Quote:”The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the impact on individuals of factors such as their physical, mental and spiritual health, as well as their physical, economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family life, community membership, and social participation, among other aspects of life. Other contributing factors to welfare are privacy and the control of information about the person, and the treatment of human biological materials according to the free, informed and ongoing consent of the person who was the source of the information or materials. A person’s or group’s welfare is also affected by the welfare of those

Chapter 1 – Ethics Framework

who are important to them. Harm includes any negative effects on welfare, broadly construed (for the relationship between risk and harm, see Chapter 2, Section B). Note that, for the purposes of this Policy, “group” and “community” are used in their ordinary sense. More detailed types of community as defined in Chapter 9 are specific to Aboriginal contexts.

Concern for Welfare means that researchers and REBs should aim to protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable risks associated with the research. They are to provide participants with enough information to be able to adequately assess risks and potential benefits associated with their participation in the research. To do so, researchers and REBs must ensure that participants are not exposed to unnecessary risks. Researchers and REBs must attempt to minimize the risks associated with answering any given research question. They should attempt to achieve the most favourable balance of risks and potential benefits in a research proposal. Then, in keeping with the principle of Respect for Persons, participants or authorized third parties, make the final judgment about the acceptability of this balance to them.

The welfare of groups can also be affected by research. Groups may benefit from the knowledge gained from the research, but they may also suffer from stigmatization, discrimination or damage to reputation. Engagement during the design process with groups whose welfare may be affected by the research can help to clarify the potential impact of the research and indicate where any negative impact on welfare can be minimized. Researchers must also consider the risks and potential benefits of their research and the knowledge it might generate for the welfare of society as a whole. Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend on the nature of the research being undertaken, and the individuals or group in question. This consideration does not imply, however, that the welfare of a group should be given priority over the welfare of individuals.”

Source of above:
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010.
Note: For the most recent information on amendments, please consult the official online version of the TCPS at
Permission is granted to photocopy this material.

Source of following:
Quote:” Application REBs and researchers shall carefully examine the relationship between the circumstances of the individuals and communities they aim to recruit and the research questions they aim to answer. They should not presume that these circumstances will either automatically preclude or qualify individuals or communities for participation. Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten or attenuate their vulnerability and provide special protections or consideration. This may be the case for individuals or communities who are vulnerable to abuse, unfair treatment or discrimination.

In general, researchers should be familiar with the cultural, social and economic circumstances of prospective individual research participants or host communities. Researchers should anticipate, to the best of their ability, needs of participants and their communities that might arise in any given research project. Especially when participants and their communities have a wide range of pressing needs as a result of their low socioeconomic circumstances, these needs can present significant ethical challenges for researchers.

Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of the research, and, where possible, they should arrive at agreements with the community about the scope and nature of the potential benefits that will be provided to participants and/or their communities during and after the research. The agreements should, to the extent possible, be explicit about the planned division of responsibilities for realizing these benefits. In many cases, benefits may be delivered most effectively in partnership with local organizations to better ensure balance in the relationship between researchers and participants and mutual benefit in researcher-community relations. (See Article 9.13 on mutual benefits in collaborative research as it pertains to research involving Aboriginal peoples in Canada).

Researchers shall ensure that any potential benefits for participants or their communities are not only commensurate with the risks of participation, but also fair in terms of the overall distribution of benefits between participants and researchers. A fair distribution of benefits can help ensure that individuals and communities are not included in research merely because their circumstances make their recruitment more convenient or efficient for researchers.

Benefits may, for example, take the form of information sharing, training for local personnel, or health care or similar services. Where applicable, these research agreements outlining expectations and other considerations, whether formal or informal, should be submitted to the REB under the auspices of which the research is being conducted and by the REB or other responsible body or bodies where such exists at the host research site or country for review. (See Article 8.3).

Since researchers are not aid agencies, REBs should be vigilant to ensure that the proposed distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or costly to complete the research reliably.

Researchers should normally provide copies of publications or other research reports or products arising from the research to the institution or organization – normally the host institution – that is best suited to act as a repository and disseminator of the results within the participating communities. This may not be necessary in jurisdictions when the results are readily available in print or electronically. In all cases, researchers should ensure that participating communities are informed of how to access the results of the research that should be made available to them in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports.

