Online Training Tools for Clinical Research Coordinators

by Andrew Milroy – HRPP and CQA Manager (Merita CQA)

Online training is becoming increasingly popular in nearly every field allowing for training of professionals from the comfort of their own office or home. In the field of clinical research there are several well known online training tools such as the TCPS 2 CORE Tutorial offered by the Interagency Advisory Panel on Research Ethics, and the Collaborative Institutional Training Initiative’s (CITI) ICH GCP training.

Listed below are six online training tools, including those mentioned above, that offer clinical research coordinators a means by which they can upgrade their credentials, refresh their knowledge, or just remain current with the latest developments and ideas.

The TCPS 2 Tutorial – Course on Research Ethics (CORE)

CORE provides an applied approach to the guidance provided in TCPS 2. This self-paced course is a media-rich learning experience that features interactive exercises and multi-disciplinary examples. CORE consists of eight modules ranging from Core Principles to REB Review. It is designed primarily for the use of researchers and REB members – though anyone may take this course and print their own certificate of completion.

http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

Collaborative Institutional Training Initiative’s (CITI) Program’s Good Clinical Practice (GCP)

GCP courses are suitable for research teams involved in clinical trials of drugs, biologics, and devices.

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) is suitable for individuals involved in clinical trials on drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

GCP for Clinical Trials with Investigational Medical Devices is most appropriate for organizations or individuals who desire a more international-focused GCP curriculum or a more device-focused program.

https://www.citiprogram.org/

 

Ethical and Regulatory Aspects of Clinical Research

This course is offered by the NIH to anyone interested or involved in the ethics of clinical research with human subjects. Participants represent multiple disciplines including research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students, and others.

http://www.bioethics.nih.gov/courses/index.shtml#ethical

Introduction to the Principles and Practice of Clinical Research (IPPCR)

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is offered by NIH and is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects, building a budget, plus many special topics.

http://clinicalcenter.nih.gov/training/training/ippcr.html

Training and Resources in Research Ethics Evaluation (TRREE)

TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic training, while building capacities, on the ethics of health research involving humans so that research meets highest standards of ethics and promotes the welfare of participants. TRREE achieves this goal primarily by developing a training programme with local collaborators. In its initial stages TRREE focused primarily, but not exclusively, on the needs of African countries.

TRREE provides free-of-charge access to:

e-Learning: a distance learning program and certification on research ethics evaluation

e-Resources: a participatory web-site with international, regional and national regulatory and policy resources

The e-learning programme is based on internationally recognized ethical principles and regulations. It integrates local issues and perspectives from low-and middle-income countries, most notably from African countries, that are relevant to all those who must ensure the protection of research participants and who promote highest ethical standards.

http://elearning.trree.org/

The Lab: Avoiding Research Misconduct

In “The Lab: Avoiding Research Misconduct,” you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices.

http://ori.hhs.gov/thelab

This list is not exhaustive and if you are aware of other available online training tools please feel free to contact me so that I can review and consider utilizing them for training purposes.

I can be reached at amilroy@meritacqa.com if you have any questions or would like to share additional online training tools.

References:

TCPS 2 Tutorial :: The Interagency Advisory Panel on Research Ethics (PRE). (n.d.). Retrieved December 3, 2014, from http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

Collaborative Institutional Training Initiatives. (n.d.). Retrieved December 3, 2014, from https://www.citiprogram.org/

Courses, Lectures, & Training. (n.d.). Retrieved December 3, 2014, from http://www.bioethics.nih.gov/courses/index.shtml#ethical

NIH Clinical Center: IPPCR. (n.d.). Retrieved December 3, 2014, from http://clinicalcenter.nih.gov/training/training/ippcr.html

TRAINING AND RESOURCES IN RESEARCH ETHICS EVALUATION. (n.d.). Retrieved December 3, 2014, from http://elearning.trree.org/

