I was sitting up in the middle of the night last night, pondering (ok, stressing about) the enormity of work that lies ahead of me for the upcoming week when an email arrived in my work email box and caught my interest.
Now, normally I would never have opened an email like this. Spammy-looking emails generally go right to the trash. Maybe it was the fact that it was 2 am. Maybe it was the vodka martini I’d had earlier in the evening. Maybe it was the fact that it was sitting alone in a list of read messages. Something inspired me to open it and, thus, we have inspiration for today’s post.
The sender of the email was the “Citizen Science Newsletter” and the title read “Only Hours Left to Sequence your Microbiome with Citizen Science”. I have pdf-ed the uBiome email if you’d like to read it in its entirety yourself.
The group soliciting me to sequence my microbiome is called “uBiome” and they look pretty excited about people doing science.
I’m pretty excited about regular folks doing science too, so I explored their website a bit. This group has been featured by a lot of media outlets and it seems that folks are pretty excited about their work. Even the NIH is excited about them.
The link in their email takes you to a website to donate to their cause and they have more than surpassed their funding goal.
But, why I am concerned about this project?
I should preface the rest of this post by telling you that I have been doing research with human subjects and patients for a long time. About 12 years, to be more precise. I take the privilege of being able to do human research very seriously. It is important to me to do research that protects the safety and dignity of my participants. More importantly, it is important to me that participants in my studies be informed about what their participation in my studies entails. What are the risks? What will be done to them? How will their information be used? What safeguards are in place to protect their rights?
And this brings me to what I believe to be the potentially dubious ethics of this citizen science project. One of the first questions I ask when I see any scientific project involving collecting data from humans is, “What institutional review board (IRB) is monitoring this project?” An IRB is a group that is specifically charged with protecting the rights of human research participants. The legal framework that dictates the necessary use of an IRB for any project receiving federal funding or affiliated with an investigational new drug application stems from the major abuses perpetrated by Nazi physicians during Word War II and scientists and physicians affiliated with the Tuskegee experiments. The work that I have conducted while affiliated with universities and with pharmaceutical companies has all been overseen by an IRB. I will certainly concede to all of you that the IRB process is not perfect, but I do believe that it is a necessary and largely beneficial process.
From their website, the uBiome project does not appear to be affiliated with an IRB and I find no mention of an informed consent process.
Why is informed consent process important? Informed consent assures that human research participants are fully aware of what their participation entails. It also makes participants aware of any relationships the investigators have that might influence their conduct. With both of these considerations in mind, I can see several places in which the uBiome project might be ethically dubious in a way that would be have been picked up on and probably prevented by an IRB.
1) Participation in the uBiome project requires the payment of a fee.
The coupling of payment with participation is problematic. It biases your data by limiting participation to people who can afford to participate. uBiome appears to have donated 150 kits, but that’s a trivial portion of their sample size. When I conduct research, our informed consent notifies participants that they will not be charged for participation in research. In no way will their revocation of consent influence their relationship with our institution and they are free to revoke their consent at any time. Participants in the uBiome project do not appear to have that right.
Now, let’s be clear that I am not necessarily saying that uBiome shouldn’t crowdsource their funding. I am saying that data collection and crowdsourcing should be separated, even if that limits the efficacy of the crowdsourcing.
2) There is no clear statement about what will be done with the data or samples.
Let’s imagine I collect blood. I am required to disclose to our participants exactly what I am analyzing the sample for. I have to disclose whether I will share the sample with anyone and whether an individual’s identity will be tied to the sample. I also have to have a plan for destroying samples. None of this appears to be disclosed by the uBiome folks. It could be that the particularly unique chlamydia sequence they find in your vaginal swab (that you didn’t know you had) would be shared with hundreds of other researchers, ultimately ending up incorporated into some GMO tomato somewhere that your mother adds to her spaghetti sauce. Maybe you’re ok with being the person that changes the face of chlamydia research and tomato growing, but you should have to right to make that decision. It’s not enough to know that people can go to their database, but will they actively send your information to people?
3) There is no apparent plan for how your identity will be protected.
