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When Leslie spoke to FERCAP about Coast at the 2009 Conference, she noted that the USFDA was committed to checking up on sites conducting trials outside the US territory (see also HHS 2001). She also noted that these check ups would be document based audits. When FERCAP conducts Surveys, Surveyors remind the surveyed committees that while they actually observe a board meeting as part of the SIDCER recognition program, all that an auditor will have to go on is the paperwork. Thus through the promise of the examination of paperwork, concern about documentation grows. Riles (2011:67) reminds us that documents travel across ‘cultural boundaries, forms of expertise, institutions, physical distances, by virtue of their material and aesthetic form.’ Bhatt’s powerpoint and the Thai SOPs are illustrations of the point. For some, FERCAP surveys are a precursor to hosting international research; for some, the hope is that accreditation will attract research to the institution. As Cristina comments:

[The survey] has an impact on an entire research team. You can put the name on your website. I receive queries from sponsors who ask us if we’ve visited this EC and if we have recognised them. Sponsors like assurance that EC is doing their job. Thats how we do our work.

What can be said of ethics when it is international guests one hopes to attract? A Bertrand Russell quotation from the concluding slide of a GCP training in Manila gives us a starting point for reflection: ‘Ethics is in origin the art of recommending to others the sacrifices required for cooperation with oneself’ (Russell (1981 [1917]: 82). A woman a few rows away in the lecture theatre pushed him to comment. ‘I was thinking’, she said, ‘how to interpret it?’ The lecturer pushed against the lectern, looking down. ‘Um, well the way I see it we are all aware of ethical principles’, he began:

And it really requires a lot of sacrifices. But there is a need for an external body to be able to tell us if what we’re doing is ethical or not. Because of the presence of the possibility of conflicts of interest. That’s my thought on that. We know that there are sacrifices that we have to undergo when we are involved in ethics but it has to be recommended by others, or to others. I don’ t know if that’s what Bertrand Russell meant, but [trails off]

’But why would you consider it a sacrifice to comply?’ asked another audience member. ‘No’ he said, ‘its not a sacrifice to comply, its a sacrifice of removing your interests in whatever study you do.’ The quote the lecturer chose is, in one reading, a Russell quip. It is a laconic reflection on the selfishness of ethics — of teaching to others the sacrifices they must make so they can work with you — given your principles, your ‘ethics.’ In this interpretation, ‘ethics’ is reduced to self-interest.

But in the extract from my field-notes, the lecturer’s explanation carries quite another spin. The self is not the requiring self, but the sacrificing self; the sacrifice you make upon the request of an external body. This shift of subject position is revealing, as it neatly reflects the positions of host and sponsor countries in research.

As many researchers are very aware, in order to undertake US sponsored research, the site, investigators and IRB must conform to American specifications. The export of these regulations is exactly — and non-ironically — the requirement of the former interpretation: you must do these things so we can come to your country. A researcher I interviewed in Sri Lanka had been involved with a research project with Duke University in America. He made some perceptive, and revealing comments on the course he followed in preparation for the project.

For their IRB, before being researchers we had to follow a course. They sent us the teaching material, [we] read, they asked us questions, we had to mark the correct answers and submit. They sent us all these documents — consent, anonymity, confidentiality, about minors, assent. They covered all areas with documents. We were expected to read through and answer the email questionnaire. What they really want is for us to be educated. They don’t want to find out how good I am, they want to educate me on research. I thought that was very good, because before we embarked we knew what is good and wrong. So we would not make the same mistakes. [We] would tarnish whatever institution collaborating with, if we did.

As Cristina’s pitch of the SIDCER recognition program to the Cancer Center in China showed (p.26) attracting research is no small part of achieving recognition. The researcher’s comments above about ‘tarnishing’ a collaborating institution added to the sacrificial spin of the lecturer’s interpretation of Russell illustrate just the frame in which the desirability of international research mingles with ideas about developing the host through the presence of the guest.

While FERCAP aims towards an equilibrium of a certain standard, tailoring its improvement recommendations towards each committee, some committees are seeking further, ‘higher’

recognition. In Taiwan FERCAP’s success (recognising over 21 committees in six years) left it with a problem. Having been the object of competition between committees, as Edith had explained to me, the question was becoming ‘what more can FERCAP provide? Further unique comments?’ In interviews, Taiwanese IRB members were concerned that FERCAP might lose its competitive edge to an accrediting organisation called AAHRPP¹⁸, the American Association of Human Research Protection Program, based in the USA. AAHRPP has, in recent years made inroads into the Asian market, accrediting a committee in Singapore, a high-tech post-colony which does not participate in FERCAP’s activities, as well as China (1), India (3) and Korea (3).¹⁹ Cristina reported a conversation she had had with Marjorie Speers of AAHRPP in Geneva:

where she presented her accreditation program. I said our [FERCAP’s] approach was developmental and if a group is just starting up we try to help you achieve a level of competence. That is why we call it “recognition “ not “accreditation’. Their focus is institutional - the human protection program of the institution. So she said we complement each other, we are different. And I suppose we are. But in Asia they think of the US as the gold standard. It’s the WHO that’s important to us. That is where we derive our…

reputation, and some amount of, how to say, some sense of importance.