The Lab. (n.d.). Retrieved December 3, 2014, from http://ori.hhs.gov/thelab

Code Brown – Some Trivia for your Long Weekend

Was reading “Uncle John’s Funniest Ever Bathroom Reader” and came across a piece worth sharing. Here it is:

Code Brown

Actual abbreviations and terms used in the ER by doctors and nurses who – by necessity – have a morbid sense of humor

TMB: Too Many Birthdays (suffering from old age)

FORD: Found On Road Dead

House Red: Blood

TRO: Time Ran Out

Frequent Flyer: Someone who is regularly taken to hospital in an ambulance, even though they aren’t sick (because it’s something to do)

Code Zero: Another name for a “Frequent Flyer.” The real radio codes range from Code 1 (not serious) to Code 4 (emergency)

Code Yellow: A patient who has wet the bed

Code Brown: (You can guess this one yourself)

FOOSH: Fell Onto Outstreched Hand (a broken wrist)

T&T Sign: Tatoos-and-teeth. (Strange but true: Patients with a lot of tatoos and missing teeth are more likely to survive major injuries.)

DFO: Done Fell Out (of bed)

MGM Syndrome: A “patient” who is faking illness and putting on a really good show

WNL: Will Not Listen

SYB: Save Your Breath, as in, “SYB, he WNL”

Insurance Pain: An inordinate amount of neck pain following a minor auto collision with a wealthy driver

ALP: Acute Lead Poisoning – a gunshot wound

ALP (A/C): Acute Lead Poisoning (Air Conditioning) – multiple gunshot wounds

Flower Sign: Lots of flowers at a patient’s bedside (may indicate the patient is a good candidate for early discharge, since they have people who can care for them)

ART: Assuming Room Temperature (deceased)

Bagged and Tagged: A corpse ready for the morgue (it’s in a body bag and has a toe tag)

AMF Yo Yo: Adios, Motherf@#*!, You’re On Your Own

 

 

Determining when a question is too sensitive

Often research studies have accompanying questionnaires for qualitative aspects of the study and some of those questionnaires ask fairly sensitive information. It is important that there be concern for the participants welfare and so often REBs will ask questioned deemed too sensitive to be removed. But how do we determine a sensitive question from a normal or non-sensitive question. I believe the literature on sensitive research can help provide answers.

After reading through some of the literature I believe found a workable solution (or at least something to start a discussion) in response to the dilemma of determining when a question is too sensitive for inclusion in a questionnaire.

In the book Doing Research on Sensitive Topics by Raymond Lee (Lee 1993) he puts forward a definition of sensitive research that was widely received and accepted by more recent authors on the subject such as Virginia Dickson-Swift et al. in the book Undertaking Sensitive Research in the Health and Social Sciences: Managing Boundaries, Emotions and Risks (Dickson-Swift et al. 2008).

Lee defines sensitive research as “research which potentially poses a substantial threat to those who are or have been involved in it.” Adding to this definition, a threat can be grouped into three broad areas. The first is “intrusive threat” which deals with areas that are private, stressful or sacred e.g. sexual or religious practices. Second type is a “threat of sanction”, i.e. the research question involves the possibility of revealing information that is stigmatizing or incriminating. The third type of threat is “political threat” which refers to when researchers ask questions which “trespass” into areas that involve a social conflict involving the vested interests of the powerful in society.

Areas in which research questions are likely to be threatening include:

  • where question intrudes into the private sphere or delves into some deeply personal experience;
  • where the question is concerned with deviance or social control;
  • where the question impinge on the vested interests of powerful persons or the exercise of coercion or domination; or
  • where the question deals with things that are sacred to those being asked that they do not wish to profane.

A final comment I would like to make is that the above criteria for determining if a particular question in a questionnaire is too sensitive, cannot be used when the research topic itself is of a sensitive nature.

Please feel free to comment if you have one or ask questions.

