THE PENROSE INQUIRY
Final Report

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Appendix 1

Inquiry Procedures

Terms of Reference

The Terms of Reference for the Inquiry were agreed between the Scottish Ministers and Lord Penrose. By letter to Lord Penrose dated 12 January 2009 the then Cabinet Secretary for Health and Wellbeing, Nicola Sturgeon MSP, provided further explanation of certain aspects of the Terms of Reference. An amendment to the Terms of Reference for the Inquiry was announced on 13 November 2009 to include three additional deaths which were to be investigated and a further amendment to them was made on 22 February 2011 to remove one of those individuals from the investigation. The Terms of Reference as amended are:

Term of Reference 1:

To investigate the systems in place in Scotland for the collection, treatment, licensing, testing, preparation for supply and supply for use by the NHS of blood and blood products with particular reference to the risks of transmission of the Hepatitis C virus and HIV to patients treated by the NHS in Scotland, including the role of government in regulation and setting guidelines and standards.

Term of Reference 2:

To investigate the systems in place for informing patients treated by the NHS in Scotland of the risks associated with the use in their treatment of blood or blood products, with particular reference to the risks of infection with the Hepatitis C virus and HIV.

Term of Reference 3:

To investigate the systems in place in Scotland for obtaining consent from, and testing for infection with Hepatitis C and HIV, patients treated with blood or blood products, and informing any patients found to be so infected.

Term of Reference 4:

To investigate the systems for recording and monitoring the numbers of NHS patients in Scotland treated with blood and blood products, with particular reference to the numbers exposed to risk of infection with the Hepatitis C virus and HIV and the numbers contracting either or both such infections as a consequence of such treatment.

Term of Reference 5:

To examine the circumstances generally in which patients treated by the NHS in Scotland became infected with Hepatitis C, HIV, or both through the use of blood or blood products in the course of their treatment, taking account of the development of scientific and clinical understanding and evidence internationally.

Term of Reference 6:

To investigate the deaths of Reverend David Black, Mrs Eileen O'Hara, Alexander Black Laing and Victor Tamburrini, with particular reference to the circumstances in which they became infected with the Hepatitis C virus, HIV or both.

Term of Reference 7:

To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland, including NHS Boards and the Scottish National Blood Transfusion Service (SNBTS), their officers and employees and associated agencies, once Hepatitis C and HIV were identified, to trace individuals who might have become infected with one or both of them as a result of receiving blood or blood products; and to identify any other or further steps that might reasonably have been taken to trace such individuals.

Term of Reference 8:

To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and the SNBTS, their officers and employees and associated agencies, to prevent the provision of infected blood and blood products.

Term of Reference 9:

To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and the SNBTS, their officers, employees and associated agencies to inform individuals who might have received infected blood or blood products of the risks associated with their treatment for themselves and their families; and to offer treatment to any individual at risk, and to identify any other or further steps that might reasonably have been taken to inform and to treat such individuals.

Term of Reference 10:

To examine any particular adverse consequences for patients treated by the NHS in Scotland, and their families, of infection through blood and blood products with Hepatitis C and HIV, including the treatment offered.

Term of Reference 11:

To identify any lessons and implications for the future, and make recommendations.

Term of Reference 12:

To report as soon as practicable.

The Inquiries Act 2005 and the Inquiries (Scotland) Rules 2007

The Inquiry was established under the Inquiries Act 2005 ('the 2005 Act'). Inquiry procedures were governed by the 2005 Act and the Inquiries (Scotland) Rules 2007 ('the 2007 Rules').

Procedure Directions, Guidance Notes and Restriction Orders

Section 17 of the 2005 Act states that, subject to the provisions of the Act itself or of the 2007 Rules, the Chairman of the Inquiry may make his own directions as to the procedure and conduct of the Inquiry. Under this section, Lord Penrose issued a number of procedure directions and guidance notes which were published on the Inquiry's website. These are listed in Appendix 5.

Sections 19 and 20 of the 2005 Act provide that restriction may be imposed on attendance at an Inquiry or any particular part of it and on disclosure or publication of any evidence or documents given, produced or provided to an inquiry. Under these sections of the 2005 Act the Chairman made the restriction orders listed in Appendix 5.