The site states “Your data is open to the world… if you choose. Your data is yours — you can download it, share it, do whatever you want with it. We encourage you to opt-in to share your data with our scientists, but we respect your privacy and will not force you to do so. The data is also anonymized and private.” It’s not clear to me how this process works. Do you have the choice to “opt out” before or after you find out you have science-changing chlamydia? This is the sort of question an IRB would ask.
They also state “uBiome will never release any of your personal identifying data. We will never even store your data in such a way that anyone could figure out who you are from it.”
I suspect, if they are directly linking your ability to access your results either through email or a website that this is not true. If it is true, I would certainly like to hear more about it…
With my projects, we have a very rigorous data protection plan. We disclose all of the potentially identifying information that we collect. Birth dates. Medical history. Everything. We disclose both to the participant and to the IRB the locations where their name is linked to their data. We disclose how long we will keep those materials and how we will destroy them. We disclose the encryption on our computers, phones, and other devices that prevents people from accessing identifying information about our participants. The uBiome project’s data protection plan appears to amount to “Trust us! We love science!”
4) It’s not clear what conflicts the major players in the project might have.
The site states “our team will analyze the results to explore scientific research questions such as how the microbiome influences human health and disease”. The major players in the project appear to be a graduate student, an entrepreneur, a postdoc, a couple of pharmaceutical company employees, a physician, and a couple of independent investigators. How are their relationships influencing their work on this project? Will any of the university-affiliated staff be using your data for publication or will the pharmaceutical companies be using your information for drug development? That may be difficult without IRB approval. Are either of these groups either funding the project or receiving money from it? You should know about the financial relationships that surround a project that might influence your participation. There’s not guarantee that a citizen science project has to tell you any of that.
5) The benefits you’ll receive are grossly over-stated
These are the statements on the site that bother me the most:
“uBiome is not a diagnostic test. However, we can give you valuable information about your microbiome that you can use to learn more about your health. You and your doctor can discuss the results of the test and determine the best way to proceed.”
And…
“First, you can use it to understand what is going on in your body. If you have a tricky health condition and would like more information about your body, your uBiome profile might add useful additional data points. If you are going on a diet, experiencing a bowel flare-up, or changing your lifestyle, we can help you see how your microbiome is before and after. If you would like to know how your microbiome compares to others or to yourself over time (or both), we can help with that too.
Also, the information you contribute allows all of us to learn more about the microbiome, and, going forward, to better understand and possibly cure disease.”
Granted, the investigators do state that uBiome is not a diagnostic test, but they couple it with statements that the results should be discussed with the participant’s doctor and that this information may be useful data in treating difficult disease. It gives the participant hope that their doctor will be able to decode some information from the data. I’ve posed this to a few of my physician colleagues this morning and they agree that they are not sure how they would use this data, if at all. They would probably treat their patient according to evidence based guidelines.
This is especially troubling when an individual has to pay for their data. It’s not hard to make the leap to the scenario where people pay $1337 for the kit with the hope that they will learn something that helps them treat their difficult illness only to find themselves none the wiser and about a thousand dollars poorer.
To the best of my knowledge, there are no medical guidelines for the use of microbiome data and uBiome does not have a medical pathology-grade laboratory. The project should tell people that the uBiome is not a diagnostic test. End of story.
6) There is no statement as to what your risks of participation are.
I am sure that swabbing a region of the body is generally harmless, but it’s also not hard to jump to the scenario where people learn something they may not have realized they would learn. For example, it’s not difficult to imagine a scenario where a mother swabs herself, her husband, and her child and learns that the husband and child share a common STD. Or, where someone swabs a partner purposefully, using this information to make a judgement, but receives a contaminated result.
In our research projects, we must disclose any risks of participation and we must give individuals the right to tell us what information they want to know and what they don’t want to know.
7) Children are included, but it’s not apparent how they are protected.
This brings me to my final concern (for now). It’s not apparent how children are treated, other than an answer to a FAQ about whether you can swab your child that essentially says “Sure!” Can you swab someone else’s child? Can you swab your disabled family member? A prisoner?
I note these groups, among others, because they are specially protected groups in research because of their difficulty providing consent. An IRB takes special care in evaluating research using these groups because they, historically, have been subjected to abuse. There is no evidence to me that consideration of these groups has been given by this project in the same way that it would be considered in a classically-conducted research study.