During my research, AAHRPP had begun to perform accreditation in Taiwan and South Korea.

‘In Asia, if one gets [it], others feel pressure to get [it],’ commented Desmond, a researcher who served on an IRB in Taiwan. ‘Now that almost all the committees in Taiwan have been recognised by FERCAP,’ he told me, ‘some are trying to shift to AAHRPP. Now it has become the gold standard.’ From Desmond I got the impression that it wasn’t just the fact that one committee in Taiwan had succeeded in getting recognised by AAHRPP, it was the three others, in South Korea.

His committee colleague Dana was sure there was an element of competition in the committees seeking accreditation. ‘We like competition,’ she said:

It’s our culture. Because, if you were independent, and I have AAHRPP or FERCAP and you don’t have, people will think your IRB not good enough, so that’s the reason why we have to get more and more.

In this quick sentence, Dana has mapped out a logic that I saw repeated again and again in my interviews in Taiwan, which I tried to unpick with the question ‘good enough for what?’ Dana’s reply was ‘quality of review.’ ‘For our thinking, we can say I’ve got an international recognition, you know I’m an international level.’ I pressed her on why she thought this was this important.

18 Pronounced “A-Harp”

19 Numbers of accredited institutions per country correct as of September 2012.

‘For fame!’ she told me. ‘If people involved in IRB thing, they all know about FERCAP, if [you]

get recognition, they’ll think you’re so international level quality.’ It was not just the opinion of others that mattered, though. Dana explained that when her committee was recognized, she felt a strong sense of pride. ‘I know how it feels,’ she said,

If I got FERCAP recognition, it means our IRB is well organized, our procedures are no problem. Just as some institutions proud of AAHRPP put accredit mark on their website — to show themselves they are excellent.

Although she raised them, she felt ambivalent about AAHRPP’s ‘excellence’:

I think AHRPP is too detailed. I don’t know the details, but because AAHRPP is American, from America, and regulations are not...not really subject to our country. I think FERCAP is OK because they can see the requirements, it’s not limited to just some countries, its very basic for procedures and archiving. If you finish FERCAP recognition, you get a whole view of IRB procedures.

Compare Dana’s explanation of accreditation with Edith’s, as she explains how it is that her committee is ‘good.’ ‘We have two certificates,’ Edith tells me ‘the international FERCAP on, and one from government. Because we have to follow the local laws and regulations in Taiwan, we need the Taiwan accreditation. And the other we want, the international, so we have got it.’ She pauses. ‘I know another system’, she says. ‘It’s an accreditation for the US, mostly,’ she tells me,

‘but they have also done some in Asia: AAHRPP. [Committees] get AAHRPP because they are more strict than FERCAP.’ Edith’s perception of AAHRPP as ‘more strict’ lent it status but, like Dana, Edith wasn’t entirely sure of how this strictness took form. They had many criteria, like FERCAP; it had to be renewed every three years, like FERCAP; and she knew it followed a similar procedure. Nonetheless, ‘getting’ it was ‘very hard.’ Dana expanded on the topic, saying that while hospitals had FERCAP recognition, they were starting to think it ‘was not enough.’ ‘They wanted AAHRPP,’ she said. Dana linked AAHRPP’s appeal to the existing markers of quality that her committee had attained, and the motivations that had fueled them.

I think we want to make sure our quality is very good and we want to have a high standard, and reach, and they can teach us more how to improve. It is for continuing improvement.

[...] In my way, I think our committee is just the beginning, it is not mature.

Dana’s colleague Desmond however, was skeptical of the success that AAHRPP would achieve relative to FERCAP, claiming that despite the appearance that it occupied the same niche, it was a

‘different type of thing’:

FERCAP has recognised 50,²⁰ AAHRPP has recognised 200 in the US territory alone. It wants to jump into the Asian market. You can’t apply a US standard though. The money is different, the structure, and the mentality are different. If you want something here you can’t use the US standard. FERCAP can operate because it doesn’t cost too much. They use rotating volunteers, it’s a good strategy. With AAHRPP, it’s ‘you pay, we send.’

What does Desmond mean when he says the money, the structure and the mentality are different?

I listen as he tries to explain. First, the price tag on an AAHRPP evaluation will sway people, he thinks. ‘It is more expensive, therefore it must be better,’ he tells me. Then its origins in the USA carries cache. Furthermore, it will demand a great deal of work. The survey becomes an audit, in name as well as practice now, encompassing the committee, PIs of projects reviewed, officials of the institution and staff. Desmond thinks interrupting the work of such ‘high’ people for a foreign audit would be the most difficult task. Then there is the matter of the auditors themselves.

