Research lab ethical dillemma, advice needed

[conky124]

I have a dilemma concerning my current research position and as an applicant for clinical PhD programs. Would someone be able to weigh in on how I should manage this situation, or perhaps whether I should leave this lab?

Background:

I work as a “research associate” for a clinical trial studying addiction and it is my second month working with this lab. We are testing the usefulness of a drug to treat addiction and part of my job is to conduct individual CBT sessions with patients. Although I aspire to practice psychotherapy and have experience working on a crisis hotline, I am concerned whether it is ethical for me to do this work because I have only a bachelor’s degree in psychology and have no credential that qualifies me to do this work. Also, I just applied to clinical psych phd. programs and am nervous about this counting against me. When I was hired for this job, I expressed this concern and my PI (an epidemiologist) promised I would receive clinical supervision and instructed me to just follow the manual. After a month went by with out any clinical supervision, my boss and lab manager pressured me to increase my caseload. I brought the issue back up to my boss and she became very bitter and passive aggressive but, finally found someone I could meet with for supervision for a half our every other week. I have emailed this person and she has not responded to me for close to a week. Should I refuse to continue this work until I have supervision, and should I require an hour a week? Furthermore, should I not be doing this work even if I did have clinical supervision?

I frequently debate leaving this lab, but I am nervous about being unemployed during grad school interviews and having to explain this situation. I do find the work very interesting, but I am also growing concerned that my PI and her lab could be toxic for my career in research as I am discovering that she has a history of unethical decisions to cut corners.

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[AcronymAllergy]

Unfortunately, this sounds like a situation where the folks conducting the trial have fallen in with the crowd of people who say, "hey, it's therapy and it's manualized, how hard can it be?"

My take (and I don't at all mean this in an accusatory fashion) is that no, you aren't qualified to provide psychotherapy, even with supervision. Generally, licensing guidelines stipulate that trainees can conduct psychotherapy when they're a part of a graduate training program (which isn't the case here), and when they are working under the direct supervision of a licensed professional (which an epidemiologist is not). If you'd had a masters degree and/or were some type of certified substance abuse counselor, this would be different. But what do they expect you to do if the person voices suicidal or homicidal ideation? Or expresses knowledge of ongoing child or elder abuse?

As difficult as it might be, and I realize it's exceedingly difficult, I'd suggest indicating that you don't feel you're qualified to perform the work even with supervision. Are there any psychologists or other mental health professionals working on the project...? If so, they may be putting their license at jeopardy here.

Edit: And agree with everything Ollie said below, as well.

Double edit: And my cynical side wonders if they're having the therapy provided in this fashion to essentially stack the deck in terms of demostrating increased efficacy of the medication.

 

[Ollie123]

Wow. No one can make the decision for you with regards to balancing ethics/future aspirations/the need to feed your family, but I think you are right to be very worried.

There are plenty of situations in which I could see it being completely appropriate for someone with a BA to be conducting treatment (i.e. studies deliberately examining paraprofessional delivery), but I find it hard to imagine folks doing so without support would ever even get IRB approval. What if someone discloses SI? Some psychological interventions are even designed to be implemented by folks with BA's.

Wish I could offer some solutions, but all I can really offer is empathy. Personally, I think the responsibility for the situation should fall on PI and not you, but that doesn't mean all would see it that way. I'd continue to push and would consider going to administrators or others if need be, though recognize it may mean the end of your job.

 

[conky124]

Thank you so much for your input, and I completely agree that I am not qualified to do this work and that I need to tell them I am not comfortable doing this work. There are no psychologists or licensed MHP on this study. The PI has taken on some of these patients after I expressed my concerns (even one I already started seeing) which, I think is inappropriate because she is not qualified either. The other person who does the CBT sessions has an MSW, she and I are on the same page about this but, she does seek supervision from an LCSW. I already put on my CV that I "conduct manualized CBT sessions under the supervision of a clinician" because I was promised this would happen and needed to submit an updated CV a while ago to clinical programs. Will this count against me for my applications? Also, should I stop doing this work?

 

[conky124]

Wow. No one can make the decision for you with regards to balancing ethics/future aspirations/the need to feed your family, but I think you are right to be very worried.

There are plenty of situations in which I could see it being completely appropriate for someone with a BA to be conducting treatment (i.e. studies deliberately examining paraprofessional delivery), but I find it hard to imagine folks doing so without support would ever even get IRB approval. What if someone discloses SI? Some psychological interventions are even designed to be implemented by folks with BA's.

