Subpart A Subcommittee (SAS) Felix Gyi and Daniel Nelson Co-Chairs Presentation to the Secretary’s Advisory Committee on Human Research Protections (SACHRP)

Subpart A Subcommittee(SAS)

Subpart A Subcommittee(SAS)

Felix Gyi and Daniel NelsonFelix Gyi and Daniel Nelson

Co-ChairsCo-Chairs

Presentation to the Secretary’s Advisory Committee on Human Research Protections (SACHRP)

October 29, 2007

Outline of Today’s PresentationOutline of Today’s Presentation

• Subcommittee charge and membership

• Update on prior recommendations

• Recommendations for consideration today• Exemptions• Alternative Models of IRB Review

• Next topics for subcommittee consideration

Charge to the Subcommittee Charge to the Subcommittee • Review and assess

• All provisions of Subpart A of 45 CFR 46• Relevant OHRP guidance documents

• Based on this review and assessment• Develop recommendations for consideration by SACHRP in three categories:

• Interpretation of specific Subpart A provisions• Development of new or modification of existing OHRP guidance• Possible revisions to Subpart A

Based on memo to Subcommittee from E. Prentice, Chair of SACHRP, 1/14/05and subsequent discussion by SACHRP

Charge to the Subcommittee Charge to the Subcommittee

• Goals • Enhance protection of human subjects • Reduce regulatory burdens that do not

contribute to the protection of human subjects

• Promote scientifically and ethically valid researchh

Based on memo to Subcommittee from E. Prentice, Chair of SACHRP, 1/14/05and subsequent discussion by SACHRP

Subcommittee MembershipPast and Present

Subcommittee MembershipPast and Present

• Ricky Bluthenthal, RAND Corporation• Gary Chadwick, University of Rochester• Bruce Gordon, University of Nebraska Medical Center • Felix Gyi,* Chesapeake Research Review, Inc• Isaac Hopkins, Community Research Advocate (UMDNJ) †• Nancy Jones, Wake Forest University NIH• Moira Keane, University of Minnesota• Susan Kornetsky, Children’s Hospital Boston• Gigi McMillan, We Can Pediatric Brain Tumor Network• Daniel Nelson,* University of North Carolina at Chapel Hill• Ernest Prentice, University of Nebraska Medical Center• Thomas Puglisi, PriceWaterhouse Coopers VA• Lorna Rhodes, University of Washington• Ada Sue Selwitz, University of Kentucky• David Strauss, New York State Psychiatric Institute

• SACHRP Members Myron Genel, Patty Marshall, Neil Powe, James Powell, Francine Romero, Samuel Tilden

• With input from ex officio reps of Common Rule agencies

*co-chairs

Isaac (Ike) W. Hopkins, Jr1930-2007

Isaac (Ike) W. Hopkins, Jr1930-2007

“The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy.”

MLK (1963)

Subcommittee MeetingsSubcommittee Meetings• January 18, 2005 via teleconference January 18, 2005 via teleconference

• February 14, 2005 in Alexandria, VAFebruary 14, 2005 in Alexandria, VA

• May 20, 2005 via teleconferenceMay 20, 2005 via teleconference

• July 20-21, 2005 in Alexandria, VAJuly 20-21, 2005 in Alexandria, VA

• October 4, 2005 via teleconferenceOctober 4, 2005 via teleconference

• January 9, 2006 via teleconferenceJanuary 9, 2006 via teleconference

• January 30-31, 2006 in Rockville, MDJanuary 30-31, 2006 in Rockville, MD

• May 11-12, 2006 in Gaithersburg, MDMay 11-12, 2006 in Gaithersburg, MD

• September 11, 2006 via teleconferenceSeptember 11, 2006 via teleconference


• February 15-16, 2007 in Arlington, VA (with retreat)February 15-16, 2007 in Arlington, VA (with retreat)

• March 9, 2007 via teleconferenceMarch 9, 2007 via teleconference

• May 31-June 1, 2007 in Arlington, VA May 31-June 1, 2007 in Arlington, VA

• July 16, 2007 via teleconferenceJuly 16, 2007 via teleconference

• August 16-17, 2007 in Arlington, VAAugust 16-17, 2007 in Arlington, VA


• Supplemented by Working Group calls and e-mailsSupplemented by Working Group calls and e-mails

Finalized RecommendationsFinalized Recommendations

• 1st letter to Secretary Leavitt accepted• Recommendations approved 2005-2006

• Continuing Review• Expedited Review Federal Register notice on 10/26/07

• 2nd letter to Secretary Leavitt accepted• Recommendations approved March 2007

• Required Training• IRB Members, IRB Staff, Institutional Officials, Investigators

• 3rd letter to Secretary Leavitt in preparation• Recommendations approved March & July 2007

• Minimal Risk Analytical framework and examples

Final Report and Final Report and Recommendations Regarding Recommendations Regarding Exemption under Department Exemption under Department of Health and Human Services of Health and Human Services

(HHS) Regulations as (HHS) Regulations as Specified in 45 CFR 46.101(b)Specified in 45 CFR 46.101(b)

Final Report and Final Report and Recommendations Regarding Recommendations Regarding Exemption under Department Exemption under Department of Health and Human Services of Health and Human Services

(HHS) Regulations as (HHS) Regulations as Specified in 45 CFR 46.101(b)Specified in 45 CFR 46.101(b)

Subpart A Subcommittee (SAS) Report and Recommendations to SACHRP

Special Thanks to Subcommittee Working Group on Exemptions

Special Thanks to Subcommittee Working Group on Exemptions

• Ada Sue Selwitz (group leader)• Ricky Bluthenthal• Gary Chadwick• Samuel Tilden

• With technical assistance from… • Edward Bartlett, OHRP• Michael Carome, OHRP• Suzy Fitzpatrick, FDA • Laura Odwazny, OGC/HHS• Ivor Pritchard, OHRP

Input Sought from Common Rule Agencies About Issues with Exemptions

Input Sought from Common Rule Agencies About Issues with Exemptions

• Department of Health and Human Services (OHRP)• Department of Education• National Science Foundation• Agency for Healthcare Research and Quality• Department of Agriculture• Central Intelligence Agency• Health Resources and Services Administration• Department of Veterans Affairs• Environmental Protection Agency• U.S. Agency for International Development

BackgroundBackground

• HHS Regulations:HHS Regulations: The exemption provision The exemption provision included in 45 CFR 46.101(b) is as follows:included in 45 CFR 46.101(b) is as follows:

