nit VIII Case Study Select one of the three NIOSH Health Hazard Evaluation Reports listed below, and perform a critical analysis of the report. Option 1. Health Hazard Evaluation Report, HETA 2010-0114-3168. (2012). Ergonomic Evaluation of Surfacing and Finishing Tasks during Eyeglass Manufacturing � Minnesota.http://www.cdc.gov/niosh/hhe/reports/pdfs/2010-0114-3168.pdf Option 2. Health Hazard Evaluation Report, HETA 2010-0008-3148. (2011). Ergonomic and Safety Climate Evaluation at a Brewery � Colorado.http://www.cdc.gov/niosh/hhe/reports/pdfs/2010-0008-3148.pdf Option 3. Health hazard evaluation report, HETA 2007-0098-3061. (2008). Ergonomic Evaluation of Frank Hangers at a Turkey Processing Plant – California. http://www.cdc.gov/niosh/hhe/reports/pdfs/2007-0098-3061.pdf Your case study review must include the following headings per APA guidelines: 1. Introduction �Provide a description of the selected case. Describe the issues of the case, and state the purpose for the paper. 2. Methods � State the evaluation criteria used in the NIOSH HHE Report. 3. Results � Present the findings from the Health hazard evaluation. 4. Recommendations � Describe the recommendations for improvements. 5. Discussion � Review relevant literature on the subject. Does research support the recommendations of the case? In addition, are there any other issues of concern? 6. Conclusion � Present your comments on the case. What did you learn in this review? What more would you like to have seen discussed in the report? In general, your own opinions should only be included in this section. Instructions: Your answer to this assignment must be four to six pages, double spaced, and 12 point font (separate title page and reference page are not included in the page length). The assignment requires that you use your textbook and at least two other references and readings which pertain to the topic in question. CSU requires that students use APA style for papers and projects. Therefore, the APA rules for formatting, quoting, paraphrasing, citing, and listing of sources are to be followed. A document titled �Citation Guide� is available for you to download in the Learning Resources area of the myCSU Student Portal. It may also be accessed from the Student Resources link on the Course Menu of Blackboard. For comprehensive information on APA formatting and research databases, you are encouraged to visit the Learning Resources tab in the myCSU Student Portal. The Success Center provides APA and writing assista