Wish I could offer some solutions, but all I can really offer is empathy. Personally, I think the responsibility for the situation should fall on PI and not you, but that doesn't mean all would see it that way. I'd continue to push and would consider going to administrators or others if need be, though recognize it may mean the end of your job.

By push do you mean, stop doing this work? or continue to push for supervision? It sounds like its an ethical issue even if I do have supervision.

 

[Ollie123]

I would need to know way more than it is realistic to convey via internet post to know if it would be ethical for you to proceed even if you did have proper supervision. That gets into the nuance of the population, the nuance of the protocol, the purpose of the treatment, the nature/quality of the supervision and support, etc. Some treatments are designed for paraprofessionals. Behavioral activation has received some attention in this regard, particularly in community health settings where their often isn't the salary to support enough full-time licensed clinicians to meet demand. These are often dumbed-down versions, but some research suggests they may be just as effective so....

With proper safeguards in place, I don't take issue with folks doing research on it. I generally wouldn't recommend it to someone over a professional therapist, but I think it is fair game to study and would defer to the individual IRBs at each institution to determine risk/benefit. It sounds like NO safeguards are in place at present though, which is a very clear problem.

 

[WisNeuro]

Considering it's addiction and you're working with a patient population with an increased risk of suicide and impulsive behaviors, I would be very worried. Throw on top of that that you're working with an experimental use of a pharmacological agent, yeah, there needs to be qualified, licensed mental health professionals on board with this project. How did this make it past an IRB?

 

[deleted343839]

So many red flags here. As project personnel it should not be your job to seek out independent supervision. That should be coming from a PI or co-investigator. How this made it through an IRB is beyond me.

Though I understand your concerns about leaving the position, this would make a great story for the inevitable interview questions about "how you handled a difficult situation."

 

[conky124]

Considering it's addiction and you're working with a patient population with an increased risk of suicide and impulsive behaviors, I would be very worried. Throw on top of that that you're working with an experimental use of a pharmacological agent, yeah, there needs to be qualified, licensed mental health professionals on board with this project. How did this make it past an IRB?

It is a large study that has over 30 sites across the country and we are just one of them working out of a drug treatment agency. Tomorrow, I'm going to see if I can find what was submitted to the IRB concerning the "CBT sessions". The funding our lab receives is based on how many people we enroll, pass the screening process, and begin dosing. The PI of this lab did not design the study, but is just frantically trying to maintain enrollment and avoid protocol deviations. She only focuses on the ones that get automatically reported through the time sensitive measures and doesn't realize that her bad practices are digging her a deeper hole with the study monitors who make audits. I am learning she has a history of doing unethical things to cut corners, such as deliberately unblinding herself, during the previous trial, to know whether a specific patient was on the study drug or placebo. The lab coordinator makes poor choices as well and has bad methods for collecting physio data, such as blatantly performing the measure wrong for expediency, and choosing vital sign scores to record that she feels is accurate based on her "gut instincts". I have worked in four different research labs, two of them were NIH funded clinical trials, I am aware of how chaotic research can be, but this specific lab site is a hot mess and potential disaster for my career if something goes wrong.

I have frequently expressed concern about my lack of supervision and whether it was appropriate for me to do these sessions in (eventhough it is work I am interested in). I strongly feel it is unethical for me to continue doing this work, whether I finally have supervision or not. I am afraid of what might happen due to my inexperience and the lack of safeguards with these patients. However, if I refuse to continue the sessions with patients I could loose my job and have to explain in grad school interviews why I am no longer working at my current lab. No matter how right I may be for leaving, it will still make me look like someone you don't want working in your lab.

My plan so far and please correct and comment if you feel appropriate:
Continue pushing for clinical supervision and investigate what the IRB has approved for this part of the study. I'll complete the grad school interviews while still working with this lab (hoping that I'm invited to some) and afterwards, I'll quietly resign. In the meantime I'll need to continue my job, but somehow protect myself and the patients from potential disaster. For the psychotherapy, I'll just stick to the psycho-education in the manual, talk to them about how they are generally feeling/ validate concerns and emotions. Though, I am very interested in psychotherapy (especially interpersonal and humanistic) I'll stay away from delving into those topics. Generally, I am trying to avoid stirring people up in an unhealthy way, but still be useful.