• Unless otherwise required by department of Unless otherwise required by department of (typo: or)(typo: or) agency heads, research activities in agency heads, research activities in which the only involvement of human subjects which the only involvement of human subjects will be in one or more of the following will be in one or more of the following categories are categories are exempt from this policy.exempt from this policy.• Reminder that “this policy” Reminder that “this policy” 45 CFR 46, 45 CFR 46,

Subpart A Subpart A Common Rule Common Rule

45 CFR 46.101(b)(1)45 CFR 46.101(b)(1)45 CFR 46.101(b)(1)45 CFR 46.101(b)(1)

• Research conducted in established or Research conducted in established or commonly accepted educational settings, commonly accepted educational settings, involving normal educational practices, such involving normal educational practices, such as (i) research on regular and special as (i) research on regular and special education instructional strategies, or (ii) education instructional strategies, or (ii) research on the effectiveness of or the research on the effectiveness of or the comparison among instructional techniques, comparison among instructional techniques, curricula, or classroom management curricula, or classroom management methods.methods.

• Research involving the use of educational tests Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of procedures, interview procedures or observation of public behavior, unless: (i) information obtained is public behavior, unless: (i) information obtained is recorded in such manner that human subjects can be recorded in such manner that human subjects can be identified, directly or through identifiers linked to the identified, directly or through identifiers linked to the subjects; subjects; andand (ii) any disclosure of the human subjects’ (ii) any disclosure of the human subjects’ responses outside the research could reasonably place responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, damaging to the subjects’ financial standing, employability, or reputation.employability, or reputation.


• Research involving the use of educational tests Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of procedures, interview procedures, or observation of public behavior that is not exempt under paragraph public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the without exception that the confidentiality of the personally identifiable information will be maintained personally identifiable information will be maintained throughout the research and thereafter.throughout the research and thereafter.


• Research, involving the collection or study of Research, involving the collection or study of existing data, documents, records, pathological existing data, documents, records, pathological specimens, or diagnostic specimens, if these specimens, or diagnostic specimens, if these sources are publicly available or if the sources are publicly available or if the information is recorded by the investigator in information is recorded by the investigator in such a manner that subjects cannot be such a manner that subjects cannot be identified, directly or through identifiers linked to identified, directly or through identifiers linked to the subjects. the subjects.


• Research and demonstration projects which are Research and demonstration projects which are conducted by or subject to the approval of conducted by or subject to the approval of department or agency heads, and which are department or agency heads, and which are designed to study, evaluate, or otherwise examine: designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits changes in methods or levels of payment for benefits or services under those programs.or services under those programs.


• Taste and food quality evaluation and consumer Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is additives are consumed or (ii) if a food is consumed that contains a food ingredient at or consumed that contains a food ingredient at or below the level and for a use found to be safe, or below the level and for a use found to be safe, or agricultural chemical or environmental agricultural chemical or environmental contaminant at or below the level found to be safe, contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Food and Drug Administration or approved by the Environmental Protection Agency or the by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Food Safety and Inspection Service of the U.S. Department of Agriculture.Department of Agriculture.


OHRP Guidance on Interpretation of the Provisions under 45 CFR 46.101(b)

OHRP Guidance on Interpretation of the Provisions under 45 CFR 46.101(b)

• Four broad categoriesFour broad categories• Formal Guidance DocumentsFormal Guidance Documents• Frequently Asked QuestionsFrequently Asked Questions• E-mail Related CorrespondenceE-mail Related Correspondence• Finding LettersFinding Letters

• See Appendix ASee Appendix A

What is the problem?

What are we trying to fix?

What is the problem?

What are we trying to fix?

Working AssumptionsWorking AssumptionsWorking AssumptionsWorking Assumptions

• Inappropriate interpretation/application of regulatory Inappropriate interpretation/application of regulatory provisions (e.g., expedited or full board review of provisions (e.g., expedited or full board review of exempt research) imposes administrative burden exempt research) imposes administrative burden without adding meaningful human research without adding meaningful human research protectionsprotections

• Practices that do not demonstrably enhance the Practices that do not demonstrably enhance the safe and ethical conduct of research diminish overall safe and ethical conduct of research diminish overall human subject protections human subject protections resource allocation resource allocation

What are we trying to fix?What are we trying to fix?

• In order to effectively and consistently use the exemptions available under 45 CFR 46.101(b), institutions and investigators need guidance on applying the exemption categories. There is considerable confusion within the research community regarding how the categories should be interpreted. The confusion leads to inconsistency in review and can create unnecessary delays in the review process for these low risk studies.

What are we trying to fix?What are we trying to fix?

• OHRP has issued several useful documents and “frequently asked question” responses that clarify how the exemption categories should be applied; however, the guidance issued to date should be consolidated into a single document so that it can easily be accessed by institutional officials, IRB members and researchers.

• Also, there are several critical issues that are not addressed in the current OHRP resource materials, but need to be.

Recommendation #1Recommendation #1

• OHRP should develop a consolidated, OHRP should develop a consolidated, comprehensive guidance document on the comprehensive guidance document on the implementation of the provisions under HHS implementation of the provisions under HHS regulations at 45 CFR 46.101(b) for exemption regulations at 45 CFR 46.101(b) for exemption of research from the requirements of 45 CFR of research from the requirements of 45 CFR 46. The guidance should address both general 46. The guidance should address both general issues impacting the application of the issues impacting the application of the exemption categories and specific guidance for exemption categories and specific guidance for each of the six existing exemption categories. each of the six existing exemption categories.

General Recommendations That Apply to All

Exemption Categories

General Recommendations That Apply to All

Exemption Categories

Recommendation #2Recommendation #2• Relationship between the Exemptions and the Definitions Relationship between the Exemptions and the Definitions

of “Human Subject” and “Research.”of “Human Subject” and “Research.” Institutions and Institutions and investigators are still confused about the decision steps investigators are still confused about the decision steps for determining the applicability of the HHS regulations for determining the applicability of the HHS regulations prior to making exemption determinations. Some prior to making exemption determinations. Some activities that do not meet the regulatory definition of activities that do not meet the regulatory definition of “research” (45 CFR 46.102(d)) or “human subjects” (45 “research” (45 CFR 46.102(d)) or “human subjects” (45 CFR 46.102(f)) are inappropriately reviewed through use CFR 46.102(f)) are inappropriately reviewed through use of the exempt categories. The guidance should clearly of the exempt categories. The guidance should clearly state the sequence and interrelationships between the state the sequence and interrelationships between the definitions of “research” and “human subject” with the definitions of “research” and “human subject” with the exemptions. exemptions.