Preliminary hearing and the two phases of the Inquiry

On 31 March 2009 a preliminary hearing was held at which the Chairman outlined the approach he intended to take to the conduct of the Inquiry and in fulfilling his remit.

The Inquiry was conducted in two broad phases.

The purpose of phase 1 was to focus the issues which the Inquiry required to consider at the public hearings and, having regard to the Chairman's obligations under section 17(3) of the 2005 Act (duty to act with fairness and to avoid any unnecessary cost), to reduce the length of these hearings.

Phase 1 of the Inquiry consisted of:

  • The gathering of documentary evidence from various sources.
  • The taking of witness statements.
  • The consideration of the evidence with the aim of establishing as much as possible of the medical and scientific background and identifying the controversial facts and issues which required further investigation.
  • The drafting and publishing of the Preliminary Report.

Due to the volume of documentation which the Inquiry examined, the complexity of the medical and scientific background and the extent of the time period covered by the Inquiry's Terms of Reference, a decision was made early in the Inquiry process that it was both appropriate and necessary for the Inquiry to produce a Preliminary Report. The aim of the Preliminary Report was to provide the results of the Inquiry's research and analysis of the information received and the evidential background to the topics identified in the Terms of Reference in order to provide a basis on which to move forward and examine the areas of controversy at the public hearings.

Phase 2 of the Inquiry involved:

  • The gathering of further evidence.
  • Holding public hearings into the issues which had been identified as requiring further investigation (see 'List of topics ...' section below).
  • Sending warning letters and considering the responses to these.
  • Writing the Final Report containing a detailed analysis of the evidence on the topics and the conclusions reached in respect of these.

Call for evidence

On 24 June 2009 the Inquiry issued a public call for documents and witness statements relating to the Inquiry's Terms of Reference. This call for evidence was made in a press release to the national, local, online and broadcast media (including all health correspondents). All persons and organisations holding documents relevant to the Terms of Reference were invited to contact the Inquiry Secretary to discuss the documents held and the best means of producing them. In addition, patients who contracted Hepatitis C and/or HIV through receiving blood and/or blood products from the NHS in Scotland, and the relatives of such patients, who wished to provide a statement were asked to contact the Inquiry.

The Inquiry also sought to reach potential witnesses with a call for evidence on its own website, in a Google advert, by Twitter and on Facebook. The Inquiry distributed a poster and leaflet to all haemophilia centres in Scotland and to all health boards asking that they be distributed to all GP practices. With the help of Community Pharmacy Scotland the posters and leaflets were also sent to all pharmacies in Scotland. Haemophilia Scotland distributed the leaflets through its membership newsletter and promoted the Inquiry through its website and through membership meetings.

On 18 March 2010 Lord Penrose made a radio broadcast on Radio Scotland to appeal for more witnesses to come forward. At this time a further call for witnesses was made in local newspapers across Scotland.

Notices for, and request for, production of evidence

Section 21(2) of the 2005 Act gives the Chairman the power to require a person to provide evidence to the Inquiry in the form of a written statement and to provide any documents in his or her custody or under his or her control that relate to a matter in question at the inquiry.

As this is a Scottish inquiry, section 28(4) of the 2005 Act provides that those powers are not exercisable so as to require any evidence document or other thing to be given, produced or provided by or on behalf of, amongst others, Her Majesty's Government in the United Kingdom.

The use of these statutory powers to recover documents did not necessarily mean that an organisation was unwilling to assist the Inquiry. Where an organisation held documents containing personal data or which were confidential, then providing the documents to the Inquiry in response to a Section 21 Notice meant that the data were lawfully processed.

On 17 September 2009 Lord Penrose served a notice under section 21 of the 2005 Act on Scottish Ministers requiring production of all documents in their custody or under their control relating to the Inquiry's Terms of Reference and dating from the period from 1 January 1974 to 31 December 2006. In response to that notice, the Scottish Government produced over 37,000 documents to the Inquiry. At the request of the Inquiry, two officials from the Scottish Government provided written witness statements in relation to the procedures for the identification and production of those documents and to explain the position as regards documents that had been destroyed or were being withheld by reason of legal professional privilege.

