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Can IRB approve a research proposal to collect blood and saliva of hospitalized small children before successfully developing the assay? I would like to seek your opinion on a case that our IRB is reviewing. The researcher aims to “develop and validate a novel 24-plex quantitative assay” to measure antibody production against pneumococcal vaccines; In the proposed research, the researcher plans “after establishing the assays, we will compare the quantity and quality of antibody against the pneumococcal conjugate vaccine in saliva and serum from vaccinated children who are hospitalized”. We think that the research proposal has 2 phases including development of a new testing kit and validation of the kit on clinical samples. The first phase might not be successful, thus, it is inappropriate to collect the human samples, especially from small hospitalized children.
We are considering two options for making the decision as follows: (1) We will request that the researcher should only apply the first phase for IRB approval this time, then he can continue to apply for an IRB implementation after finishing the first phase. However, the researcher argues that it takes more time to get IRB approval because he cannot apply it now. He states that he will only collect blood and saliva after finishing the development of the testing kit. Or
(2) We will approve the proposal with a condition that the researcher can only collect blood and saliva samples after providing evidence of a successful method development. However, our IRB committee is not familiar with this process and does not want to monitor his reseach.
In addition, the researcher should explain the reason for recruiting hospitalized small children instead of health vaccinated children or outpatient children.
We greatly appreciate it if you could give us your suggestion.
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Good. IRB can approve proposal at initial stage. They can not give full permissions to perform research involving samples like saliva and blood. This done by national level or authorized institution.
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I am reaching out on behalf of my cohort at Alliant International University, at the Fresno campus. We are PhD students in Clinical Psychology conducting research and being supervised by our program director Dr. Debra A. Bekerian. Our cohort is conducting a preliminary study to find out how often health professionals assess race related stress during intakes for clients of color. As race related stress is such a significant issue in our society, we would like to research how often health care providers assess stress levels related to one’s race and if yes what assessments they implement. To do this, we will be conducting pilot projects to investigate the use of race related stress indices within three populations: Mental Health Providers (pilot 1), Health Providers (pilot 2), and Patients (pilot 3). We are inquiring as to whether any research related to this topic has been conducted by APA and if so whether we can have access. Of course, the research group will share any findings with APA or any other institution that have similar interest we do, and we will be happy to provide you with information on our methodology if you wish.
Update currently: The IRB is in the works and the surveys and inform consent are complete If you guys could help us to post our project out
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There are alot of scales that measure Stress... but as of yet have not seen one that focuses on stress related to racial concerns.... We have just developed a scale - Workplace Inclusion Scale which is now validated.... Peer Review article on the World at Work Website.... and attached is a Trade Journal article about this scale... please let us know if this would be helpful to your research....
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As I had to collect smartphone data from users, I have to take IRB ethics clearance. But still, confused about what to do specifically to apply for the same? Is there any content or format in which we have to apply? Can anyone help me?
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Any answer to that question would necessarily involve asking what field you're doing research in and whether the IRB is located in hospital, university or elsewhere.
Data Collection has its specifics drawn out in the methods used for research, the type of research and the length of time until theoretical saturation, if that's the goal (as it usually is). Data retention follows in terms of peculiarity, especially when recordings are transcribed and kept, not destroyed. Happy to help, with a Canadian lens, which utilizes a document called the Tri-Council Policy Statement by the three largest government funders of research in Canada, you can google it TCPS 2018.
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I am an independent self-funded toxicologist not affiliated with an institution and according to the US DHHS' Office of Human Research Protection, I don't need IRB approval to conduct human studies, because I am self-funded. However, I am having trouble finding journals that will publish my work without IRB approval. Do you know of any journals that don't require IRB approval for human studies?
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There is no specific journal that doesn't require IRB approval
Actually it depends on the nature of research which demands IRB approval, simple observations do not need IRB approval
Which interventional studies can not be done with out prior IRB approval
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I have a questionnaire and a few interview questions for providers that relate to prediabetes am trying to reach or partner with health providers in Florida in order to complete I am also a dietitian but this is for public health coursework would be able to complete remotely and school has IRB
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You may start blogging for specific topic,it will help you to connect with people. It may also increase the chances of learning various experiences of different group of persons all over the 🌎. I hope it will help you .
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Forgive me if this seems like a silly question, but if I am publishing a narrative review, and not collecting any data of my own, do I need IRB approval?
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no - there was no direct use of human subjects and if it is a narrative then the studies referenced showed already be in the public domain
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My project is:
Effect of Aromatherapy and Music Therapy on Alzheimer’s Disease Caregiver Perceived Stress & Salivary cortisol levels.
So I will be collecting saliva samples and conducting an experiment.
Thank you
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I aggree: You will need a full review IRB (depending on your state, however) and you will have to point out the clinical relevance of your research since you a most likely include patients who are not (fully) able to give informed consent.
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I am currently doing "in the field" research. I am interviewing people at specific locations, all of which I need to de-identify for IRB. My issue is that I am also doing a follow-up interview to compare and contrast their answers and not sure of a method to de-identify yet also know who is who for the follow-up interview and furthermore, how to go about it to write my study. I am interested in finding a book or an in-depth article with different methods to figure what method I like best.
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The suggestions of Mary Wilson are excellent, but be aware that there are several diverse "IRB" systems worldwide. The most common is to address the research proposal to the ethical committee of your university or research institute. If this body does not exist, you need a formal clear research authorization from your supervisor plus institutions, communities, or individuals involved. The "de-identication" is a process to keep anonymous the informants during the research publication process be it a report, a Ph.D. dissertation, or an academic paper. The researcher must know the informants with very rare exceptions as, for example, investigations in jails, hospitals, or religious communities living in a strict cloister. Thus, you are allowed to create a system that is yours and the most comfortable for organizing properly your data and its analysis. Normally, I advise students to use Atlas.ti or equivalent since this software allows for the analysis of huge amounts of texts and images if you are also observing settings, informants' clothes, gests, and this type of data. Mary Wilson experience is simple as long as you are able to manage it in the process of writing your report or dissertation and readers have a clear understanding of the information sources.