Recommendation #2 (cont)Recommendation #2 (cont)

• It would also be helpful for OHRP to cross-It would also be helpful for OHRP to cross-reference and incorporate elements from their reference and incorporate elements from their existing “Guidance on Research Involving Coded existing “Guidance on Research Involving Coded Private Information or Biological Specimens” Private Information or Biological Specimens” (dated August 10, 2004), which helps make this (dated August 10, 2004), which helps make this distinction and provides relevant examples.distinction and provides relevant examples.

Level of Risk Generally Determines Level of Review

“Exempt”*

Expedited*

Convened Meeting

Minimal Risk

RISK

*defined by lists in regulations

Recommendation #3Recommendation #3• Relationship between Exemptions and Expedited Relationship between Exemptions and Expedited

Review Categories.Review Categories. The guidance should clearly state The guidance should clearly state the sequence and interrelationships between the the sequence and interrelationships between the exemptions under 45 CFR 46.101(b) and the expedited exemptions under 45 CFR 46.101(b) and the expedited review process, especially when categories of research review process, especially when categories of research activities eligible for exemption and the categories of activities eligible for exemption and the categories of research eligible for review under an expedited review research eligible for review under an expedited review procedure address similar research methods. procedure address similar research methods. Examples should be used including research with focus Examples should be used including research with focus groups, video taping, specimens, etc. These examples groups, video taping, specimens, etc. These examples should compare the exempt and expedited categories should compare the exempt and expedited categories that might apply to the example activity. that might apply to the example activity.

Recommendation #4Recommendation #4• Subpart D LimitationsSubpart D Limitations: The guidance should address : The guidance should address

the limitations placed on the applicability of the the limitations placed on the applicability of the exemption category at 45 CFR 46.101(b)(2) by subpart exemption category at 45 CFR 46.101(b)(2) by subpart D of 45 CFR part 46 for research involving children.D of 45 CFR part 46 for research involving children.

• Furthermore, to assist institutions and researchers, any Furthermore, to assist institutions and researchers, any other federal agencies that have adopted the subpart D other federal agencies that have adopted the subpart D limitations should be listed (e.g., U.S. Departments of limitations should be listed (e.g., U.S. Departments of Education and Homeland Security). In addition, any Education and Homeland Security). In addition, any differences between 45 CFR part 46 and other agency differences between 45 CFR part 46 and other agency regulations should be noted. (e.g., FDA regulations, regulations should be noted. (e.g., FDA regulations, which do not include exemption categories.)which do not include exemption categories.)

Recommendation #5 Recommendation #5 • Institutional Mechanisms for Making the Determination of Exempt Institutional Mechanisms for Making the Determination of Exempt

StatusStatus. It is appropriate for institutions to put in place mechanisms for . It is appropriate for institutions to put in place mechanisms for making determinations that research is exempt from the federal making determinations that research is exempt from the federal regulations. The guidance should retain the current OHRP regulations. The guidance should retain the current OHRP interpretation, which recommends that institutions have policies in place interpretation, which recommends that institutions have policies in place that designate the individual(s) or entity(ies) with the authority to that designate the individual(s) or entity(ies) with the authority to determine whether human subjects research qualifies for exemption determine whether human subjects research qualifies for exemption under HHS regulations at 45 CFR 46.101(b). This individual or entity under HHS regulations at 45 CFR 46.101(b). This individual or entity can be any knowledgeable and appropriately trained person designated can be any knowledgeable and appropriately trained person designated by the institution and does not have to be affiliated with the IRB. The by the institution and does not have to be affiliated with the IRB. The guidance also should reiterate the current OHRP recommendation that guidance also should reiterate the current OHRP recommendation that investigators not be given the authority to make an independent investigators not be given the authority to make an independent determination that their own human subject research is exempt.determination that their own human subject research is exempt.

Recommendation #6Recommendation #6• Application of Regulatory Standards to Exempt Research.Application of Regulatory Standards to Exempt Research. The The

guidance should make it clear that, if research is determined to guidance should make it clear that, if research is determined to be exempt under 45 CFR 46.101(b), the regulatory provisions in be exempt under 45 CFR 46.101(b), the regulatory provisions in the remainder of 45 CFR part 46 the remainder of 45 CFR part 46 do not applydo not apply. Examples of . Examples of regulatory provisions that do not apply if research is certified as regulatory provisions that do not apply if research is certified as exempt include: review by the convened IRB; expedited review; exempt include: review by the convened IRB; expedited review; continuing review; IRB review of informed consent process; and continuing review; IRB review of informed consent process; and IRB review of documentation of informed consent, assent, or IRB review of documentation of informed consent, assent, or parental permission (i.e., consent/permission/assent forms). IRB parental permission (i.e., consent/permission/assent forms). IRB review is not required because these protections are generally review is not required because these protections are generally not warranted for exempt research, weakens the line of not warranted for exempt research, weakens the line of responsibility of investigators, and drains resources from responsibility of investigators, and drains resources from regulation-required activities.regulation-required activities.

Recommendation #7Recommendation #7• Application of Ethical Principles to Exempt Research.Application of Ethical Principles to Exempt Research. Even Even

when research is exempt from regulatory requirements when research is exempt from regulatory requirements under the Common Rule, institutions and investigators still under the Common Rule, institutions and investigators still have an obligation to adhere to the underlying ethical have an obligation to adhere to the underlying ethical principles for research involving human subjects. principles for research involving human subjects. Institutions should refer to the principles described in the Institutions should refer to the principles described in the Belmont Report rather than the regulatory requirements in Belmont Report rather than the regulatory requirements in 45 CFR part 46 in meeting these ethical obligations. 45 CFR part 46 in meeting these ethical obligations. Institutions should assure that exempt research is conducted Institutions should assure that exempt research is conducted to be consistent with these ethical principles. At the same to be consistent with these ethical principles. At the same time, institutions should not unduly burden researchers nor time, institutions should not unduly burden researchers nor unduly hinder these types of research activities. unduly hinder these types of research activities.


• Therefore, the guidance should emphasize that Therefore, the guidance should emphasize that institutions have the responsibility to educate institutions have the responsibility to educate their investigators on the ethical principles in the their investigators on the ethical principles in the Belmont Report. Educational programs should Belmont Report. Educational programs should explain how these ethical principles apply to explain how these ethical principles apply to exempt research. In addition, the guidance exempt research. In addition, the guidance should mention that investigators should apply should mention that investigators should apply standards adopted by their professional standards adopted by their professional discipline. discipline.