Respect for Communities and Minimizing Social Disruption

Researchers should recognize that communities, as well as individuals within those communities, can be put at risk or their vulnerability may be exacerbated by research activities. They should be aware of the implications of their research for local communities and should be attentive to social changes that might be introduced by their research projects. Researchers should also take care not to create unrealistic expectations among participants within those communities with respect to the potential benefits of the research. They should demonstrate respect for the communities they engage in research by exercising due diligence to anticipate and minimize any risk and social disruption that might be created by the research.

Source of following:

Ref: Prof. Tim Caulfield
Health Law Institute, University of Alberta
Law Centre, University of Alberta
Edmonton, AB T6G 2HS

Quote:”Conference on Conflicts of Interest in Research
Summary of Proceedings
Toronto Marriott Bloor Yorkville Hotel
February 22-23, 2007

Industry has a profound effect on popular representations of scientific developments. The media is the primary source of such information for patients and clinicians and such reporting impacts their behaviour. In media reports:
Risks tend to be underreported.
Conflicts and funding sources are often ignored.
Methodological and other limits of studies are commonly downplayed.
Interviews with investigators may give a more enthusiastic impression than is warranted.
Neither the media source nor the investigator(s) being interviewed have an incentive to downplay the significance or implications of the scientific findings. Therefore, reports of new discoveries may tend to be unduly sensationalized.”


Drugs RSVP

I checked my RSVP list George … You know the one that tells me what Topics I need to avoid in order not to be cosidered a social deviant … 

RSVP? … You know George … Religion, Sex, Politics …
V? Not sure about that one.

Anyway what I discovered is that nowhere do I find drugs on the RSVP list.
Drugs George … we can talk about drugs.
That’s what keeps the world together. 
How do I know? 
Well I suppose I must confess to my ignorance George.  It is really not something I know for sure.

I do not really know very much of anything for sure.  What I do is just poke around and eventually find a bit of information here and a bit of information there … Oh and from what I hear on the news … And why would I not believe what I hear?

So for the drugs I went to Duke University.
Nary a sign of drugs there.

Found a drug-related something called environmental monitoring in Toronto

And auditing … Even something here called Pharmaceutical Auditing … And what you can learn if you want to take a course 
regulatory requirements and quality standards as well as the ability to carry out in-depth audits of quality systems in the pharmaceutical industry.

four main components of the quality system: management controls, design controls, production and process controls, and corrective and preventive actions …”
“… how to plan, execute, report and close-down complicated and advance pharmaceutical, biopharmaceutical and supplier audits.”

Why would someone want to close-down an audit George … Am I wrong in thinking that an audit is something that keeps the world operating the way the world is supposed to operate?

Yes I am aware that a company usually gets a warning before auditors come in … That way they can clean up their act and keep everybody happy and nobody is the wiser … Isn’t that the way it works George?

But you know what … There really is a lot more to drugs than I ever realized … Something called “Pharmaceutical Regulatory Affairs
Hmmmmm … What do you think George?

Something along the lines of 
“rules and regulations affecting pharmaceutical, biological, natural health products and medical devices.”

Some real important sounding stuff too
“international food and drug laws, regulations and guidelines … regulatory submissions and requirements … intellectual properties … pharmaceutical drug development 

Non-clinical studies … regulatory filings … human clinical trials …

Hnnnn wonder what this is: “global submission in the CTD format”

Ah hhhh here it is George
marketing applications for drugs and biologics, known as the Common Technical Document (CTD) … finalized by the International Conference on Harmonization (ICH) in 2003.  Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.”

Wonder what that ICH means … No George not itch … Nothing to do with being itchy … Well … Unless you have an allergy I suppose …
Then again I suppose there are companies that might be itching to get a new product out as soon as possible … You know what they say George “time is money”
No George I don’t think it has anything to do with running a business from prison. … Then again …

hmmmm good place to go to get letters after your name … Sounds real professional … Well like in all these new careers
CMW – certified medical writing
DM – document management

Check this mouthful George
GRAC – global regulatory affairs compliance

Yep … Sure are one pile of new careers George … At least they might be careers …

FDA, CBER, IND, NDA, BLA, ANDA, ABLA …. No George … No idea what they mean … Sure sounds important though … Guess you need to be an insider to understand the arcane language.

Guess that’s enough drugs for today.