Returning to your concrete question, you can consult the following books:
- DARLINGTON, Yvonne & SCOTT, Dorothy. Qualitative research in practice
Stories from the field. Crows Nest: Allen & Unwin, 2002.
- LIAMPUTTONG, Pranee. Researching the Vulnerable. A Guide to Sensitive Research Methods. London: SAGE, 2007.
- IPHOFEN, Ron & TOLICH, Martin (eds.). The SAGE Handbook of Qualitative Research Ethics. London: SAGE, 2018, especially pp. 133-147.
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As per my knowledge, it is mandatory to have an ethical clearance from an authority, especially from the institutions a researcher works, to perform research.
But, for some reason, my IRB has a slow rate doing the necessary things in time.
How the delay could be managed?
Can I have an ethical clearance from any other institution in this case? If yes, then how? If no, then why?
Thanks in advance
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There are several diverse "IRB" systems, some institutional, others informal. Normally, universities must have an ethical committee that addresses, surveys, and authorizes research with "human subjects" taking into account the most diverse cautions, protections, and implications. I suggest you try to find in your university or research institution this kind of body. If it doesn't exist, ask your supervisors for a research authorization explaining the investigation methods and goals. Use it with the institutions or communities being researched. Publish or refer in a proper note this authorization in the presentation of your research be it a simple report, a Ph.D. dissertation, or an academic paper.
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Ok ,so here is another question about qualitative studies. In my dissertation IRB I included the following:
  1. Video recordings of mentor/intern meetings
  2. Virtual focus group meetings with mentors and interns
  3. Individual interviews after focus group meetings as necessary to address unanswered questions from above related to my research questions.
  4. Reflections from interns over the course of the study with specific prompts
My question is, if the interns and mentors do not want to do all the items listed above, is it okay to allow them to only participate in focus groups. If they don't want to do focus groups with other mentors/interns would it be okay to just have interviews with mentor/interns that work together (in pairs). I think some of the mentors are hesitant to participate with others (not sure why exactly other than possibly the comfort level). Do you think this strays too far even if it can help answer my research questions? Should I turn in an amended IRB? I know I will have to rewrite parts of my chapter 3 but I have heard/understand things like this happen in qualitative studies and sometimes you get a completely different set of data than you originally planned for because of what you learn/gain throughout the study. I love the idea of qualitative studies and learning from participants, but I struggle because sometimes I think too much in black/white pictures. I am a "rule follower" of sorts.
Thanks everyone!
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I just had to amend my report. My data collection method changed from face to face interviews to online self-report surveys due to covid. It doesn't take long to complete the amendment form and it's better to safeguard your research and marks by completing one. Oh and don't forget to reflect on the changes in your method section (^◡^ )
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Going through dissertations, I came across one which referenced the IRB approval when researching secondary public data. My university only has an IRB process for research involving human subjects (such as in a clinical setting). It does not have anything for dealing with non-human sources. What should I do under these circumstances?
Thank you in advance for your time and response.
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If you are sure that there is no applicable EU or national or institutional ethics guidance requiring ethics review of secondary analysis of data already available (published) in the public domain, you should assume that such secondary analysis is exempt from further ethics review and state this in your work. All data sources must be fully referenced.
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I think most businesses have changed their menus around, relocated products in the store, and in other ways changed aspects of the experience, specifically to see how customers would respond so that they could improve their operations.
Facebook got in a lot of hot water for changing its algorithm around to see how its users would react. Now, the users aren't exactly customers, as they're not paying for anything and are volunteering to use the service. But that just means that if FB is going to get into hot water for such studies, other businesses that are analyzing their customers' behavior might get into hot water too.
But there's really no standard or discussion, that I know of (and maybe I'm quite wrong here, which would be fine) as to when IRB approval would be necessary for businesses to change their way of doing business to test customer activity. Should there be, and what should that protocol be?
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Abraham Graber I was on my school's IRB. IRB approval is not only for experimentation. It is for any kind of data collection from human subjects, including qualitative methods. However.....
A school can survey students, survey faculty, survey alumni, etc., without going through IRB. It can analyze enrollment trends based on data collected from students without going through IRB. Admissions can collect and make use of data on prospective students. Foundations collect a lot of data directly from prospects, particularly for major gifts fundraising.
I would be interested to know of any institutions where these undertakings require IRB approval.
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I had a mixed methods research study investigating the literacy content knowledge, orientation literary instruction, and literacy efficacy beliefs of student teachers that was in progress when COVID mandated school closures. As such, they did not have a typical length of time of this experience. The post-interview data did not yield a tremendous difference of data from the pre-interview. I had planned an explanatory sequential design. I still conducted the interviews at the predetermined times and included added questions on the impact of COVID. However, I am wondering if I should make an adjustment to how I had planned to write this up. Does anyone have any advice or experience in how to handle this? Do I need to work with the IRB?
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Interested
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Dear Colleagues,
Have a good day; I'm planning to conduct a multi-country study on "Stigma Towards Health Care Providers Taking Care of COVID-19 Patients".
for more information, please find the project link on RG
The IRB approval has been secured from the University of Bagdad. The survey is available in both English & Arabic versions.
The research team is planning to include the following EMRO countries:
Countries in the WHO Eastern Mediterranean Region
  • Afghanistan
  • Bahrain
  • Djibouti
  • Egypt
  • Iran (Islamic Republic of)
  • Jordan
  • Kuwait
  • Lebanon
  • Libya
  • Morocco
  • Oman
  • Pakistan
  • Saudi Arabia
  • Somalia
  • Sudan
  • Syrian Arab Republic
  • Tunisia
  • United Arab Emirates
  • Yemen
If you're interested in joining, please send me the following info to nursing861@gmail.com
Name:
Affiliation:
Country: 
No. of Physicians:
No. of Nurses:
No. of Pharmacists and other HCPs:
Need for IRB approval/exemption:
Best regards
Abdulqadir Nashwan
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It's my pleasure to collaborate in this project....
Fatma, Nursing Department, Oman
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Is IRB Approval necessary for writing a research paper on marketing based on quantitative research?
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Dear Minisha
better to have the approval before submission.
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I want to conduct some analysis on public datasets for COVID19 in my country, do I need an IRB / Ethical committee approval? This includes publishing this data on a journal.