On 2 October 2009 Lord Penrose served a notice under section 21 of the 2005 Act on the Common Services Agency for the Scottish Health Service requiring the production of 482 Scottish National Blood Transfusion Service files listed in the Appendix to the Notice. The 482 files in question were selected by the Inquiry Team from an index, referred to as 'the documentation account', which had been prepared by the SNBTS in anticipation of requests for production of documents from its records. In view of the importance of the documentation account in the identification of the files to be produced to the Inquiry, a request was made to the SNBTS for a witness statement on various issues arising in relation to its preparation. Such a statement was provided by the SNBTS Public Inquiry Team Co-ordinator.

In 2006 the Department of Health commissioned a review of all documents held between 1970 and 1985 in relation to blood safety. The Review of documentation relating to the safety of blood products 1970-1985 (Non A non B hepatitis) was issued on 22 May 2007. Early in 2009 the Inquiry advised the Department of Health that it would require files relating to blood and blood products between 1986 and 1991. In September 2009 the Department of Health produced a list of about 166 files they had identified as possibly relevant to the Inquiry. Many such files ran to several volumes. On 26 October 2009 the Inquiry requested copies of documents previously disclosed by the Department of Health in terms of Freedom of Information releases. After further correspondence with the Department of Health in June 2010 the Inquiry advised the Department of Health that it was particularly interested in files between 1 January 1989 and 1 September 1991 relating to the testing of donated blood for Hepatitis C. The Inquiry indicated 50 files which appeared to it to be of relevance and these files, together with some others, were made available for inspection by the Inquiry. Between 1 and 4 November 2010 two members of the Inquiry Team visited the Department of Health to review files of potential relevance to the Inquiry. As a result of this visit the Inquiry was provided with 63 documents.

Documentary evidence

Nearly 120,000 documents were recovered from both public and private sources. The majority came from the records of the Scottish Government and various NHS bodies.

In addition, statements were provided by patients and their relatives, clinicians and others. These statements were often accompanied by supporting documents.

Appendix 2 gives further information about how the documentary evidence was processed and used by the Inquiry.

Annual summaries and framework document

Much of the Inquiry's work during the first year consisted of the team considering the documentary material as it was recovered. This task was undertaken by means of summarising the relevant documents and then inserting references to the documents in summaries prepared for each of the key years - the annual summaries. Within each annual summary, documents were referred to under three separate hearings: developments in respect of HIV; developments in respect of HCV; and developments in respect of blood products. From these annual summaries the main events relevant to the Terms of Reference were extracted. The Inquiry drafted a framework document containing the references of all documents relevant to the Terms of Reference. This framework document ran to 107 pages and became a timeline reference for subsequent work of the Inquiry.

Taking of statements from patients and relative witnesses

The Inquiry engaged three statement takers to meet with and take statements from the patient and relative witnesses. These statement takers were provided with specific training for this purpose.

Those witnesses who attended the Inquiry for the purpose of giving their witness statements were entitled to apply for an award of travel and subsistence expenses and/or for compensation for loss of time, under Procedure Direction No. 2.2 - Award of Travel and Subsistence Expenses 1 April 2011 (original direction dated 22 June 2009) and Procedure Direction No. 4.1 - Award of Compensation for Loss of Time 17 February 2011 (original direction dated 22 June 2009).

Seventy-eight patient and relative statements were finalised prior to the publication of the Preliminary Report. These 78 statements were reported on in Chapter 4 of the Preliminary Report. A further 81 patient and relative statements were finalised after the Preliminary Report was published. This figure excludes the witness statements taken from the relatives of those whose deaths were specifically referred to the Inquiry under Term of Reference 6. The witness statements are summarised in Chapter 4. The identities of these witnesses were not disclosed to any other party.

Core Participants

Rule 4 of the 2007 Rules provides that the Chairman may designate a person as a Core Participant in the Inquiry. A 'Core Participant' is usually understood to refer to a participant who will be expected to have a key role during the inquiry, attending for all or substantial parts of the proceedings, either personally or by their recognised legal representatives, and participating actively in the proceedings by making statements or asking questions, subject to the control of the Chairman.