Directions for Examples 1­–5 :
Read the example and construct a coherent response based on the situation described below. Responses should be well-organized, accurate, and demonstrate mastery over course content. Use bullet points, charts, or other techniques to organize your answers in short clear responses.
No credit will be given for information unrelated to the subject area.
Example 1 – Personal Continuous Air Monitor
Patent No. 6,011,479
The radiation detection and measurement industry is a large field encompassing monitoring, measurement and safety aspects of radiation exposure. In the past, the radiation detection and measurement field was related mainly to the Department of Energy, including nuclear weapons production, fuel production, decontamination teams and nuclear power plants. This industry is currently in a state of change with the risk of radiation exposure growing due to the heightened risk of terrorism in the world today. The need for radiation detection and measurement has now expanded into the Emergency Responder teams and areas of the Department of Defense.
Los Alamos National Lab (LANL), a federal nuclear research lab, has developed a technology that is able to detect and measure airborne radioactive particulate in the personal breathing zone of the user. This product is called the Personal Continuous Air Monitor (PCAM) and has significant benefits over the existing Continuous Air Monitoring (CAM) product offerings.
The attributes of the PCAM have the potential to open up new opportunities in the radioactive particulate and Emergency Responder market places. Initial market probing has indicated that there is a strong interest in the PCAM technology since there is no existing CAM product that can be worn by the user or is able to monitor the radioactive worker’s personal breathing zone.
LANL owns the patent for the PCAM technology; therefore, the technology must be licensed from this federal lab if it is to be commercialized.
Certain countries in Europe have more stringent protection and safety requirements than the United States and use nuclear energy on a wider scale. Nuclear radiation detection and measurement is a global industry and there mightbe global opportunities for the PCAM. The International Plutonium industry and nuclear power plant technology areon the increase at about 5­8% per year. Although the grassroots fear of nuclear energy mightcontinue to challenge the growth of the nuclear energy industry, this fear may also benefit the recognition of the PCAM as a needed tool in all radiation related industries.
General Description and Important Technical Attributes
The Personal Continuous Air Monitor (PCAM) is a device that is capable of warning immediately of hazardous nuclear particles in the air. This device will allow people to monitor their own air space environment for airborne radioactivity. The PCAM is a battery-operated airborne particle monitor and recorder. The PCAM has a filter/detector head that is worn near the breathing zone of a user, containing a filter mounted adjacent to radiation detectorsand a preamplifier. The filter/detector head is connected to a belt pack to be worn at the waist or on the back of a user. The belt pack contains a signal processor, batteries, a multi-channel analyzer, a logic circuit, and an alarm. An air pump also is provided in the belt pack for pulling air through the filter/detector head by way of an air tube. The PCAM continuously samples the breathing zone of the user and alarms, almost instantly, if any of the predefined airborne radionuclides are detected. Once an incident is recorded, the sample filter can be analyzed to determine the user’s exposure level.
The PCAM senses radioactivity in the breathing zone of a user by using a filter capable of trapping radioactive particles with a radiation detector mounted adjacent to the filter. The radiation detector is capable of outputting electrical signals when radioactivity is present. A preamplifier is connected to the radiation detector for amplifying the output of the radiation detector. Electronic means receive the amplified output from the preamplifier for outputting a signal when a predetermined level of radioactivity has been exceeded. An air pump pneumatically draws ambient air through the filter.
Benefits of the Technology
• LANL’s PCAM technology is unique because it is the only alpha particle radionuclide detector that is small, unobtrusive, and able to monitor the breathing zone of the user.
• Because the PCAM is battery-operated, it can be carried on the user’s body as an independent unit. Current Continuous Air Monitors (CAMs) are difficult to use in areas that are small or have limited access whereit is particularly important to have the PCAM technology because airflow patterns in these areas are not well-defined.
• The previously mentioned attributes of the PCAM have the potential to open up new opportunities in both the radioactive particulate and Emergency Responder market places. Currently, many groups represented by the previously mentioned market places maintain fixed CAM products. There is no existing CAM product that can be worn by the user and is able to monitor the radioactive worker’s breathing zone.
J. Susan Sprake
Project Leader
Industrial Business Development Office
P.O. Box 1663, Mail Stop C333
Los Alamos, NM 87545
(505) 665-3613
FAX: (505) 665-3125
Questions for Example 1 –
You are developing a market research plan for performing a Quicklook on the PCAM technology. List the types of primary and secondary sources you would target for research. For each of your targeted types of sources, identify and explain the goals of your research—types of information to gather or information goals of the interviews.
Example 2
You and two friends have formed a company to try and commercialize the previously described Los Alamos PACM technology.
Founders
Founder 1: You – you bring your business training and knowledge of how to package businesses and get them started.
Founder 2: A PhD nuclear physicist who was the original inventor of the Los Alamos technology and who joined the company because she believes she can make significant improvements to the technology and that there is a large market opportunity.
Founder 3: A former sales and marketing executive for a safety company that sells hazardous materials response equipment to government and industry who sees the market potential for this technology in the same markets he sold to previously.