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I think yes, you need it.
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I am interested in understanding more about NGOs that work with refugees. I am brainstorming a project that does not involve IRB approval.
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Hello Mary,
In general, using publicly available data is exempt from requiring IRB oversight. However, some IRBs, as Daniel Wright 's response correctly notes, may wish to rule on whether a study is exempt from IRB oversight. Others may be content to let the researcher assume the risk if the project adheres to excepted categories that they (the local IRB) have published or adopted.
Once you get some ideas, it wouldn't hurt to contact your university IRB officer to confirm that your proposed research endeavors would, in fact, be exempt.
Good luck with your work.
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I am conducting dissertation research that will involve the entirety of a population (i.e., all 23 Ohio community colleges). As I will be administering a 7 question survey to business faculty at each institution, I should need to complete IRBs for each school in order to be allowed to contact the faculty.
There is a likely benefit to my survey to the institutions who take part (e.g., learning whether a particular initiative results in better results on the characteristics that comprise the state's performance-based funding formula) and essentially no risks involved to the participants. I've gone through NIH Protecting Human Research Participants training, have submitted and been approved by host institution's IRB, and have made steady progress at most of the schools where I will be administering my survey.
However, one institution's department of institutional research "declined to participate". While I had anticipated some possible reluctance by some faculty who might actually be inconvenienced by the survey, I was not anticipating being "denied entry" by the IRB portion of the process (there was no reason given and no option for me to submit additional documentation to support my application to the IRB). I completely respect anyone's choice to not participate in the project, but I thought that the role of the IRB was to ensure the study protected the participants, not to gatekeep based on behalf of the institution about the overall nature of the research.
Has anyone ever encountered this or anything similar? My default response is to "just move on", but this whole situation somehow just doesn't feel right. I was advised by my dissertation chair to follow-up with the rejecting school and inquire as to their rationale for declining to participate (if nothing else, to add some additional insight in terms of the discussion areas of my dissertation). It goes against my nature to question a rejection because I don't want to be "that" person, so I would definitely welcome some input here.
Thank you in advance!
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This is your research. If you were rejected, why wouldn't you be willing to ask? I have heard of IRB rejecting studies from people who want to do research on animals when their university does not have the authority to accept such research. You won't know unless you ask. It might be something you can fix. If it can't be fixed and you can conduct the research without them then leave them out and write that up as a limitation.
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I'm interested in running statistics on compiled patient data that has been previously published in case reports on PubMed and other research hubs. Do I need patient consent or IRB approval to use this data, or is it free to use for publication (with citations) similar to a meta analysis, since it has already been published?
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Just to add that in most cases, you will not need patient re-consent for such use of existing data (that should be free of identifiable patient data) but that call can only be made by an IRB not yourself. You will definitely need to get in contact with an IRB in order to get things down to earth. Follow Alexander Serenko advice.
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Comprehensive knowledge of bacteria that can induce corrosion.
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Dear Okoh,
The less stable corrosion scales tended to be more stable with sulfate increase, which was evidenced by the gradually decreased iron release and the increased stable iron oxides. Bacterial community analysis indicated that when switching to high sulfate water, iron reducing bacteria (IRB) maintained dominant for pipes with stable corrosion scales, while significant increase of sulfur oxidizing bacteria (SOB), sulfate reducing bacteria (SRB) and iron oxidizing bacteria (IOB) was observed for pipes with less stable corrosion scales.
The pipes historically transporting treated surface water can be more stable corrosion scales and only slight increase of iron release occurred when changing to water with multiply higher sulfate; while the pipes historically transporting treated groundwater or blends can be more severe iron release when feed water sulfate concentration increased.
Hope this is helpful for you.
Ashish
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To all researchers,
Upon submitting the IRB along with my advisor, I am meticulously cautious as to the overall quality of each attached material except for the Recruitment Flyer, in which the Flyer itself is not visually representative as I intended. For instance, the flyer attachment shows bullet points as unclear to the Board and the title of the Research flyer not shown. Should I be concerned that the Board will outright reject my proposal because of this mistake given this is my first revision after initially sending it along with the faculty advisor? Thank you.
Best,
Gabriel Sanchez
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Dear Gabriel Sanchez as long as you make the changes that will satisfy IRB reviewers which aim that the information in the flyer is clear enough and complete for potential participants, and do not see a reason for rejection of your proposal. Good luck.
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Hey Ya'll,
I am wanting to test salivary cortisol levels in my participants. its a lab value and I do not know if we need to answer validity and reliability questions?
I could not find articles that discussed it? what is your input considering its a scientific procedure not really a scale? If I do need it, do you have any useful resource for me?
Would I need IRB approval for a study that requires salivary sample?
thank you
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Katherine Henson you should ask the lab what testing kit they use, they should have the validity and reliability on hand. If not, you can check on the website. They can probably tell you what swab or passive drool materials they prefer to work with as well.
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Greetings,
Hope this message finds you well. I am working on designing a survey questionnaires that can effectively discover a local military community's needs, so that a nonprofit organization can best meet those needs in the ares of:
1. Work/life balance problems
2. Household management problems
3. Financial problems
4. Legal problems
5. Health care system problems
6. Relationship problems
7. Child well-being problems
8. Problems with own well-being
9. Problems with spouse’s/partner’s well-being
Would you happen to know an IRB approved survey instrument that I could use, or any suggestions on the best survey questions to ask in those areas?
How many questions are appropriate in each category to discover the true problems and the magnitude of the problems?
This will help the NPO to redefine their strategic planning and effectively utilize their limited resources to serve those needs.
Thank you so much for your help!
Lijuan Stahl
(613) 884 0125
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Look at the different questionnaires we have used and you may find them applicable. Also attitudes towards the community could easily be measured:
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dose meta analysis research require IRB confirmation?
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No, as there is no intervention with humans.
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THANKS TO EVERYONE WHO PARTICIPATED. THE SURVEY IS NOW CLOSED.
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Stephen, thanks for bringing that to my attention! Link is working now.
