Revised Common Rule Changes to the Consent Process and Consent Form

REFERENCES

1. 1.↵
   National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Published April 1 8, 1979. Accessed January 21, 2019.
2. 2.↵
   1. Nelson-Marten P,
   2. Rich BA

   . A historical perspective of informed consent in clinical practice and research. Semin Oncol Nurs. 1999 May;15(2):81-88. doi: 10.1016/s0749-2081(99)80065-5.

   OpenUrlCrossRefPubMed
3. 3.↵
   1. Silverman HJ,
   2. Luce JM,
   3. Lanken PN

   , et al; NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network (ARDSNet). Recommendations for informed consent forms for critical care clinical trials. Crit Care Med. 2005 Apr;33(4):867-882. doi: 10.1097/01.ccm.0000159201.08203.10.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.
   1. Perrenoud B,
   2. Velonaki VS,
   3. Bodenmann P,
   4. Ramelet AS

   . The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Oct;13(10):82-94. doi: 10.11124/jbisrir-2015-2304.

   OpenUrlCrossRef
5. 5.
   1. Flory J,
   2. Emanuel E.

   Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-1601. doi: 10.1001/jama.292.13.1593.

   OpenUrlCrossRefPubMedWeb of Science
6. 6.↵
   1. Lentz J,
   2. Kennett M,
   3. Perlmutter J,
   4. Forrest A

   . Paving the way to a more effective informed consent process: recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials. 2016 Jul;49:65-69. doi: 10.1016/j.cct.2016.06.005.

   OpenUrlCrossRef
7. 7.↵
   1. Niemiec E,
   2. Vears DF,
   3. Borry P,
   4. Howard HC

   . Readability of informed consent forms for whole-exome and whole-genome sequencing. J Community Genet. 2018 Apr;9(2):143-151. doi: 10.1007/s12687-017-0324-6.

   OpenUrlCrossRef
8. 8.↵
   1. Sugarman J

   . Examining provisions related to consent in the revised common rule. Am J Bioeth. 2017 Jul;17(7):22-26. doi: 10.1080/15265161.2017.1329483.

   OpenUrlCrossRef
9. 9.↵
   Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Social Security Administration; Agency for International Development; Department of Housing and Urban Development; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; Department of Transportation. Federal policy for the protection of human subjects. Final rule. Fed Regist. 2017 Jan 19;82(12):7149-7274.

   OpenUrlCrossRef
10. 10.
    Impact of certain provisions of the revised Common Rule on FDA-regulated clinical investigations. U.S. Food and Drug Administration. www.fda.gov/regulatory-information/search-fda-guidance-documents/impact-certain-provisions-revised-common-rule-fda-regulated-clinical-investigations. Published October 2018. Accessed January 25, 2019.
11. 11.↵
    1. Chadwick GL

    . Final rule material: comprehensive guide to informed consent changes. about.citiprogram.org/wp-content/uploads/2018/07/Final-Rule-Material-Comprehensive-Guide-to-Informed-Consent-Changes.pdf. Published 2017. Accessed January 18, 2019.
12. 12.↵
    1. Burris JF,
    2. Puglisi JT

    . Impact of federal regulatory changes on clinical pharmacology and drug development: the Common Rule and the 21st Century Cures Act. J Clin Pharmacol. 2018 Mar;58(3):281-285. doi: 10.1002/jcph.1026.

    OpenUrlCrossRef
13. 13.
    1. DeRenzo EG,
    2. Moss J,
    3. Singer EA

    . Implications of the revised Common Rule for human participant research. Chest. 2019 Feb;155(2):272-278. doi: 10.1016/j.chest.2018.09.022.

    OpenUrlCrossRef
14. 14.↵
    1. Hodge JG Jr.,
    2. Gostin LO

    . Revamping the US Federal Common Rule modernizing human participant research regulations. JAMA. 2017 Apr 18;317(15):1521-1522. doi: 10.1001/jama.2017.1633.

    OpenUrlCrossRef
15. 15.↵
    Highlights of revisions to the Common Rule. National Human Genome Research Institute. www.genome.gov/27568212/highlights-of-revisions-to-the-common-rule/. Updated March 7, 2017. Accessed January 25, 2019.
16. 16.↵
    1. Bierer BE,
    2. Barnes M,
    3. Lynch HF

    . Revised ‘Common Rule’ shapes protections for research participants. Health Aff (Millwood). 2017 May 1;36(5):784-788. doi: 10.1377/hlthaff.2017.0307.

