{"id":33620,"date":"2023-09-13T05:05:04","date_gmt":"2023-09-13T05:05:04","guid":{"rendered":"https:\/\/www.goodacademic.com\/blog\/questions\/1-complete-the-irb-form-for-tomorrow-2-alternative-therapy-for-depression-to-teach-patients-but-i-do-not-want-to-teach-the-patient-i-would-like-to-teach-the-therapists-nursing-staff-in-order-for\/"},"modified":"2023-09-13T05:05:04","modified_gmt":"2023-09-13T05:05:04","slug":"1-complete-the-irb-form-for-tomorrow-2-alternative-therapy-for-depression-to-teach-patients-but-i-do-not-want-to-teach-the-patient-i-would-like-to-teach-the-therapists-nursing-staff-in-order-for","status":"publish","type":"questions","link":"https:\/\/www.goodacademic.com\/blog\/questions\/1-complete-the-irb-form-for-tomorrow-2-alternative-therapy-for-depression-to-teach-patients-but-i-do-not-want-to-teach-the-patient-i-would-like-to-teach-the-therapists-nursing-staff-in-order-for\/","title":{"rendered":"1) Complete the IRB form for tomorrow #2 Alternative therapy for depression to teach patients, but I do not want to teach the patient I would like to teach the therapists\/Nursing staff in order for them to teach the patient."},"content":{"rendered":"

Flyer: I love the picture and contact information!  <\/span>I would add some bullets of what grounding
\ntherapy is or what patients will need to do. 
\n<\/span>You can do bullet points.  <\/span><\/span><\/span><\/p>\n

Self
\nConsent form: missing study title<\/span><\/span><\/p>\n

Missing attachments:<\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>All
\nEducation materials and teaching plans<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>All
\nPre and Post-test (if using this)<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>Letter
\nof approval from site (stating that they do not have an IRB at your facility,
\nor IRB approval from your facility if they do require this)<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>Any
\npublished tools that you are using for measurement (copy of tool)<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>Approval
\nto use any published tool that is not of the public domain (this can be an
\nemail from the publisher)<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>Student
\nACRP human subjects certificate<\/span><\/span><\/p>\n

\u00b7        
\n<\/span><\/span><\/span>Chair\/Professor\u2019s
\nACRP\/CITI human subjects certificate (I will send)<\/span><\/span><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

IRB Application:<\/span><\/p>\n

 <\/span><\/p>\n

Pg 1 <\/span><\/p>\n

 <\/span><\/p>\n

Missing project title.  <\/span>Remove your E-mail<\/span><\/p>\n

 <\/span><\/p>\n

Pg 2<\/span><\/p>\n

 <\/span><\/p>\n

Add my information as
\nco-investigator-1<\/span><\/p>\n

 <\/span><\/p>\n

Page 3<\/span><\/p>\n

 <\/span><\/p>\n

Check yes<\/span><\/p>\n

 <\/span><\/p>\n

Pg 5<\/span><\/p>\n

 <\/span><\/p>\n

Missing signature<\/span><\/p>\n

 <\/span><\/p>\n

Pg 6<\/span><\/p>\n

 <\/span><\/p>\n

Missing duration of
\nstudy.  <\/span>Give yourself wiggle room- 6
\nmonths<\/span><\/p>\n

 <\/span><\/p>\n

Missing study population<\/span><\/p>\n

Missing number of
\nparticipants<\/span><\/p>\n

 <\/span><\/p>\n

Pg 7<\/span><\/p>\n

 <\/span><\/p>\n

Make font larger in
\nBackground so we can see it<\/span><\/p>\n

Spell out all acronyms the
\nfirst time- example GAD<\/span><\/p>\n

This academic project’s
\ngoals are to advance evidence-based knowledge and offer justification for using
\nalternative therapies to treat GAD in the senior population. There is a need to
\ninvestigate alternative strategies that can supplement or improve the current
\ntechniques, <\/span>even though standard
\npsychotherapy has been extensively researched and proven to be a successful
\ntreatment for many mental health issues (delete this)<\/span><\/b>,<\/span><\/b> including GAD (Lewis et al., 2022). This study seeks to
\ngive empirical data and add to the knowledge of innovative therapies that might
\nbe helpful for elderly people by comparing the effectiveness of daily grounding
\n(earthing) in treating GAD.<\/span><\/p>\n