The company has received a license from Los Alamos and has set up shop in Austin, TX. Each of you has put $50,000 into the company to enable production of marketable units in its present state. The technology works and can be sold in its present state of development.The design of the technology from Los Alamos uses certain materials that are costly and make the units too expensive for the largest and broadest target markets. The PhD scientist has a research and development plan to identify and test new materials that she believes will enable the company to hit the lower target unit price for the largest and broadest markets and allow the company to introduce the product widely.
This research and development plan will require approximately $1 million to complete and the PHD scientist expects that upon completion of the research plan, the company will need an additional $3 million to fully scale up production for the new and improved units.
Expected markets based upon your market research are:
• In the current form and with no progress on the unit cost – Total available annual markets on the order of $10-$20 million with sales to military and specialty hazardous materials response units possible
• With planned for decrease of unit cost – Total available market on the order of $300-$500 million and markets in the military and civilian nuclear industry worldwide and more general hazardous materials response units at state and local levels
Development plan for the company:
Years 1-2 – Complete the $1 million research plan anticipated to lower the unit cost and open the broader market
Years 2-3 – Bring an additional $3 million to the company to begin production and sales of the lower priced unit. Expect to hire an additional 10 people in Austin
Years 3-4 –Grow the company with a target sales total of $60 million and growing by year 4. Hire as many as 30 people in Austin with sales staff around the US and EU.Look to be acquired by the safety company for whichFounder 3 previously worked for 2-3X revenues.
Questions for Example 2 – Your co-founders are looking to you to formulate the business plan to make your company’s development and marketing plans a reality. Identify and explain/justify what types of funding/cash generation strategies you would suggest as the funding source(s) that the company could use for: (1) the $1 million research plan, and (2) the $3 million expansion plan. If looking to external sources, describe what significant elements about your company/opportunity you would highlight to the targeted funding source(s) to try and close the deal. Why would they fund you?
Example 3 – Read the following example of a new combined PET and MRI machine.
Positron emission tomography (PET) is a medical imaging technique used in conjunction with small amounts of radiolabeled compounds to visualize anatomy function. Magnetic Resonance Imaging (MRI) uses a very high magnetic field to image the structure of the anatomy to very fine detail. A small company, Tiny Imaging, is close to finalizing development of an imaging device that will combine the abilities of PET to visualize function and MRI to visualize structure. The device will be one of a few machines that can actually combine PET and MRI imaging.
It is the combination of MRI and PET merged in one device which opens up new avenues for researchers and medical doctors. The device would provide high-resolution images of the body structure while simultaneously showing the functional activities occurring in healthy and diseased tissue. This device would enable scientists and doctors to simultaneously analyze the structure and function of the brain down to the molecular level. While MRI differentiates between different types of tissue in the body, PET makes the physiological and biochemical activities of the tissue visible. This combined imaging technique holds out great promise for researchers and doctors to exactly visualize cancerous tissue and plan treatments or review treatment outcomes.
The small company, Tiny Imaging, has discovered that Siemens has developed prototypes of a combined PET and MRI device and is close to launching it in the human medicine market. Siemens sold a few prototypes into the large animal medical research field. Based on market research, it appears that the other two major companies in this medical imaging field (GE and Phillips), are not actively researching a combined PET with MRI device and are far behind Siemens in this development.
Tiny Imaging has identified three potential markets for their combined PET and MRI technology. The three markets are the small animal (rats and mice) medical research market, the large animal (dogs and pigs) pre-clinical medical research market, and the human medicine market. Tiny Imaging has completed market research and knows the following things about the three markets:
Small Animal Research Market –
• This market is dominated by GE Imaging, Siemens, and Phillips Imaging.
• This imaging market overall is large ($250 million+/yr) and competition between these large companies is intense because all human drugs need to go through small animal testing and the companies react quickly to competitive moves in this market.
• Imaging using PET or MRI is a common way to examine the effectiveness of the drugs given to the animals.
• No company yet has developed a combined PET and MRI device for this market.
• Market research with key small animal research facilities has indicated moderate interest in a combined PET and MRI device.
Large Animal Research Market –
• This market is served by the same three companies, GE Imaging, Siemens, and Phillips Imaging.
• This imaging market is small ($50 million/yr) and many of the machines in this market are specialized and not mass produced.
• Siemens sold fewer than five experimental combined PET and MRI machines into this market and the machines were well received. However, Siemens has announced that it will not manufacture any more combined PET and MRI machines for this market and will instead focus their combined PET and MRI machine on human medicine.
• Market research with key large animal research facilities has indicated that many of the large animal research facilities are very interested in a combined PET MRI machine to help them compete for grants and do large animal research.
Human Medicine –
• This imaging market is huge ($1 billion+/yr) and growing.
• The market is dominated by GE, Siemens, and Phillips.
• Siemens has announced that it will soon introduce a human medicine combined PET and MRI device and early adopters are lining up to buy the early devices.
