area where the blood was drawn if you develop these symptoms they will be treated if needed other possible side effects of blood draws are lightheadedness and dizziness I have become faint in the past when my blood was drawn well I'll note that and we'll make sure that you're lying down when we draw your blood you can withdraw from the study at any time and for any reason now I may also end your participation in the study if I feel that the study has become too difficult for you or if the symptoms have become too severe okay okay there are no direct medical benefits to you from participating in this study and we hope this research will help others with depression in the future if compound X works for me can I continue to use it after the study is over compound X is an investigational drug it's not approved by the FDA and is therefore not available in the community we will provide you with standard medication for your depression for ten weeks after the study is over and if you wish we can consult with your community physician to provide him or her with our recommendations for continued treatment that would be good I know I do not want to go back on any of the other drugs I've tried you will be informed of the results of your medical and lab tests and if any unanticipated risks become apparent during the course of the study that might affect your willingness to continue to participate then we're going to discuss those with you what do you mean well for example if the study medication causes you or any other participant to experience potentially dangerous changes in blood pressure I wouldn't do not expect us to happen I just use it as an example there I think it's important that you understand that there are alternatives to participating in this particular research effective treatments for depression are available in the community such as antidepressants and talk therapy I understand I've tried some of those treatments already and none of them have worked for me hmmm well why are you participating in research here however you will have a medical record and a research record both will be kept confidential we cannot release medical records without your permission however because we are a federal facility there are several agencies such as Congress and the FDA that may have access to your medical records under certain unusual circumstances such as a review of the protocol itself that we use and we would also have to break confidentiality in order to provide clinical treatment if you were to become suicidal or a dangerous to others we will provide short-term treatment for any injury you incur while participating in the study we do not provide long-term treatment for research related injuries you have the right to seek legal acts should you feel a long-term injury has resulted from your participation in research I think now you should also know that there is no compensation or payment for your participation you understand that okay here is my telephone number it's 301 nine nine nine eight eight eight eight if you need to reach me urgently you may contact the NIH page operator at 3:01 four nine six one two one two NIH also provides you access to a patient care representative this is an individual who is employed by the clinical center to address any concerns or complaints that subjects or their family members may have during your study participation her telephone number is here on the consent form this is the line for your signature now we would like for you to sign and date it but before you sign and date it do you have any questions I don't think so you've touched on all my concerns okay great design that and David if you may okay fantastic this is mrs. hunt she's going to sign the consent form as a witness okay thank you Miss I appreciate that now would you be interested in being contacted regarding future studies I'm not sure at this time but I'll certainly think about it great correct well thank you and now remember that your signature on this is not a binding contract it just indicates that you have agreed to participate and once again you are free to drop out of the study at any time feel free to ask questions of me or my staff throughout your participation in the study now this is a signed copy of the consent for you to keep thank you for coming by and participating in the study with us important considerations witness role during the informed consent process it should be emphasized that the witness must observe the subject when she signs the informed consent document this video does not show a copy of the signed consent document being made for the subject it is recommended that the original be placed in the subjects medical record a copy be given to the subject and the investigator retains a copy for the research record storing samples for future research if the subject elects to participate in future research projects involving the collection of samples such as blood for genetics a full discussion of current guidelines regarding the storage and use of samples should be presented you've just seen the essential elements contained in an effective informed consent procedure to sum up there should be an introductory conversation between the researcher and subject that includes a discussion of the voluntary nature of research participation study purpose qualifications to participate design and duration risks discomforts right of withdrawal benefits new findings alternative treatments confidentiality the policy regarding research related injuries compensation and contact information to address any problems or questions the subject might have regarding the study mainly a prospective subject a consent form prior to the actual face-to-face session can facilitate an understanding of the research protocol as illustrated in the video body language tone of voice and maintaining good eye contact contribute to the effectiveness of the consent procedure we realize of course that you have your own personal style and we hope that these suggestions will enhance the manner in which you present your information in conclusion our goal is to safeguard the candidates human subject protections as well as to ensure adequate subject education and preparation prior to entrance into the study it is also important to ensure the studies ongoing ability to meet institutional review board Institute clinical Center and NIH standards of good research we hope this training has been helpful to you and will improve the quality of the informed consent process thank you for watching [Music] you [Music] you [Music] you