Level of Risk Generally Determines Level of Review

“Exempt”*

Expedited*

Convened Meeting

Minimal Risk

RISK

*defined by lists in regulations

Recommendation #8Recommendation #8• Assessment of RiskAssessment of Risk. The 1981 Preamble to 45 CFR part . The 1981 Preamble to 45 CFR part

46 states that an underlying assumption of the exemption 46 states that an underlying assumption of the exemption categories was that the research be of little or no risk (FR categories was that the research be of little or no risk (FR 28007). Although the Common Rule does not specify the 28007). Although the Common Rule does not specify the meaning of “little or no risk,” most institutions interpret this meaning of “little or no risk,” most institutions interpret this to mean “not greater than minimal risk.” Even though the to mean “not greater than minimal risk.” Even though the regulations do not require the institution to assess the risk regulations do not require the institution to assess the risk of proposed exempt research, OHRP should recommend of proposed exempt research, OHRP should recommend in its guidance that research conducted under the exempt in its guidance that research conducted under the exempt categories be determined to be no greater than minimal categories be determined to be no greater than minimal risk. risk.


• OHRP guidance should acknowledge that OHRP guidance should acknowledge that different agencies have different interpretations different agencies have different interpretations and institutions are cautioned to ensure and institutions are cautioned to ensure compliance with those agency interpretations compliance with those agency interpretations when reviewing/conducting studies when reviewing/conducting studies funded/governed by those agencies. funded/governed by those agencies. Specific Specific examples should be included in the guidance, examples should be included in the guidance, such as the Department of Veterans Affairs such as the Department of Veterans Affairs requirement that exemptions be minimal risk. requirement that exemptions be minimal risk. [DELETE][DELETE]

Recommendation #9Recommendation #9• Independent Application of Categories.Independent Application of Categories. One area of One area of

current difficulty in application of the exemption current difficulty in application of the exemption categories occurs when studies that are exempt under categories occurs when studies that are exempt under the category at 45 CFR 46.101(b)(1) use techniques the category at 45 CFR 46.101(b)(1) use techniques such as surveys or interviews that are addressed in the such as surveys or interviews that are addressed in the category at 45 CFR 46.101(b)(2). If an activity satisfies category at 45 CFR 46.101(b)(2). If an activity satisfies the requirements for any one exempt category, it the requirements for any one exempt category, it maymay be deemed exempt. The guidance should include be deemed exempt. The guidance should include examples clarifying this interpretation. examples clarifying this interpretation.

Recommendation #9 (cont)Recommendation #9 (cont)• An example of this issue: A student teacher An example of this issue: A student teacher whowho (delete?) (delete?) designs a designs a

research project to compare teaching strategies employed by two teachers research project to compare teaching strategies employed by two teachers in her practice school and her data collection method is surveys of the in her practice school and her data collection method is surveys of the students and interviews with the teachers. This research might be students and interviews with the teachers. This research might be contrasted with an example where the exemption at 45 CFR 46.101(b)(1) contrasted with an example where the exemption at 45 CFR 46.101(b)(1) could not be used, but another category could be, e.g., a survey study of could not be used, but another category could be, e.g., a survey study of graduate students that asks about drug use behavior. While the survey graduate students that asks about drug use behavior. While the survey may take place in a commonly accepted educational setting, the research may take place in a commonly accepted educational setting, the research topic/activity (the drug use survey) is not a “normal educational practice.” topic/activity (the drug use survey) is not a “normal educational practice.” The guidance should make the point that, just because research happens in The guidance should make the point that, just because research happens in a school, this does not make it automatically exempt. Conversely, a school, this does not make it automatically exempt. Conversely, research that is exempt under a category other than 45 CFR 46.101(b)(1) research that is exempt under a category other than 45 CFR 46.101(b)(1) can be conducted in educational settings even if they do not study can be conducted in educational settings even if they do not study educational practices.educational practices.


• Another example of this issue: Student teachers are Another example of this issue: Student teachers are often trained by observing classroom activities, often trained by observing classroom activities, participating in activities, or a combination of the two. A participating in activities, or a combination of the two. A research study using observations/ratings of skill levels at research study using observations/ratings of skill levels at points in the training of student teachers who are learning points in the training of student teachers who are learning with the different methods could be designed. The with the different methods could be designed. The guidance should address the following questions: How do guidance should address the following questions: How do the exemptions at 45 CFR 46.101(b)(1) and (2) interface the exemptions at 45 CFR 46.101(b)(1) and (2) interface in this example? What if the observation includes an in this example? What if the observation includes an assessment of stress levels (student teachers and assessment of stress levels (student teachers and children)? What if surveys or interviews are used?children)? What if surveys or interviews are used?


• Vulnerable PopulationsVulnerable Populations. Many institutions are hesitant to allow . Many institutions are hesitant to allow exemptions if a study population is “sensitive.” These groups, exemptions if a study population is “sensitive.” These groups, which may be more “at risk” because of the research, are often which may be more “at risk” because of the research, are often referred to as “vulnerable” by investigators and even IRBs. In referred to as “vulnerable” by investigators and even IRBs. In the guidance on exemptions and appropriate other new OHRP the guidance on exemptions and appropriate other new OHRP guidance, it should be emphasized that just because the guidance, it should be emphasized that just because the research or the data is “sensitive” or the population may be research or the data is “sensitive” or the population may be adversely affected by the research, that does not automatically adversely affected by the research, that does not automatically equate to research with “vulnerable populations;” nor does it equate to research with “vulnerable populations;” nor does it automatically remove the activity from consideration for an automatically remove the activity from consideration for an exemption. exemption.

Recommendation #11Recommendation #11• Removal of Subpart C Limitations.Removal of Subpart C Limitations. Many research Many research

opportunities afforded to general populations should be opportunities afforded to general populations should be available to prisoners; therefore, permitting the application available to prisoners; therefore, permitting the application of the exemptions to research involving prisoners should be of the exemptions to research involving prisoners should be part of the redrafting of the HHS regulations at Subpart C of part of the redrafting of the HHS regulations at Subpart C of 45 CFR part 46, especially when the current provision 45 CFR part 46, especially when the current provision under 45 CFR 306(b) is considered. The language in the under 45 CFR 306(b) is considered. The language in the restrictive footnote to 45 CFR 46.101(b) regarding the restrictive footnote to 45 CFR 46.101(b) regarding the prohibition against applying the exemptions to research prohibition against applying the exemptions to research involving prisoners should also be removed. involving prisoners should also be removed.