• Phillips and GE do not have a combined PET and MRI device on the drawing board and appear to be far behind in this development.
• Market research with key human medicine facilities has indicated cautious interest that could grow rapidly if Siemens’ new devices show significant improved patient outcomes.
Questions1 for Example 3 –For each market identified above, evaluate the potential of the Tiny Imaging technology to be either a disruptive innovation or a sustaining innovation in that market. Explain for each market why the technology could be disruptive or sustaining.
Questions 2 for Example 3
The technology developer of the new combined PET and MRI device, Tiny Imaging, is a small R&D company with minimal commercialization experience. The technology is not yet fully developed and is 1 year away from being ready for first sales. The company has the option of launching in any one of the three markets within a year or licensing the technology to someone else. What path(s) to commercialization and value maximization would you recommend for Tiny Imaging? Defend/justify your choice(s) and identify the potential risks and benefits of your suggested approach.
Example 4 – Read the following example of a solar powered ice generation machine.
Cooling and ice creation solutions are needed for applications where available power is variable due to the nature of its generation. This is typically the case for areas dependent upon alternative energy sources such as wind power or areas where power grids are “loosely controlled” with respect to the quality of power available from the power grid such as in developing countries.
An innovation by a Cedar Park, TX company addresses this issue with an ice creation solution which is highly efficient when variable power loads are present. The preferred embodiment of the invention uses solar power to generate food grade ice. This unique ice generation solution can use solar power and a maintenance free ice unit to produce high quality fresh water ice from seawater or other non-potable water sources. The ice created can then be used for cold storage purposes or be converted to clean drinking water. The preferred embodiment produces 1 ton of ice per day for a unit that costs $100,000 and requires no trained operators or expensive maintenance and no consumables other than water and sunlight.
The nature of this solution allows for ice creation to occur in a variety of areas where conventional ice making solutions are considered problematic due to minimal or low quality available power and/or no access to clean water. This is significant as the availability of ice can serve multiple purposes ranging from medical and food preservation to personal consumption.
The developing company is interested in commercializing the technology but they are small and don’t have extensive commercialization experience. They have identified three markets for their device.
Potential Markets Market Benefits
Developing countries, development programs, and medical services providers • Lower costs through prevention of food spoilage as lost food, and foundation for added economic development (commerce)
• Path to market likely works with aid groups and governments to deploy units
US FEMAResponse
• Lower health costs by transitioning high quality ice into potable “clean” water that may also aid in the prevention of water borne illnesses.
• Lower costs associated with quicker disaster recovery
• Lower costs through prevention of medicine spoilage
• Lower costs through prevention of food spoilage
• Low cost solution for medical requirements associated with storage and medical procedures
Military • Increased efficiency as ice is a motivator for hydration which supports health and force readiness requirements (lowers force readiness costs)
• Supplemental source for potable water
Questions 1 for Example 4 – Do any of the market approaches appear to offer the possibility of disruption? Why or why not?
Questions 2 for Example 4- The technology developer of the solar ice machine is a small R&D company with minimal commercialization experience. What would you suggest as paths to the commercial market for the technology for each of the 3 specified markets (licensing to an existing player or a spin-out company focused on commercialization of this technology with an appropriately experienced team)? Explain your choices and the potential risks and benefits of your suggested approach for each of the 3 markets.
Example 5
A seed stage company has been formed around a licensed technology that has been developed using $10 million in federal funds. The technology is a very early stage biotech product that has shown effectiveness in treating hemorrhagic shockin small studies on rabbits. It has been discovered by a leading researcher at a major university. It is many years away from product sales and has not gone through any formal trials. The belief is that the drug could treat hemorrhagic shock even after the trauma and shock has begun in the injured patient. Shock is a major problem for trauma patients and a major cause of death. The company estimates that the US market is a potential annual market of over$500 million. No drug treatment for shock post injury exists and patients have limited treatment options.
Patents have been filed on the technology, and initial feedback from the patent office has been positive but the patents are not yet issued. The seed stage company has licensed the patent-pending technology from the university. The company has one employee, the CEO, who is a former Business Director from a large drug development company. The innovator will not join the company but will continue to do company directed research on the technology. The innovator has a history of successful products moving into commercialization, including one product with $800 million in annual sales that is the leader in its drug category. The innovator remains at the university and is a technical advisor to the company. The company has $50,000 cash on hand and is trying to raise a $1 million first round of funding to continue the development of the technology and hit a key FDA approval milestone.
Questions for Example 5 – As part of the fundraising process, the company has entered into negotiations with a group of angel investors to invest in the company. The company is seeking a $1 million investment. What is your estimate of an appropriate starting valuation (pre-investment) for the company and why?