Thank you all for the input, it is all much appreciated.

 

[bmedclinic]

So many red flags here. As project personnel it should not be your job to seek out independent supervision. That should be coming from a PI or co-investigator. How this made it through an IRB is beyond me.

Though I understand your concerns about leaving the position, this would make a great story for the inevitable interview questions about "how you handled a difficult situation."

My guess, based on my history with an IRB, is that the actual submitted IRB looks very different from whats happening here. I bet if OP pulled IRB paperwork, there'd be lots of raised eyebrows compared to whats actually happening. Just my hunch, no inside knowledge.

Think about it- how hard is it to flat out lie on an IRB application? Though the IRB lists the PI/Co-PI, there's never room to list everyone in the lab that will work with that study..And they may have gotten approval pending hiring a therapist, then OP (not an actual therapist) was hired because "eh, good enough".

 

[smalltownpsych]

It is a large study that has over 30 sites across the country and we are just one of them working out of a drug treatment agency. Tomorrow, I'm going to see if I can find what was submitted to the IRB concerning the "CBT sessions". The funding our lab receives is based on how many people we enroll, pass the screening process, and begin dosing. The PI of this lab did not design the study, but is just frantically trying to maintain enrollment and avoid protocol deviations. She only focuses on the ones that get automatically reported through the time sensitive measures and doesn't realize that her bad practices are digging her a deeper hole with the study monitors who make audits. I am learning she has a history of doing unethical things to cut corners, such as deliberately unblinding herself, during the previous trial, to know whether a specific patient was on the study drug or placebo. The lab coordinator makes poor choices as well and has bad methods for collecting physio data, such as blatantly performing the measure wrong for expediency, and choosing vital sign scores to record that she feels is accurate based on her "gut instincts". I have worked in four different research labs, two of them were NIH funded clinical trials, I am aware of how chaotic research can be, but this specific lab site is a hot mess and potential disaster for my career if something goes wrong.

I have frequently expressed concern about my lack of supervision and whether it was appropriate for me to do these sessions in (eventhough it is work I am interested in). I strongly feel it is unethical for me to continue doing this work, whether I finally have supervision or not. I am afraid of what might happen due to my inexperience and the lack of safeguards with these patients. However, if I refuse to continue the sessions with patients I could loose my job and have to explain in grad school interviews why I am no longer working at my current lab. No matter how right I may be for leaving, it will still make me look like someone you don't want working in your lab.

My plan so far and please correct and comment if you feel appropriate:
Continue pushing for clinical supervision and investigate what the IRB has approved for this part of the study. I'll complete the grad school interviews while still working with this lab (hoping that I'm invited to some) and afterwards, I'll quietly resign. In the meantime I'll need to continue my job, but somehow protect myself and the patients from potential disaster. For the psychotherapy, I'll just stick to the psycho-education in the manual, talk to them about how they are generally feeling/ validate concerns and emotions. Though, I am very interested in psychotherapy (especially interpersonal and humanistic) I'll stay away from delving into those topics. Generally, I am trying to avoid stirring people up in an unhealthy way, but still be useful.

Thank you all for the input, it is all much appreciated.

This is scary stuff. We all make decisions based on this research. I think I might even be more concerned about the bad research than the unsupervised, inexperienced person providing therapy.

 

[deleted343839]

This is scary stuff. We all make decisions based on this research. I think I might even be more concerned about the bad research than the unsupervised, inexperienced person providing therapy.

I wonder who decided it was OK to have an epidemiologist act as a site PI for a therapy trial. And did this slip under the program officer's radar or is this sort of thing now fair game for federally funded collaborative trials?

Continue pushing for clinical supervision and investigate what the IRB has approved for this part of the study. I'll complete the grad school interviews while still working with this lab (hoping that I'm invited to some) and afterwards, I'll quietly resign. In the meantime I'll need to continue my job, but somehow protect myself and the patients from potential disaster. For the psychotherapy, I'll just stick to the psycho-education in the manual, talk to them about how they are generally feeling/ validate concerns and emotions. Though, I am very interested in psychotherapy (especially interpersonal and humanistic) I'll stay away from delving into those topics. Generally, I am trying to avoid stirring people up in an unhealthy way, but still be useful.