In conclusion, the project investigators state:
“We are funding this project through citizen science for several reasons. First, we want to bring this technology directly to the public as quickly as possible. Second, we want to prove that citizen science is a viable way to do science, and an alternative to slower, more traditional methods. And finally, going directly to the public does not prevent more traditional funding later — we just wanted to get you all involved as soon as possible!”
I want the average citizen to be excited about science. That’s why I do stuff like blogging. I also think it is valuable when people feel invested in science, but I am frightened by the phrase “we want to prove that citizen science is a viable way to do science, and an alternative to slower, more traditional methods.” Faster science shouldn’t be the motivation for citizen science especially when some aspects of the “traditional methods” exist for a reason – to protect human research subjects and guide investigators in the responsible and ethical conduct of research.
I worry that the use of human subjects by citizen scientists has the potential to return us to an era where human subjects abuses were more prevalent. At the extreme, I worry that “citizen science” projects may provide a route for scientists affiliated with universities and pharmaceutical industries (individuals who should know better) to circumvent the IRB process when it is convenient for them.
I worry that, for as much as we think “citizen science” and “crowdsourcing” is the way of the future, we are actually taking a huge step backward.
You could very well be writing this about 23andme. just substitute the name and “for profit company” for “citizen science”.
Nice explication of the (very serious and significant) concerns, btw.
Thanks, Drugmonkey!
Wait! You are saying that these people have not had their human research project cataloguing human microbiomes from samples of human tissue/fluids provided by participants reviewed by an IRB???????? If so, that is fucken deranged!!
I see no mention of an IRB on the uBiome website soliciting money. I searched the page for “IRB”, “Institutional Review Board”, and “consent” and found nothing.
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I think you’re right, for the most part. At the same time, I sure *hope* any IRB who would approve something like this would let me sample my kid’s diapers and spare them a colonoscopy (see http://www.ncbi.nlm.nih.gov/pubmed/22768065).
I believe in IRBs as a good regulatory step for researchers. At the same time, in this particular case I think I’d be satisfied if they get FDA approval for applying the kit to actual diagnosis for one disease (inflammatory bowel disease is the most likely for microbiome sampling from what I’ve heard), and make it clear that other applications don’t yet have a robust research base. That would be an alternative way of going about it. The lack of *any* oversight is a huge concern though.
(As an aside- watch out with the chlamydia and tomato thing. I think it’s a funny example, but I also think there’s gotta be a rule for “anything that can be used as an anti-science whackaloon talking point can be found somewhere on the internet”)
If you want their kit to be FDA approved, chances are the FDA would require human testing. That returns us to the IRB issue.
And if your child has an issue that requires a colonoscopy, I’d be careful in considering whether you’d be satisfied with a test with zero standards for quality control and zero imposed standards for specificity and sensitivity. This is exactly the type of reasoning that frightens me about the people participating in this “research.”
Melissa,
Hello, I’m Jessica at uBiome and just saw your post. You raise some very good points, and we wanted to address them briefly here.
We will have an extensive consent process as part of sending out our kits, including a consent for children, as well as details of our data policy, privacy policy, sample handling policy, risks, and conflicts (as well as the other items you mentioned).
Our Indiegogo page does address some of the issues you mentioned, but not in detail. We didn’t address risks, conflicts, or how to deal with the issue of children’s samples on our website as they are part of our consent form and sample collection process. We do address the data handling and privacy aspects on our page in several places, but don’t go into the detail that we will when our participants get our kits.
We have given extensive thought to our consent process and IRB approval and wish you had contacted us before posting here so we could have told you in more detail about our plans.
We’d like to keep this dialog open, and are grateful for your perspective. Thanks for thinking so deeply about the issues involved in citizen science — we’re all working towards a future that is simultaneously collaborative and ethical, and we appreciate your help in this journey.
But, you say “will” and “have given thought to.”
Does this mean that you have not completed the process as of today?
I should add that my concerns would be answered easily with the phrase “This study is approved by the (insert organization) institutional review board.” I’d only then have the follow up question of whether they approved your website and fundraising. Our IRB requires that all advertising be pre-reviewed and include a statement about the IRB approval.