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Case study 11

Questions for discussion

What ethical issues might arise in the conduct of this research? MJ’s research reflects a growing trend in the use of electronic means to gather and record data. This is particularly the case where studies focus on the needs and experiences of people who find other research methods too demanding. Some previous studies on adults who have survived traumatic brain injuries illustrate this point. Egan et al. [1], for example, con- ducted email interviews in Australia with adults who had survived traumatic brain injuries. When asked their opinion of this method of data collection, partic- ipants ‘overwhelmingly reported that they preferred email interviewing to a face-to-face encounter’. Reasons for this preference included difficulties in coping with the multiple stimuli generated in face-to- face meetings in which verbal and non-verbal signals have to be de-coded alongside whatever is being said, the need for frequent breaks because of pain or other physical problems, and limited energy levels. Using email to collect data allowed participants to take part in their own time, as and when they felt able, and take breaks whenever they liked.

Thus, participation can be combined with other activities such as watching television or minding chil- dren [2]. Participants may be widely dispersed over large geographical areas and still be able to take part; the researcher will not have to make appointments or bear the costs of travel [1,3,4]. The lack of face-to- face communication can have a disinhibiting effect, enabling participants to talk frankly about issues that they might otherwise feel too embarrassed or unable to discuss [2]. Thus participants who have survived traumatic brain injury, may feel able to talk freely, in emails, about those aspects of their lives which those

immediately involved in caring for them do not wish or know how to address.

However, using email can also create a number of challenges for MJ. First is the issue of access and skills. Whilst email and the internet have the poten- tial to enable the recruitment of participants from many different social and geographical settings they also may exclude the poor, elderly and, unemployed [3]. MJ ought to consider whether the people she plans to study have access to email and the skills required to take part in the study. Egan et al. [5,6] developed a training programme for survivors of traumatic brain injury. All those involved had cogni- tive-linguistic impairments but proved able to learn. If they are to take part in research, participants need to be literate in the language used in the project, able to switch on a computer, and know how to use email. Training may help to make the project more attractive to potential recruits and be seen, by them, as one of the benefits of taking part. Thus MJ could say, in her information for participants, that training in basic computer skills and in using email will be given as part of the project. However, training is only useful if it is backed up by good support so that participants know whom to turn to if difficulties arise. Researchers should be computer literate and familiar with the procedures they are asking participants to use. They should either able to cope with electronic problems themselves or have good technical support in place.