Recommendations That Apply to Specific Exemption Categories

Recommendations That Apply to Specific Exemption Categories

Exemption CategoryExemption Category

• 101(b)(1) Research conducted in established or 101(b)(1) Research conducted in established or commonly accepted educational settings, involving commonly accepted educational settings, involving normal educational practices, such as (i) research on normal educational practices, such as (i) research on regular and special education instructional strategies, or regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom among instructional techniques, curricula, or classroom management methods.management methods.


Clarification of Terms.Clarification of Terms. The terms The terms “established” and “commonly accepted “established” and “commonly accepted education settings” and “normal education settings” and “normal educational practices” need clarification.educational practices” need clarification.

Recommendation #12 (cont)Recommendation #12 (cont)• The guidance should include the current OHRP interpretation of The guidance should include the current OHRP interpretation of

the terms “established” and “commonly accepted educational the terms “established” and “commonly accepted educational setting” as including nontraditional settings such as a grocery store setting” as including nontraditional settings such as a grocery store (e.g., nutrition class), a pharmacy, or automotive garage (e.g., safe (e.g., nutrition class), a pharmacy, or automotive garage (e.g., safe driving or how to do preventative maintenance on a car), as long driving or how to do preventative maintenance on a car), as long as the educational setting is established in the local area. The as the educational setting is established in the local area. The OHRP guidance clarification should include additional examples to OHRP guidance clarification should include additional examples to clarify what a “commonly accepted” educational setting is such as: clarify what a “commonly accepted” educational setting is such as: evaluation of resident training; hospital grand rounds; professional evaluation of resident training; hospital grand rounds; professional conferences; home school; land-grant extension agents providing conferences; home school; land-grant extension agents providing training in the farm setting. Examples are also needed to clarify training in the farm setting. Examples are also needed to clarify what qualifies as an “established setting.” what qualifies as an “established setting.”


• The guidance clarification/examples should also The guidance clarification/examples should also address international and cultural differences. address international and cultural differences. For example, if the educational practice is For example, if the educational practice is commonly accepted in a specific population commonly accepted in a specific population such as Amish or Native Americans, it should be such as Amish or Native Americans, it should be considered “commonly accepted” for research considered “commonly accepted” for research within that population.within that population.


• The guidance also should provide the current OHRP The guidance also should provide the current OHRP interpretation of “normal educational practices” as not being interpretation of “normal educational practices” as not being restricted to only traditional settings, but may include such restricted to only traditional settings, but may include such practices as computerized training, the use of a kiosk to practices as computerized training, the use of a kiosk to provide education, or using a software program to study the provide education, or using a software program to study the education of non-English speaking students on learning education of non-English speaking students on learning English. The guidance should expand upon the definition English. The guidance should expand upon the definition with some additional examples and should clarify that with some additional examples and should clarify that determining whether the research uses “normal educational determining whether the research uses “normal educational practices” is distinct from the determination whether the practices” is distinct from the determination whether the setting is “established” or “commonly accepted.”setting is “established” or “commonly accepted.”

Recommendation #13Recommendation #13• Other Examples.Other Examples. Additional examples could be added to the guidance Additional examples could be added to the guidance

to clarify whether “action research” (also called “community-based to clarify whether “action research” (also called “community-based participatory research”) fits under this category. These types of participatory research”) fits under this category. These types of activities usually are designed to contribute to generalizable activities usually are designed to contribute to generalizable knowledge; however, the design of the study plan (protocol) does not knowledge; however, the design of the study plan (protocol) does not follow the “traditional” model. The study plan develops as part of the follow the “traditional” model. The study plan develops as part of the interaction with the community/subjects. One major issue with this interaction with the community/subjects. One major issue with this type of research is whether consent needs to be obtained. The type of research is whether consent needs to be obtained. The guidance should use examples to illustrate when actions or guidance should use examples to illustrate when actions or community-based participating activities do not meet the definition of community-based participating activities do not meet the definition of research, fit under this exemption category or another category, or are research, fit under this exemption category or another category, or are eligible for IRB review under an expedited review procedure.eligible for IRB review under an expedited review procedure.


• Other Agency Rules.Other Agency Rules. OHRP guidance OHRP guidance should note if this exemption does not should note if this exemption does not apply to research regulated by other apply to research regulated by other agencies.agencies.

Exemption CategoryExemption Category• 101(b)(2) Research involving the use of educational 101(b)(2) Research involving the use of educational

tests (cognitive, diagnostic, aptitude, achievement), tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or survey procedures, interview procedures or observation of public behavior, unless: (i) information observation of public behavior, unless: (i) information obtained is recorded in such manner that human obtained is recorded in such manner that human subjects can be identified, directly or through identifiers subjects can be identified, directly or through identifiers linked to the subjects; linked to the subjects; andand (ii) any disclosure of the (ii) any disclosure of the human subjects’ responses outside the research could human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial liability or be damaging to the subjects’ financial standing, employability, or reputation.standing, employability, or reputation.


• Examples NeededExamples Needed. The guidance should . The guidance should provide examples of each of the types of provide examples of each of the types of activities included in this exemption: activities included in this exemption: educational tests; survey procedures; educational tests; survey procedures; interview procedures; observation of public interview procedures; observation of public behavior. behavior.

Recommendation #15 (cont)Recommendation #15 (cont)• The guidance should include the current OHRP The guidance should include the current OHRP

interpretation of “public behavior” as being behavior interpretation of “public behavior” as being behavior generally open to view by any member of a community generally open to view by any member of a community and/or which would not involve any special permission to and/or which would not involve any special permission to observe, such as, at a park, in a mall, at a movie theater, observe, such as, at a park, in a mall, at a movie theater, etc. The guidance also should provide the OHRP etc. The guidance also should provide the OHRP interpretation that what occurs in a classroom would not interpretation that what occurs in a classroom would not generally be considered observation of public behavior. generally be considered observation of public behavior. Consistency across agencies is essential to effective Consistency across agencies is essential to effective regulatory compliance, and OHRP guidance should resolve regulatory compliance, and OHRP guidance should resolve or explain any interdepartmental differences in interpretation or explain any interdepartmental differences in interpretation of the applicability of the exemption at 45 CFR 46.101(b)(2). of the applicability of the exemption at 45 CFR 46.101(b)(2).