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I am interested in looking into the neuroethics of people who have suffered from severe and sustained trauma and/or neglect and getting them to consent to invasive neurological procedures. With a population where people have frequently adopted instant submission to authority as a survival mechanism, is consent possible? How do we make sure that any sort of procedure isn't somehow retraumatizing? How do we make sure that these people feel comfortable declining to do certain things or voicing their needs, if they have learned that it is dangerous to do so? Do we need to take a different approach or special considerations with trauma subjects than we do with other sorts of subjects? what would those considerations be? Do you personally feel that IRB boards, in general, have enough trauma literacy to understand the risks?
*This question is in reference to people who have NOT yet undergone trauma therapy. *
I'm happy to get anything from opinions, to references, to videos, and literature, any and everything... pertaining to this subject!
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We’re working on a retrospective cohort study using patients records. The biostatisticians calculated the sample size for us, which was 301 With 95% CI. The proposal was submitted and the IRB approval was granted. But, we found that we can collect more data than our calculated sample size ( we can get around 400-500 samples).
- Is it possible to do so? Is it recommended? and what would be the benefits?
- Do we have to go over the proposal or the sample calculation again if we increased our data?
- Does it increase the power of the study?
your kind recommendations are highly appreciated.
Thank you
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Dear Khalid,
If I understand correctly, you are doing retrospective study, therefore performing exploratory analyses. In this case, more patients you include, stronger would be your conclusion and I see no problem with including more patients. The power of your findings will increase (more likely that they would get statistically significant) and you will be able to obtain better conclusions about different subgroups of patients. I do not see the problem with regulatory IRB approval in this context, the concept of the study remains the same, if it was valid for the first time, it remains valid and ethical even after inclusion of additional patients.
Kind regards, Marko
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I am working on a doctoral dissertation, entitled, “Investigating the effect of Universal Design framework to design a pre-college-level math course.” My research will be overseen by my faculty mentor and the School of Education doctoral committee at Capella University.
I will use a quasi-experimental, quantitative research design with non-probability purposive sampling techniques to examine whether there a statistically significant difference in the mean gain scores between students taking a pre-college-level math course designed using a UDL framework and students taking a pre-college-level math course that is not designed using the UDL framework. To conduct my research, I will need to compare two classes with the only difference between the classes being that one will be treated by implementing the UDL framework in the design, while the other one will not be treated at all. Both courses will be otherwise identical in course objectives (i.e., learning outcomes, learning material, and one instructor teaching both the experimental and the control groups).
I am requesting permission to conduct my dissertation research at a community college that teaches a pre-college level math with one teacher who delivers the same course twice in the same section. By pre-college level I mean a course that students need to take because they are not eligible to take college-level math yet based on their college placement exam. Specifically, I am requesting permission to engage in the following research activities:
· Implement the UDL guidelines and touchpoints into the course design (please see Guidelines document attached). This will form the experimental group. All modifications made to the course will be recorded and collected for data analysis.
· The redesigned course will be presented to a UDL expert for review and approval, then presented to the faculty and Dean at the research site to ensure that the course meets the College design standards.
· Once the course is approved, it needs to be delivered by a faculty member so that I can collect the data (pre- and post- tests grade information with NO personal identifiers to protect student information).
· Interested participants will fill out required consent forms, per IRB standards.
· All post-test scores will be collected from each course and analyzed using a two-tailed t-test with SPSS statistical software.
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That is the plan. Thanks again.
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Has anyone used PsychData for their online surveys in the field of psychology? I was interested in using them because they are specifically tailored for the needs of research in this field but not many people seem to have heard of them - despite the long list of uni that subscribe. If anyone could provide an opinion, it would be appreciated.
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I haven't used PsychData in years. They advertise that they live up to the highest human subjects ethical standards. I had no problems when I used their services but it was years ago. I also had no problems with Google Sheets and Qualtrics.
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If you have pediatric experience and looking for research collaborations, all done with ethical standards / IRB approval, you can post here and let us hope we can form a pediatric research core on RG.
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Welcome dr Hani.Temsah
What type of collaborative research you are looking for?
I have an important research about depression in secondary school students.
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Hi, colleagues,
I am working on my master's proposal on specific reading comprehension skills in an English class in a bilingual school in Puerto Rico, and I have been searching for a pre-existing validated pre-test/post-test on determining main idea and making inferences to present to IRB. This step would truly help a lot to further the study.
If anyone has knowledge of this, or has one and is willing to share it, I would be so incredibly grateful and, of course, I would give credit to the author, if I am able to use it.
Thank you in advance.
Lourdes Nieves
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Lourdes,
Best of luck with your research.
Please get back to me if you do not get what you need and I will contact my friends here.
Lee Anne
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This question is regarding researchers who are interested in conducting research after grad school but are not affiliated with an organization or university.
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Dear Jade. Thank you for your question. IRB approval is required in research that will involve humans or animals. The aim in such situations is to ensure that the study protocol is consistent with the ethical and human code, and no harm will be imposed. Also, to ensure that the method and the design of the research are consistent with the research questions and can be achieved. Also, issues about confidentiality, consent of participants, storage of data, freedom of participants to withdraw, explanation of the project to participants, and that there are no conflicts of interest are all well addressed as per the research institutes and universities code. The IRB approval also indicates, even indirectly, that there are facilities to conduct such methods in the institute, and there is a peer-review process has been carried out by the IRB committee for the research application. Thus, IRB approval aim at protecting the participants, protecting the community, ensuring that the research is doing no harm and useful, and at the same time protecting the rights of the researchers.
Moreover, the IRB is a requirement by most journals for publishing your research. So if the authors fail to present the IRB approval body name, date and number, most likely, the study will not be published. However, some research does not need IRB approval, for example, assessing the quality and accuracy of online videos do not cause any harm to anyone and the videos are a public domain. However, not every research on social media does not need ethical approval. This is an exciting and growing area, and we are currently identifying areas of research in social media that should receive ethical approval. I hope this answers your question and is helpful to you.
Best regards, Prof S. Azer
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Ashely Madison was a website used for establishing extramarital affairs, it suffered a major data breach in July 2015 (https://en.wikipedia.org/wiki/Ashley_Madison_data_breach). User data could later be found on the internet. Imagine you are an evolutionary psychologist interested in extramarital relationships, you would like to know their usual duration, simultaneity, count etc. Would you use such data in your research (provided the data can answer your questions)? Would your IRB approve of the use of such data? What reason for and against do you see?