Second, MJ will need to consider the ethical prin- ciple of respect for autonomy [7]. Potential partici- pants should be regarded in the same light as anyone else invited to take part in research. Participant infor- mation is just as important, although MJ can explore the possibility of different modes of presentation such as podcasts, rather than text, providing that these

Ethical issues in using the internet in research: commentary PAULA McGEE Birmingham City University, Birmingham, UK

This study appeared in full in the last issue of Research Ethics Review (2008; 4 (2): 68). MJ’s research focuses on those patients with brain damage following trauma such as a road traffic accident. She wants to find out about their experiences of daily life once they have been discharged from hospital. She plans to use a phenomenological approach in which each participant will be asked to take part in a series of in-depth interviews, via email, over a period of about two years. These interviews will allow her to compare participants’ experiences in different parts of the UK. MJ has a research partner in Auckland; the two of them are planning a similar series of interviews in New Zealand to allow for comparison between participants’ experiences in the two countries.

https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/265288760_Internet_Communication_and_Qualitative_Research_A_Handbook_for_Researching_Online?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/265288760_Internet_Communication_and_Qualitative_Research_A_Handbook_for_Researching_Online?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/38310623_Challenging_Methodological_Traditions_Research_by_Email?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43448891_Accessible_Internet_training_package_helps_people_with_aphasia_cross_the_digital_divide?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182893_The_Ethics_of_Using_the_Internet_to_Collect_Qualitative_Research_Data?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182893_The_Ethics_of_Using_the_Internet_to_Collect_Qualitative_Research_Data?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/7587755_An_Internet_training_intervention_for_people_with_traumatic_brain_injury_Barriers_and_outcomes?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43493712_The_Principles_of_Biomedical_Ethics?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
meet research governance standards. Consent could also be recorded verbally and stored in a sound file unless a written signature is deemed essential and can be obtained [8]. What matters is that potential partic- ipants receive appropriate information and are able to make informed decisions about whether they wish to take part. However, extra care may be needed in obtaining consent from those who have survived brain injuries. Egan et al. [1] asked each potential participant to nominate a support person who could go through the information with them and verify their understanding. The involvement of the support person continued throughout the project providing help if the participant became distressed and acting as a point of contact for the researcher if she became worried about an individual. Consent was also obtained from legal guardians, where these had been appointed. On paper, this approach seemed very rea- sonable but nine people, that is to say half, of the par- ticipants deeply resented it. They argued that they were highly dependent on others for every aspect of their lives and their involvement in the project pro- vided a space in which they could deal with some- thing by themselves; the project offered one small step towards independence. Clearly the views of these participants did not match those of researchers and REC members who tend to regard those with brain injuries as ´vulnerable`. Egan et al’s research [1] demonstrates that ideas about vulnerability may be experienced as patronising and perhaps unhelpful by those they are intended to protect. One solution to this issue may be found in consulting directly with people who have survived brain injury and trying to elicit their views on the best approaches to use.

Third, and allied to respect for autonomy, is the ethical principle of non-maleficience, the avoidance of harm [7]. Data collection is likely to remind partic- ipants of very painful experiences: the events sur- rounding their trauma, being in hospital, fear of death, changes in family relationships and coping with, what for some, may be a profound disability and loss of independence. Such recollections can be diffi- cult for both the participant and the researcher. The researcher has a responsibility to ensure that all rea- sonable steps are taken to help participants cope with the aftermath of the interview. Providing appropriate help requires careful thought, the ability to anticipate some of the problems that may arise and a willingness to try different approaches. For example, a debriefing programme might be developed in the form of a pod- cast that could be sent either when the interview is complete or at any point at which the researcher becomes concerned about a participant’s well being [8]. Alternatively, it may be appropriate to identify and recruit help from local sources of support. Egan et al. [1] were correct in principle to appoint local support people but more consideration was needed to

clarify their role. Much depends on the individual sit- uation; the researcher ‘must decide on a case-by-case basis whether the distressing information demands a response, if a response or intervention is indeed a possibility’ [9]. From the researcher’s perspective, coping with distressing interview content can be very stressful and disturbing whether it arises in email or face-to-face encounters. MJ may need to arrange some debriefing support, especially if she has not pre- viously undertaken work with adults who have acquired serious disabilities.