 <\/span><\/p>\n

This study aims to find
\npotentially helpful and cost-effective techniques for enhancing mental health
\noutcomes in this vulnerable group by contrasting the efficacy of daily
\ngrounding (earthing) to conventional psychotherapy. Daily grounding, also known
\nas “earthing,” is physical contact with the Earth’s surface, such as
\nwhen you walk barefoot on grass or sand. It has been proposed that this
\npractice has physiological benefits for lowering stress and promoting mental
\nwell-being<\/span>.  <\/span>I don\u2019t think you will be able to compare
\nthese two groups.  <\/span>I believe I have made
\nseveral comments regarding this.  <\/span>My
\nconcern is your grounding patients most likely are in therapy and you can\u2019t
\nethically pull them out.  <\/span>You can either
\ncompare to baseline or compare psychotherapy to psychotherapy combined with
\ngrounding.  <\/span>And the psychotherapy
\ntechniques must be identical in this case to prevent extraneous variables.  <\/span><\/span><\/p>\n

 <\/span><\/p>\n

Page 8<\/span><\/p>\n

 <\/span><\/p>\n

Participant Informed
\nConsent: Participants will receive comprehensive information about the study’s
\nobjectives, procedures, potential risks, and benefits. <\/span>How will this take
\nplace?  <\/span>How will you recruit patients?
\nReferral?  <\/span>Flyers only?  <\/span>Phone call?<\/span><\/p>\n

Baseline Assessments:
\nBaseline assessments will include the collection of demographic information,
\nmedical history, and current lifestyle habits using standardized surveys. <\/span>Which surveys will be
\nused?  <\/span>These need to be attached and you
\ncan refer to them as \u201cAppendix A\u201d etc<\/span><\/p>\n

Uniform Group Activities:
\nAll participants will be placed in the same group with consistent activities
\nrelated to nutrition, diet, activity, or a combination of these factors. <\/span>You will group them
\nphysically or in the data?<\/span><\/p>\n

Pre and Post-Intervention
\nTests: <\/span>Physiological
\nmeasurements, including height, weight, waist circumference, and body
\ncomposition, will be systematically documented at predetermined intervals. Are these recorded in the beginning?  <\/span>You need to be very clear what variables you
\nare collecting and have the surveys attached<\/span>.  <\/span><\/span><\/span><\/p>\n

Intervention: The
\nintervention phase will involve either daily grounding therapy or baseline
\nmeasures, depending on the assigned group<\/span>. How are you assigning groups?  <\/span>Are these new patients? Are they already in
\npsychoterhapy?<\/span><\/p>\n

Data Collection: Data
\nwill be collected before and after the 10-week intervention period.<\/span><\/p>\n

Data Analysis:
\nQuantitative data collected through surveys and physiological measurements will
\nbe subjected to statistical analysis using appropriate techniques such as
\nt-tests, ANOVA, and regression analysis.<\/span><\/p>\n

Where is the tool you were
\ngoing to use to measure anxiety?  <\/span>I don\u2019t
\nsee that listed here?<\/span><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

Tasks (pg 8):<\/span><\/p>\n

 <\/span><\/p>\n

Initial Assessment (1-2 hours): Includes a review of
\nmedical history, a physical exam, and anthropometric measures. Conducted in a
\nclinical setting by skilled research professionals<\/span>.  <\/span>How will this be
\nfunded?  <\/span>Will you be doing this?  <\/span>What specific data is collected?  <\/span>Need to reference the surveys  <\/span>Where will this occur?<\/span><\/p>\n

7-day assessment of dietary intake- <\/span>is this needed for your study?  <\/span>This doesn\u2019t seem relevant?<\/span><\/span><\/p>\n

Participants keep a thorough food journal for a week.<\/span> is this needed for your study?  <\/span>This doesn\u2019t seem relevant?<\/span><\/span><\/p>\n

Keep track of all food and drink consumption, serving
\nsizes, and cooking techniques. <\/span>is this needed for
\nyour study?  <\/span>This doesn\u2019t seem relevant?<\/span><\/span><\/p>\n

Evaluations of the Follow-up (30 minutes to 1 hour): To
\ntake place following the intervention period and reflect the first assessment. <\/span>Where will this take place?  <\/span>Who will do this?  <\/span><\/span><\/span><\/p>\n

 <\/span><\/p>\n

The tasks should just list the surveys and expectations
\nof what the subjects will do.  <\/span>The
\ndetails should be further outlined in the methodology section.  <\/span>You seem to be collecting a lot of data that
\nhas nothing to do with your study?  <\/span>Your
\nPICOT in the class have discussed the impact of grounding on anxiety.  <\/span>You can gather demographic measures, but the
\ndata needed is regarding anxiety.  <\/span>Where
\nis your measuring tool you discussed for measuring anxiety?  <\/span>The diet and physiological measures etc are
\nnot needed for this study.  <\/span><\/span><\/p>\n