• Including examples and clarification in the Including examples and clarification in the guidance about research methods that are not guidance about research methods that are not specifically listed in the exemption regulations, specifically listed in the exemption regulations, but that may qualify for exemption, would also but that may qualify for exemption, would also be useful. OHRP guidance should use be useful. OHRP guidance should use examples to show how a research method fits examples to show how a research method fits into this category or when it does not meet the into this category or when it does not meet the definition of research. These methods include: definition of research. These methods include: focus groups; ethnography; oral history.focus groups; ethnography; oral history.


• OHRP should revise its current interpretation to OHRP should revise its current interpretation to indicate that, for non-HIPAA regulated research, indicate that, for non-HIPAA regulated research, audiotape information alone does not, based solely on audiotape information alone does not, based solely on the medium, constitute private identifiable information. the medium, constitute private identifiable information. That is, it should not be automatically presumed that That is, it should not be automatically presumed that audiotapes are individually identifiable, as many are audiotapes are individually identifiable, as many are not. On the other hand, there may still be times when not. On the other hand, there may still be times when audiotapes are identifiable, depending on the audiotapes are identifiable, depending on the circumstances (e.g., limited sample size, unique voice circumstances (e.g., limited sample size, unique voice characteristics, recognizable participants). characteristics, recognizable participants).


• The guidance should include examples The guidance should include examples illustrating what “through identifiers linked to the illustrating what “through identifiers linked to the subject” means. Examples would also be useful subject” means. Examples would also be useful to illustrate what “readily ascertained” means and to illustrate what “readily ascertained” means and expand upon contextual considerations that may expand upon contextual considerations that may be relevant to ascertaining identity. be relevant to ascertaining identity.

• Examples should be included in the guidance Examples should be included in the guidance that illustrate when research activities could “be that illustrate when research activities could “be damaging to the subjects’ reputation.”damaging to the subjects’ reputation.”


• Clarification Needed.Clarification Needed. The guidance The guidance should emphasize the use of the should emphasize the use of the conjunction “and” in the wording of the conjunction “and” in the wording of the exception to this exempt category and exception to this exempt category and provide examples outlining when this provide examples outlining when this exception is and is not applicable. exception is and is not applicable.


• Risk Determination.Risk Determination. The guidance The guidance should clarify that the nature of the should clarify that the nature of the survey or interview questions impacts survey or interview questions impacts the applicability of this category. the applicability of this category. Examples of activities with greater than Examples of activities with greater than minimal risk should be used to show minimal risk should be used to show when the exemption should not apply.when the exemption should not apply.


• Regulatory LimitationsRegulatory Limitations. Subpart D . Subpart D limitations would be discussed in the limitations would be discussed in the general section but, for emphasis, should general section but, for emphasis, should be referred to under this heading also. be referred to under this heading also. OHRP should give specific examples of OHRP should give specific examples of agencies that did not adopt exemptions agencies that did not adopt exemptions for children (e.g., FDA).for children (e.g., FDA).


• 101(b)(3) Research involving the use of educational 101(b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or survey procedures, interview procedures, or observation of public behavior that is not exempt under observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of require(s) without exception that the confidentiality of the personally identifiable information will be the personally identifiable information will be maintained throughout the research and thereafter.maintained throughout the research and thereafter.


• Examples neededExamples needed. The guidance should include . The guidance should include examples of “public officials.” In particular, the examples of “public officials.” In particular, the guidance should include examples that OHRP has guidance should include examples that OHRP has provided in the past, provided in the past, such assuch as (clarifying that)(clarifying that) university faculty, public school teachers, and police university faculty, public school teachers, and police officers in general are not considered to be elected officers in general are not considered to be elected or appointed public officials, whereas mayors, or appointed public officials, whereas mayors, governors, school superintendents, school board governors, school superintendents, school board members, and police chiefs are considered to be members, and police chiefs are considered to be elected or appointed public officials. elected or appointed public officials.


• List Statutes.List Statutes. The guidance should The guidance should specifically list examples of federal specifically list examples of federal statutes that meet the criteria outlined in statutes that meet the criteria outlined in (ii). The guidance needs to clarify that (ii). The guidance needs to clarify that this category does not apply to state law. this category does not apply to state law.

Recommendation # 21Recommendation # 21

• Other AgenciesOther Agencies. OHRP should point out . OHRP should point out whether this exemption applies to research whether this exemption applies to research regulated by other federal agencies.regulated by other federal agencies.


• 101(b)(4) Research, involving the 101(b)(4) Research, involving the collection or study of existing data, collection or study of existing data, documents, records, pathological documents, records, pathological specimens, or diagnostic specimens, if specimens, or diagnostic specimens, if these sources are publicly available or if these sources are publicly available or if the information is recorded by the the information is recorded by the investigator in such a manner that subjects investigator in such a manner that subjects cannot be identified, directly or through cannot be identified, directly or through identifiers linked to the subjects. identifiers linked to the subjects.


• Examples/ClarificationExamples/Clarification. The guidance . The guidance should provide clarification with should provide clarification with corresponding examples that address the corresponding examples that address the following terms:following terms:


• ““Existing”: The guidance should retain the current OHRP Existing”: The guidance should retain the current OHRP interpretation on what constitutes “existing” data, etc. interpretation on what constitutes “existing” data, etc. The guidance should include a clarification that the The guidance should include a clarification that the definition of “existing” is dependent upon when the study definition of “existing” is dependent upon when the study is reviewed/approved by the institution. The rationale for is reviewed/approved by the institution. The rationale for OHRP’s long-standing interpretation of the meaning of OHRP’s long-standing interpretation of the meaning of “existing,” which was articulated in the 1993 IRB “existing,” which was articulated in the 1993 IRB Guidebook, should be included in the updated guidance. Guidebook, should be included in the updated guidance. The guidance should specifically state that data obtained The guidance should specifically state that data obtained prospectively does not qualify for exempt review.prospectively does not qualify for exempt review.


• ““Publicly available”: The guidance should provide Publicly available”: The guidance should provide examples and discussion regarding what constitutes examples and discussion regarding what constitutes publicly available data (e.g., telephone directories). For publicly available data (e.g., telephone directories). For example, do discussions in on-line blogs or internet sites example, do discussions in on-line blogs or internet sites (i.e., Myspace, Facebook or other networking sites) meet (i.e., Myspace, Facebook or other networking sites) meet the publicly available criterion? The guidance should cite the publicly available criterion? The guidance should cite examples of data that are examples of data that are notnot publicly available, publicly available, especially providing examples that are not publicly especially providing examples that are not publicly available due to federal legislation (e.g., student records available due to federal legislation (e.g., student records and the Family Educational Rights and Privacy Act).and the Family Educational Rights and Privacy Act).