In deciding whether to designate a person as a Core Participant, the Chairman must have particular regard to the desirability of including persons who fall within certain categories stated in Rule 4(2). These categories include those who have a significant interest in an important aspect of the matters to which the Inquiry relates.

It was impracticable and inconsistent with the Chairman's duties under section 17(3) of the 2005 Act (duty to act with fairness and to avoid any unnecessary cost) to designate as a Core Participant every person who had a significant interest in the Inquiry. Given the number of people infected with Hepatitis C or HIV and their family members, such an approach could have resulted in a substantial number of people being designated as Core Participants. Instead, the Chairman considered that a process of selection was required to ensure that the main groups of those with an interest in the subject matter of the Inquiry were represented as Core Participants.

A public invitation was extended to those interested to apply, by 7 July 2010, for designation as a Core Participant. Over 70 applications were received from patients and relatives of patients. Applications were also received from the personal representatives of the five deceased named in Term of Reference 6, the Scottish Ministers, the Common Services Agency for the Scottish Health Service on behalf of the SNBTS, the 14 Scottish Area Health Boards and the Haemophilia Society (known in Scotland as 'Haemophilia Scotland').

All the patients and relatives who applied for designation as Core Participants were represented by Thompsons, Solicitors. On 16 July 2010 the Chairman gave further guidance to these applicants on how he proposed to select those to be designated as Core Participants. He stated that he proposed to designate Core Participants (a) to reflect the distinct interests that could be identified from the circumstances set out in the applications and any relevant witness statements, and (b) to ensure that no more Core Participants were designated than were sufficient to ensure that Thompsons was adequately instructed to represent those interests at the hearings. A hearing was held on 10 August 2010 to consider submissions on this proposed approach.

Following the hearing, the Chairman decided that patient and relative Core Participants should be selected under appropriate groupings of interests, namely:

  • Transfusion cases up to and including 1979.
  • Transfusion cases in the 1980s.
  • Transfusion cases in the 1990s.
  • Hepatitis C cases associated with Haemophilia A up to and including 1979.
  • Hepatitis C cases associated with Haemophilia A in the 1980s.
  • Hepatitis C cases associated with Haemophilia B up to and including 1979.
  • Hepatitis C cases associated with Haemophilia B in the 1980s.
  • HIV cases associated with Haemophilia A or B.

Fourteen patients and relatives who fell within these groupings were provisionally designated as Core Participants, subject to these persons consenting to being so designated. An issue arose as to whether it was necessary for the identities of those who were designated Core Participants to be published. Having considered representations made on behalf of the provisional Core Participants the Chairman decided that only the initials of the Core Participants and the class of interest under which they had been selected would be published. He also decided, to ensure fairness to all concerned, that their identities would only be disclosed to the other Core Participants, subject to explicit undertakings of confidentiality. On that basis, on 30 September 2010, all 14 provisionally designated Core Participants consented to their designation. One further Core Participant was designated in December 2010 to illustrate two of the groupings listed above.

Those designated as Core Participants and their recognised legal representatives are listed in Appendix 3.

Funding of Core Participants

All the individual Core Participants were awarded the expenses of their legal representation. Section 40 of the 2005 Act provides that the Chairman may award reasonable amounts in respect of legal representation in relation to the Inquiry. This section provides that such awards may be made to those attending the Inquiry to give evidence or to produce documents and to persons, including Core Participants, whether individuals or representative bodies, considered by Lord Penrose to have a sufficient interest to justify an award. Rules 17 to 20 of the 2007 Rules make detailed provision in relation to awards. Rule 18 provides that the Chairman has to take into account the financial resources of the applicant and the public interest so far as relating to the making of an award. In addition, a Determination by Scottish Ministers made under section 40(4) of the Act stated certain qualifications and conditions on the Chairman's power to make such awards. The Chairman issued an Inquiry Procedure Direction No 3.1, Applications for legal representation at public expense, in which he provided details about the procedure and conditions for applying for and being awarded such expenses.

Publication of Preliminary Report

On 8 September 2010 the Inquiry published its Preliminary Report. The Preliminary Report set out the evidential background to the topics identified in the Terms of Reference. It did not reach any conclusions on matters of fact. It identified matters that appeared to be controversial and which required further investigation.