Now, it’s very possible that there is no requirement for IRB involvement in your work ( see http://answers.hhs.gov/ohrp/categories/1562) because you’re a private company and theoretically not receiving federal funds or working on FDA-regulated development. The folks involved in your company might never handle data in conjunction with their pharmaceutical or university affiliation. You might not want to ever publish in a peer-reviewed journal. In that case you’d be perfectly right to thumb your nose at me, but that’s the part of citizen science that makes me nervous.
We have given extensive thought to our consent process and IRB approval and wish you had contacted us before posting here so we could have told you in more detail about our plans.
I’m very proud of you for having thought of these things. Jessica, do you have IRB approval or not?
I wonder how this would be received:
“We’ve given extensive thought to our use of stray cats for invasive electrophysiology experiments in our crowd funded garage startup neuroscience lab. We even thought really hard about IACUC approvals and look forward to an open dialog as we move forward with our recordings. Luckily, the cats supply consent when they enter the garage in search of the can of tuna we open every morning at 6am.”
This is an interesting ethics exercise, Drugmonkey. And, it really makes us ponder the question of how far citizen science could go without having to deal with the same types of regulations that govern folks at federally-funded institutions.
I reckon citizen science promoters will need to be more proactive in their commitment to inform and empower the “citizens” they’re involving in the process of their rights and responsibilities, the costs and benefits of their participation (and not on the narrowest construal), and of the power they ought to have to opt-out midstream if that’s what they choose (because, autonomy!).
Otherwise, especially these biomedical citizen science projects seem likely to attract some smart and creative personal injury lawyers to pick up the pieces in the event that the citizen-scientist collaborations doesn’t turn out to be as happy-shiny as promised on fundraising websites.
If these fools had IRB approval, they would have presumably told us so, right?
In a heart beat, Comradde.
there is a connection here to companies that encourage the movement to make personal genetics and really any medical test available without the guidance of a professional (geneticist, md, etc). this sort of “direct to consumer” medical testing, while satisfying libertarian needs, needs to be approached with a great deal of caution.
And…this intersects with the use of human genetic information by medical professionals in unethical ways…
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BTW, world, complaining that someone told on you instead of coming to you first is silly. If you don’t like public criticism, well, that’s it.
I have published a few tweets pointing to uBiome via @openscience on Twitter, and have personally supported the project. Although I know better, in this case I failed to consider most of your important points above. (Consent crossed my mind, I thought I’d ping Wilbanks on PLC, but that didn’t hold back my RT-finger.) Thank you for taking the time here and for reaching out to them, I will do the same and expect we’ll get somewhere.
On informed-enough consent for example, whether by traditional means or with innovations like Sage Bionetworks / Wilbanks’ Portable Legal Consent, we cannot let ‘open’ mean lower standard, or less prudent, and so on. In this case, IRB oversight may not be legally required per their funding and purpose, but the pitch implies professionalism through to the research products, so as you write with regard to publishing, oversight is implied.
I also published tweets pointing to @americangut. They seem to have provided or prepared more of the answers; on their fundraising project page, an IRB gets a mention, at least. For both of these projects and kin, I hope to see more communication, documentation, and openness in general and again, I expect we will.
I caution against using these questions to cast aspersions on “citizen science,” which is much broader, with a fuzzy definition at that. This is really about uBiome — even if they unfortunately called that solicitation a “Citizen Science Newsletter,” then wrote only about their own campaign. I don’t suppose they disclosed that connection in the email?
In many cases, citizen science is not at all less professional than any other science, it merely refers to a type or level of engagement with the general public. No one should think differently of the Cornell Lab of Ornithology, the Galaxy Zoo, Foldit, nor of so many others because of this discussion. Please consider changing the title of your post.
I also hope you continue writing with patience and clarity about the ethical conduct of variously bottom-up biomedical research. Whether it’s more patient- or health-centered, I expect a small explosion in crowdfunding biomed. The Cancer Research UK success, for example should be attempted in American patient communities along with many smaller, less mainstream efforts. In terms of individual data sharing, everyone expects growth in PatientsLikeMe, 23andMe, and related research. Remains to be seen how often these will mix in highly delicate ethical soup, but with technology marching on and the personalized medicine push, citizen science including human subjects seems ever more likely. I also expect more of the DIYbio crowd to start asking biomedical questions, and for that to require a great deal more patience and clarity.