• ““Recorded”: The guidance should clarify Recorded”: The guidance should clarify that a researcher can view identifiers, but that a researcher can view identifiers, but if the identifiers are not recorded in the if the identifiers are not recorded in the research data/records, the study may still research data/records, the study may still be exempt. The guidance also should be exempt. The guidance also should address overlaps and inconsistencies address overlaps and inconsistencies between the HIPAA Privacy Rule and 45 between the HIPAA Privacy Rule and 45 CFR part 46.CFR part 46.


• ““Cannot be identified directly or through identifiers Cannot be identified directly or through identifiers linked to the subjects”: The guidance should linked to the subjects”: The guidance should include examples of direct and indirect links such include examples of direct and indirect links such as hospital numbers, codes, or links that tie dates as hospital numbers, codes, or links that tie dates back to the list of subject. One helpful example back to the list of subject. One helpful example that OHRP has used in the past is that exemption that OHRP has used in the past is that exemption category 45 CFR 46.101(b)(4) applies to a category 45 CFR 46.101(b)(4) applies to a retrospective chart review where the researcher retrospective chart review where the researcher records the dates of medical procedures, unless records the dates of medical procedures, unless the dates of medical procedures would allow the dates of medical procedures would allow investigators to identify subjects.investigators to identify subjects.


• SequencingSequencing. Reference should be made in . Reference should be made in the guidance to the sequence of the guidance to the sequence of determinations addressed under determinations addressed under Recommendation 2 above (i.e., definition of Recommendation 2 above (i.e., definition of human subject, the exemption at 101 (b)human subject, the exemption at 101 (b)(4), and the applicability of the expedited (4), and the applicability of the expedited review categories).review categories).


• Other Agencies.Other Agencies. OHRP should point out OHRP should point out whether this exemption applies to research whether this exemption applies to research regulated by other federal agencies. regulated by other federal agencies.


• 101(b)(5) Research and demonstration projects which 101(b)(5) Research and demonstration projects which are conducted by or subject to the approval of are conducted by or subject to the approval of department or agency heads, and which are designed to department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible benefits or services under those programs; (iii) possible changes in or alternatives to those programs or changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those levels of payment for benefits or services under those programs.programs.

Background for Recommendations on Exemption Category 101(b)(5)


• OHRP has issued a guidance document OHRP has issued a guidance document on this exemption entitled “Exemption for on this exemption entitled “Exemption for Research and Demonstration Projects on Research and Demonstration Projects on Public Benefit and Service Programs.” It Public Benefit and Service Programs.” It states that unless the following criteria states that unless the following criteria are met, the exemption cannot be are met, the exemption cannot be invoked: invoked:



1.1. The program under study must deliver a public benefit (e.g., The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).services as provided under the Older Americans Act).

2.2. The research or demonstration project must be conducted The research or demonstration project must be conducted pursuant to specific pursuant to specific federalfederal statutory authority. statutory authority.

3.3. There must be no statutory requirement that the project be There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).reviewed by an Institutional Review Board (IRB).

4.4. The project must not involve significant physical invasions The project must not involve significant physical invasions or significant intrusions upon the privacy of participants.or significant intrusions upon the privacy of participants.


• Definition of “Significant.”Definition of “Significant.” When developing When developing new guidance, criterion (4) above should be new guidance, criterion (4) above should be deleted, because the foregoing deleted, because the foregoing recommendation stipulating “not greater than recommendation stipulating “not greater than minimal risk” makes this a moot point.minimal risk” makes this a moot point.

Recommendation #26Recommendation #26• Federal and state.Federal and state. Criterion (2) above is interpreted too Criterion (2) above is interpreted too

narrowly and institutions should be able to apply this narrowly and institutions should be able to apply this exemption to public programs supported by state exemption to public programs supported by state departments and agencies as well as federally supported departments and agencies as well as federally supported public programs. OHRP has explained that the broadening public programs. OHRP has explained that the broadening of the exemption is not possible within the constraints of the of the exemption is not possible within the constraints of the current regulations. When developing new guidance, OHRP current regulations. When developing new guidance, OHRP should broaden its interpretation to include using the should broaden its interpretation to include using the exemption for activities that involve federal flow-through exemption for activities that involve federal flow-through monies to the state public benefit programs. Note that it monies to the state public benefit programs. Note that it would need to be made clear that state university research would need to be made clear that state university research did not fit under an expanded exemption.did not fit under an expanded exemption.


• Federal versus state.Federal versus state. If it is not possible to If it is not possible to broaden the interpretation of this exemption broaden the interpretation of this exemption category, the guidance should specifically category, the guidance should specifically indicate that state programs do not fit under this indicate that state programs do not fit under this category and list the federal programs with the category and list the federal programs with the statutory authority to fit in the category.statutory authority to fit in the category.


• 101(b)(6) Taste and food quality evaluation and 101(b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug level found to be safe, by the Food and Drug Administration or approved by the Environmental Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.Service of the U.S. Department of Agriculture.

Recommendation #28Recommendation #28• Clarification needed.Clarification needed. This category is used This category is used

inconsistently, and sometimes inappropriately, by the inconsistently, and sometimes inappropriately, by the research community because it is not understood by research community because it is not understood by institutions or researchers. The guidance should institutions or researchers. The guidance should indicate that the category addresses two different types indicate that the category addresses two different types of research activity. Then each type of activity should of research activity. Then each type of activity should be discussed in detail providing explanations regarding be discussed in detail providing explanations regarding when this category can be used, delineating any when this category can be used, delineating any corresponding regulations that apply, and discussing corresponding regulations that apply, and discussing examples of studies that fit within the category.examples of studies that fit within the category.


• Consistent application of exemption categories.Consistent application of exemption categories. The The Secretary of HHS, acting in consultation with the Secretary Secretary of HHS, acting in consultation with the Secretary of Education, should convene an interagency working of Education, should convene an interagency working group to draft a joint guidance document on the group to draft a joint guidance document on the relationship between the Federal Policy for the Protection relationship between the Federal Policy for the Protection of Human Subjects (the “Common Rule”), the Family of Human Subjects (the “Common Rule”), the Family Education and Rights Privacy Act, and the Protection of Education and Rights Privacy Act, and the Protection of Pupil Rights Amendment. This workgroup should also Pupil Rights Amendment. This workgroup should also address any differences in interpretations of the exemption address any differences in interpretations of the exemption requirements (e.g., definitions of educational settings, requirements (e.g., definitions of educational settings, whether classroom activities are publicly available, etc.).whether classroom activities are publicly available, etc.).