You're taking on a lot of responsibility and some risk too. Though it is a personal decision, I hope that your plans to "quietly resign" include notifying the IRB chair and the institution's research compliance manager. The NIH has guidelines for whistleblower protection for people who report research misconduct in good faith. http://ori.hhs.gov/guidelines-whistleblowers

 

[conky124]

"After enrollment, subjects will receive manual-guided, individual behavioral therapy once a
week for 5 weeks, then bi-weekly (every 2 weeks) up until injection 6, at which point it will
occur monthly to accompany the pharmacotherapy as indicated in the SOEs. Behavioral therapy will continue through the end of
the study (EOS/ET visit). It is at the Investigator’s discretion to provide additional behavioral
counseling above this standard frequency. The reason(s) that additional counseling was provided
should be documented in source documentation. Behavioral therapy can be conducted by any
appropriately trained staff member at the site."

-Protocol's mention of the therapy. I was handed a manual and not trained at all.

"Manual-Guided individual behavioral therapy once a week.
Completed by a clinician (therapist, MD, nurse, PA, etc)"

-From a very long ppt presentation of the protocol that I had to confirm over email that I understood it (before I started working)

 

[conky124]

I wonder who decided it was OK to have an epidemiologist act as a site PI for a therapy trial. And did this slip under the program officer's radar or is this sort of thing now fair game for federally funded collaborative trials?



You're taking on a lot of responsibility and some risk too. Though it is a personal decision, I hope that your plans to "quietly resign" include notifying the IRB chair and the institution's research compliance manager. The NIH has guidelines for whistleblower protection for people who report research misconduct in good faith. http://ori.hhs.gov/guidelines-whistleblowers

Frankly, I might need to resign sooner, given the new information I found today. I presented the information from the protocol and protocol ppt. to my PI and said that I was concerned about how this might influence my future career because those ppt slides say a clinician needs to do the therapy and the protocol says an appropriately trained staff, I am neither. She said she had double checked with the study monitors and other people at the agency that what I was doing was fine. I asked if there was someone I could talk to about this to verify for my comfort or some correspondence I could read and she said that I should just stop doing the therapy and that she prefers it all to go through her. I agreed that I would stop doing the therapy but, that I would need to make a transition plan for the patients instead of abruptly ending the sessions without reason.

Honestly, I don't need the lab experience and I am afraid to be associated with this lab.

 

[deleted343839]

You are in a tough spot and I don't envy your decision-making process. Document all of your conversations and observations if you have not been doing so up to now.

In terms of your own career, I would not be worried about how it looks to others that you were doing therapy unsupervised. You stumbled into a situation that no reasonable person would expect you to have anticipated, and it hasn't taken you long to recognize the problems in this situation and take steps to remedy them as best as you can. As Ollie mentioned above, your level of training does not preclude you from serving as a study interventionist if the protocol is meant to represent a paraprofessional level of practice and there was some meaningful oversight of the intervention. But it sounds like the reality is very different. You're doing the right thing here.

 

[conky124]

So much has happened. This morning I submitted an official complaint to the IRB, but phrased it as a question such as, who is qualified to conduct the behavioral therapy for the study? I also told them my account of what has been happening as objectively as I could and that I was concerned this was an ethical issue. They responded that they are forwarding the complaint to their regulatory body to look into it.

Today, I calmly told my PI that I would continue seeing the patient's I am assigned until she has found them an appropriate counselor, and that it could be a problem if they were ripped away immediately. Characteristically, she took this personally and became angry and yelled at me that I was accusing her of ripping patients away. She also pulled me into her office and presented me with a job description which excluded the counseling and the lab work that brought me to the study to begin with. All of the tasks were reduced to paper work and getting patients coffee (although I don't mind it). I have over four years of research experience and it is clear she is trying to push me out of the tasks where I wanted to learn new skills. HR also emailed me today and asked me a bunch of questions surrounding "how things were going in the research" and whether I wanted to switch to a different department. I told them my ethical concerns and how raising them to my PI made her rude and unprofessional towards me. After I gave all this information and my account, I learned that they were going to look into the ethical issue themselves. I am now concerned that what I said will be used against me and working here will be dreadful.

I feel now that I need to stay with the lab because the work with the patients and the study has been meaningful for my career despite all the blaring issues. I even wrote about it in my personal statement, I'm worried if I leave my grad school interviews will focus towards that topic and not my potential with the clinical psych programs.

Thanks for listening and for the support.