All the best,

Andrew

Communication of Clinical Trial Results with Participants: Beyond Publication

Researched and Written by:       Andrew Milroy1

Edited by:                           Gordon B. Robinson , B.A.Sc. (Eng),  Ph.D2.

Today in the minds of the public and certainly with potential Clinical Trial Participants, there exists a great deal of suspicion and a lack of positive attitudes towards such Trials.  While awareness campaigns may improve public perception, there still are many areas for considerable improvement throughout the Trial’s life-cycle.

Purpose of the Paper

To examine Clinical Trial Researchers‘ attitudes towards Participants and specifically, towards the current, common-UHN practice of communicating Trial Results  solely  through Publication.

Background

Any Trial Participant is an investment on the part of the entire research community.  Once recruited, many aspects of attitudes towards and how Participants are treated  go a long way towards maximum retention.   Throughout and at the finish-point of a Study, where the Participant feels they were a valued member of the research team, will go considerably further towards creating a positive attitude towards Trials in the minds of the public.

Discussion

Participants want the opportunity to be informed of their Trial’s results which was explained in a recent paper3. This publication reviewed the current environment regarding the communication of Clinical Trial  results with Participants.  It cited, as a best-practice, the Center for Information and Study on Clinical Research Participation  (“CISCRP”) Program for sharing such results in lay language , similar to that in Informed Consent Forms ( “ÏCF”) . It concludes with a statement that any organization should develop industry- leading policies relating to repeated communication with Trial Participants. Not only is there an ethical foundation for the practice of communicating Clinical Trial results to Participants, it also has wide-spread support among “Stakeholders” of the Clinical Research enterprise.

Recently4, it was shown that the Chairs of Canadian REB-s overwhelmingly supported sharing results with Participants.  Not only the Chairs favour sharing, studies show that a high-percentage of Participants want to be advised of a Trials results5    A  study in late 2013 surveyed more than 5,600 Study Participants and discovered that learning of the results was one of the foremost reasons for participating5.  Another study4 showed the percentage of those wanting to receive the results at 90 %   Further, Principal Investigators themselves have been shown to be highly supportive of this sharing.

Despite wide-spread support from other “Stakeholders”, the majority of Participants never receive results4    In another Study, about 90% reported that they never learned the results from Investigators, Staff, the Institution  or the Sponsors3 . Some of the numbers:

  • Only 5 out of 150 Institutions surveyed had any formal mechanism for returning Research Results to Participants
  • Only 6 out of 180 Leukemia Clinical Trials indicated that Participants could receive Study Results
  • Only 9 out of 22 Canadian REB-s surveyed had policies addressing communication of results or required Investigators to address the issue themselves..

Eighteen Studies provide sufficient data on the overwhelming desire by Participants to receive, in layman’s language, their Study Results4.  Thus, there is clear evidence that improvements in how Clinical Trials should be run, but unfortunately, Participant preferences are seldom considered when developing policy and what  seems like a simple process as it is not in the cultural framework of Trial operations6. One Cancer Study reported that 86% of the Participants were not even offered the chance to receive the results at all7  while another3 showed less than 5% received results.

Often the practice of sharing Clinical Trial results, if at all, is done through publications and posting information to clinicaltrial.gov or similar on-line platforms. Further, when shared the results remain in technical language which is not in keeping with the guiding principles for Informed Consents.  Such on-line platforms are meant for a different audience than Participants.  It defies logic and common sense that Trial results are not offered in lay-language !!  In fact, Kenneth Getz, the co-founder of CISCRP stated that such practices fail to satisfy the critical obligation to communicate results with Participants3.

Clearly Participants want to receive their Clinical Trial results and more research on this issue in not needed. Attention must be given to efficiently share results in lay-language with Participants. Doing so would provide Participants with a much-needed sense of appreciation and help considerably to build increasing trust in the Clinical Trial enterprise.

An opportunity currently exists to build stronger ties with Participants through intelligent results-sharing, before it is mandated.  In March of 2014,, The European Parliament voted overwhelmingly in favour of regulations that all Clinical Trial results be accompanied with a lay-language summary.  Such programs are increasingly being implemented on a voluntary basis by Sponsors to honour and thank Participants5 .