Recommendations in

Other Areas

Recommendations in

Other Areas

Alternative Models of IRB Review

Alternative Models of IRB Review

• OHRP workshop in November 2005

• National conference in November 2006– Report now available via AAMC website

• SACHRP asked Subpart A Subcommittee to consider report and future directions

Recommendations Relating to Alternative Models of IRB Review


• SACHRP supports the efforts of the planning group for recent national conferences and initiatives (including representatives of OHRP, NIH, AAMC, ASCO, VA and others) to keep the topic of alternative IRB models before the research community.

• SACHRP endorses the consideration and utilization of collaborative IRB models, appropriate to the circumstances of a given research scenario.



• OHRP should continue its efforts to develop guidance on IRB models.• This guidance should include a sample “toolkit”

(including SOPs and model agreements) for use by institutions that are considering review models other than review by the local IRB.

• SACHRP requests the HHS Secretary to encourage the NIH Director to explore more widespread use of collaborative IRB models, including expanded use of Centralized IRBs (CIRBs) for NIH-sponsored research.

WHAT NEXT?

Topics for Consideration by

Subpart ASubcommittee

WHAT NEXT?

Topics for Consideration by

Subpart ASubcommittee

Topics for Consideration by SASTopics for Consideration by SAS

Continuing review Expedited review

• Minor changes to previously approved research• Contingencies from convened IRB review

Training and Education Minimal Risk• IRB membership issues

• Number, Diversity, Expertise, Qualifications• Community (unaffiliated) representation• Member conflicts of interest• Quorum, Alternates• “Scientist” and “non-scientist”

Identified at inaugural on-site meeting, subsequently expanded and refined

Topics (continued)Topics (continued)• Assurances

• “Engaged in research”• Off-site research in nontraditional settings

• Multi-site research• Cooperative review mechanisms• Barriers to use of alternative models

• Recordkeeping and reporting• Investigator responsibilities• Informed consent

Waivers and alterations• Content• Documentation

•Alternatives to 30 page consent forms


Topics (continued)Topics (continued)• Exemptions

• Funding agency interpretations• IRB review of exceptions and deviations• Vulnerable populations

• Definition of “vulnerable”• What makes a population or individual

vulnerable?• What are adequate safeguards?• Informed consent in vulnerable populations• Legally authorized representatives• Decisionally-impaired NEW SUBCOMMITTEE


Topics (continued)Topics (continued)

• Definitions (…see all the above!)•“Research”•“Human Subject”

• OHRP is developing draft guidance

• NOT on the list as discrete topic…• Adverse event reporting

What Next? Selected Topics for Consideration

What Next? Selected Topics for Consideration

• In 2007 SAS formed Working Groups in the following areas…

• Exemptions• Informed Consent• Institutional Responsibilities

Informed ConsentInformed Consent Waiver of consent • Documentation of consent

• Waiver of documentation • Delinking 46.116 and 46.117• Use of the Short Form• Use of addenda• Readability• Overly lengthy/complex consent documents

• AAMC initiative to simplify and shorten consent documents

• Liability and consent• Testing for comprehension?• What do subjects want?• Consent in international settings• Coordination with SIIIDR

• Assurances

• Engagement in Research

• Institutional Official (IO) Responsibilities

• Multi-site studies

Institutional ResponsibilitiesInstitutional Responsibilities

AssurancesAssurances

• Identifying legal components• Who is covered (who is an agent)?• FWA filing requirements• Reading/understanding the Terms of Assurance• Authorized signatures• Easier to use but more room for confusion

• e.g., IRBs cited without their knowledge • Communications with institutions

• Institutional models are growing and evolving• Often no longer single chair as point of contact

AssurancesAssurances• Modifying the FWA for single study or limited

relationships• Many don’t know this is required• Those that do know, find problematic

• Frequent tinkering with high-level documents• Potentially 100s of IRBs listed for collaborative

institutions• Updating rosters• Use of external agreements

• IRB Authorization Agreement (IAA)• Individual Investigator Agreement (IIA)

• Why are institutions “unchecking the box?”• Is this healthy for the research enterprise?

Engagement in ResearchEngagement in Research

• Revised OHRP guidance• Must determine if something is human subjects research (HSR)

first before determining engagement• Tendency to reverse this order

• What happens when Principal Investigator (PI) leaves one institution and joins another in the middle of a study? How can duplicate, repetitive, and “too late” processes be avoided? What if the PI is at the data analysis stage?

• Variable understanding by funding agencies and within agencies• Applies to many policies and interpretations

• Requirements for additional assurances by common rule agencies catch some institutions off guard

Engagement in ResearchEngagement in Research

• Are there exceptions to direct awardees being considered engaged?

• Performing a commercial service vs. engaged in research?• Institutions outside the research sites administer study

intervention or draw bloods, etc.• Use of an institution’s facilities vs employees/agents

conducting research.• Confusion with OHRP’s guidance on research using coded

specimens or information • Are institutions engaged when employees or agents receive/use

coded private information or specimens?

Institutional Official (IO) ResponsibilitiesInstitutional Official (IO) Responsibilities

• Resources and support are needed for all components of the human resource protection program (HRPP)

• Walking the fine line Support without interference in IRB decisions• Periodic reminders from OHRP directed to IOs?

• Reinforce importance of role• OHRP initiatives to reach IOs are very useful and should be endorsed so

they continue• Conflict of Interest (COI)

• Policies and mechanisms required for investigators, IRBs, and the Institution

• Data security and its implications for confidentiality• Attention to IRB “mission creep”

• Clarify true responsibilities of IRB and limit “dumping”• Identifying, recruiting, rewarding, recognizing IRB member service

• Conversely, avoid disincentives• Checklist of IO responsibilities

Multi-site ResearchMulti-site Research

• Models of IRB review 2006 conference report • How to remove barriers to cooperative review?

• Liability concerns• How to allocate responsibilities?

• Local accountability • VA points to consider

Stay tuned... Don’t touch that dial… There is much more to come from SAS

Stay tuned... Don’t touch that dial… There is much more to come from SAS