    OpenUrlAbstract/FREE Full Text
17. 17.
    1. O’Rourke PP

    . The final rule: when the rubber meets the road. Am J Bioeth. 2017 Jul;17(7):27-33. doi: 10.1080/15265161.2017.1329484.

    OpenUrlCrossRef
18. 18.
    1. Menikoff J,
    2. Kaneshiro J,
    3. Pritchard I

    . The Common Rule, updated. N Engl J Med. 2017 Feb 16;376(7):613-615. doi: 10.1056/NEJMp1700736.

    OpenUrlCrossRef
19. 19.
    1. Kraft SA,
    2. Porter KM,
    3. Shah SK,
    4. Wilfond BS

    . Comprehension and choice under the revised Common Rule: improving informed consent by offering reasons why some enroll in research and others do not. Am J Bioeth. 2017 Jul;17(7):53-55. doi: 10.1080/15265161.2017.1328535.

    OpenUrlCrossRef
20. 20.↵
    1. Dresser R.

    Research information for reasonable people. Hastings Cent Rep. 2018 Nov; 48(6):3-4. doi: 10.1002/hast.927.

    OpenUrlCrossRef
21. 21.↵
    1. Falagas ME,
    2. Korbila IP,
    3. Giannopoulou KP,
    4. Kondilis BK,
    5. Peppas G

    . Informed consent: how much and what do patients understand? Am J Surg. 2009 Sep;198(3):420-435. doi: 10.1016/j.amjsurg.2009.02.010.

    OpenUrlCrossRefPubMed
22. 22.↵
    1. Paasche-Orlow MK,
    2. Taylor HA,
    3. Brancati FL

    . Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003 Feb 20;348(8):721-726. doi: 10.1056/NEJMsa021212.

    OpenUrlCrossRefPubMedWeb of Science
23. 23.↵
    1. Garrison NA

    . Genomic justice for Native Americans: impact of the Havasupai case on genetic research. Sci Technol Human Values. 2013;38(2):201-223. doi: 10.1177/0162243912470009.

    OpenUrlCrossRefPubMedWeb of Science
24. 24.↵
    1. McGuire AL,
    2. Beskow LM

    . Informed consent in genomics and genetic research. Annu Rev Genomics Hum Genet. 2010;11:361-381. doi: 10.1146/annurev-genom-082509-141711.

    OpenUrlCrossRefPubMed
25. 25.↵
    1. Tabor HK,
    2. Berkman BE,
    3. Hull SC,
    4. Bamshad MJ

    . Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics. Am J Med Genet A. 2011 Dec;155A(12):2916-2924. doi: 10.1002/ajmg.a.34357.

    OpenUrlCrossRef
26. 26.↵
    1. McGuire AL,
    2. Hamilton JA,
    3. Lunstroth R,
    4. McCullough LB,
    5. Goldman A

    . DNA data sharing: research participants’ perspectives. Genet Med. 2008 Jan;10(1):46-53. doi: 10.1097/GIM.0b013e31815f1e00.

    OpenUrlCrossRefPubMed
27. 27.↵
    1. Ludman EJ,
    2. Fullerton SM,
    3. Spangler L,
    4. et al.

    Glad you asked: participants’ opinions of re-consent for dbGap data submission. J Empir Res Hum Res Ethics. 2010 Sep;5(3):9-16. doi: 10.1525/jer.2010.5.3.9.

    OpenUrlCrossRefPubMedWeb of Science
28. 28.↵
    1. D’Abramo F,
    2. Schildmann J,
    3. Vollmann J

    . Research participants’ perceptions and views on consent for biobank research: a review of empirical data and ethical analysis. BMC Med Ethics. 2015 Sep 9;16:60. doi: 10.1186/s12910-015-0053-5.

    OpenUrlCrossRef
29. 29.↵
    1. Lynch HF,
    2. Bierer BE,
    3. Cohen IG

    . Confronting biospecimen exceptionalism in proposed revisions to the Common Rule. Hastings Cent Rep. 2016 Jan-Feb;46(1):4-5. doi: 10.1002/hast.528.

