Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'. End Notes

05/01/2001

1 – NBAC Report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance at, for example, pages 57, 58, 59 and 61.

2 – Widely varying definitions for “genetic testing” and “genetic information” have been proposed and/or adopted by professional associations and advisory committees, in legislation, and in regulations. The charge to the Working Group did not include a mandate to define these terms. The Working Group acknowledges that these differences in definition will need to be resolved jointly by the relevant federal agencies, the scientific community (including the Secretary’s Advisory Committee on Genetic Testing), the public, and industry.

3 – Ibid. at page 59.

4 – OPRR Report #95-02 provides guidance for carrying out this responsibility and explicitly states that a researcher cannot be the final arbiter of whether or not his or her research is subject to the Regulations. The report can be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc95-02.htm

5 – Relevant current guidance:

6 – NBAC Report at page 60.

7 – Ibid. at page 61.

8 – When therapeutic products are manufactured from human cells or tissue, safety of the recipient becomes the overriding concern. In sharp contrast to the issues posed by concerns for donor confidentiality, extensive experience has demonstrated repeatedly that inadequate knowledge of biological source materials can be life-threatening. The two primary concerns are: (a) microbiological safety testing will not necessarily identify all pathogens; and (b) donor characteristics that are not understood at present may prove to exert decisive effects on the clinical outcome. Thus, the ability to reexamine issues related to donor characteristics may prove crucial to treatment of unexpected adverse effects in biological materials recipients as well as continued scientific progress.

9 – NBAC Report at page 61.

10 – The Working Group notes that the process of certifying that research is not covered by the Regulations does not generally involve the broad array of expertise necessary to (1) judge the expected value of the proposed study (using anonymized samples), (2) assess the expected value of the same study if conducted with identifiable samples, and (3) draw conclusions about whether the difference in expected value is justified. The Working Group believes that such determination of comparative scientific value should remain within the purview of scientific merit review bodies.

11 – Relevant current guidance:

12 – The Institutional Review Board Guidebook, Chapter 3(a) “Risk Benefit Analysis” can be found at: http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm#e1

13 – The Institutional Review Board Guidebook, Chapter 3(d) “Privacy and Confidentiality” can be found at: http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm#e4

14 – The Institutional Review Board Guidebook, Chapter 4 “Considerations of Research Design” can be found at: http://ohrp.osophs.dhhs.gov/irb/irb_chapter4.htm

15 – The Institutional Review Board Guidebook, Chapter 5(h) “Human Genetic Research” can be found at: http://ohrp.osophs.dhhs.gov/irb/irb_chapter5ii.htm#h12

16 – Memorandum titled “IRB Knowledge of Local Research Context” (August 27, 1998, updated July 21, 2000) can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm

17 – Certificates of confidentiality is addressed in “Privacy Protection for Research Subjects”, which can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/certconpriv.htm

18 – NBAC Report at page 64.

19 – In 1997, NIH issued a Request For Applications (RFA) soliciting proposals to study the informed consent process, and funded 18 of the applications received in response to the RFA. The third meeting of these NIH supported investigators was held in April, 2000, and the researchers are collaborating on a joint report of the research results. In addition, in 1999 a Program Announcement (PA) titled “Research on Ethical Issues in Human Studies” was published in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/pa-files/PA- 99-079.html). This PA, supported by 20 Institutes and Centers of the NIH and by the CDC, is intended to support research on any topic relevant to ethical issues in research, including studies focusing on conditions under which consent is obtained. To date, four applications have been funded under this PA. A condition of funding is participation in yearly meetings to report progress, discuss problems and share information with other investigators funded under the Program.

20 – Results of the study, funded by NCI, are currently being analyzed. The investigators examined the use of the National Action Plan for Breast Cancer model consent form in the clinical setting. The study is designed to evaluate whether prospective subjects accept the format, whether information included in the consent form is retained, and what staff and fiscal resources are required for using this model form for obtaining consent in the clinical setting. Preliminary results indicate that information in the consent form was understood and retained, and that obtaining informed consent using this model requires additional time and may possibly require dedicated personnel. The study also raises questions about tracking consents, once samples are stored, in order to ensure compliance with the wishes of the sample sources and about processes and procedures to be used if and when a subject wishes to withdraw consent.

21 – NBAC Report at page 64.

22 – The “Informed Consent Checklist” (Sept 30, 1998) can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm

23 – Additional relevant materials are contained in the FDA Information Sheets for IRBs and Clinical Investigators. In particular the sheet “A Guide to Informed Consent”, which can be found at http://www.fda.gov/oc/oha/IRB/toc5.html, contains guidance on the meaning of 21 CFR 50.25(a)(8).

24 – NBAC Report at page 64.

25 – Ibid. at page 66.

26 – Ibid.

27 – “Points to Consider in Development of Informed Consent Documents that Include the Collection and Research Use of Human Biological Materials” (Information Sheet #15, revised August 2000) from the Office of Human Subject Research (OHSR) at NIH can be found at: http://ohsr.od.nih.gov/info/oinfo_15.php3

28 – Pages 43-46 of the current version of the CDC guide to writing informed consent documents specifically addresses options that may be appropriate to include in consent documents when requesting permission to store human biological materials for future research. The document is found at: http://www.cdc.gov/od/ads/consent.pdf

29 – Sample consent forms and IHS guidelines about the collection and use of research specimens can be found at: http://www.ihs.gov/NonMedicalPrograms/Research/irb.htm

30 – The circumstances spelled out in the regulations are (1) a life threatening situation when there is no time to get consent, or (2) when consent is not feasible during specific military operations involving combat or the immediate threat of combat.

31 – OHRP guidance titled “Knowledge of Local Research Context” is relevant to this issue and can be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm

32 – OHRP guidance to clarify this regulation can be found in decision chart 3 at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm

33 – NBAC Report at page 72.

34 – Ibid.

35 – The Community Consultation was undertaken to obtain input on the responsible collection and use of samples from members of identified populations for the National Institute of General Medical Sciences Human Genetic Cell Repository. The report of the meeting can be found at http://www.nigms.nih.gov/news/reports/communityconsultation.html

36 – NBAC Report at page 72.

37 – The exception refers to instances when the proposed research is to be conducted on an American Indian or Alaska Native reservation. In that case, the tribal government has the legal authority to permit or to refuse permission for that research to be conducted.

38 – International Committee of Medical Journal Editors. Protection of patients’ rights to privacy. BMJ 1995; 311: 1272.

39 – Foster MW, Sharp RR, Freeman WL, Chino M, Berensten D, Carter H. The role of community review in evaluating the risks of human genetic variation research. Am J. Hum Genet 1999; 64 (6): 1719-1727.

40 – NIH Guide for Grants and Contracts, June 5, 2000.

41 – The brochure, entitled Research on Human Specimens: Are you Conducting Research Using Human Subjects can be found at http://www-cdp.ims.nci.gov/policy.html, and at the NIH site, Bioethics Resources on the Web at http://www.nih.gov/sigs/bioethics/

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