 

[WisNeuro]

Best of luck. Hopefully this will be something that will lead to a lot of growth down the road. Lots of people would have just kept their head down and not wanted to rock the boat. Kudos for sticking up for what you felt was right and making the right inquiries. Patient and study participants come first. Keep that in mind and it'll keep you in the right frame of mind.

 

[Therapist4Chnge]

It's better you went to the IRB than say nothing. Years from now hopefully this will just be an example of why we have IRBs and why research work needs to be carefully managed.

 

[deleted343839]

You did the right thing. You are a whistleblower and that should afford you some protection. If you do start to get some blowback, here is how to contact the NIH program officer:

(1) Go to https://projectreporter.nih.gov/reporter.cfm
(2) Enter the PI's name, project title, or other info
(3) Once you find the project, click on the title
(4) On the "Project Information" page, click the "DETAILS" tab and you can get the name and address of the program officer

 

[AcronymAllergy]

It's better you went to the IRB than say nothing. Years from now hopefully this will just be an example of why we have IRBs and why research work needs to be carefully managed.

Agreed.

To the OP: you mentioned above some concerns about how this experience might negatively affect POIs' perceptions of you. I can say that based on what you've said, you're the exact type of student most advisors would love to have in their lab.

 

[Ollie123]

Do we know this is an NIH trial? My impression was that this is likely an industry-sponsored clinical trials site. Even off subcontracts, I've never heard of an NIH grant where funding was disbursed according to enrollment - that seems very much a traditional "big pharma" clinical trial where that sort of payment is par for the course. I suspect the psychological intervention is a mere afterthought and probably something that has to be included to justify a placebo control, so with an unscrupulous PI it is getting short shrift.

Agree with the above. Good for you. Not an easy conversation to have, but it sounds like it was a necessary one.

 

[deleted343839]

Ollie, good point. The OP mentioned being involved in NIH trials in the past and I realize I jumped to that assumption in this case. Though if psychological intervention is indeed an "afterthought" it could still very well be an NIH-funded trial!

To echo AcronymAllergy's comment, I agree! this series of actions reflects critical thinking, valuing the well-being of patients over one's own personal gain, commitment to resolve ethical conflict through appropriate channels, and recognizing the limits of one's competence. All very admirable qualities for an RA and essential qualities for a psychologist!

 

[conky124]

I originally thought the study was sponsored by both a big pharma and NIH or NIDA, but I think it is only sponsored by the pharma company. It is registered through NIH and clinicaltrials.gov if that makes any difference.

The study uses "behavior therapy" for all participants who are fully enrolled and dosing. The study is testing a delivery method for a drug that only needs to be delivered monthly and is used for medication managed treatment ( MMT). Addiction counseling is always supposed to accompany MMT treatment, I'm told. If this were an MMT clinic for addiction, one would never receive only the mmt without group and individual counseling. My PI, and perhaps the entire study, doesn't value the importance of counseling and think it's all about the drug. Although the drug eliminates cravings, and blocks receptor sites, and prevents withdrawal, I've noticed patients will start to abuse another drug. My PI doesn't realize that these patients need to learn how to cope with life again and need support through the many study commitments the prod into and stir up their personal lives. One of my patients I've lost contact with because the clarity provided by the study drug made him realize the suffering that surrounds him on the streets (is also homeless and diagnosed with ptsd). We had a great rapport, but the patient was in a dark place during our last session and I could feel him giving up hope. I really feel these patients deserve proper treatment, but the pharma sponsor may not care and claim it's not part of the provided treatment, I hope the IRB will feel differently.

Again, I can't thank you all enough for the encouragement and support. I'll seek the whistleblower protection, thank you Mamaphd for outlining the steps!

Edit: I removed some details about type of drug and other minor details for anonymity.

 

[Therapist4Chnge]

You may want to take one some of the details you posted for reasons of anonymity.

 

[Justanothergrad]

I think you adherence to ethical standards, even before entering a graduate training program where you get more familiar with them, is laudable. I know that feedback is not the purpose of this thread, but I commend your efforts to ensure good client care. This is not only an excellent learning opportunity for you in terms of ethics, but it is a remarkably strong example that you can bring up with resolving ethical issues now and in the future (interviews, etc). You have good reasoning about the issue, as others have noted as well. This process of thinking makes you MORE qualified for clinical training programs instead of less.

As others in the thread have stated, your concerns are legitimate and the risks associated are very real, manualized or not.