Thank you for your opinions!
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Why not, with appropriate reference? Internet is part of our life, and it is possible use internet source of the information as other one, according same rules.
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I have a proposal for a research project and I am looking for a hospital or surgical center where I can submit the IRB.
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There is a research group in Coeur d'alene Idaho called
Institute for Orthopedic Research and Innovation. They work with multiple ortho docs. They may be willing to work with you.
Good luck!!!
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I have a dataset which basically collected and belong to an approved research project, this dataset can produce many papers/ publications; do I need a new IRB approval for any new possible publication using same dataset even this dataset were collected for a different purpose?
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Always look to your own IRB for these questions. Your IRB has the authority to answer your questions.
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Hi everyone,
I am conducting a systematic review/meta-analysis and I plan to ask authors of previously published papers (papers that will be included in the study) for additional/follow-up data of patient outcomes (specifically tumor recurrences after studies were published). I suppose in order to obtain this information (probably through chart review), these researchers may need an IRB from their institution. But what about me? Do I also need an IRB? Moreover, do we also need to do a multisite IRB (SMARTIRB) for this reason?
Thank you in advance!
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Dear Giannis A. Moustafa , although systematic review does not require an IRB, when you deal with secondary data, which in your situation is the case, you must get an IRB to review your protocol. In your case it will be an application for approval in the category of “exemption from full review”; but your IRB will have to make that determination.
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I stumbled upon a research idea that seems significant and might reduce Shaken Baby incidences. Currently I am not affiliated with a hospital or university to use their IRB for review.
I'm not sure I need an IRB because I'm comparing the outcome of two activities mothers engage in normally with infants.
What are you thoughts?
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I would call the chief IRB authority in France for their direction. For further discussion, you may want to contact a university-related IRB in France near you and ask for their help and advice.
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Does a cross-sectional survey study where participation was voluntary, and all participants remained anonymous require a IRB review?
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IRB is required before commencing the study
it doesnt mean that u want to publish research summary than only u will go For irb approval
it’s part of an ethics of an Researcher we should adhere to decleration of Helsinki as we are taking personal and private information of study subjects
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I got ethical approval for my research, but while submission, I noticed that editors comments need changing one word to the title into another word. Can I change it while I got ethical approval with old title? Will the journal ever ask for the actual ethical approval document to compare titles?
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As long as that one word does not change the situation
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Does starting a community based questionnaire survey requires IRB clearance?
Does the questionnaire is to be verified/certified or validated?
How to calculate the number of participants for the survey?
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I totally agree with the previous answers. When planning to conduct population survey you need a number of steps:
1. Endorsement of the study itself by some referent body
2. Endorsement and validation of the questionnaire. If you use an already validated questionnaire, then you need only endorsement.
3. Some sort of communication and coordination with key figures in the targeted population to facilitate the survey
4. Definitely you need an estimate of the sample size. For this, you use the formula suggested by Ishag Adam above. It is the simplest formula. From previous studies you need some estimation of P (the proportion of people with a characteristic you study. I do not know what information you gather in your survey but let me assume that one piece of data collected is proportion of smokers among adult males. Lets assume that previous studies put this proportion at .24, The sample size for your study can be calculated as:
Z squared*P(1-P) 1.96 *1.96 *0.24* 0.76
N=---------------------------------= ----------------------------------- = 280 adults at least
e squared 0.05 *0.05
If we assume there is one adult per family, then you need to visit at least 280 families
Note: The sample size will be much bigger of e is smaller, e.g.=0.02 for example N=1750
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I obtained my EdD a year ago. I have a study and a population in mind for a research study that has to do with interviewing parents. How do I go about getting IRB approval?
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Thank you for the responses. I will contact the IRB of Walden University where I received my EdD
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Is the article, Should patients who use illicit drugs be offered a second heart-valve replacement? Does it have IRB approval? Thanks
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I think that you have to go back to the originate IRB and request the approval document of the research. As for the valve replacement, it will be the policy of the patients' institution.
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My goal is to develop effective public and programs for elected officials and practitioners. At the same time, I want to receive credit for my work. I am not connected with an University.
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Thanks for the answers. For my small business development research project, I may stick with secondary research data, since the focus is to create policies and programs that will allow local entrepreneurs to succeed in gentrified communities.
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I'm planning to do a research based on questionnaire/ survey and population are clinical researchers from the whole country. The count of researchers in the country in unknown (I don't know how to get this info). My aim is to publish the results.
1- How to calculate the sample size?
2- Should IRB approve the research?
3- What is the least number of questions they should answer to be included in the stats? or percentage
4- Can I cite the same article(s) in more than on research? The information found in these articles are relevant and I can use for literature.
Thanks in advance.
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You need to identify the hypotheses, power, or beta (usually 0.80), p-value threshold, or alpha (usually 0.05), the statistical method you want to use and hopefully find an approximate effect you want to find (smaller effect needs larger sample). G*power is great and free. Power analysis assumes perfect distributions, so, you can consider increasing the sample size by perhaps 10-20%, to compensate for skewness and outliers in a continuous variable.
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Do quality improvement projects need IRB approval?
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If you mean what I understand to be quality assurance research, it doesn’t require such approval, at least, in Canada. This is research used to improve services (e.g., hospital food or student services in a university). There will be no publications that come out of such research. It is different from hypothesis-driven original research that results in the dissemination of a scholarly product.
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Study: Interviewing HCPs about experiences treating a certain population crossed with interviewing that population about experiences in treatment. 
Confusion: I know I have to go through the IRB at my home university. It is human subjects and aspects of it involve minors. However, the HCPs will be interviewed completely separately from the population. Several of the HCPs work at the same hospital. I would not be identifying or asking about individual patients, nor was I planning to identify the hospital in my research for confidentiality reasons. I know I'm probably going to end up asking through the hospital's research coordinator, but for future reference and just so I get an idea of the answer I might get: do I need to submit a separate IRB to the hospital since I am planning to use their employees?
Thanks in advance! 