Within 5 years, pharmaceutical and biotech companies will routinely provide Clinical Trial results to study volunteers in response to regulatory mandate, public pressure and desire to strengthen relationships with those volunteers.

Although it is reasonable to believe that lay-summaries will be required, some postulate that there are barriers, which could include4 , although some of these possibilities have been negated. In fact Miller4  found that negative consequences were not a deterrent to a vast majority of Participants in one Study.

Communication Practices

Any barriers can be overcome and there are examples of successful programs that shared results with Participants. One example is the MA.17 Trial5 which tested whether extended adjuvant therapy with the aromatase inhibitor ‘letrozole’ after ‘tamoxifen’ reduced the risk of breast cancer reoccurrence.  When, mid-way through the Trial, that ‘letrozole’ improved disease-free survival, the Trial was halted and the Coordinator sent-out an e-mail  to akk Study Sites 3 days before any public announcement and each Participant was immediately offered open-label to ‘letropzole’  with such greatly  improved communications improving the attitudes of Participants.

Another example of exemplary communications with Trial Participants Is through the work of

‘CISCRP’ which began in 2010 when they started a program of communicating in lay-language, Trial results to Participants and have stated that they can … “easily, feasibly and affordably establish as a standard practice within organizations and industry-wide” 3 ,  CISCRP-lead studies showed that what a majority of Participants wanted was a small recognition and information of when the results would be available understandably to them.  Further assessment indicates that such a practice is feasible and generally easy to perform.

Currently, CISCRP is assisting more than 12 companies in support of their post-Trial communication initiatives3  and although it was slow to begin, they have seen a doubling in each of the past 2 years of Sponsors joining, bringing to about 24 .

Such a communication imitative positively impacts volunteer recruitment, retention and long-term trust in the Clinical Research Trials by recognizing the Participant as a fellow “Stakeholder”  in the process showing signs of respect for the risks assumed  and the commitments’ made by the Participant3 .

Opportunities for Relationships

Substantial missed opportunities of building trust and establishing relationships with Study Participants are encountered when they do not receive appropriate communication. Only lay-summaries shared with Participants, rather than the current usual practice of publication, should be considered as a means of meeting ethical obligations.

With Participants and Investigative sites amongst others, all asking for Study Results and growing support from Sponsors to providing lay-summaries, there needs to be greater demand in the form of institutional  policies mandating that results be shared with Participants in a form that they can understand. In addition, this policy when applied during a Trial, can yield positive results.  Furthermore, in keeping with ethical standards, the plan for communication should be discussed both in the ICF and in Protocols.

Policies that increase the level of importance placed on communicating Trial Results and their subsequent enactment shows respect for the collaborative relationship between Investigators and Participants and would enhance trustworthiness of Research and Researchers.

Conclusion

The 3-R’s …. In order to maintain or increase the number of Recruited and Retained, Clinical Trial Participants, UHN must improve the level of Respect in which such Participants are viewed.

UHN should consider development of a country-leading, communication policy where Clinical Trial Participants are communicated with both in periodic appreciation and then, with understandable verbiage of lay-language summaries of the Trial Results.

Further, this policy would be concomitant with that of Consent Forms which mandates language at a 6th– 8th– grade education level.

Such an action on the part of UHN would be another example of how it is leading in Research Ethics compliance.