Concerns about distressing content lead into con- siderations of privacy and the ways in which this may be compromised by the research. Participants will need to be assured that the information they provide will be treated in confidence and that they will not be identified in any reports or documents. This may be particularly important for those seeking legal redress or who are engaged in other forms of litigation, such as access to their children, in which their current mental state and abilities may be subject to assess- ment. Those attempting to rebuild their lives may also not want others to know about their thoughts and experiences. Finally, participants may want to express criticisms of services, their families and car- ers but, at the same time, wish to avoid jeopardising relationships with people on whom they depend. MJ will need to establish the level of assistance that indi- viduals require in order to contribute their views and experiences. In some instances, additional software or hardware may be necessary to enable individuals to use a computer independently.

What role might the REC play in enabling MJ to address these ethical concerns? The impact of email and the internet is still very new and, consequently, there are as yet no definitive guidelines for researchers [8]. Constructive dialogue between researchers and REC members is, therefore, essential in developing good practice and ethically- sound research. REC members may feel rather over- whelmed by the technicalities of conducting a project of this kind and worry that they are not sufficiently computer-literate to give an opinion. Such feelings are reasonable but not altogether well-founded. The REC members’ central focus is still the rights and well being of the participants and the ethical issues inher- ent in the design. Participant information remains crucial; it is not the format that matters but the con- tent. Free and informed consent is essential; how it is recorded, providing that some permanent format is used, matters less.

Thus, from the REC members’ perspective, con- structive dialogue is rooted in the principles of research governance which remain the same, irre- spective of the research design. In this instance, these principles are to be applied flexibly and creatively.

Paula McGee118

https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182913_Techno-Research_and_Cyber-Ethics_Challenges_for_Ethics_Committees?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182913_Techno-Research_and_Cyber-Ethics_Challenges_for_Ethics_Committees?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182913_Techno-Research_and_Cyber-Ethics_Challenges_for_Ethics_Committees?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43493712_The_Principles_of_Biomedical_Ethics?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
REC members will need to have open minds, and a willingness to engage with novel approaches whilst bearing in mind that their advice and opinion will carry weight for the future as a contribution towards consensus on good practice in this type of research.

What concerns might the REC have about data management in this proposed research? Data management will, in many respects, differ little from that in other research projects. The nature of the data to be collected, how they will be stored, who will have access to them, how they will be used and destroyed are routine topics for consideration in any ethical review. The difference here is that MJ is plan- ning to do a series of interviews in New Zealand and then compare the outcomes with those conducted in the UK. It is not clear whether this work is to run concurrently with the UK project or as a later exten- sion but the MJ her colleague will need to follow the procedures for research governance that pertain in New Zealand. Data collection and management in the UK is governed by the Data Protection Act 1998. Sharing data between researchers within the European Union is fairly safe in that all member states have to comply with regulations governing the processing and movement of data [10](Directive 95/46/EC). New Zealand has had legislation about privacy since 1993 and the Office of the Privacy Commissioner [11] regularly produces guidance on how data should be handled. In both countries REC members may wish to satisfy themselves about the

ways in which data will be shared via the internet and ensure that adequate arrangements are in place.

References 1. Egan J, Chenoweth L, McAuliffe D. Email-facilitated qualitative

interviews with traumatic brain injury survivors: a new accessible method. Brain Injury 2006; 20(12): 1283-94.

2. Rodham K, Gavin J. The ethics of using the internet to collect qualitative research data. Res Ethics Rev 2006; 2(3): 92-7.