 <\/span><\/p>\n

Recruitment
\nprocedures (pg 8)<\/span><\/p>\n

 <\/span><\/p>\n

Potential
\nparticipants will be located through a variety of means, such as
\nrecommendations, neighborhood announcements, web advertisements, and outreach
\nto senior organizations– you will need to attach all
\nadvertisements and outreach scripts. 
\n<\/span>This needs to be described in detail in the methodology.  <\/span>Are these facilities associated with the
\nresearch site?<\/span><\/span><\/p>\n

 <\/span><\/p>\n

The
\nfull study disclosure and permission forms will be delivered to eligible
\nparticipants electronically or by mail, with the option of in-person sessions
\nfor those who prefer them. In person consent or
\ngrounding teaching?<\/span>  <\/span>Strict
\nprivacy safeguards will be put in place, including participant anonymity and
\ndata security.<\/span><\/p>\n

 <\/span><\/p>\n

You are not using deception- so no debriefing is
\nnecessary<\/span><\/p>\n

 <\/span><\/p>\n

Page
\n9<\/span><\/p>\n

 <\/span><\/p>\n

You checked yes and no on photographs but did not check
\nanything under video tapes?<\/span><\/p>\n

 <\/span><\/p>\n

You must collect identifiers in order to compare the pre
\nand post of your anxiety screening tool. Unless you expect the subjects to
\ncorrectly remember their number?  <\/span>You
\nwill need a coding system and have this locked behind TWO locks ie password
\nprotected computer and locked drawer etc 
\n<\/span><\/span><\/p>\n

 <\/span><\/p>\n

Page
\n11<\/span><\/p>\n

 <\/span><\/p>\n

It
\nis advised to apply password security methods for your files and save them on a
\nsecure computer or make use of cloud storage services that offer encryption
\nfeatures in order to ensure the integrity of the data.<\/span><\/p>\n

Create
\nand use surveys or questionnaires to collect primary information from people.
\nPaper-based forms must be stored in a designated, secure location with access
\nlimited to those who have been given permission in order to ensure their
\nsecurity.<\/span><\/p>\n

I would specifically write what you are going to do.  <\/span>Shouldn\u2019t be general<\/span><\/p>\n

 <\/p>\n

Page 12 Risks and benefits<\/p>\n

You need to check over 65 <\/span><\/p>\n

Page 13<\/p>\n

1. To ensure their informed consent, all participants will get change to
\nreceive<\/span><\/b> <\/span>thorough information about
\nthe research’s objectives, procedures, potential risks, and benefits prior to
\nparticipating in the study. Participants will be given enough time to ask
\nquestions and give written consent, but only if they fully understand and voluntarily
\nagree to participate.  <\/span>How will you determine if someone is capable of informed
\nconsent?  <\/span>Any concerns with this?<\/span><\/p>\n

2. Ethical Approval: An institutional review board (IRB)
\nwill thoroughly assess the study project’s ethical considerations. To protect
\nthe welfare and rights of the study subjects, the Institutional Review Board
\n(IRB) is in charge of ensuring that the research is conducted in compliance
\nwith ethical standards.<\/p>\n

3. Maintenance of Confidentiality and Anonymity: The study
\nwill guarantee the highest level of subject data during its duration. The
\nremoval or anonymization of identifying information will be conducted, and the
\naccess to personal data will be restricted solely to approved researchers. Change to the primary
\ninvestigator<\/span><\/b><\/p>\n

 <\/span><\/b><\/p>\n

Page 14<\/p>\n

Participants will be given enough time to ask questions and
\ngive written consent, but only if they fully understand<\/u> and voluntarily
\nagree to participate.  <\/span>How do you determine if they fully understand? <\/span><\/p>\n

 <\/span><\/b><\/p>\n

Benefits for society- section needs
\nediting and clarification of the comparison. 
\n<\/span>I would delete \u201cDespite minor concerns like discomfort or inconvenience,
\nthe advantages of better mental health for society outweigh them\u201d  <\/span>You should not be causing discomfort for the
\nsubjects?<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Flyer: I love the picture and contact information!  I would add some bullets of what grounding therapy is or what patients will need to do.  You can do bullet points.  Self Consent form: missing study title Missing attachments: \u00b7         All Education materials and teaching plans \u00b7         All Pre and Post-test (if using this) \u00b7         Letter […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":[],"disciplines":[190],"paper_types":[],"tagged":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions\/33620"}],"collection":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions"}],"about":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/types\/questions"}],"author":[{"embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/comments?post=33620"}],"version-history":[{"count":0,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions\/33620\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/media?parent=33620"}],"wp:term":[{"taxonomy":"disciplines","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/disciplines?post=33620"},{"taxonomy":"paper_types","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/paper_types?post=33620"},{"taxonomy":"tagged","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/tagged?post=33620"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}