List of topics for investigation at the public hearings

The Preliminary Report contained a draft list of topics which the Chairman considered should be examined at the public hearings in light of the Inquiry investigations to date. Responses to this list, including proposed additions or modifications to it, were invited from anyone who had suggestions to make. Fifteen submissions were received and considered. In February 2011 the draft list of topics was finalised taking account of these submissions. The list of topics investigated at the public hearings was as follows:

Part A

The deaths of Reverend David Black, Mrs Eileen O'Hara, Alexander Black Laing and Victor Tamburrini, with particular reference to the circumstances in which they became infected with the Hepatitis C virus, HIV or both.

Part B - HIV/AIDS

B1) The efforts made to discourage 'higher risk' donors from giving blood (by the dissemination of information, including leaflets); whether these efforts went far enough and began early enough.

B2) The use of blood product concentrates in Scotland, including any perceived disadvantages of such products, from their introduction in or around 1974; the continuation of the use of commercial concentrates in particular after:

  • International realisation that these carried a risk of AIDS.
  • The proposal by Dr Galbraith of the Public Health Laboratory Service in May 1983 that use in the UK should be stopped.
  • Significant progress towards self-sufficiency in the manufacture of blood products by the NHS in Scotland had been made.

B3) The implementation of heat treatment against LAV/HTLV-III by the Protein Fractionation Centre in Scotland in December 1984, and the technological background to such implementation, including the history and exploration of methods of heat inactivation by the Scottish National Blood Transfusion Service.

B4) The decision not to use kits from the United States of America for testing donated blood for the virus as soon as they became available but, instead, to follow a process of evaluation of the kits before any such use.

B5a) The information given to patients (or their parents) about the risk of AIDS before their treatment with blood or blood products.

B5b) The tracing and testing of patients who might have been exposed to the virus through their treatment with blood or blood products.

B5c) The information given to patients who might have been infected, or who were found to be infected, and their families.

B5d) In particular, the circumstances in which those patients known collectively as the Edinburgh Cohort became infected with HIV, the testing of such patients for HIV and the information given to them about their infection.

B6) The effects of infection with HIV, including the effects of treatment, on patients and their families.

Part C - Hepatitis C

C1) The acceptance of blood from 'higher risk' donors, in particular:

C1a) Prisoners.

C1b) Donors who had a history of jaundice, and who were negative for Hepatitis B when the existence of Non-A Non-B Hepatitis was known and its presence could not be excluded.

C2) The non-introduction in Scotland of surrogate testing for Non-A Non-B Hepatitis.

C3) The implementation of heat treatment sufficient to inactivate Hepatitis C in blood products by the Protein Fractionation Centre in Scotland in 1987, and the technological background to such implementation, including the achievement of this objective by the National Blood Transfusion Service in England and Wales in 1985.

C3a) The use of blood product concentrates in Scotland in the period between the introduction of NHS heat-treated products in 1984 and the supply of NHS products sufficiently treated to inactivate Hepatitis C.

C4) The interval between the availability of tests for the Hepatitis C virus in 1989 and the introduction of screening of donated blood for the virus in the United Kingdom in September 1991.

C5a) The information given to patients (or their parents) about the risk of non-A, non-B Hepatitis and the severity of the condition before their treatment with blood or blood products.

C5b) The tracing and testing of patients who might have been exposed to the virus through their treatment with blood or blood products.

C5c) The information given to patients who might have been infected, or who were found to be infected, and their families.

C6) The effects of infection with Hepatitis C, including the effects of treatment, on patients and their families.

Topic C3A was added to the list of topics in August 2011, in response to representations from Core Participants.

Preparation of topics for public hearings

Each topic was assigned to one of the Inquiry Counsel and a paralegal. They were responsible for the preparation of each topic for the public hearings and leading the evidence on it.

Inquiry Counsel prepared notes on the line of evidence for most topics detailing the matters which required further investigation at the public hearings, the evidence required for this - namely, the witnesses and the documentary evidence - and any further investigations to be undertaken.