‘They don’t accept anything no hotel, flight.’ His interpretation of such refusals was that — for Americans — it would amount to a conflict of interest. ‘They know if come to Asia they will be treat[ed] nice[ly], so they say no hotel, no meal, only cup of coffee. Not a banquet, not a souvenir.’

AAHRPP’s anticipated refusal to engage socially with the committees appears as the antithesis of the ‘mutuality’ that FERCAP is trying to foster. Drawing a comparison between FERCAP and AAHRPP, Desmond said that FERCAP was a foundation project, its intention to ‘build capacity, help build up from ground zero,’ whereas AAHRPP was ‘already at the top floor of that skyscraper, and it gives the sign of qualified.’ Desmond was critical, arguing that assessment external to the region (not just external to the country or the institution) might raise standards on the surface, but allow practices to suffer: ‘Other groups who validate: their mission is to evaluate, and that’s it. FERCAP is not about evaluation alone. The intention is to assist and recognise.’ The distinction drawn by Desmond between evaluation and recognition here references what Cristina (Torres 2011:50) has called the equity of FERCAP’s costings. A shift by more advanced economies to AAHRPP is move that would potentially destabilise FERCAP’s financial structure of taking

20 Correct at the time of Interview, 2012 recognition figures are nearly double that.

(donations) from the rich and giving (help) to the poor, since it was those who could pay who showed interest in migrating.²¹

AAHRPP is not the only means by which American standards, accreditation and systems were spread amongst the people I worked with. Several observed that it was ‘American money’ that had made them capable of doing the jobs that they do through funding six month trainings at Western IRB (WIRB) in Olympia, Washington (Figures 19 and 20).

Figures 19 and 20: A certificate awarded to an International Fellow and a summary of the WIRB program

‘American money is here’, commented one secretary, pointing to herself. Though the ‘centre’ is geographically east of most of the countries who look to it, Western is the name it takes for its location on American’s West coast. Its name also has the effect of carrying with it the conceptual orientation towards ‘the West’. Dana and Edith were not the only secretaries I met who had received training at WIRB (Figure 19). Cassandra, who had been to WIRB for an international fellowship keeps a photograph of her group of international fellows on her desk at work in her

21 It is also possible that some institutions may ‘leapfrog’ FERCAP and move straight to AAHRPP. AAHRPP accredited its seventh institution in Asia, Jehangir Clinical Development Center, in Pune, India in September 2012. AAHRPP stated that

the accreditations are the latest indication that organizations are embracing AAHRPP’s goal of one set of standards worldwide — for CROs, independent institutional review boards, research-intensive universities, medical colleges, hospitals, and other entities engaged in research involving human participants. To attain AAHRPP accreditation JCDC had to show compliance with both India’s requirements for research protections and U.S. regulations […] JCDC CEO Pathik Divate [said] “We viewed AAHRPP accreditation as the logical step to take our program to the next level—for research participation, standardization and quality. We’ve also sent a message to the rest of the research institutes […] If they’re serious about clinical research, they should be thinking about AAHRPP accreditation (AAHRPP 2012).

IRB office. When I asked her about the experience, she explained that WIRB was a ‘well established, well organised major company’, whose job was to review human subject research.

Through the Fellows program she felt it was making a contribution to training Asian ethics committees, helping them ‘learn the best knowledge of IRB’. She told me that people sent there can:

get the knowledge. When they come back, they can modify it, use the base of the knowledge to give suggestions or comments to the policy makers...They don’t want to influence our - they will not - they, when we were in Olympia, they encourage us, they say

‘This is only for USA,’ maybe not subject to your country.

Cristinahad also trained at WIRB and knew the US regulations,

I say I learned these things, but I see it from another perspective...The US regulations are not international regulations. That’s why when I make a presentation I give GCP, Helsinki, and also say this is the practice in the US.

Surveys often exposed the limits of adopting American standards. At the close of a Survey in China, surveyors were making recommendations on how the committee determined whether to classify an application as exempt from review. The survey had found a study involving genetic material which had been classified as exempt by the process the ethics committee currently had in place. The surveyors were concerned. ‘It is the job of the ethics committee to determine whether there is a [genetic] identifier or not. Exempt means you do not do the review!’ When the committee replied that it was something they had adopted as a result of their secretary’s time in America, the surveyor became annoyed.

That’s something they exempt in the US, we do not exempt in our setting. They don’t get information from China and use it in the US. So don’t adopt OHRP,²² that’s for the American population.

The lead surveyor stepped in to explain:

It’s because [Americans] have more regulations, they can control these things. They are automatically controlled by other mechanisms, especially HIPAA²³. The US have an infrastructure to support and catch other things. They fall into other jurisdictions.

The irate surveyor interjected ‘Records are covered by HIPAA law. HIPAA protects you. Do you have HIPAA? No!’ The lead surveyor smoothed once again: ‘Some of them [USA regulations]

don’t apply because there is a different infrastructure. So you have to think about your ethics committee, in that case.’

22 Office for Human Research Protections, Department of Health and Human Services, USA.

23 Health Insurance Portability and Accountability Act, (United States Congress 1996).