Came back in hopes that someone from uBiome had appeared to answer some of these questions, but it looks like they were just drive-by commenting. Hmmm.
Color me skeptical, but I think we’re at the end of comment from the uBiome peeps.
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I’ll maintain optimism re more from uBiome on this. It is harder the more public one is, down to the dollar i.e. where it counts in this case, to avoid being held to account. Or so I keep telling people about crowdfunding and Open Science generally, so I’m rather on the hook 8)
These fuckers are out of their minds. They claim that they are going to deal with informed consent using forms packaged with the human tissue colection kits that they are going to send to people. BUT THE FUCKEN HUMAN SUBJECTS ALREADY PAID THEM MONEY AND AGREED TO PARTICIPATE IN THEIR STUDY. I’m not a human subjects expert, but don’t you need informed consent *before* money starts changing hands and you secure people’s agreement to participate in your study?
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Am I legally allowed to opt out of IRBs for this kind of research? uBiome is a startup, which means buyer beware rules apply, no.? Maybe I’m gullible but I don’t think uBiome are Nazi physicians, though I think hoisting the banner “citizen science” fairly opens them to some of the criticisms I’m reading in comments above.
Let’s say I’m a member of the quantified self movement, intensely curious about the bacteria in my gut and various orifices, AND I have disposable income. Why should I be prevented from supporting uBiome if I believe I’m making an informed decision, and I’m okay with the risks?
If the arrangement seems legally fuzzy and makes you ethically uncomfortable — don’t donate! If the science seems a bit squishy and not medically actionable — don’t donate! Plenty of people hear about 23andMe but don’t do it, maybe for those exact reasons. And more power to them.
I guess I’m like Brian and I’m okay with the risks outlined above, but I don’t speak for everyone, to be sure. Can we at least all agree that IRBs need to adapt to the Internet Age and accommodate crowdsourcing, which isn’t going anywhere anytime soon?
Full disclosure: I have not donated to uBiome or American Gut Project, but I am an early adopter of 23andMe.
@eperiste : “Am I legally allowed to opt out of IRBs for this kind of research?”
Maybe, but IRB isn’t about telling the subjects what they can do. The purpose of IRBs is ensuring research is conducted ethically and safely by the researchers.
“uBiome is a startup, which means buyer beware rules apply, no.? ”
No it doesn’t since nobody gets an ethics waiver just because they’re a startup.
“Let’s say I’m a member of the quantified self movement, intensely curious about the bacteria in my gut and various orifices, AND I have disposable income. Why should I be prevented from supporting uBiome if I believe I’m making an informed decision, and I’m okay with the risks?”
If you want to have someone inventory your gut for you, no problem. uBiome isn’t doing that, instead they appear to be collecting research data in a manner that seems to me (and apparently others) to be ethically questionable.
“Can we at least all agree that IRBs need to adapt to the Internet Age and accommodate crowdsourcing, which isn’t going anywhere anytime soon?”
No. Convenience related to a particular business model is an extremely poor reason to cut corners. We have IRBs because it has frequently been demonstrated that researchers do not universally behave in an ethical manner. There are plenty of criticisms that could be made of IRBs but whining because they don’t support a particular business model is incredibly naive and short-sighted.
I see no reason why an IRB couldn’t easily review the ubiome case. I suspect my institutions IRB would be very able to oversee a project like this.
We have IRBs because it has frequently been demonstrated that researchers do not universally behave in an ethical manner.
It is also important to point out that this has little to do with researchers’ intentions to behave ethically–nowadays it is rare that we are talking about genuinely evil exploitative abusive shitte–but rather that it is surprisingly complicated to actually implement processes and procedures that thoroughly safeguard human subjects’ rights and safety, even with the best of intentions. This inquiry has absolutely nothing to so with whether the uBiome people are nice guys who just want to do science with the best of intentions.