The paralegals sent requests for statements to witnesses. These requests asked the witnesses to provide a written statement of their evidence to the Inquiry and stated the specific matters about which the Inquiry wished the witnesses to provide information. Such requests often included documentary evidence which the Inquiry considered would assist the witnesses in this task and which the witness could consider before providing his or her statement.

Once such statements were finalised the witnesses were asked to provide a signed statement. These statements were then shared with the Core Participants on a confidential basis in advance of the public hearings. Usually they were published on the Inquiry's website.

A few witnesses were either unable or unwilling to provide a statement.

Procedure at the public hearings

The Inquiry produced a document Guidance on the Oral Hearings which set out guidance on what the Inquiry expected from Core Participants and their legal representatives and from witnesses giving oral evidence to the Inquiry and on what could be expected from the Inquiry Team.

The Inquiry heard evidence and submissions on 89 days between 8 March 2011 and 30 March 2012. Hearings were generally held from Tuesday to Friday with a morning and a lunch break each day. They were arranged in blocks with the Inquiry endeavouring to hear all evidence on individual topics together within a block.

A further procedural hearing was held on 29 October 2012 to allow Lord Penrose to hear submissions on behalf of the patients, relatives and the Haemophilia Society that certain witnesses be called to give further evidence on the topic of Statistics.

In terms of Inquiry Procedure Direction No. 6 the Chairman directed that no opening statements be made by Inquiry Counsel or by, or on behalf of, the Core Participants.

All witnesses who were required to attend the hearings were sent a notice by the Chairman under section 21(1) of the 2005 Act. 67 witnesses gave evidence at the hearings. These witnesses are detailed in Appendix 4. Each witness took the oath or made an affirmation before giving their evidence.

The Inquiry endeavoured to release to the Core Participants a list of all witnesses required to attend to give evidence related to a topic four weeks before the commencement of the respective hearings.

The Inquiry endeavoured to produce to the legal representatives of Core Participants and, where considered necessary, to witnesses the documents relied on in each topic four weeks before the start of the evidence in respect of that topic. There was a database - Courtbook - of such documents for the use of the legal representatives of the Core Participants. Appendix 2 provides further information about Courtbook. Within Courtbook documents were grouped and inventoried according to each topic. Witnesses who wished to refer to a document during their evidence were asked to produce such a document to the Inquiry no later than two weeks prior to the start of the evidence on that topic.

Questioning of witnesses was primarily carried out by Inquiry Counsel. Counsel for the Core Participants questioned witnesses on areas of importance. Initially, they were required to have obtained the Chairman's approval to do so but more flexible arrangements were introduced as the hearings progressed.

During the hearings special applications were made by the Core Participants and on behalf of witnesses to allow further documents, including additional statements and comments, to be received in evidence. In addition at times supplementary written information was requested from some witnesses.

Evidence of patient and relative witnesses

Thirteen individuals were selected from all the patient and relative witnesses to give oral evidence at the public hearings for Topics B6 and C6 (the effects of infection with HIV and Hepatitis C) as being representative of, or at least as illustrating, some of the main themes that emerged from the initial statement gathering exercise. The Inquiry selected those it considered would paint as clear and as wide a picture as possible of the severe side-effects of infection with either HIV or Hepatitis C, including the effects of treatment, on themselves and their families. Factors which were taken account of in selecting these witnesses included:

  • The means by which a person was infected with the virus(es).
  • The severity of the effects of infection and the effects of treatment.
  • The nature and range of the effects of infections and the effects of treatment.
  • Where a patient or relative lived and where he or she received treatment.
  • The sex of the patient or relative.
  • The age of the patient or relative.
  • The occupation of the patient or relative.
  • Whether the patient suffered from a pre-existing or other medical condition which meant that it was difficult to distinguish the effects of the infection with the virus.

After identifying potential witnesses to give evidence, the Inquiry wrote to these witnesses asking them if they would be prepared to do so. At the time they were asked to give evidence each of these witnesses was sent a copy of the Inquiry's Guidance on the Oral Hearings. In addition to being provided with information about giving evidence anonymously (see section on anonymity below), each witness was offered the opportunity to give evidence by video conferencing or from behind a screen. None of the witnesses chose to do so.