    OpenUrlCrossRef
30. 30.↵
    Secondary research under the final rule: new consent form language requirements with examples. CITI Program. about.citiprogram.org/wp-content/uploads/2018/07/Handout-3-New-Consent-Form-Language-Requirements-with-Examples.pdf. Published 2017. Accessed January 18, 2019.
31. 31.↵
    1. Beskow LM,
    2. Friedman JY,
    3. Hardy NC,
    4. Lin L,
    5. Weinfurt KP

    . Simplifying informed consent for biorepositories: stakeholder perspectives. Genet Med. 2010 Sep;12(9):567-572. doi: 10.1097/GIM.0b013e3181ead64d.

    OpenUrlCrossRefPubMed
32. 32.↵
    1. Roberts JL

    . Negotiating commercial interests in biospecimens. J Law Med Ethics. 2017 March;45(1):138-141. doi: 10.1177/1073110517703107.

    OpenUrlCrossRef
33. 33.↵
    1. Greenberg W,
    2. Kamin D

    . Property rights and payment to patients for cell lines derived from human tissues: an economic analysis. Soc Sci Med. 1993 Apr;36(8):1071-1076. doi: 10.1016/0277-9536(93)90125-n.

    OpenUrlCrossRefPubMed
34. 34.↵
    1. Beskow LM,
    2. Burke W

    . Offering individual genetic research results: context matters. Sci Transl Med. 2010 June 30;2(38):38cm20. doi: 10.1126/scitranslmed.3000952.

    OpenUrlFREE Full Text
35. 35.↵
    1. Allen C,
    2. Foulkes WD

    . Qualitative thematic analysis of consent forms used in cancer genome sequencing. BMC Med Ethics. 2011 Jul 19;12:14. doi: 10.1186/1472-6939-12-14.

    OpenUrlCrossRefPubMed
36. 36.↵
    1. Ravisky V,
    2. Wilfond BS

    . Disclosing individual genetic results to research participants. Am J Bioeth. 2006 Nov-Dec;6(6):8-17. doi: 10.1080/15265160600934772.

    OpenUrlCrossRefPubMed
37. 37.↵
    1. Meltzer LA

    . Undesirable implications of disclosing individual genetic results to research participants. Am J Bioeth. 2006 Nov-Dec;6(6):28-30. doi: 10.1080/15265160600935811.

    OpenUrlCrossRefPubMed
38. 38.↵
    1. Renegar G,
    2. Webster CJ,
    3. Stuerzebecher S,
    4. et al.

    Returning genetic research results to individuals: points-to-consider. Bioethics. 2006 Feb;20(1):24-36. doi: 10.1111/j.1467-8519.2006.00473.x.

    OpenUrlCrossRefPubMedWeb of Science
39. 39.↵
    1. Fernandez CV,
    2. Kodish E,
    3. Weijer C

    . Informing study participants of research results: an ethical imperative. IRB. 2003 May-Jun;25(3):12-19.

    OpenUrlPubMed
40. 40.↵
    1. Fernandez CV,
    2. Skedgel C,
    3. Weijer C

    . Considerations and costs of disclosing study findings to research participants. CMAJ. 2004 Apr 27;170(9):1417-1419. doi: 10.1503/cmaj.1031668.

    OpenUrlFREE Full Text
41. 41.↵
    1. Resnik DB

    . Disclosure of individualized research results: a precautionary approach. Account Res. 2011 Nov;18(6):382-397. doi: 10.1080/08989621.2011.622172.

    OpenUrlCrossRefPubMed
42. 42.
    1. Blasimme A,
    2. Moret C,
    3. Hurst SA,
    4. Vayena E

    . Informed consent and the disclosure of clinical results to research participants. Am J Bioeth. 2017 July;17(7):58-60. doi: 10.1080/15265161.2017.1328532.

    OpenUrlCrossRef
43. 43.↵
    1. McGuire AL,
    2. Lupski JR

    . Personal genome research: what should the participant be told? Trends Genet. 2010 May;26(5):199-201. doi: 10.1016/j.tig.2009.12.007.

    OpenUrlCrossRefPubMedWeb of Science
44. 44.↵
    1. Partridge AH,
    2. Burstein HJ,
    3. Gelman RS,
    4. Marcom PK,
    5. Winer EP

    . Do patients participating in clinical trials want to know study results? J Natl Cancer Inst. 2003 Mar 19;95(6):491-492. doi: 10.1093/jnci/95.6.491.

    OpenUrlCrossRefPubMedWeb of Science
45. 45.
    1. Fernandez CV,
    2. Taweel S,
    3. Kodish ED,
    4. Weijer C

    . Disclosure of research results to research participants: a pilot study of the needs and attitudes of adolescents and parents. Paediatr Child Health. 2005 Jul;10(6):332-334.