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How can a researcher conduct research in his or her hospital without first getting approval from the hospital's IRB? Even for a minimal risk study, the hospital's IRB is the authority who determines whether or not the research study is "minimal risk".
Dennis
Dennis Mazur
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The role of emotional trauma in the development of psychosis has been an emerging theme in both clinical work and in some research. I'm wondering how one could strategize to study the link between these two phenomena in a qualitative context and still be able to design a study that would be acceptable by IRB? 
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Please let me know if these references/sites are helpful to you:
3.  Childhood trauma as a risk factor for psychosis: A sib ...
Official Full-Text Paper (PDF): Childhood trauma as a risk factor for psychosis: A sib-pair study
4.  Risk Factors in Psychosis Secondary to Traumatic Brain ...
This study examined risk factors for developing a psychosis ... Risk Factors in Psychosis Secondary to Traumatic Brain ... Early brain trauma and schizophrenia in ...
5.  Investigating Trauma as a Risk Factor for Psychosis ...
Investigating Trauma as a Risk Factor for Psychosis Robert Freedman. Robert Freedman. 1. Department of Psychiatry, ... This PDF is available to Subscribers Only.
6.  Childhood trauma as a risk factor for psychosis: A sib ...
Childhood trauma as a risk ... to an increased risk of psychosis. • Childhood trauma, ... interest in childhood trauma as a risk factor for psychosis ...
7.  Risk Factors in Psychosis Secondary to Traumatic Brain Injury
Risk Factors in Psychosis Secondary to Traumatic Brain ... as a risk factor for developing a psychosis ... brain trauma? The current study examines risk ...
Dennis
Dennis Mazur
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I am looking for IRB approved protocol approaches on how to handle Incidental Findings (IFs) in EEG research. Starting from Wolf, et al. (2008). Managing incidental findings in human subjects research: analysis and recommendations. The Journal of law, medicine & ethics, 36(2), 219-248. who mainly refer to fMRI and genetic studies where the problem seems to be clear(er), I try to find prevalence for IFs in basic EEG research and clinical EEG research (e.g., epilepsy research).
Are there any established protocols how to handle IFs in EEG research?
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Please let me know if this reference/site may be helpful to you:
Evolution of universal review and disclosure of MRI reports to research ...
Article (PDF Available) in Brain and Behavior 6(3):n/a-n/a · February 2016 with 21 Reads .... 34% of research participants had an incidental finding identified, of which .... EEG). MRI scans from 216 studies by 63 investigators. using three scanners (Siemens 1.5 ..... able costs per scan if the IRB mandated radiology review.
Dennis
Dennis Mazur
For those interested in incidental finding guidance for research reporting, these references/sites may be useful to see the approach of others, but be sure to check with your relevant IRB(S) for what they require.
1.  Magnetic resonance imaging of … - ‎Weber - Cited by 208
Prospective study of new-onset seizures presenting as … - ‎Singh - Cited by 65
Unexpected - The Mind Research Network
Aug 2, 2010 - is based on using multi-modal imaging (MRI, MEG, EEG), genetics ... board (IRB) mandated that a neuroradiologist review all readable. MR images. ... identify incidental findings, of which 2 percent to 8 percent are clinically ...
2.  Guideline for the Reporting of Incidental and Secondary Findings to ...
Oct 1, 2014 - Incidental findings are “discoveries made in the course of research but that are .... other procedures such as blood tests, ultrasound, blood pressure, EEG, ECG, heart ...... IRB Primer: Incidental and Secondary Findings.
3.  Reporting Results and Incidental Findings to Research Participants
on Human Research Protections. Return of incidental findings to subjects. Return of individual ... IRB's: Limited experience with return of experimental results.Missing: eeg
4.  Incidental Findings Guide
Sep 27, 2016 - As part of research with human subjects, scientists and clinicians should anticipate ... incidental findings should be defined and described in the IRB ... would be picked up by a medical [MRI, fMRI, EEG, EKG, Blood draw, etc.].
5.  For Researchers: Incidental and Secondary Findings
Management of Incidental and Secondary Findings in the Clinical, Research, and ... preferences; and, if researchers decide to return certain incidental findings, .... thoughtfully deliberated and evaluated by an institutional review board (IRB).Missing: eeg
PLEASE BE SURE TO CHECK WITH YOUR IRB FOR THEIR VIEW ON INCIDENTAL AND SECONDARY FINDINGS AND WHAT THEY REQUIRE FROM THE PRINCIPAL INVESTIGATOR AND/OR STUDY SPONSOR.
Dennis
Dennis Mazur
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For a research methods course Is it okay to let students do a pilot study that includes some interviewing without going through the IRB process? The problem I am facing is that IRB approval can take well over a month at my institution. My students will not be in a position to pick a topic or even know how to put a proposal together until several weeks into the semester. I would love to hear the approach others take.
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It only takes a month at your institution?  
The federal government actually exempts social science-type questionnaire studies, such as the one you are proposing for your class exercise, from IRB requirements.  However, some universities now require EVERY study of any kind to go through an IRB regardless. 
You could possibly approach to the IRB folks and ask for an accelerated exemption, say within a week or so.  Your project serves a legitimate educational purpose.  If an individual in the IRB office knows about your project and is sympathetic, they just might grant a quick rubber-stamp approval. If not, and you teach this course every semester, you could have the next-semester's students do the interviewing after the questionnaires are IRB-approved in this semester if that would work.   Filling out the IRB forms would also be a good exercise for your students.  You could even invite an IRB staff person to give a guest lecture.
An alternative is to have students in the class interview each other.  Perhaps you could divide the class into several team projects and each team could interview everyone else in the class. That way, everyone would get experience in interviewing and being interviewed.   Good luck!
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Hello everyone
We would like to work on calcified human aortic tissue explants. Is it necessary that we have an IRB protocol approved for this purpose or are these explants available for laboratory use?
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Hi, I want to know if the human tissue sections were pruchased in company, should we get informed consent to use or have an IRB protocol approved when publish the data?
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I have a model on the genetic code that cites your work.
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No issues Sir,
I read the subject only, It is interesting
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I am searching for an Institutional Review Board that serves non-profit organizations and similar institutions who do not have their own IRB.