Bibliography

  • Andrew Milroy, former Member of the UHN, Oncology-REB (’12-’14), now employed as the HRPP & CQA Manager at Merita CQA in Montreal
  • Gordon B. Robinson, B.A.Sc. (Eng), Ph.D. is a Member of the UHN Oncology-REB (’07 – present )  and a Member of the Federal, Tri-Agency Panel on Research Ethics (PRE)
  • Getz et al, “Meeting the Obligation to Communicate Clinical Trial Results to Study Volunteers”, Expert Review Clicial Pharmacology, 2012, 5(2), pp 149 – 150
  • Shalowitz, D. I. & Miller, F. G., “Communicating the Results of Clinical Research to Participants”, PLoS Medicine, May 2008, Vol 5, Issue 5, pp 714 – 720
  • Getz K & Hallinan, Z., “Creating a Standard Practice for Communicating in Lay Language to Study Volunteers”, Exp. Rev. Clin. Pharmacol., 2012, 5, pp 145 – 156
  • Goodlow, B. J. & Furlong P., “Transparency as a Means to Increase Clinical Triasl Enrollment”, Drug Info. Journal, Vol. 44, pp 265 – 270
  • Getz K. et al, “Providing Results to Volunteers”, App. Cliun. Trials, 19(10), 52 – 59

A thought on therapeutic misconception

At work recently I’ve been going through cases of ethical misconduct for a presentation I will be delivering in the coming months and it has raised in my mind questions of therapeutic misconception.

Clearly ethical regulations and theory purport that research is for the benefit of knowledge and not the health of the participant. I.e. it’s not meant as a therapy. But is that true?

Many areas of medicine have no known treatments and people are regularly being signed up for clinical trials in the distant hope that it will benefit their condition.

For me, and perhaps some readers, this definitely raises the question of whether we are confusing participants and feeding into misconception. No doubt only the greatest intentions are meant but perhaps a review of the practice of signing up participants for the hope that it will treat them needs to be re-examined.

How does the concept of therapeutic misconception stand, or does it need to, when e.g. a cancer patient has gone through several rounds of chemo and there is really nothing left except experiment.

My worry, and how this relates to ethical misconduct is that in the past vulnerable groups have been used to push science ahead at the cost the wellbeing of participants.

I would argue that for patients who have no known standard of care and are left with either no care of experimental research that they be classified as a vulnerable population susceptible to undue influence to sign up for a study, and so be protected in research under the classification as a vulnerable population. Same as for example economically disadvantage who turn to research studies for money.

Just some thoughts. I haven’t fully developed the argument clearly but hey, this is my blog and I’ll do what I want. 🙂

Cheers.

The End’s Justify the Means? A few thoughts on deception in research.

After reading an article by the WSJ that came across my LinkedIn newsfeed (http://online.wsj.com/articles/the-role-of-deception-in-scientific-research-1409009297#livefyre-comment) I started thinking about deception in research.

Can deception ever be ethically justified in research? Isn’t that showing the end’s justify the means? I was always taught, not through formal study of ethics, that the end’s never justify the means. Is that old adage wrong when it comes to research ethics?

I don’t think so.

Perhaps the negative act of deception always trumps the gains. Deception does after all leave a bad impression on those on the receiving end. Doesn’t it erode trust in scientists as benevolent researchers and science in general?

We currently allow deception when it is low risk research and if there are no other ways to conduct the research. To that I say perhaps the research itself is low risk, but the risk of ruining trust in research after deception has occurred is actually high. Second, perhaps if the research cannot be done by any other means then it ought not be done at all.

Seems to me that by allowing deception we are going about research ethics willy-nilly. Deception is wrong outside of research, why allow it within research?

Getting Started

Hi there,

For now, I’m basically writing this post to just get started as I know right now I have no followers. I will be taking steps in the future to change that as I hope this blog can carve out its place in the online fora of ethics related sites and blogs.

My interest is largely in the areas I studied while in University, Bioethics, Social, and Political. I have an interest in Business ethics as well although have not studied it formally.

This Blog will largely feature content on subjects found in areas such as healthcare ethics, corruption, social justice, and corporate social responsibility. I am not going to limit myself at the moment but if I find a certain area that I enjoy writing about as I continue it may drift into a more specialized category of ethics.

Anyway, that’s all for now. Hope you enjoyed reading my first blog post on Ethics Nut.

Andrew