Those asked to give evidence were also advised that, as a person attending the Inquiry to give evidence, they might be entitled to legal representation and advice at Inquiry expense. Some of these witnesses chose to be legally represented and they were represented by Thompsons, Solicitors.

The Inquiry recovered all the medical records of those witnesses who agreed to give evidence. These medical records were then considered with the witness's statement before a final decision was made about that witness giving evidence.

Anonymity and protection of identity of patient and relative witnesses

It was decided that all patient and relative witnesses giving evidence at the hearings would not have their names or identities disclosed, even if they had no objection to this. This meant that the evidence of these witnesses could be heard on an equal basis.

In order to preserve anonymity, the Inquiry redacted copies of the statements and medical records of these witnesses. All details from which the witness could be identified were redacted from these documents. Each witness had the final say on the information which was redacted.

The redacted witness statements and medical records were made available only to the legal representatives of Core Participants and were provided only after they had given confidentiality undertakings.

Restriction Orders were made restricting those who could attend the hearings at which these witnesses gave evidence to members of the Inquiry Team, Counsel and one representative of the solicitors representing the designated Core Participants and any person authorised by the Chairman to accompany the witness during the hearing of that witness's evidence. The Restriction Orders also prevented the disclosure or publication of their oral evidence or documents revealing their names and identities.

Each witness chose a pseudonym under which they gave evidence and by which they are referred to in the Final Report.

Evidence of relatives of Mr Tamburrini and Mrs O'Hara

Two family members gave oral evidence at the hearings during the investigations into the specific deaths. These were Mrs Jean Tamburrini and Mrs Roseleen Kennedy. Both witnesses were identified and their unredacted witness statements were made available to Core Participants and put on the Inquiry's website.

Final written submissions and final hearing

Core Participants were directed to submit their final written submissions to the Inquiry and to intimate them to the legal representatives of other Core Participants by 5pm on 26 March 2012. Inquiry Counsel did not prepare submissions but set out a list of 67 questions which they suggested fell to be answered.

The final hearing took place on 30 March 2012. The hearing was divided into two parts. During the first part of the hearing, Counsel appearing for the Core Participants each made a brief statement explaining the approach adopted in relation to their written submissions and highlighting any points considered to be of particular importance. During the second part of the hearing Counsel for the Core Participants made closing statements in terms of Rule 10 of the 2007 Rules.

Warning letters procedure

Rule 12(7) of the 2007 Rules provides that the Inquiry must not include any significant or explicit criticism of a person in the report unless the Chairman has sent that person a warning letter and given that person a reasonable opportunity to respond to it. Neither the 2005 Act nor the 2007 Rules define what is meant by a 'significant or explicit criticism' and so the Inquiry gave these words their common sense meanings.

In terms of Rule 12(2) a warning letter must -

(a) state what the criticism or proposed criticism is;

(b) contain a statement of any facts that the Chairman considers may substantiate the criticism or proposed criticism;

(c) refer to any evidence or documents which may support those facts;

(d) invite the person to make a written statement if the person wishes; and

(e) note that the information is subject to confidentiality restrictions.

Rule 12(3) provides that the Chairman may send copies of any evidence or documents referred to with the warning letters if he considers it appropriate to do so.

The Inquiry sent 103 warning letters under Rule 12(7) of the 2007 Rules. The Inquiry sent warning letters to those persons criticised in the final report and to those persons who were subject to criticism by another person when that criticism was narrated in the Report.

Recipients of these letters were allowed 28 days and in a few cases, on cause shown, a longer period to respond. The Inquiry received 100 responses to warning letters. The responses included supporting documentation and together these totalled over 1000 pages.

All responses were carefully considered and, if it was deemed appropriate and/or necessary, the Report was amended to take account of information provided in them.

Keeper of the Records of Scotland

At an early stage of the Inquiry the Chairman consulted the Keeper of the Records of Scotland on the manner and format of creating, maintaining and transferring the records of the Inquiry to the National Records of Scotland (NRS).

In terms of Rule 16(3) of the 2007 Rules at the end of the Inquiry the Chairman will transfer the records of the Inquiry to the NRS.

Appendix 2: Inquiry Organisation and Administration >