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The free way to do this is to partner up with an academic who puts your projects through his/her university IRB. Its also not that hard to create your own ethical review committee and process.
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Please, provide me with your feedback!
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There is a lot of information on our website that would help you out. Start with this page: Who is a human subject?
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Some human research methods have no or minimum risk to the human subjects. For example, anonymized questionnaires, anonymized routine clinical exams [with no clinical tools, no touch, and with no cross-contamination risk], etc.
Do we need IRB / ethics committee approvals for such no-risk designs?
What is the threshold for exempting designs from IRB/ethical approval?
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I believe this varies from institution to institution and it's up to individual researchers to familiarise themselves with their local rules. I have seen many studies that stated they required no ethical clearance because they were anonymised questionnaires, were meta-analyses or re-analyses of existing data or were strictly observational studies of animal subjects. However IRB approval is also ideally a measure to weed out badly-designed studies as well as ones which involve an unacceptable risk of harm to human subjects so there are good reasons to subject every study to IRB scrutiny.
Loopholes sometimes exist. I am aware of one case where a lecturer in an Economics department, which had blanket exemption from the need for ethics approval because of the nature of their usual work, carried out a study which was probably more in the wheelhouse of Psychology and caused a bit of a stir. The whole story is bigger and more complicated than that but it illustrates how rules can vary and sometimes be imperfect.
Speaking about what ought to be rather than what is, my personal view is that I am strongly against any research being exempt from IRB approval because I think all researchers should give an independent body a complete explanation of their methodology and primary outcome before they begin their work and IRB approval is an excellent time to do this. Even if there is no risk of harm to the subjects there is still a risk of unethical behaviour like changing the primary outcome after the fact or failing to publish some results which we should try to guard against.
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Lagging in recruitment but want to recruit local non-veteran subjects who may benefit.  Do you need to have a separate consent form/HIPAA form or are they the same?
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VHA Handbook 1200.05 lists requirements for recruiting non-Veterans. IRB must review the justification and provide specific approval for recruitment of non-Veterans. ICD and HIPAA could remain the same.
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Im trying to write my first IRB for a Trio based study. I've done this work in the past and I use a workflow provided by golden helix. MY IRB was sent back because they didn't like the statistical analysis section. I've scrapped what I had and re-wrote it.... is this IRB worthy? Im certainly no biostatistician.
"We will test SNPs for association to susceptibility to severe osseous deformity of the lower extremity by means of a family-based design. Qualifying patients will be designated as cases and respective parents as controls. Homozygous substitutions and heterozygous de novo variants will be analyzed if they are rare (below 0.5% frequency in 1000 genomes). De novo variants will be detected by analysis of whole-exome DNA sequencing data from a family trio study. Typically, these studies generate ~100,000 variations per trio. In an advanced workflow, a combination of functional and sequence quality control measurements will be used to filter the DNA sequence data to obtain a small number of candidate de Novo, rare-recessively inherited, and compound heterozygous mutations. GenomeBrowse and SVS 8 (Golden Helix) will be used to decrease the number of false positive candidate polymorphisms. Variants found in exome data will be filtered to a manageable number based on family structure, protein altering capabilities, and data quality (based on allele depth, read depth, and genotype quality score)."
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What do you expect that manageable number to be? This number, along with your target sample size, will heavily influence your statistical power (i.e. the rough likelihood that you'll be able to find your "true positive" result if it is there). They will also be looking for how you are planning to asses the significance of each candidate variant once you have finished filtering the exome data.
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 I am working in Clinical  research organization, Drugs and cosmetics approvals are given by DCGI(Drug Control General of India). Where as in Neutraceuticals and herbal products how to get the approval from the regulatory authorities is there any specific guidelines is available to conduct the studies in healthy volunteers . I heard about neutraceuticals approvals , for neutraceuticals no need to get the approval from DCGI , can we take the approval from local IRB/IEC and conduct the studies is it true ??
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May please refer to RULE 158(B) OF Drugs and cosmetic act  to have idea of different requirement for ASU products .
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I am trying to learn about Plastid genetic engineering and saw this picture on PAGE 3-4 of the attached paper which I don't understand at all. I understand that it shows the names and color codes the function of the genes. But I have questions:
1. Why is it in a circle?
2. From the paper: The caption below the figure says "The gray arrows denote the direction of transcription for the two DNA strands of the (circularly mapping) genome, and the interior circle shows its tetrapartite structure. Abbreviations: IRA, inverted repeat A; IRB, inverted repeat B; LSC, large single-copy region; SSC, small single-copy region"
What is meant by a tetrapartite structure?
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Hi,
The circle means that the genome is circular. The chloroplast derives from a cyanobacteria (with a circular genome). The tetrapartite structure means that you have two single-copy regions (a large one and a small one) separated by the inverted repeat regions (2 single-copy regions + 1 repeated (2 regions) = 4). Is this more clear?
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Currently, I have been given the duty to perform an in depth series of interviews/oral histories with an elderly patient with severe Alzheimer's.  The purpose of the interviews is to obtain historically significant details of a life/era which will shortly disappear from memory.  However, the subjects condition is so severe that they regularly forget what year it is, let alone that they have agreed to a series of interviews.  My question, can someone with severe Alzheimer's possess the capacity for 'informed consent'?  Any literature/thoughts on the matter are highly appreciated.
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Hi Nicholas,
Informed Consent is absolutely necessary in research involving humans unless the institutional review board finds allows the otherwise on basis of very careful decision. The only reason for not taking informed consent before an intervention or a research is an emergency. In case of patients with serious cognitive disabilities where they might not be able to give consent, a consent from the 'custodian' (a person or an institution) is necessary. Additionally, assent is necessary is children below 18 years who have developed acceptable cognitive abilities.
In your case, I find no reason why the patient may not be able to understand and give consent. Further, the patient has the freedom to opt out of the study whenever he feels like. The consent is never a 'binding agreement'. If your patient, therefore, feels that he does not want to continue, he is free to leave (regardless of his consent or dementia).
I am attaching links of some literature that will be useful to you.