We have IRBs because of the recognition that the researchers themselves may not be the most objective judges of how well they are protecting the welfare of their human subjects. You know, like we have peer review because scientists recognize that they are vulnerable to fooling themselves about what their own results mean.
Objectivity: it’s a team sport.
No, eperlste, subjects cannot “opt out” of IRB on the behalf of the research team. The responsibility is on them, not the subjects. You are always free to remain ignorant of the consent materials….just so long as you sign.
A few people mentioned 23andMe and patientslikeme as comparisons.
I just checked the the 23andme website and they clearly state they have IRB approval and clearly list information that one would expect with an informed consent process: https://www.23andme.com/about/privacy/
patientslikeme is more interesting. The do state detailed data sharing and privacy policies. Based on reading around the site, it seems like they are not covered by their own IRB, but they work with academic institutions’ IRBs for specific research projects. As best as I can tell, their ethics model is that anyone can share anything and researchers can use the available data to recruit subjects for their IRB approved studies. This means data is only available for research as long as the person is able to provide consent for each study. For example, here’s a quote from one of their studies:
“Perceived benefits of sharing health data between people with epilepsy on an online platform” Wicks et al, Epilepsy & Behavior Volume 23, Issue 1, January 2012, Pages 16–23 includes, “Please note that as detailed in the text, institutional review board approval was not sought for this project given that it was a questionnaire study involving routine questions about site use rather than an interventional study. All members of PatientsLikeMe agree to be contacted for research as a condition of joining the community, and are free to elect to opt in or opt out of individual invitations to complete survey research. In line with the Declaration of Helsinki it is made clear that there will be no adverse consequences for deciding not to participate, and participants are free to withdraw their consent at any time.”
That said, here’s a journal/article that really should have listed the consenting process, but it’s not there at all:
Concordance between site of onset and limb dominance in amyotrophic lateral sclerosis
Turner et al, J Neurol Neurosurg Psychiatry doi:10.1136/jnnp.2010.208413
ubiome could adopt a model similar to patientslikeme, but it’s not clear they have. Also, for a biome-focused site, the power is in giving easy access to the entire data set. Having each project ask for it’s own consent limits the utility.
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bsci- interesting that 23andme had bothered to get IRB coverage. good for them. I mean, I’d like to know about some specific issues in which third or fourth parties can be blindsided but still. at least they bothered to be involved in the appropriate process.
Just jumping back in to let you know that we’ve updated our FAQ to respond to your questions here. We had planned to finalize our IRB after the crowdfunding process and since it ended two days ago, we’re doing that. (I suppose you have no way of knowing that we were in process already — but we definitely have been.)
We appreciate your thoughtful analysis here and have worked through these items in our IRB. Privacy, data management, risks, benefits — these are all important things to consider and we’re glad that you’ve brought these issues to public awareness. (Although calling these “ethical shenanigans” without any verification and comparing us to Nazis (!) is a bit, er, problematic.)
Citizen science has fantastic potential for increasing funding for research, increasing public engagement with science, and creating new and important approaches in biomedical research. We are on your side here and want to make sure that our research (and that of others) is conducted in an ethical manner. We are scientists too.
It is fantastic that Melissa’s post and the ensuing commentary has persuaded you to seek IRB oversight Jessica. This is great news. I suppose I should credit this as a win for openly critiqued, crowd participant science…in a way.
Melissa, thank you for this important accomplishment.
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+1 @drugmonkey @Jessica and on several points. Some of the Twitter chatter implied creating an IRB dedicated to cases like these. That may be warranted, I’m not sure whether the issues here are different enough to those already addressed by IRBs, or similarly with IACUCs, but I am sure there should be more than tweets about it. Maybe there is a right conference to tack this on.
Details such as the order in which things are done, precise words used in not only legal statements but all communications — larger issues turn on these. And awareness of research ethics in the more bottom up areas of citizen science is lacking, to name a couple — the growing biohacker and quantified self communities. This is happily less or not at all an issue for the likes of uBiome, American Gut, studies associated with PatientsLikeMe. Perhaps entities such as these, somewhat in between traditional research and further reaches of citizen science, will lead on both awareness and infrastructure for ethics.
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Would you propose starting with a free platform like WordPress or go for a paid option?
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