    OpenUrlPubMed
46. 46.
    1. Purvis RS,
    2. Abraham TH,
    3. Long CR,
    4. Stewart MK,
    5. Warmack TS,
    6. McElfish PA

    . Qualitative study of participants’ perceptions and preferences regarding research dissemination. AJOB Empir Bioeth. 2017 Apr-Jun;8(2):69-74. doi: 10.1080/23294515.2017.1310146.

    OpenUrlCrossRef
47. 47.↵
    1. McElfish PA,
    2. Purvis RS,
    3. Long CR

    . Researchers’ experiences with and perceptions of returning results to participants: study protocol. Contemp Clin Trials Commun. 2018 Jun 15;11:95-98. doi: 10.1016/j.conctc.2018.06.005.

    OpenUrlCrossRef
48. 48.↵
    1. Will JF

    . A brief historical and theoretical perspective on patient autonomy and medical decision making: part II: the autonomy model. Chest. 2011 Jun;139(6):1491-1497. doi: 10.1378/chest.11-0516.

    OpenUrlCrossRefPubMed
49. 49.↵
    1. Bergler JH,
    2. Pennington AC,
    3. Metcalfe M,
    4. Freis ED

    . Informed consent: how much does the patient understand? Clin Pharmacol Ther. 1980 Apr;27(4):435-440. doi: 10.1038/clpt.1980.60.

    OpenUrlCrossRefPubMedWeb of Science
50. 50.↵
    1. McGuire AL,
    2. Fisher R,
    3. Cusenza P,
    4. et al.

    Confidentiality, privacy, and security of genetic and genomic test information in electronic health records: points to consider. Genet Med. 2008 July;10(7):495-499.

    OpenUrlCrossRefPubMedWeb of Science
51. 51.↵
    1. Tabor HK,
    2. Stock J,
    3. Brazg T,
    4. et al.

    Informed consent for whole genome sequencing: a qualitative analysis of participant expectations and perceptions of risks, benefits, and harms. Am J Med Genet A. 2012 Jun;158A(6):1310-1319. doi: 10.1002/ajmg.a.35328.

    OpenUrlCrossRefPubMed
52. 52.↵
    1. Pinxten W,
    2. Howard HC

    . Ethical issues raised by whole genome sequencing. Best Pract Res Clin Gastroenterol. 2014 Apr;28(2):269-279. doi: 10.1016/j.bpg.2014.02.004.

    OpenUrlCrossRefPubMed
53. 53.
    1. McGuire AL,
    2. Caulfield T,
    3. Cho MK

    . Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet. 2008 Feb;9(2):152-156. doi: 10.1038/nrg2302.

    OpenUrlCrossRefPubMedWeb of Science
54. 54.↵
    1. Ayuso C,
    2. Millán JM,
    3. Mancheño M,
    4. Dal-Ré R

    . Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process. Eur J Hum Genet. 2013 Oct;21(10):1054-1059. doi: 10.1038/ejhg.2012.297.

    OpenUrlCrossRefPubMed
55. 55.↵
    1. Robinson JO,
    2. Slashinski MJ,
    3. Wang T,
    4. Hilsenbeck SG,
    5. McGuire AL

    . Participants’ recall and understanding of genomic research and large-scale data sharing. J Empir Res Hum Res Ethics. 2013 Oct;8(4):42-52. doi: 10.1525/jer.2013.8.4.42.

    OpenUrlCrossRefPubMed
56. 56.↵
    1. Einstein A

    . Albert Einstein Quotes. BrainyQuote. www.brainyquote.com/quotes/albert_einstein_383803. Accessed February 10, 2019.
57. 57.↵
    ACMG Board of Directors. Points to consider for informed consent for genome/exome sequencing. Genet Med. 2013 Sep;15(9):748-749. doi: 10.1038/gim.2013.94.

    OpenUrlCrossRefPubMed
58. 58.
    1. Bernhardt BA,
    2. Roche MI,
    3. Perry DL,
    4. Scollon SR,
    5. Tomlinson AN,
    6. Skinner D

    . Experiences with obtaining informed consent for genomic sequencing. Am J Med Genet A. 2015 Nov;167A(11):2635-2646. doi: 10.1002/ajmg.a.37256.

    OpenUrlCrossRefPubMed