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I am preparing a workshop entitled "Utilizing Facebook for Ethnographic Research" for the upcoming American Anthropological Association Conference . I would be interested to hear: 1. How you have used Facebook? 2. Was consent or IRB was involved 3. Did you use it as a source or resource for your research? 4. How you would evaluate its potential. Please also let me know if you are open to my using your comments in my workshop. Thanks!
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Hi Erik,
I used Facebook for an undergraduate paper investigating the way in which university students use Facebook as a way to create and maintain social relationships (friendships, acquaintances, contacts). I interviewed students about their use of Facebook in creating and maintaining friendships, such as when they would/would not add somebody, how many interactions would be necessary before adding them, whether meeting face-to-face was necessary or whether it could be used just as a contact machine (similarly to LinkedIn), who they thought they spoke to the most and for what reasons (finding out location of friends, discussing work, procrastinating, sharing articles, social chat, etc). I then used an app within Facebook itself called Message Counter (which records how many messages you have sent to different friends) to compare the results of who informants thought they spoke to the most and who they actually spoke to the most. I then used a programme called Wolframalpha which analyses Facebook profiles to see which words are most commonly used (eg. if an informant reported talking to most people about work but the most common words were about sports) and their activity patterns of posting/friend adding/etc.
Consent was required before the interview to discuss the project, and again before the informant's profile was run through the Wolframalpha and Message Counter programmes.
I would say Facebook has a huge potential for ethnographic research as it's a platform of communication used by millions of people daily. There's huge potential for excellent studies into the impact of online communication:
  • interpersonal communication - damaging or transformative? Now if someone writes a letter, it is considered a personal and meaningful act because it takes so much longer and much more consideration than an email. Facebook is a great platform to arrange social events, but also reduces the necessity to physically interact with people such as making a phone call or talking over the fence.
  • social practice theory - how Facebook is becoming part of a daily routine for some people (student procrastination; morning check of messages alongside emails and news...)
  • 6 degrees of separation - probably far smaller
  • cyberbulling and the assumption of invincibility through apparent anonymity
  • the paradox between becoming physically distant from neighbours but can communicate with people on the other side of the world at any time
  • the blurred lines between public and private lives on the internet
  • Etc.
Feel free to use my comments - let me know if I can help further.
Kirstie Bransfield-Garth
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I'll need unlimited participants and about 250 questions. I would like it to be as secure as possible (IRB compliant) with tools to upload the data to SPSS. Oh, did I mention cheap? lol I'm applying for (and fairly sure I'll get) grants, but I'd still like to remain below $1,000. Also, will you please tell me why you feel your recommendation is the best? Thanks!
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Surveymonkey could be counted on
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I am working with individuals with Parkinson's and Alzheimer's disease, and my IRB suggests that additional measures must be taken to ensure the capacity of individuals with memory problems to make a decision of whether or not to participate in my research. I would like to state the following:
"In addition, for participants with an Mini-mental state Exam score below 24, competency will be evaluated on an individual basis to avoid incorrect assumptions as to an individual’s ability to make decisions (45 CFR 46.111(b) and 21 CFR 56.111(b); UHCMC IRB Policies and Procedures, Appendix F): In the present study if it is believed that the prospective participant is not competent to consent for him or herself, an evaluation of the individual’s decision-making capacity and whether or not the prospective participant is competent to consent will be determined by the individual’s physician/neurologist. In the event this information cannot be obtained, the prospective participant will be asked to take a post-consent quiz to document the prospective participant’s knowledge of critical elements in the informed consent. Individuals must score 100% to participate. In some cases and in addition to the post-consent quiz, competency may be evaluated by the research team’s physician’s assistant. A determination of incompetence will be a clinical judgment that a person lacks the capacity to understand the circumstances of participating in research and to make an autonomous decision to take part."
1. Does anyone have any comments or suggestions on my approach posed here?
and
2. Does anyone have a post-consent quiz that they are willing to share? What I'm trying to get a sense of is the number of questions, how general/specific the questions are, the type of questions (true/false, multiple choice, fill in the blank, etc)
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Thanks Anthony, that is very helpful. I will be working with mild to moderate dementia as well, so it will be relevant to my population. I wonder if others use a similar strategy or can share specific questions that you ask?
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I was planning to investigate the behavioral aspect of why healthcare workers commit willful violations to biohazard guidelines. Its a qualitative study and would involve one worker per facilty. around 5 respondents will initially be selected. The study may show inadequacies (regulatory and otherwise) in the health facility and it wold not be in the best interest of the company to permit their employees to talk to me. the employees on the other hand would like to express their views especially in the light of their less than ideal working situations. So Id be in a stalemate if I seek institutional permission. Would i be justified if i dont seek institutional permissions?
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@Aftab, thank you for your answers. I have a proposal submitted for a qualitative study on reasons why clinical laboratory workers commit occupational safety violations. As I said Id be geeting several people all working from different laboratories. Currently there is much to be desired in the working conditions of clinical laboratories in the Philippines. The preliminary screener for our school's IRB however said that I should get an institutional permission for each respondent which is nearly impossible. I feel that it is not credible to me to seek permission from the laboratories management given that they themselves are said to be responsible for the poor working conditions i want to shed light on.
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A lot of patient data arises in private practice clinics across the country. Physicians mostly remain focused towards optimum medical care delivery; As a result, evidence based medicine based on the past practices and consumption of available data for research remains underutilized. There is no IRB in place in private practice settings. What would be the ways and means to contribute to knowledge base in terms of presentations and publications with unidentified patient data without violation of HIPAA requirements, all ideas are welcomed?
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HI SARTAJ,
Thank you very much. There are no additional steps needed. It is just a point you need to be aware of. It does not represent a conflict of interest either.
THANKS.
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My current area of interest is finding good online educational opportunities for persons dealing with FERPA, HIPAA, Animal research, Human subjects research, biosafety and maintaining secure computer databases.
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Many thanks, Robin
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How IRB should be related in the hirarchi of clinical research center? Should it be indepandant, or part of it?
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Institutional Review Board (IRB) are usually part of healthcare or research institutions. Conflict of interests or undue influence should not be a problem if the guidelines for setting up IRBs and standard operating procedures for IRBs are properly followed.