3. Mann C, Stewart F. Internet communication and qualitative research. London: Sage 2000.

4. McAuliffe D. Challenging methodological traditions: research by email. The Qualitative Report 2003; 8(1): 57-69.

5. Egan J, Worrall L, Oxenham D. Accessible internet training pack- age helps people with aphasia cross the digital divide. Aphasiology 2004; 18(3): 265-280.

6. Egan J, Worrall L, Oxenham D. An internet training intervention for people with traumatic brain injury – barriers and outcomes. Brain Injury 2005; 19(8): 555-568.

7. Beauchamp T, Childress J. Principles of biomedical ethics, 5th edn. Oxford: Oxford University Press 2001.

8. Haigh C, Jones N. Techno-research and cyber-ethics: challenges for ethics committees. Res Ethics Rev 2007; 3(3): 80-3.

9. Gryner A. The ethics of internet usage in health and personal nar- ratives. Social Research Update; issue 49, Spring 2007. Department of Sociology, University of Surrey Available at http://sru.soc.surre.ac.uk/SRU49.html

10. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data available at http://www.cdt.org/privacy/eudirective/EU_Directive_.html

11. Office of the Privacy Commissioner, New Zealand. At http://www.privacy.org.nz.

119Ethical issues in using the internet in research: commentary

The author has requested enhancement of the downloaded file. All in-text references underlined in blue are linked to publications on ResearchGate.The author has requested enhancement of the downloaded file. All in-text references underlined in blue are linked to publications on ResearchGate.

https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/6665237_Email-facilitated_qualitative_interviews_with_traumatic_brain_injury_survivors_A_new_and_accessible_method?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/265288760_Internet_Communication_and_Qualitative_Research_A_Handbook_for_Researching_Online?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/265288760_Internet_Communication_and_Qualitative_Research_A_Handbook_for_Researching_Online?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/38310623_Challenging_Methodological_Traditions_Research_by_Email?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/38310623_Challenging_Methodological_Traditions_Research_by_Email?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43448891_Accessible_Internet_training_package_helps_people_with_aphasia_cross_the_digital_divide?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43448891_Accessible_Internet_training_package_helps_people_with_aphasia_cross_the_digital_divide?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43448891_Accessible_Internet_training_package_helps_people_with_aphasia_cross_the_digital_divide?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182913_Techno-Research_and_Cyber-Ethics_Challenges_for_Ethics_Committees?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
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https://www.researchgate.net/publication/258182893_The_Ethics_of_Using_the_Internet_to_Collect_Qualitative_Research_Data?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/258182893_The_Ethics_of_Using_the_Internet_to_Collect_Qualitative_Research_Data?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/7587755_An_Internet_training_intervention_for_people_with_traumatic_brain_injury_Barriers_and_outcomes?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/7587755_An_Internet_training_intervention_for_people_with_traumatic_brain_injury_Barriers_and_outcomes?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/7587755_An_Internet_training_intervention_for_people_with_traumatic_brain_injury_Barriers_and_outcomes?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43493712_The_Principles_of_Biomedical_Ethics?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==
https://www.researchgate.net/publication/43493712_The_Principles_of_Biomedical_Ethics?el=1_x_8&enrichId=rgreq-3f4f4224d8836ab60fa9db259b62aaf5-XXX&enrichSource=Y292ZXJQYWdlOzI1ODE4MzA0MztBUzoxNDkyNTE3MzY3Mzk4NDFAMTQxMjU5NTc5NTE1OQ==

You and your partner have been practicing safe sex for since the beginning of your sexual relationship two months ago. You both agree to an HIV test, and the results are negative for both of you. How will this influence your behavior? The ELISA that you received detects the presence or absence of antibodies against HIV. Antibodies can take one to six months to develop after exposure to HIV. During this time between exposure and antibody production the virus can reproduce rapidly and the amount of virus present in body fluids is high. How does this information influence your behavior?