Questions related to IRB
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.
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
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?
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?
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
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.
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
Ok ,so here is another question about qualitative studies. In my dissertation IRB I included the following:
- Video recordings of mentor/intern meetings
- Virtual focus group meetings with mentors and interns
- Individual interviews after focus group meetings as necessary to address unanswered questions from above related to my research questions.
- 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.
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.
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?
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?
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
- Iran (Islamic Republic of)
- Saudi Arabia
- Syrian Arab Republic
- United Arab Emirates
If you're interested in joining, please send me the following info to firstname.lastname@example.org
No. of Physicians:
No. of Nurses:
No. of Pharmacists and other HCPs:
Need for IRB approval/exemption:
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.
I am interested in understanding more about NGOs that work with refugees. I am brainstorming a project that does not involve IRB approval.
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!
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?
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.
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?
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!
(613) 884 0125
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!
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.
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.
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.
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.
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.
This question is regarding researchers who are interested in conducting research after grad school but are not affiliated with an organization or university.
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!
I have a proposal for a research project and I am looking for a hospital or surgical center where I can submit the IRB.
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?
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!
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?
Does a cross-sectional survey study where participation was voluntary, and all participants remained anonymous require a IRB review?
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?
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?
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?
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.
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.
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!
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?
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?
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.
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?
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?
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?
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)."
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 ??
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?
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.
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!
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!
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?
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)
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?
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?
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.